Auberif 14mg FC tablets

Auberif 14mg FC tablets

S4


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of relapsing forms of multiple sclerosis (MS) in adults.

Dosage (summary)

The recommended dose is 14 mg once daily, taken orally with or without food.

Onset of Action / Duration

Therapeutic effects may take several weeks to months to become apparent.

Special Populations

  • Hepatic impairment
  • Renal impairment
  • Elderly patients
  • Patients with a history of significant infections

Pregnancy & Breastfeeding

Teriflunomide is contraindicated in pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least 2 years after discontinuation. It is not known if teriflunomide is excreted in human milk; caution should be exercised when administered to nursing mothers.

Key Drug Interactions

  • Other immunosuppressive agents may increase the risk of infections.
  • Cholestyramine or activated charcoal can accelerate the elimination of teriflunomide.
  • Caution with drugs that may affect liver function.

Contraindications

  • Pregnancy
  • Severe hepatic impairment
  • Hypersensitivity to teriflunomide or any component of the formulation
  • Active infections

Common side effects

  • Diarrhea
  • Nausea
  • Abdominal pain
  • Elevated liver enzymes
  • Alopecia
  • Rash
  • Infections

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 risk of infections and to seek medical attention if symptoms develop.
  • Discuss the importance of effective contraception during treatment and after discontinuation.

Serious warnings

  • Monitor liver function tests before and during treatment.
  • Risk of serious infections; monitor for signs and symptoms.
  • May cause fetal harm; contraindicated in pregnancy.
  • Caution in patients with pre-existing liver disease.
Important Disclaimer

The Auberif 14mg FC 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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