emtricitabine 200 MG Oral Capsule

INDICATIONS AND USAGE Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

DOSAGE AND ADMINISTRATION Testing: Prior to or when initiating emtricitabine test for hepatitis B virus infection. ( 2.1 ) Emtricitabine may be taken without regard to food. ( 2.2 ) Adult Patients (18 years of age and older) ( 2.3 ): Emtricitabine capsules: One 200 mg capsule administered once daily orally. Pediatric Patients (3 months through 17 years of age) ( 2.5 ): Emtricitabine capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally. Dose interval adjustment in adult patients with renal impairment ( 2.6 ): a. Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. Formulation Creatinine Clearance (mL/min) ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis a Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours 2.1 Testing Prior to Initiation of Treatment with Emtricitabine Prior to or when initiating emtricitabine, test patients for hepatitis B virus infection [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage Emtricitabine is taken by mouth once daily and may be taken without regard to food [see Clinical Pharmacology ( 12.3 ) ]. 2.3 Recommended Dosage in Adult Patients (18 years of age and older) Emtricitabine capsules: One 200 mg capsule administered once daily orally. 2.5 Recommended Dosage in Pediatric Patients (3 months through 17 years of age) Emtricitabine capsules: For pediatric patients weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally. 2.6 Dosage Adjustment in Patients with Renal Impairment Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of dose adjustment recommendations in patients with moderate to severe renal impairment (creatinine clearance below 50 mL/min) have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.6 )] . Table 1. Dose Interval Adjustment for Adult Patients with Altered Creatinine Clearance Formulation Creatinine Clearance (mL/min) ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis a Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours a. Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. There are insufficient data available to make dosage recommendations in pediatric patients with renal impairment.

WARNINGS AND PRECAUTIONS Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.2 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.3 ) 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before or when initiating emtricitabine [see Dosage and Administration ( 2.1 )]. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. Patients who are coinfected with HIV-1 and HBV who discontinue emtricitabine should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiation of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. 5.2 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including emtricitabine. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus , Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment. 5.3 Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including FTC, alone or in combination with other antiretrovirals. Treatment with emtricitabine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). 5.4 Dose Adjustment in Patients with New Onset or Worsening Renal Impairment Emtricitabine is principally eliminated by the kidney. Reduction of the dosage of emtricitabine is recommended for patients with impaired renal function [see Dosage and Administration ( 2.6 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )] .

CONTRAINDICATIONS Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. ( 4 )

Mechanism of Action Emtricitabine is an antiretroviral drug [see Microbiology ( 12.4 )].