Adult: In combination with lenalidomide and dexamethasone in patients who have received at least 1 prior treatment: 4 mg once weekly on Days 1, 8, and 15 of a 28-day treatment cycle. Continue treatment until disease progression or unacceptable toxicity occurs. Delayed or missed dose: Give the dose only if the next scheduled dose is ≥72 hours away. Delayed or missed dose should not be given within 72 hours of the next scheduled dose. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Renal Impairment
ESRD requiring dialysis: Reduce initial dose to 3 mg.
CrCl (mL/min)
Dosage
<30
Reduce initial dose to 3 mg.
Hepatic Impairment
Moderate to severe: Reduce initial dose to 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 to severe hepatic impairment. Pregnancy.
This drug may cause dizziness or fatigue, if affected, do not drive or operate machinery.
Monitoring Parameters
Confirm pregnancy status before starting treatment in females of reproductive potential. Monitor platelet counts monthly during treatment or more frequently during the 1st 3 cycles; CBC with differential, renal function tests and LFTs. Assess for signs and symptoms of skin reactions, peripheral neuropathy, peripheral oedema, and gastrointestinal toxicity.
Overdosage
Symptoms: Aspiration pneumonia, severe nausea, and multiple organ failure. Management: Supportive treatment.
Drug Interactions
May decrease efficacy with strong CYP3A inducers (e.g. rifampicin, carbamazepine, phenytoin); avoid concomitant use.
Food Interaction
May decrease efficacy with St. John's wort; avoid concomitant use. Decreased exposure with high-fat meals.
Action
Description: Mechanism of Action: Ixazomib is a highly selective and reversible proteasome inhibitor. It binds and inhibits the chymotrypsin-like activity of the β5 subunit of the 20S proteasome, leading to activation of signalling cascades, cell-cycle arrest, and apoptosis. Pharmacokinetics: Absorption: Decreased exposure with high-fat meals. Bioavailability: 58%. Time to peak plasma concentration: Approx 1 hour. Distribution: Plasma protein binding: 99%. Metabolism: Metabolised in the liver by multiple CYP enzymes and non-CYP proteins. Excretion: Via urine (62%, <3.5% as unchanged drug); faeces (22%). Terminal elimination half-life: 9.5 days.
Chemical Structure
Storage
Store below 30°C. Do not freeze. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L01XG03 - ixazomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
References
Anon. Ixazomib Citrate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 11/04/2023.Anon. Ixazomib. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/04/2023.Buckingham R (ed). Ixazomib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/04/2023.Joint Formulary Committee. Ixazomib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/04/2023.Ninlaro 2.3 mg Hard Capsules (Takeda Pharma A/S). MHRA. https://products.mhra.gov.uk. Accessed 11/04/2023.Ninlaro Capsule (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/04/2023.Ninlaro Hard Capsule (Takeda Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/04/2023.