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Brand Name(s): Epivir^®, Epivir-HBV^®, Epzicom^® (as a combination product containing Abacavir, Lamivudine); also available generically

Other Name(s): 3TC

IMPORTANT WARNING:

Tell your doctor if you have or think you may have hepatitis B virus infection (HBV; an ongoing liver infection). Your doctor may test you to see if you have HBV before you begin your treatment with lamivudine. If you have HBV and you take lamivudine, your condition may suddenly worsen when you stop taking lamivudine. Your doctor will examine you and order lab tests regularly for several months after you stop taking lamivudine to see if your HBV has worsened.

Epivir tablets and liquid (used to treat human immunodeficiency virus [HIV]) are not interchangeable with Epivir-HBV tablets and liquid (used to treat hepatitis B infection). Epivir contains a higher dose of lamivudine than Epivir-HBV. Treatment with Epivir-HBV in patients infected with HIV may cause the HIV virus to be less treatable with lamivudine and other medicines. If you have both HIV and hepatitis B, you should take only Epivir. If you are taking Epivir-HBV for hepatitis B infection, talk to your doctor about your risks for HIV infection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to lamivudine.

Talk to your doctor about the risks of taking lamivudine.

WHY is this medicine prescribed?

Lamivudine (Epivir) is used along with other medications to treat human immunodeficiency virus (HIV) infection in adults and children 3 months of age and older. Lamivudine (Epivir-HBV) is used to treat hepatitis B infection. Lamivudine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and hepatitis B in the blood. Although lamivudine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV or hepatitis B virus to other people.

Are there OTHER USES for this medicine?

Lamivudine is also used sometimes in combination with other medications to treat healthcare workers or other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.

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

HOW should this medicine be used?

Lamivudine comes as a tablet and oral solution (liquid) to take by mouth. Lamivudine (Epivir) is usually taken once or twice a day with or without food. Lamivudine (Epivir-HBV) is usually taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lamivudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lamivudine controls HIV and hepatitis B infection and but does not cure them. Continue to take lamivudine even if you feel well. Do not stop taking lamivudine without talking to your doctor. When your supply of lamivudine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking lamivudine, your condition may become more difficult to treat.

What SPECIAL PRECAUTIONS should I follow?

Before taking lamivudine,

• tell your doctor and pharmacist if you are allergic to lamivudine, any other medications, or any of the ingredients in lamivudine tablets or oral solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: interferon alfa (Intron A), ribavirin (Copegus, Rebetol, others), sorbitol; and trimethoprim/sulfamethoxazole (Bactrim, Septra).

• tell your doctor if you have or have ever had hepatitis C virus infection or other liver disease, kidney disease, or pancreas disease (in children only).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lamivudine, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking lamivudine.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms after starting treatment with lamivudine, be sure to tell your doctor.

• if you have diabetes, you should know that there are 3 grams of sucrose in each tablespoon (15 mL) of lamivudine solution.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Lamivudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• difficulty falling sleeping or staying asleep
• depression
• stuffy nose

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• rash
• vomiting (in children)
• nausea (in children)
• ongoing pain that begins in the stomach area but may spread to the back (in children)
• numbness, tingling, or burning in the fingers or toes
• excessive tiredness; weakness, dizziness or lightheadedness; fast or irregular heartbeat; muscle pain; stomach pain with nausea and vomiting; shortness of breath or difficulty breathing; flu-like symptoms such as fever, chills, or cough; or feeling cold, especially in the arms or legs
• light-colored bowel movements; yellowing of the skin or eyes; loss of appetite; unusual bleeding or bruising; dark yellow or brown urine; or pain in the upper right part of stomach

Lamivudine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). The oral solution does not need to be refrigerated; however, it should be stored in a cool place.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of lamivudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2018.