Bacrelba 20 mg & 40 mg Tablets
PDF Leaflet Revision Date: 15 May 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of adult patients with Ph+ CML in chronic phase.
Dosage (summary)
80 mg once daily or 40 mg twice daily; 200 mg twice daily for T315I mutation.
Special Populations
- Renal impairment
- Hepatic impairment
- Elderly
Pregnancy & Breastfeeding
Can cause fetal harm; not recommended during pregnancy or breastfeeding.
Key Drug Interactions
- Strong CYP3A4 inhibitors
- Strong CYP3A4 inducers
- CYP2C9 substrates
Contraindications
- Hypersensitivity to asciminib or excipients
Common side effects
- Thrombocytopenia
- Neutropenia
- Fatigue
- Musculoskeletal pain
- Diarrhea
Counselling Points
- Take without food; monitor for myelosuppression; use contraception during treatment.
Serious warnings
- Myelosuppression
- Pancreatic toxicity
- QT prolongation
- Hypertension
Important Disclaimer
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