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fosaprepitant

30/06/10

Generic Name: fosaprepitant (FOS a PREP i tan t)
Brand Names: Emend for Injection

What is fosaprepitant?

Fosaprepitant blocks the actions of chemicals in the body that trigger nausea and vomiting.

Fosaprepitant is used together with other medications to prevent nausea and vomiting that may be caused by cancer chemotherapy.

Fosaprepitant is given ahead of time and will not treat nausea or vomiting that you already have.

Fosaprepitant may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fosaprepitant?

You should not receive fosaprepitant if you are taking cisapride (Propulsid) or pimozide (Orap). These drugs may cause life-threatening interactions when taken together with fosaprepitant. Before you receive fosaprepitant, tell your doctor if you have liver disease. You may need a dose adjustment or special tests to safely use this medication. Fosaprepitant can make birth control pills less effective, resulting in pregnancy. This effect can last for up to 28 days after your last dose of this medication. Talk to your doctor about the use of a non-hormonal back-up form of birth control (such as condoms, a diaphragm, or spermicides) during treatment with fosaprepitant, and for 1 month afterward.

There are many other medicines that can interact with fosaprepitant. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my health care provider before I receive fosaprepitant?

You should not use this medication if you are allergic to fosaprepitant, aprepitant (oral Emend), or if you are taking any of the following drugs:

cisapride (Propulsid); or
pimozide (Orap).

The drugs listed above may cause life-threatening interactions when taken together with fosaprepitant.

Before you receive fosaprepitant, tell your doctor if you have liver disease. You may need a dose adjustment or special tests to safely use this medication. FDA pregnancy category B. Fosaprepitant is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while you are being treated with fosaprepitant. It is not known whether fosaprepitant passes into breast milk or if it could harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

How is fosaprepitant given?

Fosaprepitant is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or cancer treatment center. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

The first dose of fosaprepitant is usually given 30 minutes before your chemotherapy treatment begins.

You may also be given other medicines, including oral Emend (aprepitant capsules), for 3 or 4 days to further help prevent nausea and vomiting.

Fosaprepitant is not for long-term use.

What happens if I miss a dose?

Since fosaprepitant injection is given only once on the first day of your chemotherapy treatment, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of this medication is not likely to occur since it is given by a healthcare professional. However, overdose symptoms may include drowsiness and headache.

What should I avoid while receiving fosaprepitant?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are being treated with fosaprepitant.

Fosaprepitant side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

feeling light-headed, fainting;
slow heart rate;
pale skin, easy bruising or bleeding; or
pain or burning when you urinate.

Less serious side effects may include:

nausea, vomiting, heartburn, stomach pain;
diarrhea or constipation;
loss of appetite;
hiccups;
increased thirst or hot, dry skin;
weakness, dizziness, tired feeling;
headache;
ringing in your ears;
fever, chills, body aches, flu symptoms;
sleep problems (insomnia); or
pain or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fosaprepitant Dosing Information

Usual Adult Dose for Nausea/Vomiting — Chemotherapy Induced:

Fosaprepitant for injection is a prodrug of aprepitant to be administered intravenously as an infusion. Aprepitant is available in capsule form for oral administration. Fosaprepitant for injection (115 mg) may be substituted for aprepitant (125 mg) 30 minutes prior to chemotherapy, on day 1 only of the Chemotherapy-Induced Nausea and Vomiting (CINV) regimen as an infusion administered over 15 minutes.

Initial dose of aprepitant as a part of the CINV regimen:
125 mg orally one hour prior to chemotherapy on day 1. This dose can be substituted with fosaprepitant for injection (115 mg) administered intravenously as an infusion 30 minutes prior to chemotherapy.

The first dose is then followed by aprepitant 80 mg orally once daily in the morning on days 2 and 3.

Doses may be taken with or without food.

Aprepitant/fosaprepitant are administered for 3 days as part of a regimen that also includes a corticosteroid and a 5-HT3 antagonist.

The antiemetic effectiveness in patients receiving the aprepitant regimen throughout repeated cycles has been reported to be maintained in each of the multiple cycles. However, chronic continuous dosing is not recommended.

Usual Geriatric Dose for Nausea/Vomiting — Chemotherapy Induced:

No dosage adjustment is necessary for the elderly.

What other drugs will affect fosaprepitant?

Fosaprepitant can make birth control pills less effective, resulting in pregnancy. This effect can last for up to 28 days after your last dose of this medication. Talk to your doctor about the use of a non-hormonal back-up form of birth control (such as condoms, a diaphragm, or spermicides) during treatment with fosaprepitant and for at least 1 month after your treatment ends.

Before taking fosaprepitant, tell your doctor if you are using any of the following drugs:

diltiazem (Cardizem, Cartia, Tiazac);
tolbutamide (Orinase);
a blood thinner such as warfarin (Coumadin);
midazolam (Versed) or similar medicines such as Valium, Xanax, or Tranxene;
an antidepressant such as nefazodone (Serzone) or paroxetine (Paxil);
an antibiotic such as clarithromycin (Biaxin) or rifampin (Rifater, Rifamate);
an antifungal medication such as itraconazole (Sporanox), or ketoconazole (Nizoral);
certain cancer medicines such as etoposide (VePesid), irinotecan (Camptosar), ifosfamide (Ifex), imatinib (Gleevec), paclitaxel (Onxol, Taxol), vinblastine (Velban), or vincristine (Oncovin, Vincasar);
HIV medicines such as nelfinavir (Viracept), lopinavir/ritonavir (Kaletra), or ritonavir (Norvir);
seizure medication such as carbamazepine (Tegretol, Carbatrol) or phenytoin (Dilantin); or
steroid medicine such as dexamethasone (Decadron, Hexadrol) or methylprednisolone (Medapred, Solu-Medrol).

This list is not complete and there may be other drugs that can interact with fosaprepitant. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about fosaprepitant.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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fosaprepitant (Intravenous route)

30/06/10

fos-ap-RE-pi-tant

Commonly used brand name(s):

In the U.S.

Emend

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Neurokinin-1 Receptor Antagonist

Uses For fosaprepitant

Fosaprepitant is used with other medicines to prevent nausea and vomiting that may occur during cancer treatment (chemotherapy) .

fosaprepitant is available only with your doctor’s prescription .

Before Using fosaprepitant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fosaprepitant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fosaprepitant or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fosaprepitant in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fosaprepitant in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using fosaprepitant with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Astemizole
Cisapride
Pimozide
Terfenadine

Using fosaprepitant with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Etoposide
Ifosfamide
Imatinib
Irinotecan
Paclitaxel
Vinblastine
Vincristine

Using fosaprepitant with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam
Dexamethasone
Diltiazem
Estradiol Cypionate
Ethinyl Estradiol
Etonogestrel
Ketoconazole
Levonorgestrel
Medroxyprogesterone
Mestranol
Midazolam
Norethindrone
Norgestrel
Rifampin
Tolbutamide
Triazolam

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of fosaprepitant

A nurse or other trained health professional will give you fosaprepitant. fosaprepitant is given through a needle placed in one of your veins .

fosaprepitant is usually given on the first day of your chemotherapy as part of a three-day regimen along with other medicines. Fosaprepitant is not for long-term use, but you may need to use fosaprepitant again if you have more chemotherapy in the future .

fosaprepitant is not usually used to treat nausea or vomiting that has already started .

