What is Lamivudine?

Epivir (R)Exacerbations of Hepatitis B, and Different Formulations of LamivudineExacerbations of Hepatitis BSevere acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.Important Differences Among Lamivudine-Containing ProductsEpivir (R) tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than Epivir-HBV (R) tablets and oral solution (used to treat chronic hepatitis B virus infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 .

Epivir-HBV (R)Lactic Acidosis and Severe Hepatomegaly with Steatosis, Exacerbations of Hepatitis B, and Risk of HIV-1 Resistance if Lamivudine is Used in Patients with Unrecognized or Untreated HIV-1Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue lamivudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including lamivudine). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.Lamivudine is not approved for the treatment of HIV-1 infection because the lamivudine dosage in lamivudine is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with lamivudine and periodically during treatment .

Lamivudine is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Lamivudine will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV disease from occurring. Lamivudine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

Lamivudine is also used to treat chronic (long-term) hepatitis B virus (HBV) infection.

This medicine is available only with your doctor's prescription.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Epivir® and Epivir-HBV® both contain the same medicine, but Epivir® has more medicine in each tablet or dose of liquid. Use only the brand of this medicine that your doctor prescribed. If you have HIV or AIDS, you need to use Epivir®. If you have hepatitis B but you do not have HIV or AIDS, you can use Epivir-HBV®.

Your doctor may want to test you for HIV before you start using Epivir-HBV® and during your treatment. Your medicine may need to be changed based on these test results.

It is important to take Epivir® as part of a combination regimen. Take all of the medicines your doctor prescribed at the right time of day. This will make your medicines work better.

Keep taking lamivudine for the full time of treatment, even if you or your child begin to feel better. Do not stop taking it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

If you are using the oral liquid, use a specially marked measuring spoon, dosing syringe, or medicine cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets):
  • For treatment of hepatitis B infection:
    • Adults—100 milligrams (mg) once a day.
    • Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 3 milligrams (mg) per kilogram (kg) of body weight per day. The doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per day. If your child cannot swallow the tablets, he or she may take the oral liquid.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For treatment of HIV infection or AIDS:
    • Adults and children 17 years of age and older—300 milligrams (mg) once a day or 150 mg two times a day.
    • Children 3 months to 16 years of age—
      • Solution: Dose is based on body weight and must be determined by your doctor. The dose is usually 4 milligrams (mg) per kilogram (kg) of body weight taken two times a day, or 8 mg per kg once a day. The doctor may increase your dose as needed. However, the dose is usually not more than 150 mg two times a day, taken with other HIV medicines.
      • Tablets: Dose is based on body weight and must be determined by your doctor. The dose is usually 150 to 300 mg per day. If your child weighs at least 14 kg, it is preferred that he or she take the scored tablet.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.

Note: Patients that require treatment for both hepatitis B and either AIDS or HIV should follow the dosing schedule for HIV or AIDS.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lamivudine for the treatment of HIV infection in children 3 months to 16 years of age. However, safety and efficacy have not been established in children younger than 3 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lamivudine for the treatment of chronic hepatitis B infection in children 2 to 17 years of age. However, safety and efficacy have not been established in children younger than 2 years of age.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lamivudine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving lamivudine.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dasabuvir
• Horsetail
• Orlistat
• Sorbitol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes—The oral solution contains sucrose, which can make this condition worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease—Use with caution. May make this condition worse.

• Pancreatitis (inflammation or swelling of the pancreas), history of—Epivir® should be used with caution. May make this condition worse.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child is also taking zalcitabine or medicines containing emtricitabine or lamivudine (eg, Atripla®, Combivir®, Complera®, Emtriva®, Epzicom®, Stribild®, Trizivir®, Truvada®). Tell your doctor right away if you are using any of these medicines.

Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and liver toxicity, including an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child has stomach discomfort or cramping, nausea, vomiting, or diarrhea, a decreased appetite, a general feeling of discomfort, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

This medicine may cause worsening of hepatitis B infection when treatment is stopped.

Pancreatitis may occur while you are using Epivir®. Tell your doctor right away if you or your child has sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Your immune system may get stronger when you start taking Epivir®. This could cause a hidden infection in your body to become active. Tell your doctor right away if you or your child notice any changes in your health.

Epivir® may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

Lamivudine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not re-use or share needles or equipment with anyone. If you have any questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.