Ixempra is an injectable cancer medicine.

Ixempra is used to treat advanced breast cancer.

Ixempra is used alone or with another cancer medicine called capecitabine. Ixempra is usually given after other treatments have failed.

You should not use Ixempra along with capecitabine if you have liver problems.

Do not use Ixempra if you are pregnant. It could harm the unborn baby. You should not receive Ixempra if you are allergic to ixabepilone, or to a medication ingredient called Cremophor (synthetic castor oil). You may not be able to receive Ixempra if you have severe liver disease, or severely low platelets or white blood cell counts.

Before you receive Ixempra, tell your doctor if you have liver disease, heart disease, nerve problems, diabetes, bone marrow suppression, or a weak immune system.

Ixabepilone can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, easy bruising, unusual bleeding, burning when you urinate).

Tell your doctor at once if you develop signs of infection, such as fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, or sores in your mouth and throat. Avoid drinking alcohol during your treatment with Ixempra.

Ixempra is given as an infusion into a vein. A healthcare provider will give you this injection.

Ixempra is usually given every 3 weeks.

Ixempra must be given slowly, and the infusion can take up to 3 hours to complete.

About 1 hour before you receive Ixempra, you may be given other medications to help prevent certain side effects.

Ixabepilone can increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Usual Adult Dose for Breast Cancer:

40 mg/m2 IV 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)

Comments:
-Premedicate all patients approximately 1 hour prior to administration of this drug to minimize the chance of a hypersensitivity reaction with an H1 antagonist (e.g., diphenhydramine 50 mg orally or equivalent) and an H2 antagonist (e.g., ranitidine 150 to 300 mg orally or equivalent)
-If a patient experiences a hypersensitivity reaction in one cycle, premedicate in subsequent cycles with a corticosteroid (e.g., dexamethasone 20 mg IV 30 minutes prior to infusing this drug or orally 60 minutes prior to infusion) in addition to the H1 and H2 antagonists. Extension of the infusion time should also be considered.

Uses:
-In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting). Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.
-As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

You should not be treated with Ixempra if you are allergic to Cremophor (synthetic castor oil).

You may not be able to receive Ixempra if you have:

• liver problems and are also taking capecitabine; or

• low platelets or white blood cell counts.

To make sure Ixempra is safe for you, tell your doctor if you have ever had:

• liver disease;

• heart disease;

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

• diabetes; or

• bone marrow suppression or a weak immune system.

Ixabepilone may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using Ixempra.

Call your doctor for instructions if you miss an appointment for your Ixempra injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Grapefruit may interact with ixabepilone and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction to Ixempra: itching, hives, rash; feeling dizzy or faint; warmth or tingly feeling; difficulty breathing, chest tightness; pounding heartbeats or fluttering in your chest; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• numbness, tingling, burning pain, discomfort, or loss of feeling anywhere in your body;

• pain or burning when you urinate;

• unusual weight gain;

• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;

• chest pain, difficult breathing;

• pounding heartbeats or fluttering in your chest;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common Ixempra side effects may include:

• blisters or severe rash on the palms of your hands or the soles of your feet;

• headache;

• tiredness;

• joint or muscle pain;

• lip, mouth, and esophagus sores;

• hair loss;

• fever;

• anemia, decreased platelets;

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

• diarrhea, constipation; or

• problems with your fingernails or toenails.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ixabepilone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.