Assess hepatic & renal function prior to treatment initiation, after 3rd & 6th mth of treatment & every 6-12 mth thereafter & as clinically indicated. Patients w/ pre-existing low lymphocyte counts. Perform CBC including lymphocytes prior to initiating treatment, after 6th mth of treatment & every 6-12 mth & as clinically indicated. Perform MRI in case of clinical suspicion of progressive multifocal leukoencephalopathy (PML). Prior treatment w/ immunosuppressive or immunomodulating therapies. Renal & hepatic impairment. Severe active GI disease. Pregnancy & lactation. Childn.
Caution when in concomitant w/ antineoplastic or immunosuppressive therapies. Increased risk of clinical infection w/ live vaccines. Avoid simultaneous use w/ fumaric acid derivatives. Increased potential of renal adverse reactions w/ nephrotoxic medicinal products eg, aminoglycosides, diuretics, NSAIDs or lithium.
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