Scemblix

Philadelphia chromosome +ve chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) in adults previously treated w/ ≥2 tyrosine kinase inhibitors (TKIs). Ph+ CML in CP w/ T315I mutation in adults.

Ph+ CML-CP previously treated w/ ≥2 TKIs 80 mg once daily at approx the same time each day, or 40 mg bd at approx 12-hr intervals. Ph+ CML-CP w/ T315I mutation 200 mg bd at approx 12-hr intervals.

Should be taken on an empty stomach: Swallow whole. Do not break/crush/chew. Avoid food consumption for at least 2 hr before & 1 hr after taking Scemblix.

Risk of thrombocytopenia, neutropenia, & anemia; pancreatitis; asymptomatic elevation of serum lipase & amylase; HTN; hypersensitivity; CV toxicity (including ischemic cardiac & CNS conditions, arterial thrombotic & embolic conditions) & cardiac failure; arrhythmia (including QTc prolongation). Monitor patients for signs & symptoms of myelosuppression; pancreatic toxicity; hypersensitivity. Perform more frequent monitoring in patients w/ history of pancreatitis. Monitor & manage HTN using standard antihypertensive therapy during treatment w/ Scemblix as clinically indicated. Monitor patients w/ history of CV risk factors for CV signs & symptoms. Perform CBC every 2 wk for the 1st 3 mth of treatment & mthly thereafter, or as clinically indicated. Assess serum lipase & amylase levels mthly during treatment, or as clinically indicated. Reduce dose, temporarily w/hold, or permanently discontinue treatment based on the severity of thrombocytopenia &/or neutropenia; severity of lipase & amylase elevation; persistence of HTN for grade ≥3 HTN; persistence of hypersensitivity for grade ≥3 hypersensitivity; persistence of CV toxicity for grade ≥3 CV toxicity. Risk of embryo-fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment & for 1 wk after the last dose. May impair fertility in females of reproductive potential. Do not breastfeed during treatment & for 1 wk after the last dose. Safety & efficacy in ped patients have not been established. Insufficient data on safety or efficacy in elderly patients ≥75 yr.

Most common (≥20%): Musculoskeletal pain, fatigue; increased triglycerides, ALT, AST, & decreased platelet count, neutrophil count, Hb, lymphocyte count. Ph+ CML-CP previously treated w/ ≥2 TKIs: URTI, headache; increased creatine kinase, uric acid. Ph+ CML-CP w/ T315I mutation: Nausea, rash, diarrhea; increased lipase, amylase, bilirubin, & decreased phosphate.

Increased C_max & AUC w/ strong CYP3A4 inhibitors. Decreased C_max & AUC w/ itraconazole oral soln containing hydroxypropyl-β-cyclodextrin. Increased C_max & AUC of CYP3A4 substrates, CYP2C9 substrates, & OATP1B & BCRP substrates. Increased plasma conc of P-gp substrates.

Targeted Cancer Therapy

L01EA06 - asciminib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.

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