"The European Medicines Agency (EMA) has updated information on the risk for body fat changes and lactic acidosis associated with antiretroviral medications for HIV infection.
HIV medicines will no longer require a warning regarding fa"...
(lamivudine) tablets & oral solution
What is the most important information I should know about EPIVIR?
EPIVIR can cause serious side effects, including:
- Build-up of an acid in your
blood (lactic acidosis). Lactic acidosis can happen in some people who take EPIVIR.
Lactic acidosis is a serious medical emergency that can cause death. Call
your healthcare provider right away if you get any of the following symptoms
that could be signs of lactic acidosis:
- feel very weak or tired
- feel cold, especially in your arms and legs
- unusual (not normal) muscle pain
- feel dizzy or light-headed
- trouble breathing
- have a fast or irregular heartbeat
- stomach pain with nausea and vomiting
- Serious liver problems can happen in people who take EPIVIR. In some cases these
serious liver problems can lead to death. Your liver may become large
(hepatomegaly) and you may develop fat in your liver (steatosis). Call your
healthcare provider right away if you get any of the following signs or
symptoms of liver problems:
- your skin or the white part of your eyes turns yellow (jaundice)
- loss of appetite for several days or longer
- dark or “tea-colored” urine
- pain, aching, or tenderness on the right side of your stomach area
- light-colored stools (bowel movements)
You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines for a long time.
- Worsening of hepatitis B
virus in people who have HIV-1 infection. If you have HIV-1 (Human Immunodeficiency Virus type 1) and
hepatitis B virus (HBV) infection, your HBV may get worse (flareup) if you stop
taking EPIVIR. A “flare-up” is when your HBV infection suddenly returns in a
worse way than before. Worsening liver disease can be serious and may lead to
- Do not run out of EPIVIR. Refill your prescription or talk to your healthcare provider before your EPIVIR is all gone.
- Do not stop EPIVIR without first talking to your healthcare provider.
- If you stop taking EPIVIR, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
- Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with EPIVIR and become harder to treat (resistant).
- Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with both HIV-1 and hepatitis C virus who are taking antiretroviral medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking EPIVIR and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.
What is EPIVIR?
EPIVIR is a prescription HIV-1 medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
EPIVIR tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the same active ingredient (lamivudine) than is in the medicine EPIVIR-HBV tablets and oral solution (used to treat HBV). If you have both HIV-1 and HBV, you should not use EPIVIR-HBV to treat your infections.
The safety and effectiveness of EPIVIR have not been established in children under 3 months of age.
When used with other antiretroviral medicines to treat HIV-1 infection, EPIVIR may help:
- reduce the amount of HIV-1 in your blood. This is called “viral load”.
- increase the number of CD4+ (T) cells in your blood, which help fight off other infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
EPIVIR does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others:
- Do not share or re-use needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
Who should not take EPIVIR?
Do not take EPIVIR if you are allergic to lamivudine or any of the ingredients in EPIVIR. See the end of this Patient Information leaflet for a complete list of ingredients in EPIVIR.
What should I tell my healthcare provider before taking EPIVIR?
Before you take EPIVIR, tell your healthcare provider if you:
- have or have had liver problems, including hepatitis B or C virus infection.
- have kidney problems.
- have diabetes. Each 15-mL dose (150 mg) of EPIVIR oral solution contains 3 grams of sucrose.
- are pregnant or plan to become
pregnant. Taking EPIVIR during pregnancy has not been associated with an
increased risk of birth defects. Talk to your healthcare provider if you are
pregnant or plan to become pregnant.
Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
- are breastfeeding or plan to
breastfeed. Do not breastfeed if you take EPIVIR.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.
Some medications interact with EPIVIR. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EPIVIR. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EPIVIR with other medicines.
You should not take EPIVIR if you also take:
- lamivudine (COMBIVIR®, DUTREBIS™, EPIVIR-HBV®, EPZICOM®, TRIUMEQ®, or TRIZIVIR®)
- emtricitabine (EMTRIVA®, ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®)
Tell your health care provider if you take:
- any other medicine to treat HIV-1
- medicines to treat hepatitis viruses such as interferon or ribavirin
How should I take EPIVIR?
- Take EPIVIR exactly as your healthcare provider tells you.
- Do not change your dose or stop taking EPIVIR without talking with your healthcare provider. If you miss a dose of EPIVIR, take it as soon as you remember. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
- Stay under the care of a healthcare provider while taking EPIVIR.
- EPIVIR may be taken with or without food.
- For children 3 months and older, your healthcare provider will prescribe a dose of EPIVIR based on your child's body weight.
- Tell your healthcare provider if you or your child has trouble swallowing tablets. EPIVIR also comes as a liquid (oral solution).
- Do not run out of EPIVIR. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
- If you take too much EPIVIR, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of EPIVIR?
- EPIVIR can cause serious side effects including:
- See “What is the most important information I should know about EPIVIR?”
- Risk of inflammation of the
pancreas (pancreatitis). Children may be at risk for developing pancreatitis during
treatment with EPIVIR if they:
- have a history of pancreatitis
- have taken nucleoside analogue medicines
- have other risk factors for pancreatitis in the past
Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving EPIVIR to your child if their symptoms and blood test results show that your child may have pancreatitis.
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 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 new symptoms after you start taking EPIVIR.
- Changes in body fat can happen in people who take HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
The most common side effects of EPIVIR in adults include:
- nasal signs and symptoms
- generally not feeling well
The most common side effects of EPIVIR in children include fever and cough.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of EPIVIR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EPIVIR?
- Store EPIVIR tablets and oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep bottles of EPIVIR oral solution tightly closed.
Keep EPIVIR and all medicines out of the reach of children.
General information about the safe and effective use of EPIVIR.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Do not use EPIVIR for a condition for which it was not prescribed. Do not give EPIVIR to other people, even if they have the same symptoms that you have. It may harm them.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about EPIVIR that is written for health professionals.
For more information, go to www.viivhealthcare.com or call 1-877-844-8872.
What are the ingredients in EPIVIR?
Active ingredient: lamivudine
Inactive ingredients: EPIVIR scored 150-mg film-coated tablets: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
EPIVIR 300-mg film-coated tablets: black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
EPIVIR oral solution: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg per mL).
Last reviewed on RxList: 10/23/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Epivir Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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