Yelcidro 50 mg Powder for concentrate for solution for infusion

Indication

Treatment of adult patients (u2265 65 years) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML).

Dosage (summary)

20 mg/mu00b2 IV infusion over 1 hour daily for 5 days, repeat every 4 weeks.

Onset of Action / Duration

Onset: 4.3 months for response.

Special Populations

• Hepatic impairment
• Renal impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy and lactation; teratogenic in animal studies.

Key Drug Interactions

• Caution with other medicines activated by phosphorylation or metabolized by cytidine deaminase.

Contraindications

• Hypersensitivity to decitabine
• Lactating women

Common side effects

• Myelosuppression
• Infections
• Nausea
• Vomiting
• Diarrhoea

Counselling Points

• Use effective contraception during treatment.
• Avoid breastfeeding while on YELCIDRO.
• Caution advised when driving or operating machinery.