VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Additional important information regarding the use of VIREAD for the treatment of HIV-1 infection:

• VIREAD should not be used in combination with TRUVADA® or ATRIPLA™.

The dose of VIREAD is 300 mg once daily taken orally, without regard to food.

Dose Adjustment for Renal Impairment

Significantly increased drug exposures occurred when VIREAD was administered to patients with moderate to severe renal impairment (see CLINICAL PHARMACOLOGY). Therefore, the dosing interval of VIREAD should be adjusted in patients with baseline creatinine clearance < 50 mL/min using the recommendations in Table 15. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring hemodialysis. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients (see WARNINGS).

No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed for these patients (see WARNINGS).

Table 15: Dosage Adjustment for Patients with Altered Creatinine Clearance

The pharmacokinetics of tenofovir have not been evaluated in non-hemodialysis patients with creatinine clearance < 10 mL/min; therefore, no dosing recommendation is available for these patients.

VIREAD is available as tablets. Each tablet contains 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. The tablets are almond-shaped, light blue, film-coated, and debossed with “GILEAD” and “4331” on one side and with “300” on the other side. They are packaged as follows: Bottles of 30 tablets (NDC 61958–0401–1) containing a desiccant (silica gel canister or sachet) and closed with child-resistant closure.

Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F) (see USP Controlled Room Temperature).

Do not use if seal over bottle opening is broken or missing.

Gilead Sciences, Inc. Foster City, CA 94404. May 2007. VIREAD, EMTRIVA and TRUVADA are registered trademarks of Gilead Sciences, Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners. FDA revision date: 5/21/2007

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