Yelcidro 50 mg Powder for concentrate for solution for infusion

Yelcidro 50 mg Powder for concentrate for solution for infusion

S4
PDF Leaflet Revision Date: 05 September 2023


Clinical Summary

Quick overview from the medicine insert

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.

Serious warnings

  • Myelosuppression and associated complications likely.
  • Monitor blood counts regularly.
Important Disclaimer

The Yelcidro 50 mg Powder for concentrate for solution for infusion professional information leaflet below is the property of Hetero Drugs South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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