Aubagio (Teriflunomide) – Multiple Sclerosis | DengYueMed

Aubagio Application Scope

Aubagio is an oral immunomodulator (teriflunomide) used to treat relapsing forms of multiple sclerosis.

Characteristics

• Ingredients: Teriflunomide

• Properties:

  • Mechanism: inhibits dihydroorotate dehydrogenase

  • Reducing T‑cell proliferation by blocking de novo pyrimidine synthesis

  • 99% protein-bound; half-life ~18–19 days (steady state ~3 months)

• Packaging Specification: Supplied in blister packs (varies by region/market); typically 7 or 14 count packs

• Storage:

  • Store at controlled room temperature (20–25 °C).

  • Keep in the original container to protect from moisture and light.

• Expiry Date: Printed on packaging; typically 24–36 months from manufacture.
• Executive Standard: Meets FDA-approved prescribing information; EU SmPC guidelines
• Approval Number: U.S. NDA 202992; originally approved 09/12/2012
• Date of Revision: Latest U.S. label revision: June 2024
• Manufacturer: Sanofi-Aventis U.S. Inc.

Guidelines for the Use of Aubagio

• Dosage and Administration:

  • Recommended dose: 7 mg or 14 mg orally once daily, with or without food

  • No dose adjustment needed for mild/moderate hepatic or renal impairment

  • Avoid in severe hepatic impairment

• Adverse Reactions:

  • Common: elevated ALT, hypertension, diarrhea, alopecia, nausea

  • Serious: hepatotoxicity (rare acute liver failure), teratogenicity, hypersensitivity reactions

• Contraindications:

  • Severe hepatic impairment; pregnancy or women of childbearing potential not using reliable contraception

  • Known hypersensitivity to teriflunomide, leflunomide, or excipients; concurrent leflunomide use

• Precautions:

  • Monitor liver enzymes monthly for 6 months

  • Baseline CBC, TB screening, and blood pressure before therapy start

  • If pregnant or planning pregnancy, one must undergo the accelerated elimination procedure

  • Use caution in the elderly (≥65 years)

Aubagio Interactions

• Drug Interactions:

  • Teriflunomide may increase exposure to drugs metabolized by BCRP and OATP1B1/B3 transporters

  • Limit the rosuvastatin dose to ≤10 mg daily

  • Avoid co-administration with leflunomide

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.