| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SELZENTRY safely and effectively. See full prescribing information for SELZENTRY.
SELZENTRY (maraviroc) Tablets
SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells.
SELZENTRY is available as film-coated tablets for oral administration containing either 150 or 300 mg of maraviroc and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, and magnesium stearate. The film coat [Opadry® II Blue (85G20583)] contains FD&C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.
| CLINICAL PHARMACOLOGY
Mechanism of Action
| INDICATIONS AND USAGE
SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.
This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of SELZENTRY in treatment-experienced subjects and one study in treatment-naïve subjects. Both studies in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (NRTI, NNRTI, PI, or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
SELZENTRY should not be used in patients with severe renal impairment or end-stage renal disease (ESRD) (CrCl < 30 mL/min) who are taking potent CYP3A inhibitors or inducers.
| WARNINGS AND PRECAUTIONS
–Use caution when administering SELZENTRY to patients with pre-existing liver dysfunction or who are co-infected with viral hepatitis B or C.
–More cardiovascular events including myocardial ischemia and/or infarction were observed in treatment-experienced subjects who received SELZENTRY. Use with caution in patients at increased risk of cardiovascular events .
–If patients with severe renal impairment or end-stage renal disease (ESRD) receiving SELZENTRY (without concomitant CYP3A inducers or inhibitors) experience postural hypotension the SELZENTRY dose should be reduced from 300 mg twice daily to 150 mg twice daily.
USE IN SPECIFIC POPULATIONS
| ADVERSE REACTIONS
The most common adverse events in treatment-experienced subjects (>8% incidence) which occurred at a higher frequency compared to placebo are upper respiratory tract infections, cough, pyrexia, rash, and dizziness.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
| DOSAGE AND ADMINISTRATION
Dose Recommendations for Patients with Normal Renal Function
Table 1 gives the recommended dose adjustments.
Dose Recommendations for Patients with Renal Impairment
Table 2 provides dosing recommendations for patients based on renal function and concomitant medications.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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