Aregalu contains teriflunomide 14 mg as an oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis. Teriflunomide is the active metabolite of leflunomide and a selective, reversible inhibitor of dihydroorotate dehydrogenase (DHODH), a mitochondrial enzyme essential for the de novo synthesis of pyrimidines. By depleting pyrimidine pools in rapidly dividing activated T- and B-lymphocytes (which depend on de novo synthesis), teriflunomide reduces autoreactive lymphocyte proliferation and CNS infiltration while sparing resting and memory lymphocytes that use the salvage pathway. ATC class L04AA31. Steady-state plasma concentrations are reached after several months because of long elimination half-life (~19 days) and extensive enterohepatic recirculation.
⚠️ Warnings
Liver function: measure ALT before initiation and monthly for the first 6 months, then every 8 weeks; discontinue if ALT > 3x ULN persistently or > 5x ULN. Pregnancy: women must use effective contraception during therapy and undergo accelerated elimination procedure (cholestyramine 8 g three times daily for 11 days, or activated charcoal 50 g twice daily for 11 days) if pregnancy is planned or occurs — plasma teriflunomide must fall to < 0.02 mg/L confirmed on two tests >= 14 days apart. Men planning fatherhood: similar accelerated elimination is recommended. Blood pressure: monitor at baseline and periodically. Full blood count and TB screening before initiation. Live vaccines should be avoided during therapy and for up to 2 years after stopping (until plasma drug levels are confirmed low). Driving: caution with neurological adverse effects.
