LAMIVUDINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Epivir
• Epivir-HBV

In Canada?

• 3TC
• Heptovir

Category

• Antiviral, systemic

Description

Lamivudine (la-MI-vyoo-deen) is used in the treatmentof the infection caused by the human immunodeficiency virus (HIV) or hepatitisB virus. HIV is the virus that causes acquired immune deficiency syndrome(AIDS). Lamivudine is taken together with zidovudine (AZT) or other medicationsused to treat HIV.

Lamivudine will not cure or prevent HIV infection or AIDS; however, ithelps keep HIV from reproducing and appears to slow down the destruction ofthe immune system. This may help delay the development of problems usuallyrelated to AIDS or HIV disease. Lamivudine will not keep you from spreadingHIV to other people. People who receive this medicine may continue to haveother problems usually related to AIDS or HIV disease. Lamivudine is nota cure for the hepatitis B virus; the long-term effects of the drug on theinfection and the liver are unknown at this time.

Lamivudine is available only with your doctor's prescription, in the followingdosage forms:

Oral
• Oral solution (U.S. and Canada)
• Tablets (U.S. and Canada)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to lamivudine. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Lamivudine crosses the placenta. Studies in animalshave shown that lamivudine causes birth defects when given in very high doses.Before taking this medicine, make sure your doctor knows if you are pregnantor if you may become pregnant. Ask your doctor to register you with the PregnancyRegistry, to monitor the effect of treatment on you and your baby.

Breast-feeding? Lamivudine passes into the breast milk. If yourbaby does not already have the AIDS virus, there is a chance that you couldpass it to your baby by breast-feeding or your baby could have serious adversereactions. Talk to your doctor first if you are thinking about breast-feedingyour baby.

Children?Lamivudine can cause serious side effects. In onestudy, children with advanced AIDS were more likely than children who wereless ill to develop pancreatitis (inflammation of the pancreas) and peripheralneuropathy (a problem involving the nerves). Therefore, it is especially importantthat you discuss with your child's doctor the good that this medicine maydo as well as the risks of using it. Your child must be seen frequently andyour child's progress carefully followed by the doctor while the child istaking lamivudine.

Older adults?Lamivudine has not been studied specifically in olderpeople. Therefore, it is not known whether it causes different side effectsor problems in the elderly than it does in younger adults. Talk to your doctorfirst if you have liver, kidney, heart problems or other diseases. Your doctormay need to adjust your dose.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinglamivudine, it is especially important that your health care professionalknows if you are taking any of the following:

• Lamivudine with zidovudine (e.g., Combivir)?Should not be usedat the same time that you are taking lamivudine tablets or oral solution

• Zalcitabine (e.g., Hivid)?May cause problems with how lamivudineor zalcitabine work when used together

Other medical problems?The presence of other medicalproblems may affect the use of lamivudine. Make sure you tell your doctorif you have any other medical problems, especially:

• Combined infection of HIV and hepatitis B?May make the conditionof either of these infections worse

• Diabetes mellitus (sugar diabetes)?Lamivudine oral solutioncontains sucrose

• Hepatitis C or
• Hepatitis delta?Caution should be used; lamivudine safety hasnot been determined in patients who have hepatitis infections

• Human immunodeficiency virus?For patients with hepatitis Bvirus, your physician will talk to you about HIV before you begin taking lamivudine.You may be tested for HIV. Lamivudine tablets and oral solution for hepatitisB virus contain lower amounts of the drug than the tablets and solution forHIV. If you start on the lower-dose medication and later learn that you haveHIV, the higher-dose lamivudine may not then be effective against the infectioncaused by HIV.
• Inflamed pancreas or
• Problems with inflamed pancreas in the past or
• Other risk factors for developing an inflamed pancreas or
• Nerve damage?These conditions may occur or worsen when takinglamivudine

• Kidney disease?Patients with kidney disease may have an increasedchance of side effects

• Liver disease or
• Risk factors for liver disease or
• Obesity (being overweight)?This medicine may make liver diseaseworse in patients with liver disease, obesity and other HIV medicine use.

