Tocenar 50 mg Powder for concentrate for solution for infusion

Tocenar 50 mg Powder for concentrate for solution for infusion

S4
PDF Leaflet Revision Date: 25 April 2025

API: Decitabine | Company: Aurogen Sa

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of adult patients with newly diagnosed acute myeloid leukaemia.

Dosage (summary)

20 mg/mu00b2 IV infusion daily for 5 days, repeated every 4 weeks.

Special Populations

  • Hepatic impairment
  • Renal impairment
  • Elderly

Pregnancy & Breastfeeding

Contraindicated in pregnancy and breastfeeding; potential risk to fetus.

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
  • Avoid breastfeeding
  • Monitor for signs of infection

Serious warnings

  • Risk of severe infections
  • Monitor for interstitial lung disease
Important Disclaimer

The Tocenar 50 mg Powder for concentrate for solution for infusion professional information leaflet below is the property of Aurogen Sa 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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