Fludara 50mg Solution

Fludara 50mg Solution

S4
PDF Leaflet Revision Date: 10 July 2018

API: Fludarabine | Company: Sanofi-Aventis

Clinical Summary

Quick overview from the medicine insert

Indication

Initial treatment of B-cell chronic lymphocytic leukaemia (CLL).

Dosage (summary)

IV: 25 mg/mu00b2 daily for 5 days every 28 days; Oral: 40 mg/mu00b2 daily for 5 days every 28 days.

Special Populations

  • Renal impairment
  • Hepatic impairment
  • Elderly patients

Pregnancy & Breastfeeding

Contraindicated in pregnancy; not known if excreted in breast milk.

Key Drug Interactions

  • Pentostatin (increased pulmonary toxicity)
  • Dipyridamole (reduced efficacy)

Contraindications

  • Hypersensitivity to fludarabine
  • Renal impairment (creatinine clearance < 30 ml/min)
  • Haemolytic anaemia

Common side effects

  • Neutropenia
  • Anaemia
  • Thrombocytopenia
  • Nausea
  • Vomiting
  • Fatigue

Counselling Points

  • Monitor for neurological side effects
  • Avoid live vaccines
  • Use effective contraception during treatment

Serious warnings

  • Severe neurotoxicity
  • Leukoencephalopathy
  • Myelosuppression
  • Autoimmune phenomena
Important Disclaimer

The Fludara 50mg Solution professional information leaflet below is the property of Sanofi-Aventis 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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