• Organ transplant?Caution should be used; lamivudine safetyhas not been determined in patients who have received an organ transplant

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor. Do not takemore of it, do not take it more often, and do not take it for a longer timethan your doctor ordered. Also, do not stop taking lamivudine or zidovudinewithout checking with your doctor first.

Keep taking lamivudine for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine,check with your health care professional.

If you are using lamivudine oral suspension,use a specially marked measuring spoon or other device to measure each doseaccurately. The average household teaspoon may not hold the right amount ofliquid. The lamivudine oral suspension containssucrose. Tell your doctor if you are diabetic before you start taking thismedicine.

Only take medicine that your doctor has prescribed specifically for you.Do not share your medicine with others.

Dosing?The dose of lamivudine will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of lamivudine. Your dose may be different if you have kidneydisease. If your dose is different, do not change it unless your doctor tells you to do so:

• For oral dosage forms (oral solutionand tablets):
  • For treatment of hepatitis B infection:
    • Adults ?100 milligrams (mg) once a day.
    • Children younger than 16 years of age?Use and dose must bedetermined by your doctor.
  • For treatment of HIV infection or AIDS:
    • Adults weighing 50 kilograms (kg) (110 pounds) or more?150milligrams (mg) twice a day together with other HIV medications.
    • Adults weighing less than 50 kg (110 pounds)?2 mg per kg ofbody weight twice a day together with other HIV medications.
    • Children 3 months to 16 years of age?4 mg per kg of body weight,up to 150 mg per dose, twice a day together with other HIV medications.
    • Children younger than 3 months of age?Use and dose must bedetermined by your doctor.

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

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits.

Do not take any other medicines without checking withyour doctor first. To do so may increase the chance of side effectsfrom lamivudine.

If you have both HIV and hepatitis B virus (HBV) infections, deteriorationof liver disease has occurred when lamivudine treatment is stopped. Discussany changes in your treatment and medicines with your doctor.

HIV may be acquired from or spread to other people through infected bodyfluids, including blood, vaginal fluid, or semen. If youare infected, it is best to avoid any sexual activity involving an exchangeof body fluids with other people. If you do have sex, always wear (or haveyour partner wear) a condom (?rubber?). Only use condomsmade of latex, and use them every time you have vaginal,anal, or oral sex. The use of a spermicide (such as nonoxynol-9) mayalso help prevent transmission of HIV if it is not irritating to the vagina,rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Donot use oil-based jelly, cold cream, baby oil, or shortening as a lubricant?theseproducts can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry theirown condoms. Birth control pills and diaphragms will help protect againstpregnancy, but they will not prevent someone from giving or getting the AIDSvirus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone.In some cities, more than half of the drug users are infected, and sharingeven 1 needle or syringe can spread the virus. If you have any questions aboutthis, check with your health care professional.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor immediately if any ofthe following side effects occur:

More common?especially in children

Abdominal or stomach pain (severe); feeling of fullness; nausea; sensation or pins and needles; skin rash; stabbing pain; tingling, burning, numbness,or pain in the hands, arms, feet, or legs; unsteadinessor awkwardness; vomiting

Rare

Abdominal discomfort; decreased appetite; diarrhea; fast, shallowbreathing; feeling of fullness; fever, chills, or sore throat; general feeling ofdiscomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; unusual tiredness or weakness

Incidence not determined

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Canker sores; difficulty in moving; discouragement; ear discharge; ear swelling; feeling sad or empty; general feeling of discomfort or illness; irritability; loss of appetite; loss of interest or pleasure; nasal discharge orcongestion; pain in joints; sores, ulcers, or white spots on lips or tongue or inside the mouth; stomach pain or cramps; swollen andpainful spots on neck, armpit, or groin; swollenjoints; trouble concentrating; trouble sleeping; unusually warm skin; weight loss

Less common

Acid or sour stomach; belching; cough; heartburn; indigestion; stomach discomfort or upset

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.

Incidence not determined

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,lamivudine is used in certain patients with the following medical condition:

• Human immunodeficiency virus (HIV) infection due to occupationalexposure (possible prevention of)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.