Arava Tablets

Arava Tablets

S4


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of active rheumatoid arthritis in adults and for the treatment of active psoriatic arthritis.

Dosage (summary)

Initial dose: 100 mg once daily for 3 days, followed by a maintenance dose of 10 mg to 20 mg once daily.

Onset of Action / Duration

Therapeutic effects may take several weeks to become apparent, typically 4 to 6 weeks.

Special Populations

  • Hepatic impairment
  • Renal impairment
  • Elderly patients

Pregnancy & Breastfeeding

Not recommended during pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least 2 years after discontinuation. Not recommended during breastfeeding.

Key Drug Interactions

  • Warfarin: Increased risk of bleeding.
  • Rifampicin: May decrease Leflunomide levels.
  • Cholestyramine: Can accelerate the elimination of Leflunomide.

Contraindications

  • Severe hepatic impairment
  • Pregnancy
  • Hypersensitivity to Leflunomide or any component of the formulation

Common side effects

  • Diarrhea
  • Nausea
  • Headache
  • Elevated liver enzymes
  • Alopecia
  • Hypertension

Counselling Points

  • Advise patients to report any signs of liver dysfunction, such as jaundice or dark urine.
  • Instruct patients to maintain adequate hydration.
  • Inform patients about the potential for teratogenic effects and the need for effective contraception.

Serious warnings

  • Monitor liver function tests regularly during treatment.
  • Risk of serious infections due to immunosuppression.
  • Caution in patients with a history of significant renal or hepatic disease.
Important Disclaimer

The Arava Tablets professional information leaflet below is the property of Sanofi-Aventis 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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