Phenasen 10 mg/10 ml Concentrated solution for infusion)

Phenasen 10 mg/10 ml Concentrated solution for infusion)

S4
PDF Leaflet Revision Date: 06 February 2023


Clinical Summary

Quick overview from the medicine insert

Indication

Induction and consolidation treatment for acute promyelocytic leukaemia.

Dosage (summary)

0.15 mg/kg/day IV until hematological CR or max 60 days; consolidation 0.15 mg/kg/day 5 days/week.

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Embryotoxic and teratogenic; contraindicated in pregnancy and breastfeeding.

Key Drug Interactions

  • QT prolonging medications
  • Hepatotoxic medications

Contraindications

  • Hypersensitivity to arsenic trioxide
  • Heart block
  • Congestive cardiac failure

Common side effects

  • Leukocytosis
  • Hepatotoxicity
  • Peripheral neuropathy
  • QT prolongation

Counselling Points

  • Monitor for signs of APL differentiation syndrome
  • Use effective contraception
  • Avoid QT prolonging drugs

Serious warnings

  • APL differentiation syndrome
  • Risk of torsade de pointes
  • Potential for sudden death

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Phenasen 10 mg/10 ml Concentrated solution for infusion)
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