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ixabepilone
Ixempra Pharmaceutical company:
Bristol-Myers Squibb Co.
www.bms.com

Pharmacologic classification: microtubule inhibitor
Therapeutic classification:
antineoplastic
Pregnancy risk category:
D


AVAILABLE FORMS
Powder for injection: 15 mg, 45 mg

INDICATIONS AND DOSAGES
Taken with capecitabine to treat metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane. Or as monotherapy in patients after failure of an anthracycline, taxane, and capecitabine--
Adults: 40 mg/m2 infused I.V. over 3 hours every 3 weeks.
ADJUST-A-DOSE:
For patients with hepatic impairment, use a lower dose based on liver enzymes. For mild impairment, 32 to 40 mg/m2 infused I.V. over 3 hours every 3 weeks; for severe impairment, 20 to 30 mg/m2 infused I.V. over 3 hours every 3 weeks.

CONTRAINDICATIONS AND CAUTIONS
Contraindicated with known hypersensitivity to Cremophor EL; baseline neutrophil count under 1,500 cells/mm2 or platelet count under 100,000 cells/mm2; AST or ALT over 2.5 the upper limit of normal or bilirubin over 1 times the upper limit of normal; and in pregnant and breast-feeding women.
   Use cautiously in patients with cardiac disease.

INTERACTIONS
Drug-drug. Potent CYP3A4 inhibitors such as ketoconazole: May increase serum levels of ixabepilone. Adjust dosage accordingly.
Mild CYP3A4 inhibitors such as erythromycin, fluconazole, verapamil: May increase serum levels of ixabepilone. Monitor patient carefully.
CYP3A4 inducers such as dexamethasone, phenytoin, carbamazepine, rifampin, rifampicin, rifabutin, phenobarbital: May decrease serum levels and effectiveness of ixabepilone. Consider using other drugs, if possible.
Drug-herb. St. John’s wort: Potential for unpredictable changes in serum concentration. Avoid use together.
Drug-food. Grapefruit juice: May increase serum levels. Avoid use together.

ADVERSE REACTIONS
CNS: peripheral sensory neuropathy, asthenia, dizziness, fatigue, headache, insomnia, cognitive impairment.
CV: MI, ventricular dysfunction, supraventricular arrhythmias, flushing.
GI: abdominal pain, anorexia, nausea, stomatitis, anorexia, abdominal pain, vomiting, diarrhea, constipation.
Hematologic: neutropenia, leukopenia, anemia, thrombocytopenia.
Metabolic: dehydration.
Musculoskeletal: arthralgia, myalgia, musculoskeletal pain.
Respiratory: upper respiratory tract infection, dyspnea, cough.
Skin: alopecia, hand-foot syndrome, nail disorder, exfoliation, hyperpigmentation.
Other: hypersensitivity reaction, infection.

Reactions may be common, uncommon, life-threatening, or
COMMON AND LIFE-THREATENING.

     
   

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