Emtriva
Generic Name: emtricitabine
Dosage Form: capsule, oral solution

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals [See Warnings and Precautions (5.1)].

Emtriva is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Emtriva have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Emtriva. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.2)].

Indications and Usage for Emtriva
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®, COMPLERA®, STRIBILD™, TRUVADA®, or lamivudine-containing products [See Warnings and Precautions (5.3)].
•In treatment-experienced patients, the use of Emtriva should be guided by laboratory testing and treatment history [See Clinical Pharmacology (12.4)].
Emtriva Dosage and Administration
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 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 (12.3)]. 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 eva luated. 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  Creatinine Clearance (mL/min)
Formulation ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis*
*
Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis.
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 ev