Names and pronunciation
(ix-ab-ep′i-lone) Ixempra
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Drug reference
(ix-ab-ep′i-lone) Ixempra
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Func. class.: Antineoplastic— miscellaneous
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Chem. class.: Epothilone, B analogue
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ACTION: Microtubule stabilizing agent; microtubules are needed for cell division
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USES: Breast cancer
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CONTRAINDICATIONS: Preg- nancy, breastfeeding, hypersensitivity to products with polyoxyethylated castor oil, neutropenia of <1500/mm3, thrombocyto- penia
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Black Box Warning: Hepatic disease Precautions: Children, geriatric patients, alcoholism, bone marrow sup- pression, cardiac dysrhythmias, cardiac/ renal disease, diabetes mellitus, periph- eral neuropathy, ventricular dysfunction Black Box Warning: Hepatic dis- ease: liver function tests before, during therapy (bilirubin, AST, ALT, LDH) prn or monthly; check for jaundiced skin and sclera, dark urine, clay-colored stools, itchy skin, abdominal pain, fever, diar- rhea; contraindicated in combination with capecitabine if AST or ALT is >2.5 × ULN or bilirubin >1 × ULN due to risk of toxicity and neutropenia-related death • VS during 1st hr of infusion; check IV site for signs of infiltration • Hypersensitivity reactions, ana- phylaxis including hypotension, dys pnea, angioedema, generalized urticaria; discontinue infusion immediately; keep emergency equipment available • Effects of alopecia on body image; discuss feelings about body changes • Pregnancy/breastfeeding: do not use in pregnancy or breastfeeding
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SIDE EFFECTS CNS: Peripheral neuropathy, impaired cognition, chills, fatigue, fever, flushing, headache, insomnia, asthenia CV: Bradycardia, hypotension, abnormal ECG, angina, atrial flutter, cardiomyopa thy, chest pain, edema, MI, vasculitis GI: Nausea, vomiting, diarrhea, abdom- inal pain, anorexia, colitis, constipation, gastritis, jaundice, GERD, hepatic failure, trismus GU: Renal failure HEMA: Neutropenia, thrombocytopenia, anemia, infections, coagulopathy INTEG: Alopecia, rash, hot flashes META: Hypokalemia, metabolic acidosis MS: Arthralgia, myalgia RESP: Bronchospasm, cough, dyspnea SYST: Hypersensitivity reactions, ana phylaxis, dehydration, radiation recall reaction
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INTERACTIONS Increase: ixabepilone level—CYP3A4 inhibitors (amiodarone, amprenavir, aprepitant, atazanavir, chlorampheni- col, clarithromycin, conivaptan, cycloSPORINE, danazol, darunavir, dalfopristin, delavirdine, diltiaZEM, erythromycin, estradiol, fluconazole, fluvoxaMINE, fosamprenavir, ima- tinib, indinavir, isoniazid, itracon- azole, ketoconazole, lopinavir, micon- azole, nefazodone, nelfinavir, propoxyphene, ritonavir, RU-486, saquinavir, tamoxifen, telithromycin, troleandomycin, verapamil, voricon- azole, zafirlukast) Decrease: ixabepilone levels—CYP3A4 inducers (aminoglutethimide, barbitu- rates, bexarotene, bosentan, carBAMaze- pine, dexamethasone, efavirenz, griseo- fulvin, modafinil, nafcillin, nevirapine, OXcarbazepine, phenytoin, rifamycin, topiramate) Drug/Herb • Avoid use with St. John’s wort Drug/Food • Avoid use with grapefruit products
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DOSAGE AND ROUTES • Adult: IV INFUSION 40 mg/m2 over 3 hr q3wk Dosage reduction in those taking a strong CYP3A4 inhibitor • Adult: IV INFUSION 20 mg/m2 over 3 hr q3wk Hepatic dose • Adult: IV 20 mg/m2 q3wk, max 30 mg/m2
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Available forms: Powder for inj 15, 45 mg
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Administer: • Premedicate with histamine antagonists 1 hr before use, prevents hypersensitivity • Antiemetic 30-60 min before product and prn IV route • Let kit stand at room temperature for 30 min; to reconstitute, withdraw sup- plied diluent (8 mL for 15-mg vials, 23.5 mL for 45-mg vials); slowly inject sol into vial; gently swirl and invert to mix, final concentration 2 mg/mL; further dilute in LR in DEHP-free bags, final concentra- tion should be between 0.2 and 0.6 mg/ mL; after added, mix by manual rotation • Diluted sol stable for 6 hr at room temperature; infusion must be completed within 6 hr • Use in-line filter, 0.2-1.2 micron • Give over 3 hr
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Assess: • CBC, differential, platelet count before treatment and weekly; withhold product if WBC is <1500/mm3 or platelet count is <100,000/mm3, notify prescriber • Monitor temperature q4hr (may indi- cate beginning infection)
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Evaluate: • Therapeutic response: decreased tu- mor size, spread of malignancy
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report signs of infection: fever, sore throat, flulike symptoms • To report signs of anemia: fatigue, headache, faintness, SOB • To report any complaints or side ef- fects to nurse or prescriber • That hair may be lost during treatment; that a wig or hairpiece may make patient feel better; that new hair may be different in color, texture • That pain in muscles and joints 2-5 days after infusion is common • To use nonhormonal type of contra- ception • To avoid receiving vaccinations while receiving product
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PHARMACOKINETICS Metabolized in liver by CYP3A4; excreted in feces (65%) and urine (21%); termi- nal half-life 52 hr
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• Adult: IV INFUSION 40 mg/m2 over 3 hr q3wk Dosage reduction in those taking a strong CYP3A4 inhibitor
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• Adult: IV INFUSION 20 mg/m2 over 3 hr q3wk Hepatic dose
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• Adult: IV 20 mg/m2 q3wk, max 30 mg/m2
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