Generic Name: ixabepilone (IX ab EP i lone)
Brand Names: Ixempra

What is ixabepilone?

Ixabepilone is used to treat advanced breast cancer.

Ixabepilone is usually given after other cancer medications have been tried without successful treatment.

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

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

You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease. Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive ixabepilone, tell your doctor if you have liver or heart disease, nerve problems in your hands or feet, diabetes, or bone marrow suppression.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Avoid drinking alcohol while you are receiving ixabepilone. Tell your caregivers at once if you have serious side effects such as numbness, burning, pain, or tingly feeling in your hands or feet, sudden numbness or weakness, especially on one side of the body, chest pain or heavy feeling, fever, chills, body aches, flu symptoms, or redness, swelling, and pain on the palms of your hands or the soles of your feet.

What should I discuss with my health care provider before receiving ixabepilone?

You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease.

Before you receive ixabepilone, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• heart disease;

• nerve problems (especially in your hands or feet);

• diabetes; or

• bone marrow suppression or weak immune system.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ixabepilone.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use ixabepilone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether ixabepilone passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is ixabepilone given?

Ixabepilone is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. An ixabepilone is usually given every 3 weeks.

The medicine must be given slowly through an IV infusion, and can take at least 3 hours to complete.

About 1 hour before you receive your ixabepilone injection, you will be given other medications to help prevent an allergic reaction. You may also be given a steroid medication if you have ever had a reaction to an ixabepilone injection.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of ixabepilone is not expected to produce life-threatening symptoms.

What should I avoid while receiving ixabepilone?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid drinking alcohol while you are receiving ixabepilone.

Ixabepilone side effects

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

• numbness, burning, pain, or tingly feeling in your hands or feet;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• chest pain or heavy feeling;

• fever, chills, body aches, flu symptoms; or

• redness, swelling, and pain on the palms of your hands or the soles of your feet.

Less serious side effects include:

• tired feeling;

• joint or muscle pain;

• hair loss;

• nausea, vomiting, diarrhea, stomach pain, loss of appetite;

• diarrhea or constipation; or

• white patches or sores inside your mouth or on your lips.

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.

Ixabepilone Dosing Information

Usual Adult Dose for Breast Cancer:

40 mg/m2 infused intravenously over 3 hours every 3 weeks. The dosage for patients with a BSA exceeding 2.2 m2 should be calculated based on a 2.2 m2 body surface area.

Premedication: all patients must be premedicated approximately 1 hour prior to ixabepilone administration (to minimize the chance of a hypersensitivity reaction) as follows:
1. with an H1 antagonist (e.g., diphenhydramine 50 mg orally or an equivalent agent) plus
2. an H2 antagonist (e.g., ranitidine 150 mg to 300 mg orally or an equivalent agent)

Patients experiencing a hypersensitivity reaction in one cycle of ixabepilone treatment must be premedicated in subsequent cycles with a corticosteroid (e.g., dexamethasone 20 mg intravenously 30 minutes prior to ixabepilone infusion, or orally 60 minutes prior to infusion) in addition to the H1 and H2 antagonists. Extension of the infusion time should also be considered.

What other drugs will affect ixabepilone?

The following drugs can interact with ixabepilone. Tell your doctor if you are using any of these:

• dexamethasone (Decadron, Hexadrol);

• St. John’s wort;

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

• HIV /AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase, Fortovase);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), griseofulvin (Fulvicin, Grifulvin, Grisactin), rifampin (Rifadin, Rimactane, Rifater), telithromycin (Ketek), or troleandomycin (Tao);

• an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

• seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin); or

• an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), and others.

This list is not complete and there may be other drugs that can interact with ixabepilone. 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 ixabepilone.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 06/11/2009 2:00:31 PM.

ix-ab-EP-i-lone

Commonly used brand name(s):

In the U.S.

• Ixempra

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Chemical Class: Epothilone

Uses For ixabepilone

Ixabepilone belongs to the group of medicines called antineoplastics (cancer medicines). It is used to treat advanced or metastatic breast cancer (breast cancer that has already spread) after other treatments have failed. Ixabepilone is given alone or with another cancer medicine called capecitabine.

