"Patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation if they take any of nine direct-acting antivirals for hepatitis virus C (HCV) infection, the US Food and Drug Administration (FDA) a"...
(lamivudine) Oral Solution
Read this Patient Information before you start taking EPIVIR-HBV and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about EPIVIR-HBV?
EPIVIR-HBV 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-HBV or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death.
Lactic acidosis can be hard to identify early because the symptoms could seem like symptoms of other health problems. 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
- unusual (not normal) muscle pain
- trouble breathing
- stomach pain with nausea and vomiting
- feel cold, especially in your arms and legs
- feel dizzy or light-headed
- have a fast or irregular heartbeat
Severe liver problems. Severe liver problems can happen in people who take EPIVIR-HBV or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take EPIVIR-HBV. Call your healthcare provider right away if you get any of the following signs of liver problems:
- your skin or the white part of your eyes turns yellow (jaundice)
- dark “tea-colored” urine
- light-colored bowel movements (stools)
- loss of appetite for several days or longer
- stomach pain
You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines for a long time.
Worsening liver disease. Your hepatitis B infection may become worse after stopping treatment with EPIVIR-HBV. Worsening liver disease can be serious and may lead to death. If you stop treatment with EPIVIR-HBV, your healthcare provider will need to check your health and do blood tests to check your liver for at least several months after you stop taking EPIVIR-HBV.
Risk of HIV-1 resistance in people with unknown HIV-1 infection or in people with untreated HIV-1 infection. If you have or get HIV that is not being treated with medicines while taking EPIVIR-HBV, the HIV virus may develop resistance to certain HIV medicines and become harder to treat.
- Your healthcare provider should offer you counseling and testing for HIV-1 infection before you start treatment for hepatitis B with EPIVIR-HBV and during treatment.
- EPIVIR-HBV tablets and EPIVIR-HBV oral solution contain a lower dose of lamivudine than other medicines that contain lamivudine and are used to treat HIV-1 infection. See “What should I tell my healthcare provider?” for a list of medicines you should not take with EPIVIR-HBV.
Resistant Hepatitis B Virus (HBV). The hepatitis B virus can change (mutate) during your treatment with EPIVIR-HBV and become harder to treat (resistant). If this happens, your liver disease can become worse and may lead to death. Tell your healthcare provider right away if you have any new symptoms.
What is EPIVIR-HBV?
EPIVIR-HBV is a prescription medicine used to treat long-term (chronic) hepatitis B virus (HBV) when the disease is progressing and there is liver swelling (inflammation).
- EPIVIR-HBV will not cure HBV.
- EPIVIR-HBV may lower the amount of HBV in your body.
- EPIVIR-HBV may lower the ability of HBV to multiply and infect new liver cells.
- EPIVIR-HBV may improve the condition of your liver.
- The long-term benefits of taking EPIVIR-HBV for treatment of chronic hepatitis B infection are not known.
It is not known if EPIVIR-HBV is safe and effective in:
- people with chronic HBV who have a severely damaged liver that is unable to work properly (decompensated liver disease)
- people with hepatitis C virus or hepatitis D (delta) virus
- people who have had a liver transplant
- children with chronic HBV less than 2 years of age
EPIVIR-HBV does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Avoid doing things that can spread HBV 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 semen, vaginal secretions, or blood.
A vaccine is available to protect people at risk for becoming infected with HBV. You can ask your healthcare provider for information about this vaccine.
Who should not take EPIVIR-HBV?
Do not take EPIVIR-HBV if you are allergic to lamivudine or any of the ingredients in EPIVIR-HBV. See the end of this leaflet for a complete list of ingredients in EPIVIR-HBV.
What should I tell my healthcare provider before taking EPIVIR-HBV?
Before you take EPIVIR-HBV, tell your healthcare provider if you:
- have HIV-1 infection
- have kidney problems
- have diabetes. Each 20-mL dose (100 mg) of EPIVIR-HBV oral solution contains 4 grams of sucrose.
- have any other medical condition
- are pregnant or plan to become pregnant. It is not known
if EPIVIR-HBV will harm your unborn baby.
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 to your healthcare provider about how you can take part in this registry.
- are breastfeeding or plan to breastfeed. EPIVIR-HBV can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take EPIVIR-HBV or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Do not take EPIVIR-HBV if you also take:
- other medicines that contain lamivudine (COMBIVIR®, EPIVIR®, EPZICOM®, TRIZIVIR®)
- medicines that contain emtricitabine (ATRIPLA®, COMPLERA®, EMTRIVA®, STRIBILD®, TRUVADA®)
How should I take EPIVIR-HBV?
- Take EPIVIR-HBV exactly as your healthcare provider tells you to take it.
- Do not change your dose or stop taking EPIVIR-HBV without talking with your healthcare provider.
- EPIVIR-HBV is taken 1 time each day.
- Your healthcare provider may prescribe a lower dose if you have problems with your kidneys.
- For children 2 to 17 years of age, your healthcare provider will prescribe the right dose of EPIVIR-HBV based on your child's body weight.
- Take EPIVIR-HBV by mouth, with or without food.
- Tell your healthcare provider if you have trouble swallowing tablets. EPIVIRHBV also comes as a liquid (oral solution).
- If you take too much EPIVIR-HBV, call your healthcare provider or go to the nearest hospital emergency room right away.
- It is important to stay under your healthcare provider's care while taking EPIVIR-HBV. Tell your healthcare provider about any new symptoms that you have.
What are the possible side effects of EPIVIR-HBV?
EPIVIR-HBV may cause serious side effects, including:
See “What is the most important information I should know about EPIVIRHBV?”
The most common side effects of EPIVIR-HBV include:
- ear, nose, and throat infections
- sore throat
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-HBV. 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-HBV?
- Store EPIVIR-HBV tablets and oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep bottles of EPIVIR-HBV oral solution tightly closed.
Keep EPIVIR-HBV and all medicines out of the reach of children.
General information about the safe and effective use of EPIVIR-HBV
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPIVIR-HBV for a condition for which it was not prescribed. Do not give EPIVIR-HBV 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 pharmacist or healthcare provider for information about EPIVIR-HBV that is written for health professionals.
For more information, go to www.gsk.com or call 1-888-825-5249.
What are the ingredients in EPIVIR-HBV?
Active ingredient: lamivudine
EPIVIR-HBV tablets: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide.
EPIVIR-HBV oral solution: artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg per mL).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/6/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Epivir-HBV 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.
Find out what women really need.