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Ixabepilone

Mechanism of action

Ixabepilone is a semi-synthetic analog of epothilone B. It binds to microtubules, suppressing mitotic function. Cells are blocked in the mitotic phase of the cell division cycle, leading to cell death.

Dose

The recommended dose of ixabepilone is 40 mg/m2 infused intravenously over 3 hours every 3 weeks.

Indications

Ixabepilone is indicated in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane. It is also indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline, a taxane, and capecitabine.

Side Effects

The most common adverse reactions are peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. Additional reactions in combination treatment: palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, and constipation. Hematologic abnormalities include neutropenia, leukopenia, anemia, and thrombocytopenia.

Nursing Considerations

Premedicate all patients with an H1 antagonist and an H2 antagonist before treatment.

Dose reduction is required in certain patients with elevated AST, ALT, or bilirubin.

Ixabepilone for Injection must be constituted with supplied DILUENT. The concentration in constituted solution is 2 mg/mL. Constituted solution must be diluted with Lactated Ringer's Injection, USP, to a final concentration of 0.2 mg/mL to 0.6 mg/mL. The final solution must be used within 6 hours of preparation.

Contraindications include hypersensitivity to drugs formulated with Cremophor® EL., baseline neutrophil count <1500 cells/mm3 or a platelet count <100,000 cells/mm3. Patients with AST or ALT >2.5 × ULN or bilirubin >1 × ULN must not be treated with ixabepilone in combination with capecitabine.

Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when this medication.

FDA Approval

Manufacturer's prescribing information dated October 16, 2007.