You may receive fosaprepitant with or without food .

Precautions While Using fosaprepitant

It is very important that your doctor check your progress at regular visits to make sure fosaprepitant is working properly and to check for unwanted effects .

You should not receive fosaprepitant if you are also using pimozide (e.g., Orap®), terfenadine (e.g., Seldane®), astemizole (e.g., Hismanal®), or cisapride (e.g., Propulsid®). Fosaprepitant may cause serious or life-threatening problems if used together with these medicines .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

Birth control pills may not work while you are using fosaprepitant. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include condoms, a diaphragm, or a contraceptive foam or jelly .

fosaprepitant Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools
chills
confusion
cough
decreased urination
dizziness
dry mouth
fainting
fever
increase in heart rate
lightheadedness
lower back or side pain
pain at injection site
painful or difficult urination
pale skin
rapid breathing
shortness of breath
sore throat
sunken eyes
thirst
ulcers, sores, or white spots in mouth
unusual bleeding or bruising
unusual tiredness or weakness
wrinkled skin

Less common

Hard lump at injection site

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Drowsiness
headache
tenderness, swelling, warmth, or skin discoloration at injection site

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach
belching
diarrhea
dizziness
feeling of indigestion
hair loss, thinning of hair
hiccups
indigestion
lack or loss of strength
loss of appetite
nausea
pain in the chest below the breastbone
stomach discomfort, upset, or pain
swelling or inflammation of the mouth
weight loss

Less common

Feeling of warmth
pain or discomfort in chest, upper stomach, or throat
redness of the face, neck, arms and occasionally, upper chest
sudden sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Fosaprepitant pimozide

30/06/10

Generic Name: Fosaprepitant (FOS-ap-RE-pi-tant)
Brand Name: Emend for Injection

Fosaprepitant pimozide is used for:

Preventing nausea and vomiting associated with certain types of cancer medicines (chemotherapy). It is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Fosaprepitant pimozide is an antiemetic. It works by blocking certain substances in the brain, which helps to prevent nausea and vomiting.

Do NOT use Fosaprepitant pimozide if:

you are allergic to any ingredient in Fosaprepitant pimozide, or if you are allergic to aprepitant or polysorbate 80
you are taking astemizole, cisapride, pimozide, or terfenadine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fosaprepitant pimozide:

Some medical conditions may interact with Fosaprepitant pimozide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver problems
if you currently have nausea or vomiting

Some MEDICINES MAY INTERACT with Fosaprepitant pimozide. Tell your health care provider if you are taking any other medicines, especially any of the following:

Azole antifungals (eg, ketoconazole), diltiazem, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin), nefazodone, or troleandomycin because they may increase the risk of Fosaprepitant pimozide’s side effects
Carbamazepine or rifampin because they may decrease Fosaprepitant pimozide’s effectiveness
Astemizole, benzodiazepines (eg, alprazolam), cisapride, corticosteroids (eg, dexamethasone), ifosfamide, narcotic pain medicines (eg, fentanyl), pimozide, terfenadine, vinblastine, or vincristine because the risk of their side effects may be increased by Fosaprepitant pimozide
Anticoagulants (eg, warfarin), hormonal contraceptives (eg, birth control pills), paroxetine, phenytoin, or tolbutamide because their effectiveness may be decreased by Fosaprepitant pimozide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosaprepitant pimozide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fosaprepitant pimozide:

Use Fosaprepitant pimozide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Fosaprepitant pimozide. Talk to your pharmacist if you have questions about this information.
Tell your doctor if you already have nausea or vomiting before you receive Fosaprepitant pimozide.
Fosaprepitant pimozide is usually given as an injection at your doctor’s office, hospital, or clinic 30 minutes before chemotherapy treatment.
If you miss a dose of Fosaprepitant pimozide, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Fosaprepitant pimozide.

Important safety information:

Fosaprepitant pimozide may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fosaprepitant pimozide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fosaprepitant pimozide; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Fosaprepitant pimozide may decrease the effectiveness of your birth control pill. To prevent pregnancy, be sure to use an extra form of birth control while using Fosaprepitant pimozide and for 1 month following the last dose of Fosaprepitant pimozide.
Lab tests, including liver function, kidney function, and white blood cell counts, may be performed while you use Fosaprepitant pimozide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Fosaprepitant pimozide with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosaprepitant pimozide while you are pregnant. It is not known if Fosaprepitant pimozide is found in breast milk. Do not breast-feed while taking Fosaprepitant pimozide.

Possible side effects of Fosaprepitant pimozide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache; hiccups; loss of appetite; nausea; pain or hardening at the injection site; tiredness; upset stomach; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; fever; shortness of breath; sore throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include drowsiness; headache.

Proper storage of Fosaprepitant pimozide:

Fosaprepitant pimozide is usually handled and stored by a health care provider. If you are using Fosaprepitant pimozide at home, store Fosaprepitant pimozide as directed by your pharmacist or health care provider.

General information:

If you have any questions about Fosaprepitant pimozide, please talk with your doctor, pharmacist, or other health care provider.
Fosaprepitant pimozide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fosaprepitant pimozide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

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Fosaprepitant Dimeglumine

30/06/10

Pronunciation: (FOS-ap-RE-pi-tant dye-MEG-loo-meen)
Class: Antiemetic

Trade Names:
Emend
- Injection, lyophilized powder for solution 115 mg

Pharmacology

Fosaprepitant is a prodrug of aprepitant, which is a selective high-affinity antagonist of human substance P/neurokinin 1 receptors.

Pharmacokinetics

Absorption

Following a single IV injection, mean AUC and mean C _max are 31.7 mcg•h/mL and 3.27 mcg/mL, respectively.

Distribution

Rapidly converted to aprepitant, which is more than 95% bound to plasma proteins. Mean Vd at steady state is approximately 70 L.

Metabolism

Primarily metabolized by CYP3A4 with minor metabolism by CYP1A2 and CYP2C19.

Elimination

Recovery in the urine and feces is 57% and 45%, respectively. Terminal t _½ ranges from approximately 9 to 13 h.

Special Populations

Renal Function Impairment

No dosage adjustment is needed for patients with renal function impairment or end-stage renal disease undergoing hemodialysis.

Hepatic Function Impairment

No dosage adjustment is needed in patients with mild to moderate hepatic function impairment.

Elderly

No dosage adjustment is needed.

Gender or race

No dosage adjustment is needed.

