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SCEMBLIX

ASCIMINIB

Manufacturer: Novartis Pharmaceuticals Corporation

Score: 141.0

Quick Summary

SCEMBLIX (asciminib) is a kinase inhibitor used for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), including those with the T315I mutation. The recommended dosage is 80 mg orally once daily or 40 mg orally twice daily for Ph+ CML in CP, and 200 mg orally twice daily for Ph+ CML in CP with the T315I mutation. Important safety information includes warnings for myelosuppression, pancreatic toxicity, hypertension, and hypersensitivity. Contraindications and adverse reactions are also listed. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of adult patients with Ph+ CML in CP
  • Treatment of adult patients with Ph+ CML in CP with the T315I mutation
  • Indicated for newly diagnosed Ph+ CML in CP and previously treated Ph+ CML in CP

Important Safety Information

Warning

Myelosuppression, pancreatic toxicity, hypertension, and hypersensitivity

Contraindications

  • None

Adverse Reactions

  • Musculoskeletal pain
  • Rash
  • Fatigue
  • Upper respiratory tract infection
  • Headache
  • Abdominal pain
  • Diarrhea

Dosing Recommendations

General Guidance

Dosage modifications for adverse reactions are listed in Table 2

Ph+ CML in CP

Adult Dose

80 mg orally once daily or 40 mg orally twice daily

Pediatric Dose

Not established

Ph+ CML in CP with the T315I mutation

Adult Dose

200 mg orally twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Can cause embryo-fetal harm
  • Advise pregnant women and females of reproductive potential of the potential risk to a fetus

Nursing Mothers

  • Not specified

Pediatric Use

  • The safety and efficacy of SCEMBLIX in pediatric patients have not been established

Geriatric Use

  • No differences in safety or efficacy of SCEMBLIX were observed between patients 65 years of age and older compared to younger patients

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