Ixazomib


Concise Prescribing Info
Indications/Uses
Multiple myeloma.
Dosage/Direction for Use
Adult : PO Combined with lenalidomide and dexamethasone in patient who have received at least one prior treatment: 4 mg once weekly 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).
Dosage Details
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).
Renal Impairment
Severe CrCl <30mL/min or ESRD requiring dialysis: Initially, 3 mg.
Hepatic Impairment
Moderate or severe: Initially, 3 mg.
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.
Contraindications
Lactation.
Special Precautions
Severe renal and moderate or severe hepatic impairment. Pregnancy.
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.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
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.
Drug Interactions
Reduced serum concentration with strong CYP3A inducers (e.g. rifampicin, phenytoin, carbamazepine).
Food Interaction
Reduced serum concentration with St. John’s wort.
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.
Chemical Structure

Chemical Structure Image
Ixazomib

Source: National Center for Biotechnology Information. PubChem Database. Ixazomib, CID=25183872, https://pubchem.ncbi.nlm.nih.gov/compound/Ixazomib (accessed on Jan. 21, 2020)

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.
ATC Classification
L01XX50 - ixazomib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
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.

Disclaimer: This information is independently developed by MIMS based on Ixazomib 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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