Indications and Usage

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Contraindications

Coadministration of cisapride or pimozide; hypersensitivity to any component of the product.

Dosage and Administration

Adults

IV Fosaprepitant 115 mg infused over 15 min may be substituted for aprepitant 125 mg orally 30 min prior to chemotherapy on day 1 only of the chemotherapy-induced nausea and vomiting regimen.

General Advice

Fosaprepitant is incompatible with any solutions containing divalent cations (eg, calcium, magnesium), including Ringer’s lactate solution and Hartmann’s solution.
Chronic, continuous administration is not recommended.

Storage/Stability

Store at 36° to 46°F. Reconstituted final solution is stable for 24 h at or below 77°F.

Drug Interactions

Contraceptives, hormonal

Contraceptive efficacy may be reduced. Use alternative methods of contraception during aprepitant treatment and for 1 mo after the last dose of aprepitant.

CYP2C9 substrates (eg, phenytoin, tolbutamide, warfarin)

Plasma concentrations of these drugs may be reduced. In patients receiving warfarin, closely monitor anticoagulation parameters for 14 days after initiation of the 3-day antiemetic regimen.

CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin)

Plasma concentrations of aprepitant may be reduced, decreasing the efficacy.

CYP3A4 inhibitors (eg, clarithromycin, diltiazem, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir)

Plasma concentrations of aprepitant may be elevated, increasing the pharmacologic effects and adverse reactions.

CYP3A4 substrates (eg, alprazolam, cisapride, dexamethasone, docetaxel, etoposide, ifosfamide, imatinib, irinotecan, methylprednisolone, midazolam, paclitaxel, pimozide, vinblastine, vincristine, vinorelbine)

Plasma concentrations of these agents may be elevated, increasing the pharmacologic effects and adverse reactions. Cisapride and pimozide are contraindicated with coadministration of aprepitant. Reduce the dexamethasone dose by 50%; reduce the oral and IV doses of methylprednisolone by 50% and 25%, respectively, when coadministering aprepitant.

Paroxetine

Plasma concentrations of both aprepitant and paroxetine may be reduced.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Asthenia/fatigue (18%); headache (16%); dizziness (7%); insomnia (4%).

Dermatologic

Alopecia (24%); hot flush (3%); angioedema, Stevens-Johnson syndrome, urticaria.

EENT

Tinnitus (4%); pharyngolaryngeal pain (3%).

GI

Nausea (13%); constipation (12%); anorexia, diarrhea (10%); dyspepsia, vomiting (8%); abdominal pain, heartburn, stomatitis (5%); epigastric discomfort, gastritis (4%).

Hematologic-Lymphatic

Neutropenia (9%).

Lab Tests

Decreased WBC (9%); proteinuria (7%); increased ALT (6%); increased BUN (5%); increased serum creatinine (4%); increased AST (3%); decreased hemoglobin (2%).

Metabolic-Nutritional

Dehydration (6%).

Respiratory

Hiccups (11%).

Miscellaneous

Fever, mucosal inflammation, mucous membrane disorder (3%).

Precautions

Monitor

Monitor for antiemetic effects.

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Overdosage

Symptoms

Drowsiness, headache.

Patient Information

Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
Advise patient to report the use of any other prescription or nonprescription medication or herbal product to health care provider.
Instruct patients on chronic warfarin therapy to have their clotting status closely monitored during the 2-wk period following initiation of the 3-day regimen, particularly at 7 to 10 days after initiation.
Advise patient to use nonhormonal form of contraceptive while taking fosaprepitant and for 1 mo following the last dose of the 3-day regimen.

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foscarnet

30/06/10

Generic Name: foscarnet (fos KAR net)
Brand Names: Foscavir

What is foscarnet?

Foscarnet is an antiviral medication that prevents certain virus cells from multiplying in your body.

Foscarnet is used to treat cytomegalovirus (CMV) retinitis in people with AIDS.

Foscarnet is also used to treat herpes simplex virus (HSV) in people with a weak immune system. Foscarnet is usually given for HSV after other antiviral medications have been tried without successful treatment.

Foscarnet is not a cure for CMV or HSV, and your virus may progress during or after treatment.

Foscarnet may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about foscarnet?

Before using foscarnet, tell your doctor if you have kidney disease, a seizure disorder, heart disease, a nerve disorder, or an electrolyte imbalance such as low calcium, potassium, or magnesium.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested, and you may also need regular eye exams. Do not miss any scheduled visits to your doctor.

Stop using foscarnet and call your doctor at once if you urinate less than usual or not at all, or if you have numbness or tingling around your mouth, uncontrolled muscle movements, or pain or burning when you urinate.

Foscarnet can be harmful to the kidneys, and these effects are increased when foscarnet is used together with other medicines that can harm the kidneys. Before using foscarnet, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Foscarnet is not a cure for CMV or HSV, and your virus may progress during or after treatment.

What should I discuss with my health care provider before using foscarnet?

You should not use this medication if you are allergic to foscarnet.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

kidney disease;
epilepsy or other seizure disorder;
a history of head injury or brain tumor;
heart disease;
a nerve disorder;
low levels of calcium, magnesium, or potassium in your blood; or
any other type of electrolyte imbalance.

FDA pregnancy category C. It is not known whether foscarnet is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether foscarnet passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is foscarnet given?

Foscarnet is given as an injection through a needle placed into a vein. The medicine must be given slowly through an IV infusion pump, and can take up to 2 hours to complete.

You may be given instructions on how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

With each foscarnet injection, you may be given IV fluids to keep you from getting dehydrated.

Foscarnet is usually given for 2 to 3 weeks. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

You may need to mix foscarnet with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not give foscarnet with other medications in the same IV line.

Foscarnet should be clear and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Store foscarnet at room temperature away from very hot or very cold temperature.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include numbness or tingling, thirst, drowsiness, confusion, urinating more or less than usual, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while using foscarnet?

Avoid getting this medicine in your eyes, as it may cause burning or irritation. If it does get into your eyes rinse with water and call your doctor.

Foscarnet side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using foscarnet and call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;
drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
swelling, weight gain, feeling short of breath;
numbness or tingling around your mouth or in your hands or feet;
dry mouth, increased thirst, restless feeling, increased urination, muscle pain or weakness, fainting, or seizure (convulsions);
fever, chills, body aches, flu symptoms;
pale skin, feeling light-headed, rapid heart rate, trouble concentrating; or
restless muscle movements in your eyes, tongue, jaw, or neck;
trouble breathing; or
pain or burning when you urinate.

Less serious side effects may include:

anxiety, depressed mood;
stomach pain;
headache, dizziness;
cough;
increased sweating;
skin rash;
problems with vision;
tired feeling;
joint or muscle pain; or
pain or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Foscarnet Dosing Information

Usual Adult Dose for CMV Retinitis:

HIV/AIDS-infected patients:
Induction therapy: 90 mg/kg (90-120 minute infusion) every 12 hours or 60 mg/kg (minimum 1 hour infusion) every 8 hours over 2 to 3 weeks depending on clinical response.