Ixabepilone interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells will also be affected by ixabepilone, other side effects may occur. Some of these may be serious and must be reported to your doctor right away.

ixabepilone is available only with your doctor’s prescription.

Before Using ixabepilone

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 ixabepilone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ixabepilone 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 ixabepilone in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 ixabepilone 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.

• Amprenavir
• Atazanavir
• Carbamazepine
• Clarithromycin
• Delavirdine
• Dexamethasone
• Fosamprenavir
• Indinavir
• Itraconazole
• Ketoconazole
• Nefazodone
• Nelfinavir
• Phenobarbital
• Phenytoin
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• St John’s Wort
• Telithromycin
• Voriconazole

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ixabepilone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ixabepilone, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of ixabepilone. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes—Use with caution. ixabepilone may increase your chance of having nerve problems.

• Heart disease, history of or
• Neuropathy (numbness, tingling)—Use with caution. May make these conditions worse.

• Liver disease, mild—Use with caution. ixabepilone should not be given with capecitabine to patients with this condition.

• Liver disease, severe or
• Neutropenia (low white blood cell count) or
• Thrombocytopenia (low blood platelet count)—Should not be used in patients with these conditions.

Proper Use of ixabepilone

Ixabepilone will be given only by or under the immediate supervision of your doctor. ixabepilone is given through a needle placed in one of your veins.

ixabepilone often causes diarrhea, nausea, and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Your doctor may give you a medicine to help prevent these side effects.

Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body. Do not eat grapefruit or drink grapefruit juice while you are using ixabepilone.

Precautions While Using ixabepilone

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

Check with your doctor right away if you have chest pain, difficulty with breathing, a fast or pounding heartbeat, or unusual weight gain. These could be symptoms of a serious heart problem.

Using ixabepilone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

ixabepilone may cause peripheral neuropathy. Check with your doctor right away if you have numbness, tingling, or a burning pain in your arms, hands, legs, or feet.

Ixabepilone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood counts are low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as safety razors and fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

ixabepilone may cause a serious allergic reaction that can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.

Make sure your doctor knows if you are allergic to a medicine (e.g., Taxol®) that contains Cremophor® EL or polyoxyethylated castor oil before you start using ixabepilone.

Ixabepilone contains alcohol, which may cause some people to become dizzy or drowsy. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert .

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 (e.g., St. John’s wort) or vitamin supplements.

ixabepilone 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
• body aches or pain
• burning, numbness, tingling, or painful sensations
• burning pain on urination
• chest pain
• chills
• cough
• difficult or labored breathing
• ear congestion
• fever
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• painful or difficult urination
• pale skin
• red, swelling, or painful skin
• runny nose
• scaling of the skin on the hands and feet
• shortness of breath
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• swelling of the hands, ankles, feet, or lower legs
• swollen glands
• tightness in the chest
• tingling of the hands and feet
• troubled breathing with exertion
• ulceration of the skin
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain
• weakness in the arms, hands, legs, or feet
• wheezing

Less common

• Bleeding gums
• blood in the urine or stools
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• fast heartbeat
• hives
• hoarseness
• increase in heart rate
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness
• pinpoint red spots on the skin
• rapid breathing
• rash
• sunken eyes
• swelling of the eyelids, face, or lips
• thirst
• trouble with swallowing
• wrinkled skin

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

• Bad, unusual, or unpleasant (after) taste
• bone pain
• change in taste
• cracked lips
• diarrhea
• difficulty having a bowel movement (stool)
• discoloration of the fingernails or toenails
• feeling of warmth
• hair loss or thinning of the hair
• heartburn
• lack or loss of strength
• loss of appetite
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• stomach pain
• sudden sweating
• swelling or inflammation of the mouth
• vomiting
• weight loss

Less common

• Darkening of the skin
• flaking and falling off of the skin
• sleeplessness
• trouble with sleeping
• unable to sleep
• watering of the eyes

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.

Generic Name: ixabepilone (IX ab EP i lone)
Brand Names: Ixempra

What is ixabepilone?

