Epivir A/F (Oral)

Lamivudine is used along with other medicines to treat 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 stop HIV from making more copies of itself and seems to slow down the damage to the immune system. This may help delay serious health issues that are usually linked to AIDS or HIV disease. Lamivudine will not stop you from passing HIV to others. People taking this medicine may still experience other issues typically associated with 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.

It is very important for your doctor to check your or your child's progress during regular visits to ensure that this medicine is working properly. Blood and urine tests may be required to monitor for unwanted effects.

Do not use this medicine if you or your child is also taking zalcitabine or medicines that contain emtricitabine or lamivudine (for example, Atripla®, Combivir®, Complera®, Emtriva®, Epzicom®, Stribild®, Trizivir®, Truvada®). Inform your doctor immediately if you are using any of these medicines.

Two rare but serious reactions to this medicine are lactic acidosis (an acid build-up in the blood) and liver toxicity, which can include an enlarged liver. These reactions are more likely 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 experiences stomach discomfort or cramping, nausea, vomiting, diarrhea, a decreased appetite, a general feeling of discomfort, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellowing of the skin or eyes.

This medicine may make hepatitis B infection worse when treatment is stopped. Discuss any concerns you have about this with your doctor.

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

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

Lamivudine does not reduce the risk of transmitting HIV infection or hepatitis B infection to others through sexual contact or by contamination through blood. HIV or hepatitis B can be acquired or spread through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity that involves exchanging body fluids with others. If you do have sex, always use (or have your partner use) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you come into contact with semen, vaginal secretions, or blood. Also, do not reuse or share needles or equipment with anyone. If you have any questions about this, consult your doctor.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important things to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems in children that would limit the use of lamivudine for treating HIV infection in children 3 months and older. However, safety and effectiveness have not been established in children younger than 3 months.

Studies also have not shown specific problems in children that would limit the use of lamivudine for treating chronic hepatitis B infection in children 2 to 17 years old. However, safety and effectiveness have not been established in children younger than 2 years.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of lamivudine. However, older patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and a dose adjustment for those receiving lamivudine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of interaction. In these situations, your doctor may change the dose or take other precautions. When taking this medicine, it is important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been selected based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is generally not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Cabotegravir
• Horsetail
• Orlistat
• Sorbitol
• Tacrolimus

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

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

• Kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

• Liver disease—Use with caution. This may worsen the condition.

• Pancreatitis (inflammation or swelling of the pancreas), history of—Epivir® should be used with caution. This may worsen the condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Black, tarry stools
• bleeding gums
• bloating
• blood in the urine or stools
• blurred vision
• chills
• constipation
• cough
• dark urine
• decreased appetite
• diarrhea
• difficulty swallowing
• dizziness
• dry mouth
• fast heartbeat
• fast, shallow breathing
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort
• general tiredness and weakness
• increased hunger
• increased thirst
• increased urination
• indigestion
• light-colored stools
• loss of appetite
• muscle cramps, pain, stiffness, or spasms
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• right upper abdominal or stomach pain and fullness
• skin rash, hives, or itching
• sleepiness
• stomach discomfort
• tightness in the chest
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Belching
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• depression
• general feeling of discomfort or illness
• headache
• heartburn
• indigestion
• joint pain
• sensation of pins and needles
• sore throat
• stabbing pain
• stomach discomfort, upset, or pain
• stuffy or runny nose
• trouble sleeping
• weight loss

Incidence not known

• Hair loss or thinning of the hair
• pale skin
• sweating
• weight gain around your neck, upper back, breast, face, or waist

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Epivir
• Epivir A/F
• Epivir HBV

In Canada

• 3tc
• Heptovir

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

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 using lamivudine for the full time of treatment, even if you or your child begin to feel better. Do not stop using 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.

Dosing

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—300 milligrams (mg) once a day or 150 mg 2 times a day. Children 3 months of age and older— Solution: Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight taken 2 times a day, or 10 mg per kg once a day. The doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per 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 14 kg or more, 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.

Missed Dose

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.

Storage

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.

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