Maintenance therapy: 90 mg/kg/day (2 hour infusion). Escalation to 120 mg/kg/day may be considered should early reinduction be required because of retinitis progression. Some patients who show excellent tolerance to foscarnet may benefit from initiation of maintenance treatment at 120 mg/kg/day earlier in their treatment.

Usual Adult Dose for Herpes Simplex — Mucocutaneous/Immunocompromised Host:

Acyclovir-resistant infection:
Induction therapy: 40 mg/kg (minimum 1 hour infusion) every 8 or 12 hours for 2 to 3 weeks until healed.

Usual Adult Dose for Varicella-Zoster:

Acyclovir-resistant infection in HIV-infected patients (n=5):
40 mg/kg (minimum 1 hour infusion) every 8 hours for 14 to 26 days.

Usual Pediatric Dose for CMV Retinitis:

HIV/AIDS-infected patients:
Adolescents:
Induction therapy: 90 mg/kg (90 to 120 minute infusion) every 12 hours or 60 mg/kg (minimum 1 hour infusion) every 8 hours over 2 to 3 weeks depending on clinical response.

Usual Pediatric Dose for Herpes Simplex — Mucocutaneous/Immunocompromised Host:

Acyclovir-resistant infection:
Adolescents:
Induction therapy: 40 mg/kg (minimum 1 hour infusion) every 8 or 12 hours for 2 to 3 weeks until healed.

What other drugs will affect foscarnet?

Foscarnet can harm your kidneys. This effect is increased when you also use certain other medicines that can harm the kidneys. You may need dose adjustments or special tests when using any of these medications together with foscarnet.

amphotericin B (Abcelet, Ambisome);
pentamidine (Nebupent, Pentam);
antiviral medications;
any injected antibiotics;
medicines to treat a bowel disorder;
medication to prevent organ transplant rejection;
pain or arthritis medicines; or
HIV or AIDS medications such as ritonavir (Norvir) or saquinavir (Invirase).

This list is not complete and there may be other drugs that can interact with foscarnet. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about foscarnet.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,F

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foscarnet (Intravenous route)

30/06/10

fos-KAR-net

Intravenous routeSolution

Seizures, related to alterations in plasma minerals and electrolytes, have been associated with foscarnet sodium treatment. Therefore, patients must be carefully monitored for such changes and their potential sequelae. Mineral and electrolyte supplementation may be required.

Foscarnet sodium is indicated for use only in immunocompromised patients with CMV retinitis and mucocutaneous acyclovir-resistant HSV infections .

Renal impairment is the major toxicity of foscarnet sodium. Frequent monitoring of serum creatinine, with dose adjustment for changes in renal function, and adequate hydration with administration of foscarnet sodium, is imperative. Seizures, related to alterations in plasma minerals and electrolytes, have been reported. Mineral and electrolyte supplementation may be required .

Commonly used brand name(s):

In the U.S.

Foscavir

Available Dosage Forms:

Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Uses For foscarnet

Foscarnet is used to treat the symptoms of cytomegalovirus (CMV) infection of the eyes in patients with acquired immune deficiency syndrome (AIDS). Foscarnet will not cure this eye infection, but it may help to control worsening of the symptoms. It is also used to treat herpes simplex virus (HSV) infections of the skin and mucous membranes in people who are immunocompromised and whose infections did not improve with other therapy. Foscarnet may also be used for other serious viral infections as determined by your doctor. However, it does not work in treating certain viruses, such as the common cold or the flu.

Foscarnet is administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, foscarnet is used in certain patients with the following medical conditions:

Cytomegalovirus infections in places other than the eyes, such as the lungs, esophagus, or intestines
Varicella-zoster infection (shingles) that does not respond to treatment with acyclovir in patients with HIV infection

Before Using foscarnet

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For foscarnet, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to foscarnet or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of foscarnet in children with use in other age groups. Foscarnet can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child’s doctor the good that foscarnet may do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of foscarnet in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Using foscarnet with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Arsenic Trioxide
Bepridil
Cisapride
Levomethadyl
Mesoridazine
Pimozide
Probucol
Terfenadine
Thioridazine
Ziprasidone

Using foscarnet with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Aprindine
Astemizole
Azimilide
Bretylium
Chloral Hydrate
Chloroquine
Chlorpromazine
Cidofovir
Clarithromycin
Desipramine
Dibenzepin
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Encainide
Enflurane
Erythromycin
Flecainide
Fluconazole
Fluoxetine
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Imipramine
Isoflurane
Isradipine
Lidoflazine
Lorcainide
Mefloquine
Nortriptyline
Octreotide
Pentamidine
Pirmenol
Prajmaline
Procainamide
Prochlorperazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Risperidone
Sematilide
Sertindole
Sotalol
Spiramycin
Sulfamethoxazole
Sultopride
Tedisamil
Telithromycin
Trifluoperazine
Trimethoprim
Trimipramine
Vasopressin
Zolmitriptan
Zotepine

Interactions with Food/Tobacco/Alcohol

Proper Use of foscarnet

To ensure the best response, foscarnet must be given for the full time of treatment. Also, foscarnet works best when there is a constant amount in the blood. To help keep the amount constant, foscarnet must be given on a regular schedule.

Several glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects foscarnet has on the kidneys.

foscarnet may cause sores on the genitals (sex organs). Washing your genitals after urination may decrease the chance of your developing this problem.

Dosing

The dose of foscarnet will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of foscarnet. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For cytomegalovirus (CMV) retinitis induction (first stage of dosing):
  - Adults and children—The usual dose is 60 milligrams (mg) per kilogram (kg) (27.3 mg per pound) of body weight every eight hours for fourteen to twenty-one days. Each dose is injected slowly into a vein by an infusion pump over at least one hour.
- For CMV retinitis maintenance (second stage of dosing):
  - Adults and children—The usual dose is 90 to 120 mg per kg (41 to 54.5 mg per pound) of body weight once a day. This dose is injected slowly into a vein by an infusion pump over at least two hours.
- For herpes simplex infections:
  - Adults and children—The usual dose is 40 mg per kg (18.2 mg per pound) of body weight given either every eight or every twelve hours. This dose is injected slowly into a vein by an infusion pump over at least one hour. Treatment is usually continued for two to three weeks or until the infection in healed.

Precautions While Using foscarnet

It is very important that your doctor check your progress at regular visits. This will allow your doctor to check for possible unwanted effects.

