Ninlaro

Ninlaro

ixazomib

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ixazomib citrate
Indications/Uses
In combination w/ lenalidomide & dexamethasone for patients w/ multiple myeloma who have received at least 1 prior therapy.
Dosage/Direction for Use
Recommended initial dose: 4 mg once wkly on days 1, 8 & 15 of 28-day treatment cycle. Recommended initial lenalidomide dose: 25 mg daily on days 1-21 of 28-day treatment cycle. Recommended initial dexamethasone dose: 40 mg on days 1, 8, 15 & 22 of 28-day treatment cycle. Moderate hepatic, severe hepatic or renal impairment & ESRD requiring dialysis Reduce initial dose to 3 mg.
Administration
Should be taken on an empty stomach: Take at approx the same day & time each week for the 1st 3 weeks, at least 1 hr before or 2 hr after meals. Swallow whole w/ water, do not crush/chew/open.
Contraindications
Special Precautions
Thrombocytopenia; GI toxicities; peripheral edema; cutaneous reactions; thrombotic microangiopathy including TTP/hemolytic uremic syndrome. Monitor for symptoms of new or worsening peripheral neuropathy. Monitor platelet counts at least mthly during treatment & hepatic enzymes regularly. Hepatic or renal impairment. Men & women of childbearing potential should use effective contraception during & for 90 days following final dose. Avoid use during pregnancy. Not to be used during lactation & for 90 days after last dose. Ped patients.
Adverse Reactions
URTI, bronchitis; thrombocytopenia, neutropenia; peripheral neuropathies; diarrhoea, constipation, nausea, vomiting; rash; back pain; peripheral oedema. Herpes zoster.
Drug Interactions
Avoid concomitant use w/ strong CYP3A inducers eg, rifampin, phenytoin, carbamazepine, St. John's wort. Reduced efficacy of OCs.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XG03 - ixazomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Ninlaro hard cap 2.3 mg
Packing/Price
3's
Form
Ninlaro hard cap 3 mg
Packing/Price
3's
Form
Ninlaro hard cap 4 mg
Packing/Price
3's
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