Scemblix Generic Name & Formulations
Asciminib 20mg, 40mg; tabs.
Tabs 20mg, 40mg—60; 40mg—300 (5x60)
In adults with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with ≥2 tyrosine kinase inhibitors (TKIs); or Ph+ CML in CP with the T315I mutation.
Scemblix Dosage and Administration
Swallow whole. Take on an empty stomach. Avoid food for at least 2hrs before and 1hr after dosing. Previously treated with ≥2 TKIs: 80mg once daily (at same time each day) or 40mg twice daily (at approx. 12hr intervals). With T315I mutation: 200mg twice daily (at approx. 12hr intervals). Dose modifications for adverse reactions: see full labeling.
Scemblix Boxed Warnings
Monitor for myelosuppression, pancreatic toxicity (increase monitoring if history of pancreatitis), hypertension, hypersensitivity. Monitor for cardiovascular signs/symptoms in those with a history of cardiovascular risk factors. Reduce dose, temporarily withhold, or permanently discontinue based on severity of adverse reactions; see full labeling. Perform CBCs every 2 weeks for the 1st 3 months, then monthly thereafter or as clinically indicated. Assess serum lipase and amylase levels monthly during therapy, or as clinically indicated; temporarily withhold if lipase and amylase elevation are accompanied by abdominal symptoms. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Potentiated by strong CYP3A4 inhibitors (eg, clarithromycin); monitor closely. Antagonized by itraconazole oral soln containing hydroxypropyl-β-cyclodextrin; avoid. Potentiates certain CYP3A4 substrates (eg, midazolam); avoid concomitant with Scemblix at 200mg twice daily; monitor closely with Scemblix at 80mg daily dose. Potentiates CYP2C9 substrates (eg, warfarin). Avoid concomitant with certain CYP2C9 substrates at Scemblix 80mg daily dose; if unavoidable, reduce CYP2C9 substrate dose. Avoid concomitant with sensitive or certain CYP2C9 substrates at Scemblix 200mg twice daily dose; if unavoidable, consider alternatives (eg, non-CYP2C9 substrate). Potentiates P-gp substrates; monitor closely.
Scemblix Adverse Reactions
Upper respiratory tract infections, musculoskeletal pain, headache, fatigue, nausea, rash, diarrhea, lab abnormalities (decreased platelet count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, increased triglycerides, increased creatine kinase, increased ALT/AST, increased lipase, increased amylase, increased uric acid); hypertension, myelosuppression, pancreatic, or cardiovascular toxicity.
Scemblix Clinical Trials
Scemblix Patient Counseling