Ixabepilone

== What is Ixabepilone? ==

• Ixabepilone (Ixempra) is a microtubule inhibitor used to treat metastatic or locally advanced breast cancer that has not improved after treatment with certain other anticancer drugs.
• It is also being studied in the treatment of other types of cancer.

Ixabepilone

Ixabepilone functional group

What are the uses of this medicine?

Ixabepilone (Ixempra) is used alone or with another cancer medicine called capecitabine to treat locally advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), when certain other medicines have not worked or no longer work.

How does this medicine work?

• Ipilimumab (ip” i lim’ ue mab) is a human recombinant monoclonal immunoglobulin G1 antibody to the cytotoxic T lymphocyte antigen-4 (CTLA-4) which is used in cancer immunotherapy.
• The CTLA-4 antigen is an important check-point molecule that modulates and down regulates T cell responses.
• Inhibition of CTLA on the surface of activated T cells prevents its binding to the costimulatory factor B7, which allows for a continued activation and proliferation of T cells.
• The subsequent enhancement of cytotoxic reactivity may play a beneficial role in cancer immunotherapy and can break immunological tolerance.
• In several large multicenter studies, ipilimumab therapy resulted in a prolongation of survival in patients with advanced, metastatic or unresectable malignant melanoma, and a proportion of patients had a long term remission.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who: have low white blood cell or platelet counts. Your healthcare provider will check your blood counts. are allergic to a medicine, such as TAXOL®, that contains Cremophor® EL or polyoxyethylated castor oil. are also taking a cancer medicine called capecitabine and you have liver problems.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking 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)
• verapamil (Calan, Covera, Isoptin, Verelan, in Tarka).

Is this medicine FDA approved?

• Ixabepilone was approved for use in the United States in 2007 and current indications are for locally advanced or metastatic breast cancer given as monotherapy or in combination with capecitabine after failure of other treatments.

How should this medicine be used?

• Patients who experienced a hypersensitivity reaction to Ixempra require premedication with corticosteroids (eg, dexamethasone 20 mg intravenously, 30 minutes before infusion or orally, 60 minutes before infusion) in addition to pretreatment with H 1 and H 2 antagonists.

Recommended dosage:

• The recommended dosage of Ixempra is 40 mg/m 2 administered as a 3-hour intravenous infusion once every 3 weeks.
• Dose reduction is required in patients with elevated AST, ALT, or bilirubin.

Administration:

• Ixempra is given by an injection directly into your vein (intravenous infusion).
• Ixempra is usually given 1 time every 3 weeks.
• Each treatment with Ixempra will take about 3 hour.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Ixempra for injection, 15 mg supplied with DILUENT for Ixempra, 8 mL
• Ixempra for injection, 45 mg supplied with DILUENT for Ixempra, 23.5 mL

This medicine is available in fallowing brand namesː

• Ixempra

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness
• loss of appetite
• disorders of 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 esophagus
• tender, red palms and soles of feet (hand-foot syndrome) that looks like a sunburn
• the skin may become dry and peel.
• numbness and tingling
• Ixempra may cause fertility problems in females and males, which may affect your ability to have children.

Ixempra may cause serious side effects including:

• peripheral neuropathy
• neutropenia
• Allergic reactions
• Heart problems

What special precautions should I follow?

• Severe, life-threatening, or fatal myelosuppression can occur in patients treated with Ixempra. Neutropenia, febrile neutropenia, and infections have occurred. Monitor blood cell counts before and during treatment with Ixempra. Withhold, reduce, or discontinue Ixempra depending on severity.
• Peripheral neuropathy (sensory and motor neuropathy) occurred in patients treated with Ixempra in combination with capecitabine and in patients treated with single agent Ixempra. Monitor for symptoms of neuropathy (sensory and motor neuropathy). Withhold, reduce, or discontinue Ixempra depending on severity.
• Increased toxicity in patients with hepatic impairment. Grade 4 neutropenia, febrile neutropenia, and serious adverse reactions may occur in patients with hepatic impairment during treatment with Ixempra. Reduce dose depending on severity.
• Ixempra is contraindicated in patients with a history of a severe hypersensitivity reaction to agents containing Cremophor ® EL or its derivatives (eg, polyoxyethylated castor oil). Severe hypersensitivity reactions (including anaphylaxis) have occurred. Premedicate all patients before treatment with Ixempra. Withhold, reduce, or discontinue Ixempra depending on severity.
• Cardiac adverse reactions (myocardial ischemia and ventricular dysfunction) occurred in patients receiving Ixempra. Closely monitor patients with a history of cardiac disease during treatment with Ixempra. Consider discontinuation of Ixempra in patients who develop cardiac ischemia or impaired cardiac function.
• Based on findings in animals and its mechanism of action, Ixempra can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk to a fetus and to use effective contraception.
• The alcohol content in a dose of Ixempra may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion.
• Ixabepilone stops the growth of tumor cells by blocking cell division. It is a type of epothilone analog. Also called BMS-247550 and Ixempra.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• peripheral neuropathy
• fatigue
• musculoskeletal pain/myalgia
• gastrointestinal symptoms (nausea, anorexia, diarrhea, abdominal pain, stomatitis)

Management of overdosage:

• There is no known antidote for overdosage of Ixempra.
• In case of overdosage, closely monitor patients for adverse reactions and provide supportive treatment as clinically indicated.

Can this medicine be used in pregnancy?

• Based on findings in animals and its mechanism of action, Ixempra can cause fetal harm when administered to a pregnant woman.
• Advise females of reproductive potential and pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• The alcohol content of Ixempra should be taken into account when given to pediatric patient.
• It is not known if Ixempra is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ixabepilone
• Inactive ingredients: The DILUENT for Ixempra contains purified polyoxyethylated castor oil and dehydrated alcohol.

Who manufactures and distributes this medicine?

• Ixempra ® (ixabepilone) for injection Manufactured by: Baxter Oncology GmbH, Halle/Westfalen, Germany
• DILUENT for Ixempra Manufactured by: Baxter Oncology GmbH, Halle/ Westfalen, Germany
• Distributed by R-Pharm US LLC, Princeton, NJ USA

What should I know about storage and disposal of this medication?

• Ixempra Kit must be stored in a refrigerator at 2° C to 8° C (36° F to 46° F).
• Retain in original package until time of use to protect from light.
• Ixempra is a hazardous drug.
• Follow applicable special handling and disposal procedures.

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• Dailymed label info on Ixabepilone
• FDA Ixabepilone}