Ixabepilone is used to treat advanced breast cancer.

Ixabepilone is usually given after other cancer medications have been tried without successful treatment.

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

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

You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease. Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive ixabepilone, tell your doctor if you have liver or heart disease, nerve problems in your hands or feet, diabetes, or bone marrow suppression.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Avoid drinking alcohol while you are receiving ixabepilone. Tell your caregivers at once if you have serious side effects such as numbness, burning, pain, or tingly feeling in your hands or feet, sudden numbness or weakness, especially on one side of the body, chest pain or heavy feeling, fever, chills, body aches, flu symptoms, or redness, swelling, and pain on the palms of your hands or the soles of your feet.

What should I discuss with my health care provider before receiving ixabepilone?

You should not receive this medication if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive ixabepilone if you have severe liver disease.

Before you receive ixabepilone, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• heart disease;

• nerve problems (especially in your hands or feet);

• diabetes; or

• bone marrow suppression or weak immune system.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ixabepilone.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use ixabepilone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether ixabepilone passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is ixabepilone given?

Ixabepilone is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. An ixabepilone is usually given every 3 weeks.

The medicine must be given slowly through an IV infusion, and can take at least 3 hours to complete.

About 1 hour before you receive your ixabepilone injection, you will be given other medications to help prevent an allergic reaction. You may also be given a steroid medication if you have ever had a reaction to an ixabepilone injection.

Ixabepilone can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of ixabepilone is not expected to produce life-threatening symptoms.

What should I avoid while receiving ixabepilone?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid drinking alcohol while you are receiving ixabepilone.

Ixabepilone side effects

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

• numbness, burning, pain, or tingly feeling in your hands or feet;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• chest pain or heavy feeling;

• fever, chills, body aches, flu symptoms; or

• redness, swelling, and pain on the palms of your hands or the soles of your feet.

Less serious side effects include:

• tired feeling;

• joint or muscle pain;

• hair loss;

• nausea, vomiting, diarrhea, stomach pain, loss of appetite;

• diarrhea or constipation; or

• white patches or sores inside your mouth or on your lips.

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.

What other drugs will affect ixabepilone?

The following drugs can interact with ixabepilone. Tell your doctor if you are using any of these:

• dexamethasone (Decadron, Hexadrol);

• St. John’s wort;

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

• HIV /AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase, Fortovase);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), griseofulvin (Fulvicin, Grifulvin, Grisactin), rifampin (Rifadin, Rimactane, Rifater), telithromycin (Ketek), or troleandomycin (Tao);

• an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

• seizure medication such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin); or

• an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), and others.

This list is not complete and there may be other drugs that can interact with ixabepilone. 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 ixabepilone.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 06/11/2009 2:00:31 PM.

Generic Name: Japanese encephalitis virus vaccine (SA14-14-2)
Brand Names: Ixiaro

What is Japanese encephalitis virus vaccine (SA14-14-2)?

Japanese encephalitis is a serious disease caused by a virus. It is the leading cause of viral encephalitis (inflammation of the brain) in Asia. Encephalitis is an infection of the membrane around the brain and spinal cord. This infection often causes only mild symptoms, but prolonged swelling of the brain can cause permanent brain damage or death.

Japanese encephalitis virus is carried and spread by mosquitos.

The Japanese encephalitis SA14-14-2 vaccine is used to help prevent this disease in adults and adolescents who are at least 17 years old.

This vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

This vaccine is recommended for people who live in or travel to areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred.

You should receive the vaccine and booster dose at least 1 week prior to your arrival in an area where you may be exposed to the virus.

Not everyone who travels to Asia needs to receive a Japanese encephalitis vaccine. Follow your doctor instructions or the recommendations of the Centers for Disease Control and Prevention (CDC).

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Like any vaccine, the Japanese encephalitis SA14-14-2 vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The Japanese encephalitis SA14-14-2 vaccine is given in a series of 2 shots. The shots are usually 28 days apart. Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.

Japanese encephalitis SA14-14-2 vaccine is for use in adults and adolescents who are at least 17 years old.

