Monograph Details
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Neoplasms
> Antimicrotubule agents
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IXEMPRA |
| Manufacturer |
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Bristol-Myers Squibb |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Epothilone microtubule inhibitor. |
| Generic Name |
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Ixabepilone 15mg/vial, 45mg/vial; pwd for IV infusion after constitution and dilution; diluent contains alcohol, polyoxyethylated castor oil. |
| Indications |
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Metastatic or locally advanced breast cancer: In combination with capecitabine after failure of an anthracycline and a taxane; and as monotherapy after failure of an anthracycline, a taxane, and capecitabine. |
| Children |
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Not recommended. |
| Adults |
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Pretreat with both H1 and H2 blockers 1 hr before infusion; and with steroid if previous hypersensitivity reaction occurred. 40mg/m2 by IV infusion over 3 hrs, once every 3 weeks. Use max body surface area (BSA) of 2.2m2 to calculate dose if BSA >2.2m2. Moderate hepatic impairment (as monotherapy): initially 20mg/m2 per dose; max 30mg/m2 per dose (see literature). Neuropathy, myelosuppression, concomitant CYP3A4 inhibitors: reduce dose (see literature). |
| Contraindications |
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Baseline neutrophils <1500cells/mm3 or platelets <100,000/mm3. AST or ALT >2.5xULN or bilirubin >1xULN (in combination with capecitabine). |
| Precautions |
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Monitor liver function at baseline and periodically. Hepatic impairment (ALT or AST >10xULN or bilirubin >3xULN: not recommended; ALT or AST >5xULN: limited data, use caution). Diabetes. Neuropathy. Cardiac disease (discontinue if cardiac ischemia or cardiac dysfunction occurs). Monitor for neuropathy, neutropenia. Pregnancy (Cat.D), nursing mothers: not recommended. |
| Interactions |
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Potentiated by strong CYP3A4 inhibitors; avoid (eg, azole antifungals, protease inhibitors, certain macrolides, nefazodone, grapefruit juice). Antagonized by strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, phenobarbital). Avoid St. John's wort. |
| Adverse Reactions |
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Peripheral sensory neuropathy, fatigue, asthenia, myalgia, arthralgia, alopecia, GI upset, stomatitis, mucositis, musculoskeletal pain, palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder; myelosuppression (neutropenia, leukopenia, anemia, thrombocytopenia); hypersensitivity reactions; others. |
| How Supplied |
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Kit—1 vial (w. diluent) |
| Additional Resources |
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• Related Prescribing Note |
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