Asciminib Application Scope

It is a selective allosteric inhibitor of the BCR-ABL1 fusion protein indicated for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase:

Patients previously treated with two or more tyrosine kinase inhibitors (TKIs)
Patients with the T315I mutation
It inhibits BCR-ABL1 kinase activity through binding the myristoyl pocket, blocking leukemic cell proliferation and disease progression.

Asciminib Characteristics

Ingredients: Asciminib monohydrate (active ingredient)
Properties: Oral solid dosage form; film-coated tablets
Packaging Specification: 40 mg × 60 tablets/bottle
Storage: Store at 20–25 °C; protect from moisture and light
Expiry Date: 24 months from manufacture
Executive Standard: Conforms to local drug quality standards
Approval Number: Refer to local regulatory authority
Date of Revision: As per latest prescribing information
Manufacturer: Novartis Pharmaceuticals

Guidelines for the Use of Scemblix

Dosage and Administration:
- Recommended Dose: 40 mg orally twice daily (or 80 mg once daily for certain patients)
- Administration: Take with or without food; swallow whole; do not crush or chew
- Missed Dose: Take as soon as remembered unless it is almost time for the next dose; do not double dose
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Nausea, vomiting, diarrhea
  - Headache
  - Rash
  - Musculoskeletal pain
- Serious Adverse Reactions:
  - Myelosuppression (neutropenia, thrombocytopenia, anemia)
  - QT prolongation
  - Hepatotoxicity
  - Pancreatitis
  - Severe infections
Contraindications:
- Hypersensitivity to asciminib or any excipients
- Pregnancy and breastfeeding
Precautions:
- Monitor complete blood count regularly
- Monitor liver function tests
- Assess ECG for QT interval prolongation
- Adjust dose for hepatic impairment
- Avoid strong CYP3A4 inhibitors or inducers

Asciminib Interactions

CYP3A4 inhibitors: may increase its exposure → monitor for toxicity
CYP3A4 inducers: may reduce efficacy → avoid if possible
Other QT-prolonging drugs: additive risk → monitor ECG

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.