Aubagio 14 mg FC tablets

Aubagio 14 mg 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 severe 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 breast milk; caution is advised.

Key Drug Interactions

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

Contraindications

  • Pregnancy
  • Severe hepatic impairment
  • Hypersensitivity to teriflunomide or any of its components
  • Current or history of severe immunodeficiency

Common side effects

  • Diarrhea
  • Nausea
  • Hair loss
  • Elevated liver enzymes
  • Headache
  • Hypertension
  • Infections

Counselling Points

  • Advise patients to report any signs of liver problems, such as jaundice or dark urine.
  • Inform patients about the potential risk of infections and to seek medical advice if they experience symptoms.
  • Discuss the importance of adhering to contraception guidelines during and after treatment.
  • Encourage patients to maintain regular follow-up appointments for monitoring.

Serious warnings

  • Monitor liver function tests before and during treatment.
  • Risk of serious infections; consider screening for tuberculosis before starting therapy.
  • Patients should be monitored for signs of peripheral neuropathy.
Important Disclaimer

The Aubagio 14 mg 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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