Ixempra Generic Name & Formulations
Ixabepilone 15mg/vial, 45mg/vial; pwd for IV infusion after constitution and dilution; diluent contains alcohol, polyoxyethylated castor oil.
Epothilone microtubule inhibitor.
Kit—1 vial (w. diluent)
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.
Ixempra Dosage and Administration
Pretreat with both H1 and H2 blockers 1hr before infusion; and with steroid if previous hypersensitivity reaction occurred. 40mg/m2 by IV infusion over 3hrs, once every 3wks. Use max body surface area (BSA) of 2.2m2 to calculate dose if BSA >2.2m2. Hepatic impairment (AST/ALT ≤10×ULN + bilirubin ≤1.5×ULN): 32mg/m2; (AST/ALT ≤10×ULN + bilirubin >1.5–≤3×ULN): initially 20mg/m2 and consider increasing to max 30mg/m2, if tolerated; (AST/ALT >10×ULN or bilirubin >3×ULN): avoid. Concomitant strong CYP3A4 inhibitors (if unavoidable): reduce to 20mg/m2. Concomitant strong CYP3A4 inducers (if unavoidable): increase to 60mg/m2. Dose modifications for adverse reactions: see full labeling.
Baseline neutrophils <1500cells/mm3 or platelets <100,000cells/mm3. AST or ALT >2.5×ULN or bilirubin >1×ULN (in combination with capecitabine).
Ixempra Boxed Warnings
Toxicity in hepatic impairment.
Monitor for symptoms of neuropathy (sensory and motor). Diabetes mellitus. Preexisting peripheral neuropathy. Risk of myelosuppression. Withhold, reduce, or discontinue based on severity and persistence of peripheral neuropathy, myelosuppression. Cardiac disease (discontinue if cardiac ischemia or cardiac dysfunction occurs). Monitor CBCs and liver function at baseline, then periodically. Hepatic impairment (see Adult). Embryo-fetal toxicity. Advise to use effective contraception during and for 7 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Avoid or minimize alcohol intake. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); avoid; if unavoidable, reduce dose (see Adult). May be potentiated by weak or moderate CYP3A4 inhibitors; monitor and reduce Ixempra dose. Antagonized by strong CYP3A4 inducers (eg, rifampin); avoid; if unavoidable, increase dose (see Adult).
Ixempra Adverse Reactions
Peripheral sensory neuropathy, fatigue, asthenia, myalgia, arthralgia, alopecia, nausea, diarrhea, vomiting, stomatitis, mucositis, musculoskeletal pain, palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, constipation; myelosuppression (neutropenia, leukopenia, anemia, thrombocytopenia); hypersensitivity reactions; others.
Ixempra Clinical Trials
Ixempra Patient Counseling