EMTRIVA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Additional important information regarding the use of EMTRIVA for the treatment of HIV-1 Infection:

• EMTRIVA should not be coadministered with ATRIPLA®, TRUVADA®, or lamivudine-containing products [See WARNINGS and PRECAUTIONS].
• In treatment-experienced patients, the use of EMTRIVA should be guided by laboratory testing and treatment history [See CLINICAL PHARMACOLOGY].

Recommended Dose

EMTRIVA may be taken without regard to food.

Adult Patients (18 years of age and older)

• EMTRIVA capsules: one 200 mg capsule administered once daily orally.
• EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.

Pediatric Patients (0 - 3 months of age)

• EMTRIVA oral solution: 3 mg/kg administered once daily orally.

Pediatric Patients (3 months through 17 years)

• EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally.
• EMTRIVA capsules: for children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.

Dose Adjustment in Adult Patients with Renal Impairment

Significantly increased drug exposures were seen when EMTRIVA was administered to patients with renal impairment [See CLINICAL PHARMACOLOGY]. Therefore, the dosing interval or dose of EMTRIVA should be adjusted in patients with baseline creatinine clearance < 50 mL/min using the following guidelines (see Table 1). The safety and effectiveness of these dose adjustment guidelines have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.

Table 1: Dose Adjustment in Adult Patients with Renal Impairment

Although there are insufficient data to recommend a specific dose adjustment of EMTRIVA in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval similar to adjustments for adults should be considered.

Dosage Forms And Strengths

EMTRIVA is available as capsules and oral solution.

EMTRIVA capsules, containing 200 mg of emtricitabine, are size 1 hard gelatin capsules with a blue cap and white body, printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body. EMTRIVA oral solution is a clear, orange to dark orange liquid containing 10 mg of emtricitabine per mL.

Capsules

The size 1 hard gelatin capsules with a blue cap and white body contain 200 mg of emtricitabine, are printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body, and are available in unit of use bottles (closed with induction sealed child-resistant closures) of:

• 30 capsules (NDC 61958–0601–1).

Store at 25 °C (77 °F); excursions permitted to 15 °C–30 °C (59 °F–86 °F)

Oral Solution

The oral solution is a clear, orange to dark orange liquid, contains 10 mg/mL of emtricitabine, and is available in unit of use plastic, amber bottles ( closed with child resistant closures and packaged with a marked dosing cup) of:

• 170 mL (NDC 61958–0602–1).

Store refrigerated, 2–8 °C (36–46 °F). Emtriva oral solution should be used within 3 months if stored by the patient at 25 °C (77 ° F); excursions permitted to 15–30 °C (59–86 °F).

EMTRIVA, TRUVADA, and VIREAD are 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. MAY08. FDA rev date: 5/16/2008

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