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Indications and Dosage
Oral
Multiple myeloma Adult: In combination with lenalidomide and dexamethasone in patient who have received at least one prior treatment: 4 mg once weekly given on days 1, 8, and 15 of a 28-day treatment cycle, continue until disease progression or unacceptable toxicity. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
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Renal Impairment
Severe CrCl <30mL/min or ESRD requiring dialysis: Initially, 3 mg.
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Hepatic Impairment
Moderate or severe: Initially, 3 mg.
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Administration
cap: Should be taken on an empty stomach. Take at least 1 hr before or 2 hr after food. Swallow whole w/ water, do not crush/chew/open.
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Contraindications
Lactation.
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Special Precautions
Severe renal and moderate or severe hepatic impairment. Pregnancy.
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Adverse Reactions
Significant: Neutropenia, thrombocytopenia, rash, diarrhoea, constipation, nausea, vomiting, herpes zoster infection, peripheral oedema, peripheral neuropathy, posterior reversible encephalopathy syndrome. Rarely, hepatoxicity.
Eye disorders: Eye disease, blurred vision, conjunctivitis, xeropthalmia. Hepatobiliary disorders: Hepatic insufficiency. Musculoskeletal and connective tissue disorders: Back pain. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection. |
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Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
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Monitoring Parameters
Monitor platelet counts monthly during treatment, and more frequently during the initial 3 cycles; CBC; renal and LFT. Monitor for gastrointestinal and dermatologic toxicity; signs and symptoms of neuropathy and peripheral oedema.
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Drug Interactions
Reduced serum concentration with strong CYP3A inducers (e.g. rifampicin, phenytoin, carbamazepine).
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Food Interaction
Reduced serum concentration with St. John’s wort.
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Action
Description: Ixazomib is a proteasome inhibitor which reversibly binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome leading to activation of signaling cascades, cell-cycle arrest and apoptosis of tumour cells.
Pharmacokinetics: Absorption: Bioavailability: 58%. Food, particularly high fat meal, decreases rate and extent of absorption. Time to peak plasma concentration: Approx 1 hour. Distribution: Plasma protein binding: 99%. Metabolism: Metabolised in the liver by CYP enzymes and non-CYP proteins. Excretion: Urine (62%, <3.5% as unchanged drug); faeces (22%). Terminal half-life: 9.5 days. |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Database. Ixazomib, CID=25183872, https://pubchem.ncbi.nlm.nih.gov/compound/Ixazomib (accessed on Jan. 21, 2020) |
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Storage
Store below 30°C. Protect from moisture.
This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements. |
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MIMS Class
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ATC Classification
L01XG03 - ixazomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
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References
Anon. Ixazomib. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/03/2019. Buckingham R (ed). Ixazomib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/03/2019. Ixazomib. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 01/03/2019. Joint Formulary Committee. Ixazomib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/03/2019. Ninlaro Capsules (Millennium Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 01/03/2019.
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