Ixabepilone Injection

IMPORTANT WARNING:

Tell your doctor if you have or have ever had liver disease. Your doctor will order laboratory tests to see how well your liver is working before and during your treatment. If the tests show that you have liver problems, your doctor will probably not give you ixabepilone injection and capecitabine (Xeloda). Treatment with both ixabepilone injection and capecitabine may cause serious side effects or death in people who have liver disease.

Talk to your doctor about the risks of receiving ixabepilone injection.

WHY is this medicine prescribed?

Ixabepilone injection is used alone or in combination with capecitabine to treat breast cancer that cannot be treated with other medications. Ixabepilone is in a class of medications called microtubule inhibitors. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ixabepilone injection comes as a powder to be added to fluid and injected over 3 hours intravenously (into a vein) by a doctor or nurse. It is usually injected once every 3 weeks.

Your doctor may need to delay your treatment and adjust your dose if you experience certain side effects. Your doctor will give you other medications to prevent or treat certain side effects about one hour before you receive each dose of ixabepilone injection. Be sure to tell your doctor how you are feeling during your treatment with ixabepilone injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ixabepilone injection,

• tell your doctor and pharmacist if you are allergic to ixabepilone, any other medications, Cremophor EL (polyoxyethylated castor oil), or medications that contain Cremophor EL such as paclitaxel (Taxol). Ask your doctor or pharmacist if you do not know if a medication that you are allergic to contains Cremophor EL.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking, have recently taken, or plan to take. Be sure to mention any of the following: certain antibiotics such as clarithromycin (Biaxin) and telithromycin (Ketek); certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); delavirdine (Rescriptor); dexamethasone (Decadron, Dexpak); erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin); fluconazole (Diflucan); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); nefazodone; protease inhibitors used to treat human immunodeficiency virus (HIV) such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), ritonavir (Norvir, in Kaletra), nelfinavir (Viracept), and saquinavir (Invirase); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate and Rifater); and verapamil (Calan, Covera, Isoptin, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had diabetes; any condition that causes numbness, burning or tingling in your hands or feet; or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving ixabepilone injection. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving ixabepilone injection, call your doctor. Ixabepilone injection may harm the fetus.

• you should know that ixabepilone injection contains alcohol and may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you. Talk to your doctor about the safe use of alcoholic beverages or medications that may affect your thinking or judgment during your treatment with ixabepilone injection.

What SPECIAL DIETARY instructions should I follow?

Do not drink grapefruit juice while receiving this medication.

What SIDE EFFECTS can this medicine cause?

Ixabepilone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• hair loss
• flaky or darkened skin
• problems with toenails or fingernails
• tender, red palms and soles of feet
• sores on the lip or in the mouth or throat
• difficulty tasting food
• watery eyes
• loss of appetite
• weight loss
• heartburn
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• joint, muscle, or bone pain
• confusion
• difficulty falling asleep or staying asleep
• weakness
• tiredness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• numbness, burning, or tingling in the hands or feet
• difficulty breathing
• hives
• rash
• itching
• sudden reddening of the face, neck or upper chest
• sudden swelling of face, throat or tongue
• pounding heartbeat
• dizziness
• faintness
• chest pain or tightness
• unusual weight gain
• fever (100.5 °F or greater)
• chills
• cough
• burning or pain when urinating

Ixabepilone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• muscle pain
• tiredness

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.