Teriflunomide (teriflunomide)

Teriflunomide is a small molecule, so copies are conventional generic tablets (ANDA in the US) that must demonstrate bioequivalence to the reference product and are AB-rated/therapeutically equivalent. US exclusivity: Aubagio was the first drug to use teriflunomide as an active ingredient and received NCE exclusivity; Sanofi settled with about 20 generic developers in 2017 granting royalty-free US launches on 12 March 2023, and multiple generic versions launched on 13 March 2023. European generics were expected from Q4 2023. Among FDA-approved generics are Teva, Accord, Glenmark, Alembic, Hetero, Biocon, Natco Pharma (USA), MSN, Sola and Concord Biotech. Published US wholesale acquisition cost for teriflunomide ranges widely (USD 32.40 to USD 2,058.90 per 30-day supply), reflecting multiple generic entrants. Manufacturers supplying teriflunomide generic versions include Accord Healthcare, Alembic Pharmaceuticals, Biocon Pharma, Concord Biotech Ltd., Glenmark Pharmaceuticals, Hetero Labs Ltd., Natco Pharma Ltd., Teva Pharmaceuticals. Brands registered in Bangladesh include not in the MedEx registry.

Standard dosing for teriflunomide: 7 mg or 14 mg orally once daily, with or without food. The 7 mg and 14 mg film-coated tablets contain 7 mg and 14 mg of teriflunomide respectively. Dose adjustments: No dosage adjustment is necessary for patients with mild and moderate hepatic impairment; the pharmacokinetics in severe hepatic impairment have not been evaluated and Aubagio is contraindicated in severe hepatic impairment. No dosage adjustment is necessary for patients with renal impairment. Contraindicated in pregnancy and in females of reproductive potential not using effective contraception, in patients with a history of hypersensitivity to teriflunomide or leflunomide, and with concomitant leflunomide. If drug-induced liver injury is suspected, discontinue and start accelerated elimination (cholestyramine or activated charcoal for 11 days). Rosuvastatin dose should not exceed 10 mg once daily in patients taking Aubagio. Monitor patients on CYP2C8, OAT3, BCRP and OATP1B1/B3 substrates and on CYP1A2 substrates or warfarin.

Elimination half-life: Median t1/2 approximately 18 days after repeated 7 mg doses and 19 days after repeated 14 mg doses; approximately 3 months to reach steady state; estimated AUC accumulation ratio approximately 30. Because of the long half-life, the label advises considering it when giving live vaccines after stopping treatment.. Dosing intervals are designed around this, which is why most regimens are once or twice daily.

Teriflunomide (Pyrimidine synthesis inhibitor (dihydroorotate dehydrogenase inhibitor); oral immunomodulatory disease-modifying therapy (DMT) for multiple sclerosis, originally Aubagio by Genzyme Corporation, a Sanofi company (US label lists Genzyme Corporation, Cambridge, MA; Sanofi markets Aubagio)) Teriflunomide blocks an enzyme that activated T and B lymphocytes need to make new pyrimidines and multiply. With fewer activated lymphocytes, there is less inflammation and immune attack on the nerves, which reduces MS relapses. 7 mg or 14 mg orally once daily, with or without food. The 7 mg and 14 mg film-coated tablets contain 7 mg and 14 mg of teriflunomide respectively.

Standard dosing for teriflunomide: 7 mg or 14 mg orally once daily, with or without food. The 7 mg and 14 mg film-coated tablets contain 7 mg and 14 mg of teriflunomide respectively. Dose adjustments: No dosage adjustment is necessary for patients with mild and moderate hepatic impairment; the pharmacokinetics in severe hepatic impairment have not been evaluated and Aubagio is contraindicated in severe hepatic impairment. No dosage adjustment is necessary for patients with renal impairment. Contraindicated in pregnancy and in females of reproductive potential not using effective contraception, in patients with a history of hypersensitivity to teriflunomide or leflunomide, and with concomitant leflunomide. If drug-induced liver injury is suspected, discontinue and start accelerated elimination (cholestyramine or activated charcoal for 11 days). Rosuvastatin dose should not exceed 10 mg once daily in patients taking Aubagio. Monitor patients on CYP2C8, OAT3, BCRP and OATP1B1/B3 substrates and on CYP1A2 substrates or warfarin.

