Important Safety Information about IXEMPRA^® (ixabepilone)

Your healthcare provider should do blood tests to check how well your liver is working before you begin treatment with IXEMPRA and as needed during treatment. If blood tests show that you have liver problems, do not receive injections of IXEMPRA along with capecitabine. If you have liver problems, taking these medicines together could increase your chance of serious infection and death due to a very low white blood cell count (neutropenia).

You should not have your injection of IXEMPRA if you:

• Are allergic to medicines that contain Cremophor^® EL* (polyoxyethylated castor oil)
• Have a low white blood cell count or a low platelet count

Before you receive treatment with IXEMPRA, tell your healthcare provider about all of your medical conditions, including any of the following:

• Liver problems
• Heart problems or a history of heart problems
• An allergic reaction to IXEMPRA. (To lower the chance of an allergic reaction, you will receive other medicines about 1 hour before each dose of IXEMPRA)
• Diabetes
• Numbness, tingling, or burning in the hands or feet (neuropathy)

You should also tell your healthcare provider if you:

• Are pregnant or plan to become pregnant. IXEMPRA may harm your unborn baby
• Are breast-feeding. It is not known if IXEMPRA passes into breast milk
• Take any medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements, including St John’s wort. IXEMPRA and certain other medicines may affect each other and cause side effects

While you are on treatment with IXEMPRA, you should avoid:

• Activities that may be dangerous, such as driving or operating machinery because IXEMPRA contains alcohol and may cause dizziness and drowsiness (feeling tired)
• Drinking grapefruit juice. Grapefruit juice may cause you to have too much IXEMPRA in your blood, and this can lead to side effects

IXEMPRA may cause serious side effects. Tell your healthcare provider right away if you have any of the following while taking IXEMPRA:

• Numbness, tingling, or burning in the hands or feet (neuropathy). When they do happen, these symptoms often appear early in treatment and may be new or get worse. Your dose of IXEMPRA may need to be decreased, stopped until your symptoms get better, or stopped totally
• Low white blood cell count (neutropenia). White blood cells help protect the body from infections caused by bacteria. Symptoms of neutropenia include fever (temperature over 100.5 degrees), chills, cough, and burning or pain when you urinate. If you get a fever or an infection when your white blood cell count is very low, you can become seriously ill and die. You may need treatment in the hospital with antibiotic medicines
• Allergic reactions. Signs of an allergic reaction include itching; hives; rash; flushed face; sudden swelling of the face, throat, or tongue; tightness in the chest; trouble breathing; feeling dizzy or faint; feeling your heart beating (palpitations). Allergic reactions are most likely to occur while IXEMPRA is being injected. Severe allergic reactions can occur with IXEMPRA and may cause death in rare cases
• Heart Problems. Chest pain, difficulty breathing, palpitations, or unusual weight gain. These can be caused by decreased blood flow to the heart, problems with heart function, and abnormal heartbeat

The most common side effects of IXEMPRA, when used alone or with capecitabine, may include:

• Tiredness
• Loss of appetite
• Problems with your toenails and fingernails
• Hair loss
• Fever
• Decreased red blood cell count (anemia)
• Joint and muscle pain
• Headache
• Decreased platelet count (thrombocytopenia)
• Nausea, vomiting, diarrhea, constipation, and abdominal pain
• Sores on the lip, in the mouth, and in the esophagus
• Tender, red skin on the palms of the hands and the soles of the feet (hand-foot syndrome). It may look like a sunburn. The skin may also become dry and peel or may feel numb and tingly

If you have any questions about your health or your medicines, talk with your healthcare provider.

Please read the Patient Information section of the full Prescribing Information, including boxed WARNING regarding liver disease.