teriflunomide: clinical use

Prescribing considerations

• Treatment should be initiated and supervised by a clinician experienced in multiple-sclerosis management.
• Exclude pregnancy and counsel about contraception and prolonged persistence.
• Review liver disease, alcohol intake, hepatotoxic medicines, infection status, blood pressure and haematological risk.
• Use caution in people aged 65 years or over because clinical experience is limited.
• Consider tuberculosis management before treatment when screening is positive.
• Plan switches from other immunomodulators carefully because overlapping immune effects may occur.

Contraindications and cautions

• Pregnancy or absence of reliable contraception while plasma concentrations remain clinically relevant
• Breastfeeding
• Severe hepatic impairment
• Severe active infection until resolved
• Severe immunodeficiency
• Significant bone-marrow impairment or cytopenias
• Severe renal impairment requiring dialysis
• Severe hypoproteinaemia
• Hypersensitivity to teriflunomide or product excipients

Monitoring

• Before treatment: blood pressure, ALT and full blood count including differential and platelets; exclude pregnancy where relevant.
• During treatment: monitor liver enzymes regularly, particularly early in treatment, and intensify monitoring with hepatic risk factors or suggestive symptoms.
• Check blood pressure periodically and manage elevations.
• Repeat blood counts when clinical features such as infection suggest haematological toxicity.
• Assess new respiratory or neuropathic symptoms, serious infection, severe rash or suspected liver injury promptly.
• Use an accelerated elimination procedure when rapid clearance is clinically required.

Clinical pharmacology

Teriflunomide selectively and reversibly inhibits mitochondrial dihydroorotate dehydrogenase. It is highly protein-bound, undergoes enterohepatic recycling and has a long terminal half-life, explaining its slow spontaneous elimination and clinically important transporter interactions.

Formulation and product differences

• The selected Sandoz product is a blue, round film-coated tablet containing lactose and Allura Red AC, which may cause allergic reactions.
• It is essentially sodium-free and should not be used in specified rare hereditary disorders affecting galactose or lactose handling.

Tablet

Route: Oral

Strengths: 7 mg, 14 mg