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Ixabepilone for IV infusion
IXEMPRA™ |
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FDA Approval: |
October 2007 |
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Indication: |
Monotherapy: Metastatic or locally advanced breast cancer after treatment
failure with an anthracycline, a taxane, and capecitabine Combination therapy
with capecitabine: Metastatic or locally advanced breast cancer after
treatment failure with an anthracycline and a taxane |
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Pharmacology: |
Microtubule inhibitor |
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Usual Dose: |
Adults: 40 mg/m2 every 3 weeks by IV infusion over 3 hours |
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Contraindications: |
Hypersensitivity to Cremophor®
EL-containing products Baseline neutrophils <1500 cells/mm3 or
platelets <100,000 cells/mm3
Combination treatment: AST or ALT >2.5xULN or bilirubin >1xULN |
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Warnings: |
Monitor: For symptoms of neuropathy; CBC for myelosuppression; liver
function Premedicate with H1 antagonist and H2 antagonist; add a
corticosteroid if patient previously had a hypersensitivity reaction
Safety and efficacy not established in pediatric patients
Women should use effective contraception to avoid becoming pregnant
Lactation: Breastfeeding is not recommended during treatment
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Pregnancy Category: |
D |
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Side Effects: |
Common: Peripheral sensory neuropathy
Fatigue/asthenia
Myalgia/arthralgia
Alopecia
Nausea
Vomiting
Stomatitis/mucositis
Diarrhea
Neutropenia
Leukopenia
Anemia
Thrombocytopenia
Combination treatment:
Palmar-plantar erythrodysesthesia
Anorexia
Abdominal pain
Nail disorder
Constipation |
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Drug Interactions: |
Potent CYP450 3A4 inhibitors and inducers |
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