"The US Food and Drug Administration (FDA) has approved atazanavir and cobicistat (Evotaz, Bristol-Myers Squibb) for treatment of adults with human immunodeficiency virus (HIV-1) infection.
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Additional important information regarding the use of EMTRIVA for the treatment of HIV-1 Infection:
DOSAGE AND ADMINISTRATION
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 per kg administered once daily orally.
Pediatric Patients (3 months through 17 years)
- EMTRIVA oral solution: 6 mg per 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 subjects with renal impairment [See CLINICAL PHARMACOLOGY]. Therefore, the dosing interval or dose of EMTRIVA should be adjusted in patients with baseline creatinine clearance less than 50 mL per 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
|Formulation||Creatinine Clearance (mL/min)|
|< 50 mL/min||30-49 mL/min||15-29 mL/min||< 15 mL/min or on hemodialysisa|
|Capsule (200 mg)||200 mg every 24 hours||200 mg every 48 hours||200 mg every 72 hours||200 mg every 96 hours|
|Oral Solution (10 mg/mL)||240 mg every 24 hours (24 mL)||120 mg every 24 hours (12 mL)||80 mg every 24 hours (8 mL)||60 mg every 24 hours (6 mL)|
|a Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis.|
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.
Storage And Handling
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).
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 °C–8 °C (36 °F–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 °C– 30 °C (59 °F–86 °F).
Manufactured by: Gilead Sciences. November 2012
Last reviewed on RxList: 4/22/2013
This monograph has been modified to include the generic and brand name in many instances.
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