It is also very important that your ophthalmologist (eye doctor) check your eyes at regular visits since you may have some loss of eyesight due to retinitis even while you are receiving foscarnet.

foscarnet Side Effects

Along with their needed effects, medicines like foscarnet can sometimes cause serious side effects such as kidney problems; these are described below. Foscarnet may also decrease the amount of calcium in your blood, causing you to have a tingling sensation around your mouth, and pain or numbness in your hands and feet. If this occurs, especially while you are receiving the medicine, notify your health care professional immediately.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Increased or decreased frequency of urination or amount of urine
increased thirst

Less common

Convulsions (seizures)
fever, chills, and sore throat
muscle twitching
pain at place of injection
pain or numbness in hands or feet
tingling sensation around mouth
tremor
unusual tiredness and weakness

Rare

Sores or ulcers on the mouth or throat, penis, or vulva

More common

Abdominal or stomach pain
anxious feeling
confusion
dizziness
headache
loss of appetite
nausea and vomiting
unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Advanced,F

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fosamprenavir

30/06/10

Generic Name: fosamprenavir (FOS am pren a veer)
Brand names: Lexiva, Telzir

What is fosamprenavir?

Fosamprenavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Fosamprenavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Fosamprenavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Fosamprenavir is not a cure for HIV or AIDS.

Fosamprenavir may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fosamprenavir?

Do not take fosamprenavir with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine, and others. Fosamprenavir should not be taken together with ritonavir (Norvir) if you are also using a heart rhythm medication called flecainide (Tambocor) or propafenone (Rythmol). Ask your doctor about taking a different medication for your heart rhythm disorder. These drugs can cause life-threatening side effects if you use them while you are taking fosamprenavir.

There are many other medicines that can cause serious interactions if you use them while taking fosamprenavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex.

What should I discuss with my healthcare provider before taking fosamprenavir?

Do not take this medication if you are allergic to fosamprenavir or a similar drug called amprenavir (Agenerase).

Do not take fosamprenavir together with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine). Fosamprenavir should not be taken together with ritonavir (Norvir) if you are also using a heart rhythm medication called flecainide (Tambocor) or propafenone (Rythmol). Ask your doctor about taking a different medication for your heart rhythm disorder. These drugs can cause life-threatening side effects if you use them while you are taking fosamprenavir.

If you have any of these other conditions, you may need a fosamprenavir dose adjustment or special tests:

liver disease;
kidney disease;
diabetes;
a bleeding disorder such as hemophilia;
heart disease, history of heart attack;
high cholesterol or triglycerides; or
if you have ever used a protease inhibitor in the past.

FDA pregnancy category C. It is not known whether fosamprenavir will harm an unborn baby. Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

Taking fosamprenavir together with another HIV medicine called ritonavir (Norvir) and also using birth control pills can increase you risk of liver problems. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking fosamprenavir and ritonavir. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take fosamprenavir?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Fosamprenavir tablets can be taken with or without food.

Fosamprenavir liquid should be taken with food in children and without food in adults.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Use fosamprenavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store fosamprenavir tablets at room temperature away from moisture and heat. You may store fosamprenavir liquid in the refrigerator but do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking fosamprenavir?

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Fosamprenavir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking fosamprenavir and call your doctor at once if you have any of these serious side effects:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
pale or yellowed skin, dark colored urine, fever, confusion or weakness;
increased urination or extreme thirst;
sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate;
signs of a new infection, such as fever or chills, cough, or flu symptoms;
easy bruising or bleeding; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects of fosamprenavir may include:

mild nausea, vomiting, diarrhea, stomach pain;
numbness or tingling, especially around your mouth;
headache, mood changes; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Fosamprenavir Dosing Information

Usual Adult Dose for HIV Infection:

Therapy-naive: 1400 mg orally twice a day (without ritonavir)
or
1400 mg fosamprenavir plus 200 mg ritonavir orally once a day
or
1400 mg fosamprenavir plus 100 mg ritonavir orally once a day
or
700 mg fosamprenavir plus 100 mg ritonavir orally twice a day

Protease inhibitor (PI)-experienced: 700 mg fosamprenavir plus 100 mg ritonavir orally twice a day

Usual Adult Dose for Nonoccupational Exposure:

1400 mg orally twice a day (without ritonavir)
or
1400 mg fosamprenavir plus 200 mg ritonavir orally once a day
or
1400 mg fosamprenavir plus 100 mg ritonavir orally once a day
or
700 mg fosamprenavir plus 100 mg ritonavir orally twice a day

Duration: Prophylaxis should be initiated as soon as possible, within 72 hours of exposure, and continued for 28 days.

The alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include fosamprenavir as part of PI-based regimens.

Usual Pediatric Dose for HIV Infection:

Oral suspension:
2 to 5 years:
Therapy-naive: 30 mg/kg orally twice a day (without ritonavir)
Maximum: 1400 mg/dose

6 years or older:
Therapy-naive: 30 mg/kg orally twice a day (without ritonavir)
Maximum: 1400 mg/dose
or
18 mg/kg fosamprenavir plus 3 mg/kg ritonavir orally twice a day
Maximum: 700 mg fosamprenavir/dose; 100 mg ritonavir/dose

Therapy-experienced: 18 mg/kg fosamprenavir plus 3 mg/kg ritonavir orally twice a day
Maximum: 700 mg fosamprenavir/dose; 100 mg ritonavir/dose

Tablets:
6 years or older:
Therapy-experienced:
47 kg or more: 1400 mg orally twice a day (without ritonavir)
39 kg or more: 700 mg fosamprenavir plus 100 mg ritonavir orally twice a day

Ritonavir capsules may be administered to patients 33 kg or more.

What other drugs will affect fosamprenavir?

Many other drugs can cause serious or life-threatening drug interactions if you use them while taking fosamprenavir. Tell your doctor if you are also using:

itraconazole (Sporanox) or ketoconazole (Nizoral);
heart rhythm medicine such as amiodarone (Cordarone), lidocaine, or quinidine (Quinaglute, Quinidex);
an antidepressant such as amitriptyline (Elavil, Etrafon), imipramine (Janimine, Tofranil), or paroxetine (Paxil);
rifampin (Rifadin, Rimactane, Rifater);
steroid medicine such as dexamethasone (Decadron, Hexadrol) or fluticasone (Advair, Flonase, Flovent);
St. John’s wort;
a blood thinner such as warfarin (Coumadin);
a calcium channel blocker such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);
cholesterol-lowering medicine such as atorvastatin (Lipitor), lovastatin (Mevacor, Altocor), or simvastatin (Zocor);
drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
other HIV /AIDS medicine such as delavirdine (Rescriptor), efavirenz (Sustiva), nevirapine (Viramune), or lopinavir/ritonavir (Kaletra);
insulin or diabetes medication you take by mouth;
medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin); or
stomach acid reducers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine (Zantac).

This list is not complete and there are many other drugs that can interact with fosamprenavir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about fosamprenavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,F

Comments (0)

fosamprenavir (Oral route)

30/06/10

fos-am-PREN-a-vir

Commonly used brand name(s):

In the U.S.