Publicly listed pricing for teriflunomide in India: Denopsy (Natco Pharma) teriflunomide 14 mg tablet — INR 911 per tablet pack (MRP INR 1,071.56), 1mg listed price. Denopsy (Natco Pharma) teriflunomide 14 mg tablet - MedPlus Mart — INR 1,071.56 (regular price INR 910.83, about INR 91.08 per unit for the listed pack). The practical benchmark is therefore the Bangladesh price below, plus freight, customs duty and importer margin. Bangladesh unit prices for teriflunomide are not published per unit; the registry lists pack prices only. Prices move with pack size, pharmacy and the exchange rate — confirm current stock and price with a licensed importer before ordering.

Teriflunomide blocks an enzyme that activated T and B lymphocytes need to make new pyrimidines and multiply. Use during pregnancy or breastfeeding must be decided by the treating physician: most of these agents are contraindicated in pregnancy or carry warnings about fetal harm and are not recommended during breastfeeding.

Teriflunomide (Pyrimidine synthesis inhibitor (dihydroorotate dehydrogenase inhibitor); oral immunomodulatory disease-modifying therapy (DMT) for multiple sclerosis, originally Aubagio by Genzyme Corporation, a Sanofi company (US label lists Genzyme Corporation, Cambridge, MA; Sanofi markets Aubagio)) Teriflunomide blocks an enzyme that activated T and B lymphocytes need to make new pyrimidines and multiply. With fewer activated lymphocytes, there is less inflammation and immune attack on the nerves, which reduces MS relapses. 7 mg or 14 mg orally once daily, with or without food. The 7 mg and 14 mg film-coated tablets contain 7 mg and 14 mg of teriflunomide respectively.

Recommended monitoring for teriflunomide: Obtain transaminase and bilirubin levels within 6 months before initiation and monitor ALT at least monthly for six months after starting; Obtain a complete blood cell count within 6 months before initiation; further monitoring based on signs and symptoms of infection; Screen for latent tuberculosis infection with a tuberculin skin test or blood test before initiation; Exclude pregnancy before initiation in females of reproductive potential and ensure effective contraception during treatment and during accelerated elimination; Check blood pressure before starting treatment and periodically thereafter; If ALT greater than 3x ULN is confirmed, consider discontinuing and starting accelerated elimination; monitor liver tests weekly until normalised if liver injury suspected; Monitor for peripheral neuropathy symptoms and evaluate/consider discontinuation; Accelerated elimination: cholestyramine 8 g every 8 hours or activated charcoal 50 g every 12 hours for 11 days

Teriflunomide is a small molecule, so copies are conventional generic tablets (ANDA in the US) that must demonstrate bioequivalence to the reference product and are AB-rated/therapeutically equivalent. US exclusivity: Aubagio was the first drug to use teriflunomide as an active ingredient and received NCE exclusivity; Sanofi settled with about 20 generic developers in 2017 granting royalty-free US launches on 12 March 2023, and multiple generic versions launched on 13 March 2023. European generics were expected from Q4 2023. Among FDA-approved generics are Teva, Accord, Glenmark, Alembic, Hetero, Biocon, Natco Pharma (USA), MSN, Sola and Concord Biotech. Published US wholesale acquisition cost for teriflunomide ranges widely (USD 32.40 to USD 2,058.90 per 30-day supply), reflecting multiple generic entrants. Manufacturers supplying teriflunomide generic versions include Accord Healthcare, Alembic Pharmaceuticals, Biocon Pharma, Concord Biotech Ltd., Glenmark Pharmaceuticals, Hetero Labs Ltd., Natco Pharma Ltd., Teva Pharmaceuticals. Brands registered in Bangladesh include not in the MedEx registry.