Ninlaro

Ixazomib citrate

Adults w/ multiple myeloma who have received at least 1 prior therapy in combination w/ lenalidomide & dexamethasone. Maintenance therapy in adults w/ multiple myeloma following autologous stem cell transplantation & multiple myeloma not treated w/ stem cell transplantation.

Patient w/ multiple myeloma who have received at least 1 prior therapy in combination w/ lenalidomide & dexamethasone Recommended starting dose: 4 mg once wkly on Days 1, 8 & 15 of 28-day treatment cycle. Starting dose of lenalidomide: 25 mg daily on Days 1-21 of 28-day treatment cycle. Starting dose of dexamethasone: 40 mg on Days 1, 8, 15 & 22 of 28-day treatment cycle. Dose reduction steps: 1st reduction: 3 mg, 2nd reduction: 2.3 mg. Patient w/ multiple myeloma following autologous stem cell transplantation & those not treated w/ stem cell transplantation Initially 3 mg, escalated to 4 mg on Day 1 of cycle 5, if tolerated during first 4 cycles. Recommended dose: 4 mg once wkly on Days 1, 8 & 15 of 28-day treatment cycle. Dose reduction: Cycle 1-4: 1st dose reduction: 2.3 mg. Cycle 5: 1st dose reduction: 3 mg, 2nd dose reduction: 2.3 mg. Moderate or severe hepatic impairment, severe renal impairment & ESRD requiring dialysis Initially 2.3 mg, escalated to 3 mg on Day 1 of cycle 5, if tolerated during first 4 cycles.

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

Hypersensitivity.

Discontinue treatment in patients developing posterior reversible encephalopathy syndrome (PRES); if thrombotic microangiopathy (TMA) is suspected. Thrombocytopenia; diarrhoea, constipation, nausea & vomiting; peripheral neuropathy; peripheral oedema; rash; TMA including TTP; PRES. Monitor platelet counts at least mthly during treatment; serum K in case of severe GI events; symptoms of peripheral neuropathy; signs & symptoms of TMA; hepatic enzymes. Evaluate patient for underlying causes of peripheral oedema. Avoid concomitant use w/ strong CYP3A inducers eg, carbamazepine, phenytoin, rifampicin & St. John's Wort (Hypericum perforatum). May have minor influence on ability to drive or use machines. Women of childbearing potential & males who are able to have childn must use highly effective contraception during & 90 days after treatment; women using oral hormonal contraceptives should additionally use barrier method of contraception. Not recommended in women of childbearing potential not using contraception & during pregnancy. Discontinue breastfeeding during treatment. Childn <18 yr.

URTI, pneumonia, herpes zoster; thrombocytopenia, neutropenia; peripheral neuropathies; diarrhoea, nausea, vomiting, constipation; rash; back pain, arthralgia; peripheral oedema.

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

Targeted Cancer Therapy

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

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