Lexiva

Available Dosage Forms:

Tablet
Suspension

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For fosamprenavir

Fosamprenavir is a protease inhibitor. It is used in combination with other medicines to treat patients who are infected with the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Fosamprenavir may slow down the destruction of the immune system caused by HIV. This may help delay the development of problems usually related to AIDS or HIV disease. However, fosamprenavir will not cure or prevent HIV infection, and it will not keep you from spreading the virus to other people. Patients who are taking fosamprenavir may continue to have the problems usually related to AIDS or HIV disease.

fosamprenavir is available only with your doctor’s prescription.

Before Using fosamprenavir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fosamprenavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fosamprenavir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fosamprenavir in children less than 2 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of fosamprenavir have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of fosamprenavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fosamprenavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Using fosamprenavir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride
Delavirdine
Dihydroergotamine
Ergoloid Mesylates
Ergonovine
Ergotamine
Lovastatin
Methylergonovine
Midazolam
Pimozide
Ranolazine
Rifampin
Sildenafil
Simvastatin
St John’s Wort
Triazolam

Using fosamprenavir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone
Atazanavir
Bepridil
Colchicine
Dexamethasone
Efavirenz
Etravirine
Everolimus
Fentanyl
Garlic
Ixabepilone
Lidocaine
Nevirapine
Quinidine
Rifabutin
Rifapentine
Rosuvastatin
Saquinavir
Tipranavir
Tolvaptan

Using fosamprenavir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atorvastatin
Cyclosporine
Desogestrel
Drospirenone
Ethinyl Estradiol
Ethynodiol Diacetate
Etonogestrel
Fosphenytoin
Ketoconazole
Levonorgestrel
Lopinavir
Mestranol
Methadone
Norelgestromin
Norethindrone
Norgestimate
Norgestrel
Paroxetine
Phenytoin
Ranitidine
Ritonavir
Voriconazole

Interactions with Food/Tobacco/Alcohol

Proper Use of fosamprenavir

Take fosamprenavir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking fosamprenavir without checking first with your doctor. When your supply of fosamprenavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of fosamprenavir.

fosamprenavir comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk with your doctor if you have any questions.

Fosamprenavir suspension should be taken by adults without food. Children should take the suspension with food.

Shake the suspension well before each use. Use a marked measuring spoon, oral syringe, or medicine cup to measure the dose. The average household teaspoon may not hold the right amount of liquid.

Fosamprenavir tablets may be taken with or without food. However, it should not be taken with a high-fat meal. Taking fosamprenavir with a high-fat meal may decrease the amount of fosamprenavir that is absorbed by the body and prevent the medicine from working properly.

It is important to take fosamprenavir as part of a combination treatment. Your dose of medicine will be based on what other medicines you are taking, as well as your weight. Be sure to take all the medicines your doctor has prescribed for you, including fosamprenavir.

Keep taking fosamprenavir for the full time of treatment, even if you begin to feel better.

fosamprenavir works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses a day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed especially for you. Do not share your medicine with others.

Dosing

The dose of fosamprenavir will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of fosamprenavir. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (suspension and tablets):
- For treatment of HIV infection:
  - Adults who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir alone)—1400 milligrams (mg) (2 tablets) two times a day.
  - Adults who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—1400 mg (2 tablets) fosamprenavir with 200 mg ritonavir one time per day or 1400 mg (2 tablets) fosamprenavir with 100 mg ritonavir one time per day or 700 mg fosamprenavir with 100 mg ritonavir two times a day.
  - Adults who have taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—700 mg fosamprenavir with 100 mg ritonavir two times a day. Adults who have taken HIV medicines called protease inhibitors in the past should not take the combination of fosamprenavir with ritonavir only one time a day. Check with your doctor if you are unsure of what amounts and how many times a day you should be taking your medicines. If you are taking fosamprenavir with ritonavir and efavirenz, check with your doctor for the correct doses.
  - Children above 6 years of age who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir alone)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is 30 milligrams (mg) per kilogram (kg) of body weight two times a day.
  - Children above 6 years of age who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is fosamprenavir 18 mg per kg of body weight with ritonavir 3 mg per kg of body weight two times a day.
  - Children above 6 years of age who have taken HIV medicines called protease inhibitors in the past (fosamprenavir alone) and weigh 47 kg or more—1400 mg (2 tablets) two times a day.
  - Children above 6 years of age who have taken HIV medicines called protease inhibitors in the past (fosamprenavir together with ritonavir)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is fosamprenavir 18 milligrams (mg) per kilogram (kg) of body weight with ritonavir 3 mg per kg of body weight two times a day.
  - Children 2 to 5 years of age who have not taken HIV medicines called protease inhibitors in the past (fosamprenavir alone)—Dose is based on body weight and must be determined by your doctor. The usual suspension dose is 30 mg per kg of body weight two times a day.
  - Children below 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of fosamprenavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you or your child vomits 30 minutes after the first dose, a second dose should be taken right away.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The oral suspension may also be refrigerated. Do not freeze.

Precautions While Using fosamprenavir

It is very important that your doctor check your progress at regular visits to make sure fosamprenavir is working properly. Blood tests may be needed to check for unwanted effects.

Do not use fosamprenavir if you are also using flecainide (Tambocor®), propafenone (Rythmol®), rifampin (Rifadin®, Rimactane®), lovastatin (Mevacor®), simvastatin (Zocor®), cisapride (Propulsid®), delavirdine (Rescriptor®), pimozide (Orap®), midazolam (Versed®), triazolam (Halcion®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, Wigraine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John’s wort) or vitamin supplements.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.

Tell your doctor if you are also taking sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). Taking these medicines together with fosamprenavir may increase your risk of having side effects such as low blood pressure, changes in vision, or prolonged erection of the penis.

Birth control pills may not work as well while you are using fosamprenavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

fosamprenavir may increase blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

Serious skin reactions can occur with fosamprenavir. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; itching; white spots in the mouth or on the lips; or redness of the skin.

Check with your doctor right away if you have any of the following symptoms while taking fosamprenavir: itching; skin rash; or swelling of the face, lips, and tongue. You may be having a serious skin reaction or a condition called angioedema.

fosamprenavir may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

fosamprenavir may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Fosamprenavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

Tell the doctor in charge that you are taking fosamprenavir before you have any medical tests. The results of some tests may be affected by fosamprenavir.

fosamprenavir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Large amount of fat in the blood
severe skin rash

Less common

Abdominal pain
blurred vision
depression
dry mouth
fatigue
flushed, dry skin
fruit-like breath odor
increased hunger
increased thirst
increased urination
mood or mental changes
nausea
sweating
troubled breathing
unexplained weight loss
vomiting

Rare

Back, leg, or stomach pains
bleeding gums
blistering, peeling, or loosening of the skin
chills
cough
dark urine
diarrhea
difficulty with breathing
fever
general body swelling
itching
joint or muscle pain
loss of appetite
nosebleeds
pale skin
red skin lesions often with a purple center
red, irritated eyes
sore throat
sores, ulcers, or white spots in the mouth or on the lips
unusual tiredness or weakness
yellowing of the eyes or skin

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

More common

Itching skin
mild or moderate rash

Less common

Burning or prickling sensation around the mouth
headache

Incidence not known

Breast enlargement
buffalo hump
fat redistribution
increased fat deposits on the face, neck, and trunk
obesity

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Fosamprenavir Suspension

30/06/10

Generic Name: Fosamprenavir (FOS-am-PREN-a-vir)
Brand Name: Lexiva

Fosamprenavir Suspension is used for:

Treating HIV infection in some patients when used in combination with certain other medicines.

