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

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Tocenar 50 mg Powder for concentrate for solution for infusion
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