Aubagio is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability. Aubagio must not be given to: patients with hypersensitivity to leflunomide, teriflunomide or to any of the excipients in the tablets patients with severe immunodeficiency states, e.g. AIDS patients with significantly impaired bone marrow function or significant anaemia, leukopoenia or thrombocytopenia patients with severe, uncontrolled infections patients with severe impairment of liver function pregnant women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and for a certain period of time thereafter, as long as the plasma levels of the active metabolite are above 0.02 mg/L, unless undergoing washout treatment (see Use in Pregnancy) women who are breast-feeding patients with severe hypoproteinaemia patients who have or have had Stevens- Johnson syndrome, toxic epidermal necrolysis or erythema multiforme PRECAUTIONS Hepatotoxicity Elevations of liver enzymes have been observed in patients receiving Aubagio. During placebo controlled trials, 3-fold the upper limit of normal (ULN) or greater elevation in liver transaminases (ALT) occurred in 6.1% of patients treated with teriflunomide 14 mg, as compared to 6.2% of patients on placebo. Elevations of 5-fold the ULN (ALT) or greater occurred in 2.6%
Aubagio is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability. Aubagio must not be given to: patients with hypersensitivity to leflunomide, teriflunomide or to any of the excipients in the tablets patients with severe immunodeficiency states, e.g. AIDS patients with significantly impaired bone marrow function or significant anaemia, leukopoenia or thrombocytopenia patients with severe, uncontrolled infections patients with severe impairment of liver function pregnant women of childbearing potential who are not using reliable contraception during treatment with teriflunomide and for a certain period of time thereafter, as long as the plasma levels of the active metabolite are above 0.02 mg/L, unless undergoing washout treatment (see Use in Pregnancy) women who are breast-feeding patients with severe hypoproteinaemia patients who have or have had Stevens- Johnson syndrome, toxic epidermal necrolysis or erythema multiforme Hepatotoxicity Elevations of liver enzymes have been observed in patients receiving Aubagio. During placebo controlled trials, 3-fold the upper limit of normal (ULN) or greater elevation in liver transaminases (ALT) occurred in 6.1% of patients treated with teriflunomide 14 mg, as compared to 6.2% of patients on placebo. Elevations of 5-fold the ULN (ALT) or greater occurred in 2.6% PRECAUTIONS