Emtricitabine

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

• Testing: Prior to or when initiating emtricitabine test for hepatitis B virus infection. (
  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

  )].
  )
• Emtricitabine may be taken without regard to food. (
  2.2 Recommended Dosage

  Emtricitabine is taken by mouth once daily and may be taken without regard to food

  [see

  Clinical Pharmacology (

  12.3

  )

  ].
  )
• Adult Patients (18 years of age and older) (
  2.3 Recommended Dosage in Adult Patients (18 years of age and older)

  Emtricitabine capsules: One 200 mg capsule administered once daily orally.
  ):
• Emtricitabine capsules: One 200 mg capsule administered once daily orally.
• Pediatric Patients (3 months through 17 years of age) (
  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.
  ):
• 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 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.
  ):

Emtricitabine Capsules, containing 200 mg of emtricitabine, are size '1' capsules with sky blue cap imprinted with "EMT" in black and white body imprinted with "200" in black.

•   Immune reconstitution syndrome: May necessitate further evaluation and treatment. (
  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.
  )
•   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 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).
  )