Fosamprenavir Suspension is an HIV protease inhibitor. It works by slowing the growth of HIV, the virus that causes AIDS.

Do NOT use Fosamprenavir Suspension if:

you are allergic to any ingredient in Fosamprenavir Suspension or to amprenavir
you are taking amprenavir, cisapride, conivaptan, delavirdine, erythromycin, an ergot medicine (eg, ergotamine), an H₁ antagonist (eg, astemizole, terfenadine), pimozide, rifampin, or St. John’s wort
you are taking a hormonal contraceptive (eg, birth control pills), certain benzodiazepines (eg, midazolam, triazolam), or certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin)
you are taking flecainide or propafenone along with ritonavir

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fosamprenavir Suspension:

Some medical conditions may interact with Fosamprenavir Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have had a severe allergic reaction (eg, a severe rash, hives, itching, breathing difficulties, or dizziness) to a sulfonamide medicine such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
if you have liver problems, hepatitis, or a history of abnormal liver function tests
if you have a history of heart problems, high blood pressure, kidney problems, diabetes, bleeding problems (eg, hemophilia), high blood cholesterol or lipid levels, or a skin rash
if you smoke

Some MEDICINES MAY INTERACT with Fosamprenavir Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cisapride, an ergot medicine (eg, ergotamine), erythromycin, H₁ antagonists (eg, astemizole, terfenadine), or pimozide because serious side effects, such as seizures, blood vessel problems, or heart problems (eg, irregular heartbeat), may occur
Flecainide or propafenone along with ritonavir because serious heart problems (eg, irregular heartbeat) may occur
Certain benzodiazepines (eg, midazolam, triazolam) because serious side effects, such as increased or prolonged sedation or breathing problems, may occur
Hormonal contraceptives (eg, birth control pills), especially if taken along with ritonavir, because their effectiveness may be decreased and liver problems may occur
Amprenavir because it may increase the risk of Fosamprenavir Suspension’s side effects
Rifampin or St. John’s wort because they may decrease Fosamprenavir Suspension’s effectiveness
Conivaptan, certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), or ranolazine because the risk of their side effects may be increased by Fosamprenavir Suspension
Delavirdine because its effectiveness may be decreased by Fosamprenavir Suspension
Many prescription and nonprescription medicines (eg, used for cancer, infections, asthma, immune suppression, inflammation, aches and pains, high blood pressure, high cholesterol, heart problems, irregular heartbeat, angina, blood clotting problems, mood or mental problems, sinus problems, stomach problems or indigestion, erectile dysfunction, seizures, sleeping problems, urinary problems, HIV infection), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Fosamprenavir Suspension, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosamprenavir Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fosamprenavir Suspension:

Use Fosamprenavir Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Fosamprenavir Suspension. Talk to your pharmacist if you have questions about this information.
Adults should take Fosamprenavir Suspension by mouth without food.
Children should take Fosamprenavir Suspension by mouth with food. If vomiting occurs within 30 minutes after taking Fosamprenavir Suspension, the dose should be taken again.
Shake well before each use.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
You may refrigerate Fosamprenavir Suspension to help improve the taste. Do not freeze.
Eating grapefruit or drinking grapefruit juice while you are taking Fosamprenavir Suspension may increase the amount of Fosamprenavir Suspension in your blood. This may increase your risk for serious side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
If you take an aluminum- or magnesium-containing antacid, ask your doctor or pharmacist how to take it with Fosamprenavir Suspension.
Do not change your dose or stop taking Fosamprenavir Suspension without talking with your doctor first. Continue to take Fosamprenavir Suspension even if you feel well. Do not miss any doses.
Taking Fosamprenavir Suspension at the same time(s) each day will help you remember to take it. It is important to not miss any doses of Fosamprenavir Suspension.
If you miss a dose of Fosamprenavir Suspension, take it as soon as you remember. If you miss a dose of Fosamprenavir Suspension by more than 4 hours, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fosamprenavir Suspension.

Important safety information:

Do not take more than the recommended dose without checking with your doctor.
Fosamprenavir Suspension is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
Fosamprenavir Suspension does not stop the spread of HIV to others through blood or sexual contact. Use barrier forms of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Fosamprenavir Suspension, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Fosamprenavir Suspension may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice signs or symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Fosamprenavir Suspension.
Severe and sometimes life-threatening skin reactions have occurred in patients taking Fosamprenavir Suspension. Contact your doctor right away if you develop any type of skin reaction (eg, red, swollen, blistered, or peeling skin).
Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Fosamprenavir Suspension. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
Diabetes patients – Fosamprenavir Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Fosamprenavir Suspension may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Fosamprenavir Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
Lab tests, including liver function, cholesterol or triglyceride levels, white blood cell count, and blood sugar levels, may be performed while you use Fosamprenavir Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Caution is advised when using Fosamprenavir Suspension in CHILDREN; they may be more sensitive to its effects, especially vomiting.
Fosamprenavir Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fosamprenavir Suspension while you are pregnant. It is not known if Fosamprenavir Suspension is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Fosamprenavir Suspension to the baby.

Possible side effects of Fosamprenavir Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); loss of appetite; signs of infection (eg, fever, chills, sore throat); swollen, reddened, or blistered skin; symptoms of a heart attack (eg, chest pain; fainting; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of kidney stones (eg, lower back or side pain, blood in the urine, painful urination); unusual increase in thirst or urination; unusual tiredness or weakness; weight loss; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Fosamprenavir Suspension:

Store Fosamprenavir Suspension in the refrigerator or at room temperature, between 41 and 86 degrees F (5 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep the container tightly closed. Do not use after the expiration date. Keep Fosamprenavir Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Fosamprenavir Suspension, please talk with your doctor, pharmacist, or other health care provider.
Fosamprenavir Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fosamprenavir Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

F,Med-facts

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Fosamprenavir calcium

30/06/10

Brand names: Lexiva

Why is Fosamprenavir calcium prescribed?

Lexiva is prescribed for adults with human immunodeficiency virus (HIV) infection. HIV undermines the immune system, reducing the body’s ability to fight off other infections and eventually leading to the deadly condition known as acquired immune deficiency syndrome (AIDS).

