Ixabepilone


Concise Prescribing Info
Indications/Uses
Breast cancer.
Dosage/Direction for Use
Adult : IV Metastatic or locally advanced: 40 mg/m2 by infusion over 3 hr 3 wkly either as monotherapy or in combination w/ capecitabine. Max: 88 mg.
Dosage Details
Intravenous
Breast cancer
Adult: Metastatic or locally advanced: 40 mg/m2 by infusion over 3 hr 3 wkly either as monotherapy or in combination w/ capecitabine. Max: 88 mg.
Hepatic Impairment
As monotherapy: AST and ALT ≤2.5 times ULN and bilirubin ≤1 times ULN: No dosage adjustment needed; AST and ALT ≤10 times ULN and bilirubin ≤1.5 times ULN: 32 mg/m2; AST and ALT ≤10 times ULN and bilirubin >1.5 times ULN to ≤3 times ULN: 20-30 mg/m2; AST and ALT >10 times ULN and bilirubin >3 times ULN: Not recommended.
Reconstitution
Add 8 or 23.5 mL of the supplied diluent to the vial containing 15 or 45 mg respectively to provide a 2 mg/mL soln. Following reconstitution, dilute the soln to a final concentration of 0.2-0.6 mg/mL w/ a suitable infusion fluid (e.g. lactated Ringer's soln, NaCl 0.9% inj w/ Na bicarbonate 2 mEq inj, Plasma-Lyte A inj pH 7.4.
Contraindications
History of severe hypersensitivity to polyoxyethylated castor oil or its derivatives (e.g. Cremophol EL). Neutrophil count <1,500/mm3 or platelet count <100,000/mm3. In combination therapy w/ capecitabine: Patient w/ AST or ALT >2.5 times ULN or those w/ bilirubin greater than the ULN.
Special Precautions
Patient w/ history of CV disease; DM or pre-existing peripheral neuropathy. Hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Peripheral sensory neuropathy, hypotension, myocardial ischaemia, MI, arrhythmias, ventricular dysfunction, cardiomyopathy, dyspnoea, cough, pneumonitis, pulmonary oedema, resp failure, increases in hepatic enzymes, jaundice, acute hepatic failure, renal failure; GI disturbances, anorexia, myalgia, arthralgia, fatigue, alopecia, insomnia, headache, taste disorders, dizziness, increased lacrimation, hot flushes, nail disorders, rashes, erythema multiforme, palmar-plantar erythrodysesthesia syndrome, pruritus, skin exfoliation or hyperpigmentation, renal calculi, electrolyte disturbances, coagulopathy, cognitive disorders, syncope, thrombotic or haemorrhagic events and vasculitis.
Potentially Fatal: Febrile neutropenia.
IV/Parenteral: D
Patient Counseling Information
This drug may cause dizziness, if affected do not drive or operate machinery.
MonitoringParameters
Monitor CBC w/ differential, hepatic function esp ALT, AST and bilirubin; symptoms of neuropathy.
Overdosage
Symptoms: Peripheral neuropathy, fatigue, musculoskeletal pain/myalgia, and GI symptoms (e.g. nausea, anorexia, diarrhoea, abdominal pain, stomatitis). Management: Symptomatic and supportive treatment.
Drug Interactions
May increase plasma concentration w/ CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, telithromycin). May reduce plasma concentration w/ CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin).
Food Interaction
Increased plasma concentrations w/ grapefruit juice. Reduced plasma concentration w/ St John's wort.
Action
Description: Ixabepilone is an epothilone B analogue that binds to β-tubulin subunits on microtubules, stabilising and suppressing microtubule activity, thus arresting the cell cycle and inducing apoptosis.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 3 hr.
Distribution: Extensively distributed. Plasma protein binding: Approx 67-77%.
Metabolism: Undergoes extensive hepatic metabolism via oxidation by CYP3A4 isoenzyme.
Excretion: Via faeces (65%) and urine (21%) mainly as metabolites. Terminal elimination half-life: Approx 52 hr.
Storage
Store between 2-8°C. Protect from light.
Disclaimer: This information is independently developed by MIMS based on Ixabepilone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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