ABACAVIR AND LAMIVUDINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Epzicom

† Not commercially available in Canada.

• Antiviral (systemic)

Abacavir (a-BAK-a-veer), and lamivudine (la-MI-vyoo-deen) combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir and lamivudine combination will not cure or prevent HIV infection or the symptoms of AIDS; however, 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 infection. Abacavir and lamivudine combination 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 infection.

This medicine is available only with your doctor's prescription, in the following dosage forms:

• Oral
• Tablets (U.S.)

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 abacavir and lamivudine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to abacavir or lamivudine. This medicine should not be taken if you have ever had an allergic reaction to it or to abacavir because it could cause another severe reaction that may result in death. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Abacavir and lamivudine combination has not been studied in pregnant women. However, abacavir has been found to cause birth defects and other problems in animals at doses many times the human dose. Before taking abacavir and lamivudine combination, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether abacavir passes into breast milk, however lamivudine is passed into human breast milk. Because of the possibility that this medicine could cause unwanted effects in nursing babies and the risk of passing HIV on to the infant, breast-feeding is not recommended. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of abacavir and lamivudine in children with the use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of abacavir in the elderly with use in other age groups.

Other medicines—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 abacavir and lamivudine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Abacavir (e.g., Ziagen) or
• Lamivudine (e.g., Epivir-HBV, Combivir, Trizivir)—Using additional abacavir or lamivudine with this combination medicine may increase the chance of side effects of abacavir and lamivudine

• Zalcitabine (e.g., HIVID)—Use of this medicine with lamivudine may result in these medicines or the combination not working as well as they should

Other medical problems—The presence of other medical problems may affect the use of abacavir and lamivudine combination. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to abacavir—You should tell your doctor immediately if you have signs of an allergic reaction. If you have ever taken abacavir in the past, you should tell your doctor right away.

• Kidney disease or
• Liver problems—Patients with kidney or liver disease may have more side effects

• Risk factors for liver disease such as:
• Being overweight or
• Taking other HIV medicines for long periods of time—Serious side effects could occur; caution should be used

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

Do not stop taking abacavir and lamivudine combination without checking with your doctor first.

Dosing—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.

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

Abacavir and lamivudine combination contains a fixed amount of each medicine.

• For oral dosage form (tablets):
  • For HIV infection:
    • Adults—600 milligrams (mg) of abacavir, and 300 mg of lamivudine (equal to one tablet) once a day. This medicine can be taken with or without food.
    • Children—Use and dose must be determined by your doctor

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—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 other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits . Abacavir and lamivudine combination may cause blood problems, and your doctor will want to test your blood regularly.

This medicine may cause a severe allergic reaction in some patients. This reaction usually occurs within 6 weeks after the medicine is started but may occur at any time. If untreated, it can lead to severe low blood pressure and even death. Stop taking this medicine and check with your doctor immediately if you notice sudden fever, skin rash, diarrhea, nausea, stomach pain, vomiting, or a feeling of unusual tiredness or illness, cough, shortness of breath, or sore throat.

When you begin taking this medicine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by abacavir and lamivudine combination. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

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 may need medical attention.

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

More common

Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of face, feet, or hands; pain in joints; pain in muscles; shortness of breath; skin rash; sore throat; swelling of feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting

Incidence not known—occurred during clinical practice

Blistering, peeling, loosening of skin; bloating; burning, numbness, tingling, or painful sensations; chest pain; chills; constipation; convulsions; dark urine; decreased appetite; diarrhea; difficulty swallowing; dizziness; fast heartbeat; fast, shallow breathing; feeling of fullness; general feeling of discomfort; hives or welts; indigestion; itching; light-colored stools; loss of appetite; loss of bladder control; muscle cramping; muscle spasm or jerking of all extremities; pains in stomach, side, or abdomen, possibly radiating to the back; pale skin; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; red irritated eyes; redness of skin; red skin lesions, often with a purple center; sleepiness; sores, ulcers, or white spots on lips or in mouth; sudden loss of consciousness; swollen, painful, or tender lymph glands in neck, armpit, or groin; tightness in chest; troubled breathing with exertion; unsteadiness or awkwardness; unusual bleeding or bruising; upper right abdominal pain; weakness in arms, hands, legs, or feet; wheezing; yellow eyes and skin

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Abnormal dreams; burning feeling in chest or stomach; fear; feeling of constant movement of self or surroundings; lightheadedness; nervousness; sensation of spinning; severe and throbbing headache; sleeplessness; stomach upset; tenderness in stomach area; trouble sleeping; unable to sleep

Incidence not known—occurred during clinical practice

Abnormal breathing sounds; blurred vision; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; dry mouth; dry skin; fruit-like breath odor; flushed; hair loss; increased hunger; increased thirst; increased urination; muscle weakness; redistribution/accumulation of body fat; sweating; swelling or inflammation of the mouth; thinning of hair; unexplained weight loss

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

Developed: 10/26/2004

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