Registered South Africa · SAHPRA

TIRIFOMA

TERIFLUNOMIDE

56/32.16/0538 INN generic

What it does

Teriflunomide is a medication used to treat certain autoimmune conditions by helping to reduce inflammation.

Commonly used for: multiple sclerosis (MS), autoimmune diseases

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
56/32.16/0538
Registration date
2024/08/13
Expiry date
-
Status
Registered
Active ingredient
TERIFLUNOMIDE
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:29:10 · updated 2026-09-27 04:00:59

Drug Interactions

66
Check interactions

Pharmacodynamic Warnings

Teriflunomide appears in TABLE 1: Drugs that cause hepatotoxicity

Severe (1)

Teriflunomide - increases risk of immunosuppression

Filgotinib is predicted to increase the risk of immunosuppression when given with teriflunomide. Avoid.

Severe Theoretical

Moderate (3)

Cladribine - increases exposure

Teriflunomide is predicted to increase the exposure to cladribine. Avoid or adjust dose. Theoretical Clarithromycin → see macrolides Clavulanate → see TABLE 1 p. 1517 (hepatotoxicity) Clemastine → see

Moderate Theoretical

Olanzapine - decreases exposure

Teriflunomideispredictedtodecreasetheexposureto olanzapine.Monitorandadjustdose.oStudy com/codemedicalapps/ cal Applications)

Moderate Study

Theophylline - decreases exposure

Teriflunomide is predicted to decrease the exposure to theophylline. Adjust dose.

Moderate Study

Unknown (62)

Adefovir - increases exposure

Teriflunomideispredictedtoincreasetheexposuretoadefovir. oStudy Adenosine →seeantiarrhythmics Adrenaline/epinephrine →seesympathomimetics,vasoconstrictor Afatinib

Unknown Study

Agomelatine - decreases exposure

Teriflunomideispredictedtodecreasetheexposureto agomelatine.oTheoretical

Unknown Theoretical

Alpelisib - increases exposure

Teriflunomide is predicted to increase the exposure to alpelisib. Theoretical Alphablockers → see TABLE 7 p. 1518 (first-dose hypotension), TABLE 8 p. 1518 (hypotension) ... alfuzosin doxazosin indora

Unknown Theoretical

Aminophylline - decreases exposure

Teriflunomide decreases the exposure to aminophylline. Adjust dose.

Unknown Study

Anaesthetics,local - decreases exposure

Teriflunomide is predicted to decrease the exposure to anaesthetics, local (ropivacaine).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Teriflunomide is a medication used to treat certain autoimmune conditions by helping to reduce inflammation.

What it treats

  • multiple sclerosis (MS)
  • autoimmune diseases

How it works

It works by slowing down the immune system to reduce its attack on the nervous system.

Who it's for

This medication is for adults diagnosed with specific autoimmune conditions, particularly multiple sclerosis.

Cautions

  • • Be cautious if taking other medications that can harm the liver.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Teriflunomide

BNF-referenced

Teriflunomide is an immunomodulatory drug primarily used in the management of relapsing forms of multiple sclerosis (MS). It is a metabolite of leflunomide, which inhibits the enzyme dihydroorotate dehydrogenase, leading to decreased pyrimidine synthesis. This reduction in pyrimidine availability impacts lymphocyte proliferation and function, thereby modulating the immune response in MS patients.

Indications

  • Relapsing forms of multiple sclerosis

Dosage

Adults: 14 mg once daily, initiated by a specialist.

Mechanism of action

Teriflunomide acts by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, which is crucial for pyrimidine synthesis. This inhibition reduces the proliferation of activated lymphocytes in the central nervous system, contributing to its immunomodulatory effects in the treatment of multiple sclerosis.

Pharmacodynamics

As an immunomodulatory agent, teriflunomide decreases the number of activated lymphocytes in the central nervous system. This leads to anti-inflammatory and antiproliferative effects, which are beneficial in controlling the symptoms and progression of multiple sclerosis.

Pharmacokinetics

Teriflunomide is well absorbed following oral administration, with peak plasma concentrations occurring approximately 1 hour post-dose. It has a long half-life due to its active metabolite, resulting in prolonged effects. It is predominantly metabolized in the liver, with renal excretion playing a minor role in its elimination. Monitoring of liver function is necessary due to potential hepatotoxicity.

Contra-indications

  • Pregnancy
  • Severe hepatic impairment
  • Severe immunodeficiency

Adverse effects

  • Hepatic injury
  • Liver enzyme elevation
  • Diarrhea
  • Nausea
  • Alopecia
  • Hypertension
  • Skin rash
  • Peripheral neuropathy
  • Respiratory infections

Interactions

  • filgotinib (severe - increases risk of immunosuppression)
  • olanzapine (moderate - decreases exposure)
  • cladribine (moderate - increases exposure)
  • theophylline (moderate - decreases exposure)
  • adefovir (unknown - increases exposure)
  • agomelatine (unknown - decreases exposure)
  • alpelisib (unknown - increases exposure)
  • aminophylline (unknown - decreases exposure)
  • ropivacaine (unknown - decreases exposure)
  • anthracyclines (unknown - increases exposure)

Precautions

  • Monitor liver function regularly, especially during the first 6 months of treatment
  • Assess for interstitial lung disease in patients with dyspnea
  • Use caution in patients over 65 years
  • Monitor blood pressure periodically
  • Consider accelerated elimination procedures if serious adverse effects occur

Pregnancy

Avoid during pregnancy due to toxicity observed in animal studies.

Breast-feeding

Present in milk in animal studies; manufacturer advises to avoid use during breastfeeding.

Storage

Store in a refrigerator (2–8°C) and protect from light.

Formulations

  • 14 mg film-coated tablets for oral administration
BNF 85 (British National Formulary) p.963 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Teriflunomide

PubChem CID 54684141

Molecular formula: C12H9F3N2O2

Mechanism of action

The exact mechanism by which teriflunomide acts in MS is not known. What is known is that teriflunomide prevents pyrimidine synthesis by inhibiting the mitochondrial enzyme dihydroorotate dehydrogenase, and this may be involved in its immunomodulatory effect in MS.

Pharmacodynamics

Teriflunomide is an immunomodulatory agent that decreases the amount of activated CNS lymphocytes, which results in anti-inflammatory and antiproliferative effects.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.