Emtriva

Emtriva is a prescription medication used to treat human immunodeficiency virus (HIV) infections in adults and children. Emtriva belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTI), which decrease the amount of HIV in the blood.

This medication comes in capsule and oral solution (liquid) forms. It is taken once a day, with or without food.

Common side effects include headache, diarrhea, nausea and dizziness.

Emtriva is a prescription medicine used to treat human immunodeficiency virus (HIV) infections in adults and children.  Emtriva does not cure HIV infection or acquired immune deficiency syndrome (AIDS).

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Gilead Sciences, Inc.

Emtriva may cause serious side effects. See the "Drug Precautions" section.

The most common side effects of Emtriva used with other anti-HIV-1 medicines are headache, diarrhea, and nausea. Other side effects include allergic reaction, dizziness, sleeping problems, abnormal dreams, vomiting, indigestion, stomach pain, pain, weakness and rash. Skin discoloration may also happen with Emtriva.

This list of side effects is not complete. If you have questions about side effects, ask your healthcare provider or pharmacist. You should report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

• Do not take Emtriva if you are already taking Atripla, Complera, Truvada, Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir because these medicines contain the same or similar active ingredients.

Serious side effects have been reported including:

• 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.
  • You don't feel like eating food for several days or longer.
  • You feel sick to your stomach (nausea).
  • You have lower stomach area (abdominal) pain.
• You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like Emtriva, for a long time.
• Changes in body fat have been seen in some patients taking Emtriva and other anti-HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.
• If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow-up for several months after stopping treatment with Emtriva. Follow-up includes medical exams and blood tests to check for HBV that is getting worse. Patients with HBV infection, who take Emtriva and then stop it, may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before.

• Do not take Emtriva if you are allergic to any ingredient in it. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Emtriva there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider if you have kidney or liver problems or any other medical conditions you have.

Tell your healthcare provider if you are pregnant or breastfeeding.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines and dietary supplements. Keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your healthcare providers and pharmacist every time you visit or fill a prescription.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Emtriva falls into category B. There are no well-done studies that have been done in humans with Emtriva. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Tell your healthcare provider if you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, Emtriva can pass into your breast milk and it is not known if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.

• Take Emtriva by mouth exactly as your healthcare provider prescribed it. Follow the directions from your healthcare provider, exactly as written on the label.
• Emtriva is always used with other anti-HIV-1 medicines.
• Emtriva may be taken with or without a meal. Food does not affect how Emtriva works.
• If you forget to take Emtriva, take it as soon as you remember that day. Do not take more than 1 dose of Emtriva in a day. Do not take 2 doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do. It is important that you do not miss any doses of Emtriva or your other anti-HIV-1 medicines.
• When your Emtriva supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Emtriva and become harder to treat.
• Stay under a healthcare provider's care when taking Emtriva . Do not change your treatment or stop treatment without first talking with your healthcare provider.

Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood.
• Do not breastfeed. Emtriva can be passed to your baby in your breast milk. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

• Dosing in adults: The usual dose of Emtriva is 1 capsule once a day.
• Dosing in children: The child's doctor will calculate the right dose of Emtriva (oral solution or capsule) based on the child's weight.

If you take too much Emtriva, call your local poison control center or emergency room right away.

• Keep Emtriva and all other medicines out of reach of children.
• Store Emtriva capsules between 59 °F and 86 °F (15 °C to 30 °C).
• Store Emtriva oral solution in a refrigerator between 36 °F and 46 °F (2–8 °C). Do not freeze. Alternatively, the product may be stored at room temperature for up to 3 months and any remaining solution in the bottle must be discarded after the 3 months.
• Do not keep your medicine in places that are too hot or cold.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

WARNINGS: 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.

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.