Lexiva slows the progression of HIV by interfering with an important step in the virus’s reproductive cycle. The drug is a member of the group of “protease inhibitors.” Lexiva is prescribed only as part of a “drug cocktail” that attacks the virus on several fronts. It is not to be used alone.

Lexiva is not a cure for HIV infection or AIDS. It does not completely eliminate HIV from the body, nor does it totally restore the immune system. There is still a danger of developing serious opportunistic infections (that is, infections that develop when the immune system falters). It is important, therefore, to continue seeing your doctor for regular blood counts and tests. Notify your health care provider immediately of any change in your general health.

Most important fact about Fosamprenavir calcium

Combining Lexiva with certain drugs can cause serious—and possibly life-threatening—side effects (see “Possible food and drug interactions when taking Fosamprenavir calcium”). Be sure to tell your doctor and pharmacist what medications you are taking, both prescription and over-the-counter, and let them know when you stop taking any medication.

How should you take Fosamprenavir calcium?

Lexiva can be taken with or without food. Take Lexiva every day as prescribed. Do not change your dose or stop taking Lexiva without talking to your doctor.

If you miss a dose…
Take the forgotten dose as soon as you remember, then return to your normal schedule. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.

Storage instructions…
Store at room temperature. Keep the container tightly closed.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Lexiva.

Side effects may include:
Diarrhea, headache, nausea, rash, vomiting

Why should Fosamprenavir calcium not be prescribed?

If Lexiva causes an allergic reaction, you will not be able to use it. If you have severe liver damage, you should not use Lexiva.

Certain drugs should never be combined with Lexiva due to the risk of serious—and possible life-threatening—side effects (see “Possible food and drug interactions when taking Fosamprenavir calcium”).

Special warnings about Fosamprenavir calcium

There is no reason to believe that taking Lexiva lowers your chances of transmitting HIV to others. Continue to take precautions to prevent transmission of virus.

Lexiva can interfere with oral contraceptives. Use a backup form of birth control to avoid an unwanted pregnancy.

Lexiva must be used with caution if you have liver problems. If you have any liver disorder, make sure your doctor is aware of it.

One serious potential side effect of Lexiva is a rash that occasionally becomes so severe as to be life-threatening. If you notice any signs of rash, inform your doctor immediately. If the rash gets worse or is accompanied by fever, blisters, mouth sores, red eyes, swelling, or flu-like symptoms, stop taking the drug and call your doctor.

Lexiva may trigger diabetes or make it worse. If this occurs, you may have to start taking insulin or oral diabetes drugs, or have your dosage of these medications adjusted. Lexiva plus ritonavir can increase levels of a lipid called triglyceride, possibly resulting in the need for treatment.

Like other HIV drugs, Lexiva sometimes causes a redistribution of body fat, resulting in added weight around the waist, a “buffalo hump” of fat on the upper back, breast enlargement, and wasting of the face, arms, and legs. It’s not known why this occurs, or what long-term effects it might have.

Lexiva belongs to the sulfonamide family of drugs. If you have an allergy to sulfa drugs such as sulfamethoxazole, be sure to tell your doctor.

Possible food and drug interactions when taking Fosamprenavir calcium

Be sure to check with your doctor about the medicines and herbal remedies that should NOT be taken with Fosamprenavir calcium. Due to the danger of life-threatening side effects, Lexiva should never be combined with any of the following:

Cisapride
Dihydroergotamine
Ergonovine
Ergotamine
Lovastatin
Methylergonovine
Pimozide
Midazolam
Simvastatin
Triazolam

Due to the potential for serious or life-threatening side effects, your doctor will monitor you closely if you must take Lexiva with any of the following:

Amiodarone
Antidepressants known as tricyclics, such as amitriptyline and imipramine
Certain cholesterol-lowering drugs in the statin family, such as atorvastatin
Bepridil
Lidocaine
Quinidine

If you are taking both Lexiva and the HIV drug ritonavir, you must be careful to avoid the heart medications flecainide and propafenone.

Rifampin and St. John’s wort should never be given with Lexiva because they combat the antiviral effects of Lexiva. Delavirdine should not be given with Lexiva as the combination may lead to resistance to delavirdine.

Be careful about combining Lexiva with Viagra or other erectile dysfunction drugs such as tadalafil or Levitra. The combination increases the risk of the side effects of those agents, such as low blood pressure, changes in your vision, and persistent painful erection.

If Lexiva is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Lexiva with the following:

Acid reflux medications classified as “proton pump inhibitors” such as esomeprazole and rabeprazole
Antifungal medications such as itraconazole and ketoconazole
Antiulcer medications classified as H₂-receptor antagonists, such as cimetidine and ranitidine
Anxiety medications (tranquilizers) such as alprazolam, clorazepate, and diazepam
Dexamethasone
Efavirenz
Flurazepam
High blood pressure and angina medications (calcium channel blockers), such as amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine, and verapamil
HIV medications such as indinavir and nelfinavir
Immune-suppressing drugs such as cyclosporine, sirolimus, and tacrolimus
Lopinavir/ritonavir
Methadone
Nevirapine
Oral contraceptives
Rifabutin
Ritonavir
Saquinavir
Seizure medications such as carbamazepine, phenobarbital, and phenytoin
Warfarin
You should not take nevirapine and Lexiva without ritonavir.
While taking Lexiva and rifabutin, the dosage of rifabutin should be cut down by half or more.

Special information if you are pregnant or breastfeeding

The effects of Lexiva during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, tell your doctor immediately.

Since HIV infection can be passed to your baby through breast milk, you should not breastfeed.

Recommended dosage for Fosamprenavir calcium

ADULTS

If you have never taken anti-HIV medication before

Your doctor will prescribe one of the following regimens:

Lexiva 1,400 milligrams (two 700-milligram tablets) twice daily (without ritonavir)
Lexiva 1,400 milligrams (two 700-milligram tablets) once daily plus ritonavir 200 milligrams once daily
Lexiva 700 milligrams (one 700-milligram tablet) twice daily plus ritonavir 100 milligrams twice daily

If you have taken anti-HIV medication anytime before

The recommended dose of Lexiva is 700 milligrams twice daily plus ritonavir 100 milligrams twice daily. HIV-infected persons who have taken protease inhibitors before should NOT take Lexiva plus ritonavir once daily.

If you are taking Lexiva and ritonavir with efavirenz

If you are taking this combination once a day, your doctor will increase the usual dose of ritonavir to 300 milligrams. No dosage adjustment is needed if you are taking this combination twice a day.

CHILDREN

Lexiva is not recommended for use in children.

THOSE WITH REDUCED LIVER FUNCTION

Your doctor may prescribe Lexiva at a reduced dose of 700 milligrams twice daily if you have mild or moderate liver damage and are not also taking ritonavir. Lexiva is not recommended for people with severe liver damage.

Overdosage

Little is known about the symptoms of Lexiva overdose. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Detailed,F

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