Darbect 50 mg Powder for concentrate for solution for infusion
PDF Leaflet Revision Date: 25 April 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of adult patients (> 65 years) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML).
Dosage (summary)
20 mg/mu00b2 IV infusion over 1 hour for 5 consecutive days, repeated every 4 weeks.
Special Populations
- Hepatic impairment
- Renal impairment
- Elderly
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding; potential risk to fetus unknown.
Key Drug Interactions
- Caution with drugs activated by phosphorylation
- Caution with cytidine deaminase inhibitors
Contraindications
- Hypersensitivity to decitabine
- Lactating women
Common side effects
- Myelosuppression
- Infections
- Febrile neutropenia
- Nausea
- Vomiting
Counselling Points
- Use effective contraception during treatment
- Monitor for signs of infection
- Caution advised when driving or operating machinery
Serious warnings
- Risk of severe infections
- Interstitial lung disease
- Myelosuppression complications
Important Disclaimer
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