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Scemblix
asciminib
Adult Dosing .
Dosage forms: TAB: 20 mg, 40 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
Ph-positive CML, chronic phase
- [T315I-negative disease]
- Dose: 80 mg PO daily; Alt: 40 mg PO bid; Info: avoid food for at least 2h before and 1h after administration; do not cut/crush/chew tab
- [T315I-positive disease]
- Dose: 200 mg PO bid; Info: avoid food for at least 2h before and 1h after administration; do not cut/crush/chew tab
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x1wk after D/C
- caution: patients of childbearing potential
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
Drug Interactions .
Overview
asciminib
kinase inhibitor
- CYP3A4 substrate
- CYP2C8 inhibitor, weak
- CYP2C9 inhibitor, moderate
- CYP3A4 inhibitor, weak
- BCRP inhibitor
- P-gp inhibitor, weak
- cardiotoxic effects
- hypertensive effects
- immunomodulatory effects
- myelosuppressive oncologic agent
- prolongs QT interval (conditional)
- thrombogenic effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- thrombocytopenia
- neutropenia
- anemia
- pancreatitis
- HTN
- hypersensitivity reaction
- cardiotoxicity
- cardiac failure
- arrhythmia
- QT prolongation
Common Reactions
- hypersensitivity reaction
- musculoskeletal pain
- thrombocytopenia
- neutropenia
- fatigue
- URI
- rash
- lipase incr.
- amylase incr.
- headache
- HTN
- diarrhea
- abdominal pain
- arthralgia
- anemia
- dyslipidemia
- arrhythmia
- constipation
- nausea
- cardiac failure
- vomiting
- pancreatitis
- lymphocytes decr.
- ALT or AST incr.
- uric acid incr.
- calcium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff at baseline, q2wk x3mo, then qmo or as clinically indicated; lipase, amylase at baseline, then qmo or as clinically indicated, or more frequently if pancreatitis history; BP
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity, embryo-fetal death, and incr. development rate based on animal data at <1x systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x1wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x1wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for asciminib: unknown; CYP450: 3A4 substrate; UGT: 2B7, 2B17 substrate
Excretion: for asciminib: feces 80% (57% unchanged), urine 11% (2.5% unchanged); Half-life: 5.5h (80 mg/day dose), 9h (400 mg/day dose)
Subclass: Kinase Inhibitors, BCR-ABL Inhibitors
Mechanism of Action
for asciminib: binds BCR-ABL myristoyl pocket, inhibiting BCR-ABL tyrosine kinase, including both wild-type and T315I mutant
Formulary .
No Formulary Selected
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