Ninlaro

In combination w/ lenalidomide & dexamethasone for treatment of 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.

In combination w/ lenalidomide & dexamethasone for treatment of adult w/ multiple myeloma who has received at least 1 prior therapy Starting dose: 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 in adult w/ multiple myeloma following autologous stem cell transplant & for those who had not been treated w/ stem cell transplantation Administer once wkly for 3 wk on days 1, 8, & 15 followed by 13 days rest period (days 16-28). Repeat 4-wk treatment cycle. Cycle 1-4: 3 mg. Cycle 5 or later: 4 mg. Dose reduction steps: Step 1: Cycle 1-4: 2.3 mg. Cycle 5 or later: 3 mg. Step 2: Cycle 1-4: Discontinue. Cycle 5 or later: 2.3 mg. Step 3: Cycle 5 or later: Discontinue. Patient w/ moderate (total bilirubin >1.5-3 x ULN) or severe (total bilirubin >3 x ULN) hepatic impairment, severe renal impairment (CrCl <30 mL/min) or ESRD requiring dialysis Reduced dose of 3 mg is recommended.

Should be taken on an empty stomach: Take at approx the same time on days 1, 8, & 15 of each cycle at least 1 hr before or at least 2 hr after food. Swallow whole w/ water, do not crush/chew/open.

Hypersensitivity.

Reports of thrombocytopenia; diarrhoea, constipation, nausea & vomiting; peripheral neuropathy; peripheral oedema; rash; thrombotic microangiopathy (TMA); drug-induced liver & hepatocellular injury, hepatic steatosis, cholestatic hepatitis & hepatotoxicity (uncommon). Discontinue if SJS occurs; if diagnosis of TMA is suspected; in patients developing posterior reversible encephalopathy syndrome. Monitor platelet counts at least mthly during treatment, & more frequently during the 1st 3 cycles; serum K level in case of GI events; for symptoms of peripheral neuropathy; for signs & symptoms of TMA. Regularly monitor hepatic enzymes. Evaluate for underlying causes of peripheral oedema & provide supportive care as necessary. Avoid concomitant use w/ strong CYP3A inducers eg, carbamazepine, phenytoin, rifampicin & St. John's wort (Hypericum perforatum). Minor influence on ability to drive or use machines (fatigue & dizziness have been observed). Male & female patients must use effective contraception 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. Not recommended during pregnancy. Discontinue breastfeeding during treatment. Safety & efficacy have not been established in childn <18 yr.

URTI, bronchitis; thrombocytopenia, neutropenia; peripheral neuropathies; diarrhoea, constipation, nausea, vomiting; rash; back pain; peripheral oedema. Herpes zoster.

Decreased C_max & AUC w/ strong CYP3A inducers eg, rifampicin. Risk of reduced efficacy of OCs w/ dexamethasone.

Targeted Cancer Therapy

L01XG03 - ixazomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.

Rx