contact with semen, vaginal secretions, or blood.
◦Do not breastfeed. Emtriva is secreted in breast milk. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
•The long term effects of Emtriva are unknown.
•Emtriva capsules and oral solution are for oral ingestion only.
•It is important to take Emtriva with combination therapy on a regular dosing schedule to avoid missing doses.
•Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with Emtriva should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) [See Warnings and Precautions (5.1)].
•Patients with HIV-1 should be tested for Hepatitis B virus (HBV) before initiating antiretroviral therapy.
•Severe acute exacerbations of Hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva.
•Emtriva should not be coadministered with ATRIPLA, COMPLERA, STRIBILD, or TRUVADA; or with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine) [See Warnings and Precautions (5.3)].
•Dose or dosing interval of Emtriva may need adjustment in patients with renal impairment [See Dosage and Administration (2.5)].
PATIENT INFORMATION
Emtriva® (em-treev'-ah) capsules
Emtriva oral solution
Generic name: emtricitabine (em tri SIT uh bean)
Read the Patient Information that comes with Emtriva before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
You should stay under a healthcare provider's care when taking Emtriva. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about Emtriva.
What is the most important information I should know about Emtriva?
•Some people who have taken medicines like Emtriva (a nucleoside analog) have developed a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs of lactic acidosis.
◦You feel very weak or tired.
◦You have unusual (not normal) muscle pain.
◦You have trouble breathing.
◦You have stomach pain with nausea and vomiting.
◦You feel cold, especially in your arm and legs.
◦You feel dizzy or lightheaded.
◦You have a fast or irregular heartbeat.
•Some people who have taken medicines like Emtriva have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs of liver problems.
◦Your skin or the white part of your eyes turns yellow (jaundice).
◦Your urine turns dark.
◦Your bowel movements (stools) turn light in color.