This vaccine is recommended for people who live in or travel to areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred.

You should receive the vaccine and booster dose at least 1 week prior to your arrival in an area where you may be exposed to the virus.

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to a Japanese encephalitis vaccine.

Before receiving this vaccine, tell the doctor if you are allergic to any foods or drugs, or if you have:

• a bleeding or blood clotting disorder;

• a weak immune system caused by disease such as HIV or AIDS, bone marrow transplant, or by using certain medicines or receiving cancer treatments.

You can still receive a vaccine if you have a cold or low fever. In the case of a more severe illness with a high fever (more than 100 degrees) or any type of infection, wait until you get better before receiving this vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with the Japanese encephalitis virus. It is not known whether Japanese encephalitis vaccine 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 this vaccine given?

This vaccine is given as an injection (shot) into a muscle of your upper arm. You will receive this injection in a doctor’s office or other clinic setting.

The Japanese encephalitis SA14-14-2 vaccine is given in a series of 2 shots. The shots are usually 28 days apart. Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.

In addition to receiving the Japanese encephalitis vaccine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could infect you with the Japanese encephalitis virus.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

This vaccine side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; dizziness, weakness, fast heart rate; swelling of your face, lips, tongue, or throat.

Less serious side may include:

• headache, tired feeling;

• muscle pain, back pain;

• low fever, chills, flu symptoms;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• mild itching or skin rash.

• nausea, diarrhea; or

• pain, redness, tenderness, or a hard lump where the shot 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.

What other drugs will affect Japanese encephalitis virus vaccine (SA14-14-2)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

• medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can affect Japanese encephalitis vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. 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 may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 06/08/2009 3:49:31 PM.

Generic Name: Vitamin B Complex/Vitamin C/Biotin/Folic Acid/Zinc (VYE-ta-min B/VYE-ta-min C/BYE-oh-tin/FOE-lik AS-id/zink)
Brand Name: Examples include Ivites Rx and Nephplex Rx

Ivites Rx is used for:

Treating or preventing a lack of certain vitamins, folic acid, or zinc. It may also be used for other conditions as determined by your doctor.

Ivites Rx is a vitamin and folic acid combination. It works by providing vitamins and folic acid to the body to help meet nutritional requirements.

Do NOT use Ivites Rx if:

• you are allergic to any ingredient in Ivites Rx

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

Before using Ivites Rx:

Some medical conditions may interact with Ivites Rx. 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 (including soy)
• if you have anemia (eg, pernicious anemia)

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

• Fluorouracil because the risk of its side effects may be increased by Ivites Rx
• Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Ivites Rx

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ivites Rx 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 Ivites Rx:

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

• Take Ivites Rx by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you are also taking eltrombopag, a quinolone antibiotic (eg, levofloxacin), or a tetracycline antibiotic (eg, doxycycline), ask your doctor how you should take it with Ivites Rx.
• If you miss a dose of Ivites Rx, take it as soon as possible. If it is almost time for your next dose, 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 Ivites Rx.

Important safety information:

• Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed by your doctor.
• Ivites Rx contains pyridoxine (vitamin B₆) and folic acid. Before you start any medicine, check the label to see if it has pyridoxine or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• This product may contain tartrazine dye (FD & C Yellow No. 5). This may cause an allergic reaction in some patients. The risk may be higher if you are allergic to aspirin. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.
• Ivites Rx may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ivites Rx.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ivites Rx while you are pregnant. It is not known if Ivites Rx is found in breast milk. If you are or will be breast-feeding while you are using Ivites Rx, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ivites Rx:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Ivites Rx. 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); decreased coordination; decreased sensation of touch, temperature, or vibration; numbness or tingling of the skin.

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 confusion; decreased coordination; mental or mood changes; numbness or tingling of the hands or feet.

Proper storage of Ivites Rx:

Store Ivites Rx at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ivites Rx out of the reach of children and away from pets.

General information:

• If you have any questions about Ivites Rx, please talk with your doctor, pharmacist, or other health care provider.
• Ivites Rx 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 Ivites Rx. 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.