Selzentry Disease Interactions

Hepatotoxicity has been reported with the use of maraviroc. Severe rash or evidence of systemic allergic reaction (e.g., fever, eosinophilia, elevated immunoglobulin E [IgE]) prior to the development of hepatotoxicity may occur. Patients with signs/symptoms of hepatitis or allergic reaction after use of maraviroc should be evaluated immediately. Appropriate laboratory testing (including ALT, AST, and bilirubin) should be conducted before starting maraviroc and periodically during therapy as clinically indicated. Additional monitoring may be necessary when administering maraviroc to patients with preexisting liver dysfunction or who are coinfected with hepatitis B and/or C virus. The safety and efficacy of maraviroc has not been studied in patients with significant underlying liver disorders; caution is recommended.

An increased risk of postural hypotension may occur in patients with severe renal dysfunction or in those with ESRD due to increased exposure to maraviroc in some patients. This drug should be used with caution in these patients only if they are not receiving a concomitant potent CYP450 3A inhibitor or inducer, but maraviroc should only be considered for patients with severe renal dysfunction or ESRD when no alternative treatment options are available. The dose should be reduced if any symptoms of postural hypotension occur. No studies have been performed in patients with severe renal dysfunction (CrCl less than 30 mL/min) or ESRD who are concomitantly taking potent CYP450 3A inhibitors or inducers, and maraviroc is contraindicated in these patients.

Cardiovascular events (including myocardial ischemia and/or infarction) were reported in 11 therapy-experienced patients (1.3%) receiving maraviroc during phase 3 trials; these patients generally had cardiac disease or cardiac risk factors before using maraviroc. Patients with cardiovascular comorbidities, history of/risk factors for postural hypotension, or receiving concurrent medication known to lower blood pressure, could be at increased risk of cardiovascular adverse events triggered by postural hypotension; additional monitoring may be necessary.