Ninlaro

Ninlaro

ixazomib

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ixazomib
Indications/Uses
In combination w/ lenalidomide & dexamethasone for adults w/ multiple myeloma who have received at least 1 prior therapy. Maintenance therapy w/ multiple myeloma following autologous stem cell transplant & for those who had not been treated w/ stem cell transplantation.
Dosage/Direction for Use
In combination w/ lenalidomide & dexamethasone for adult patient w/ multiple myeloma who have received at least 1 prior therapy Initially 4 mg once wkly on days 1, 8, & 15 of a 28-day treatment cycle. Starting dose of lenalidomide: 25 mg daily on days 1-21 of a 28-day treatment cycle. Starting dose of dexamethasone 40 mg on days 1, 8, 15, & 22 of a 28-day treatment cycle. Dose reduction steps: Starting dose: 4 mg. 1st reduction: 3 mg. 2nd reduction: 2.3 mg. Maintenance therapy w/ multiple myeloma following autologous stem cell transplant & those not treated w/ stem cell transplantation Cycle 1-4: 3 mg. Cycle 5 onwards: 4 mg. Administer once wkly for 3 wk on days 1, 8, & 15 followed by 13 days rest period (days 16-28). Dose reduction steps: Step 1: Cycle 1-4: 2.3 mg. Cycle 5 onwards: 3 mg. Step 2: Cycle 1-4: Discontinue. Cycle 5 onwards: 2.3 mg. Step 3: None. Cycle 5: Discontinue. Moderate or severe hepatic impairment, severe renal impairment (CrCl <30 mL/min) or ESRD requiring dialysis Reduced dose to 3 mg.
Administration
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
Special Precautions
Monitor platelet counts at least mthly during treatment & more frequently during the 1st 3 cycles. Monitor serum K level in case of severe GI events. Peripheral neuropathy & oedema. Discontinue if SJS occurs; thrombotic microangiopathy including thrombocytopenic purpura is suspected; posterior reversible encephalopathy syndrome develops. Regularly monitor hepatic enzymes & adjust dosing for grade 3 or 4 symptoms. Avoid concomitant use w/ strong CYP3A inducers eg, carbamazepine, phenytoin, rifampicin & St. John's Wort (Hypericum perforatum). Minor influence on the ability to drive or use machines. Male & female patients must use effective contraceptive measures during & for 90 days following treatment. Not recommended in women of childbearing potential not using contraception; women using oral hormonal contraceptives should use additional barrier method of contraception. Avoid during pregnancy. Discontinue breastfeeding during treatment. Childn <18 yr.
Adverse Reactions
URTI, bronchitis; thrombocytopenia, neutropenia; peripheral neuropathies; diarrhoea, constipation, nausea, vomiting; rash; back pain; peripheral oedema. Herpes zoster.
Drug Interactions
Decreased Cmax & AUC w/ strong CYP3A4 inducers eg, rifampin. Reduced efficacy of OCs due to interaction w/ dexamethasone.
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 cap 3 mg
Packing/Price
((blister wallet)) 3 × 1's
Form
Ninlaro cap 4 mg
Packing/Price
((blister wallet)) 3 × 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in