Emtriva (emtricitabine)

WARNING

POSTTREATMENT EXACERBATION OF HEPATITIS B

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.

Emtriva can cause serious side effects, including:

• Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before starting treatment with Emtriva. If you have HBV infection and take Emtriva, your HBV may get worse (flare-up) if you stop taking Emtriva. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
  • Do not stop taking Emtriva without first talking to your healthcare provider.
  • Do not run out of Emtriva. Refill your prescription or talk to your healthcare provider before your Emtriva is all gone.
  • If you stop taking Emtriva, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medication to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Emtriva.

What are the possible side effects of Emtriva?

Emtriva may cause serious side effects, including:

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-infected person starts taking antiretroviral medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting Emtriva.
• Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you develop any of these symptoms:
  • weakness or being more tired than usual
  • unusual muscle pain
  • being short of breath or fast breathing
  • stomach pain with nausea and vomiting
  • cold or blue hands and feet
  • feel dizzy or lightheaded
  • fast or abnormal heartbeat
• Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Your healthcare provider may tell you to stop taking Emtriva if you develop new or worse liver problems during treatment with Emtriva. Tell your healthcare provider right away if you develop any of these symptoms:
  • fatigue
  • weakness
  • yellowing of your skin or the white part of your eyes (jaundice)
  • nausea and vomiting
  • confusion
  • dark “tea-colored” urine
  • loss of appetite for several days or longer
  • light-colored stools
  • stomach-area (abdominal) swelling and pain

The most common side effects of Emtriva include:

• headache
• abnormal dreams
• diarrhea
• rash
• nausea
• abdominal pain
• tiredness
• weakness
• dizziness
• cough
• depression
• runny nose
• problems sleeping

Skin discoloration in children may also happen with Emtriva.

These are not all the possible side effects of Emtriva.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Testing Prior To Initiation Of Treatment With Emtriva

• Prior to or when initiating Emtriva, test patients for hepatitis B virus infection.

Recommended Dosage

• Emtriva is taken by mouth once daily and may be taken without regard to food.

Recommended Dosage In 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.

Recommended Dosage In Pediatric Patients (0-3 months of age)

• Emtriva oral solution: 3 mg per kg administered once daily orally.

Recommended Dosage In Pediatric Patients (3 months through 17 years of age)

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

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.

Table 1 : Dose Interval Adjustment for Adult Patients with Altered Creatinine Clearance

• There are insufficient data available to make dosage recommendations in pediatric patients with renal impairment.

The potential for drug interactions with Emtriva has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling.

• Available data from the APR show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Emtriva during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.
• The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.
• Based on published data, FTC has been shown to be present in human breast milk.
• It is not known if FTC affects milk production or has effects on the breastfed child. Because of the potential for: (1) HIV transmission (in HIV-negative infants); (2) developing viral resistance (in HIV-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking Emtriva.