Aubagio Disease Interactions

Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents. Patients receiving immunosuppressants are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections. Caution should be exercised when considering their use in patients with severe or chronic infections. It is recommended to interrupt therapy in patients who develop a new infection while undergoing treatment and to monitor these patients closely for any sign or symptom indicative of infection.

Immunosuppressive agents may increase the risk of progressive multifocal leukoencephalopathy (PML). Certain agents are contraindicated in patients who have or have had PML. Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with these agents. Health care professionals should monitor patients for any new sign or symptom suggestive of PML. Therapy dosing should be withheld immediately and an appropriate diagnostic evaluation should be performed at the first sign or symptom suggestive of PML.

Teriflunomide is contraindicated in patients with severe hepatic impairment. No dosage adjustment is necessary for patients with mild and moderate hepatic impairment. Severe liver injury including fatal liver failure have been reported in patients treated with leflunomide. A similar risk would be expected for teriflunomide because recommended doses of teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Concomitant use of teriflunomide with other potentially hepatotoxic drugs may increase the risk of severe liver injury. If drug-induced liver injury is suspected, discontinue therapy with teriflunomide and start an accelerated elimination procedure with cholestyramine or charcoal. Patients with preexisting liver disease may be at increased risk of developing elevated serum transaminases while on therapy with teriflunomide. It is recommended to obtain transaminase and bilirubin levels within 6 months before initiation of therapy. Monitor ALT levels at least monthly for six months after starting therapy.

Teriflunomide may increase the blood pressure. Caution should be taken when using this agent in hypertensive patients. It is recommended to check blood pressure before the start of teriflunomide treatment and periodically thereafter and elevated blood pressure should be appropriately managed during treatment with teriflunomide.

Cases of decrease in white blood cell count and in platelet count have been observed with the use teriflunomide. Care should be taken when using this agent in immunosuppressed patients. It is recommended to obtain a complete blood cell count within 6 months before the initiation of treatment and further monitoring should be based on signs and symptoms suggestive of bone marrow suppression.

Peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), has been reported with the use of teriflunomide. Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy. Care should be taken when prescribing this agent to patients at risk and if a patient develops symptoms consistent with peripheral neuropathy, such as bilateral numbness or tingling of hands or feet, consider discontinuing teriflunomide therapy and performing an accelerated elimination procedure.

Interstitial lung disease and worsening of preexisting interstitial lung disease, including acute interstitial pneumonitis, have been reported during treatment with teriflunomide. Caution should be exercised when prescribing this agent to patients with pulmonary complication. New onset or worsening pulmonary symptoms, such as cough and dyspnea, with or without associated fever, may be a reason for discontinuation of therapy and if discontinuation of the drug is necessary, consider initiation of an accelerated elimination procedure.

Cases of tuberculosis have been observed with the use of teriflunomide. It is recommended to screen patients for latent tuberculosis infection before initiating therapy with teriflunomide. The safety of teriflunomide in patients with a positive tuberculosis screen, and in individuals with latent tuberculosis infection is unknown. Care should be exercised and in those patients testing positive, standard medical practice treatment should be given prior to teriflunomide therapy initiation.

Vaccination with live vaccines is not recommended in patients treated with teriflunomide. No clinical data are available on the efficacy and safety of live vaccinations in patients taking teriflunomide. The long half-life of teriflunomide should be considered when contemplating administration of a live vaccine after stopping treatment.