ABACAVIR, LAMIVUDINE, AND ZIDOVUDINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Trizivir

Category

• Antiviral (systemic)

Description

Abacavir (a-BAK-a-veer), lamivudine (la-MI-vyoo-deen), and zidovudine (zye-DOE-vyoo-deen) combination is used in the treatment of human immunodeficiencyvirus (HIV) infection. HIV is the virus that causes acquired immune deficiencysyndrome (AIDS).

Abacavir, lamivudine, and zidovudine combination will not cure or preventHIV 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 helpdelay the development of serious health problems usually related to AIDS orHIV infection. Abacavir, lamivudine, and zidovudine combination will not keepyou from spreading HIV to other people. People who receive this medicine maycontinue to have other problems usually related to AIDS or HIV infection.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, therisks 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, lamivudine,and zidovudine combination the following should be considered:

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

Pregnancy?Abacavir, lamivudine, and zidovudine combinationhas not been studied in pregnant women. However, abacavir has been foundto cause birth defects and other problems in animals at doses many times thehuman dose, and zidovudine has been studied in animals and causes birth defectswhen given in very high doses. Before taking this abacavir, lamivudine, andzidovudine combination, make sure your doctor knows if you are pregnant orif you may become pregnant.

Breast-feeding?Zidovudine passes into human breast milk. Itis not known whether abacavir or lamivudine passes into human breast milk.However, if your baby does not already have the AIDS virus, there is a chancethat you could pass it to your baby by breast-feeding. Talk to your doctorfirst if you are thinking about breast-feeding your baby.

Children?Abacavir, lamivudine, and zidovudine combinationcontains a fixed amount of each medicine that cannot be decreased. Therefore,this medicine is not recommended for patients who weigh less than 40 kilograms(88 pounds) because the amounts of abacavir, lamivudine, and zidovudine inthis product cannot be adjusted for smaller body sizes.

Older adults?Many medicines have not been studiedspecifically in older people. Therefore, it may not be known whether theywork exactly the same way they do in younger adults or if they cause differentside effects or problems in older people. There is no specific informationcomparing use of abacavir, lamivudine, and zidovudine combination in the elderlywith use in other age groups.

Other medicines?Although certain medicines should not be used together at all, in other casestwo different medicines may be used together even if an interaction mightoccur. In these cases, your doctor may want to change the dose, or other precautionsmay be necessary. When you are taking abacavir, lamivudine, and zidovudinecombination, it is especially important that your health care professionalknow if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Clozapine (e.g., Clozaril) or
• Colchicine or
• Didanosine (e.g., Videx) or
• Eflornithine (e.g., Ornidyl) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A)?Using any of these medicineswith the combination medicine may cause blood problems to become worse

• Abacavir (e.g., Ziagen) or
• Lamivudine (e.g., Epivir) or
• Zidovudine (e.g., Retrovir)?Using additional abacavir, lamivudine,or zidovudine with the combination medicine may increase the chance of sideeffects of abacavir, lamivudine, or zidovudine

• Doxorubicin (e.g., Adriamycin) or
• Ribavirin (e.g., Virazole) or
• Stavudine (e.g., Zerit)?Use of these medicines with abacavir,lamivudine, and zidovudine combination may result in these medicines or thecombination not working as well as they should

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

• Blood problems, including anemia and decreased bone marrow production?Abacavir,lamivudine, and zidovudine combination may make these conditions worse

• Kidney disease or
• Liver disease?Patients with kidney or liver disease may havemore side effects

Proper Use of This Medicine

Take this medicine exactly asdirected by your doctor. Do not take more of it, do not take it moreoften, and do not take it for a longer time than your doctor ordered. Also,do not stop taking abacavir, lamivudine, and zidovudine combination withoutchecking with your doctor first.

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 withyour health care professional.

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

Dosing?Abacavir, lamivudine, and zidovudine combinationcontains a fixed amount of each medicine.

• For oral dosage form (tablets):

• For human immunodeficiency virus (HIV) infection:

• Adults, teenagers, and children who weigh more than 40 kilograms(kg) (88 pounds)?300 milligrams (mg) of abacavir, 150 mg of lamivudine,and 300 mg of zidovudine (equal to one tablet) two times a day.
• Adults, teenagers, and children who weigh 40 kg (88 pounds) or less?Useis not recommended.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

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 yourdoctor check your progress at regular visits. Abacavir, lamivudine,and zidovudine combination may cause blood problems, and your doctor willwant to test your blood regularly.

This medicine may cause a severe allergic reaction in some patients. Thisreaction usually occurs within 6 weeks after the medicine is started but mayoccur at any time. If untreated, it can lead to severe low blood pressureand even death. Stop taking this medicine and check withyour doctor immediately if you notice abdominal or stomach pain; cough; diarrhea;fever; headache; nausea; numbness or tingling of face, feet, or hands; painin joints; pain in muscles; shortness of breath; skin rash; sore throat; swellingof feet or lower legs; unusual feeling of discomfort or illness; unusual tirednessor weakness; or vomiting.

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

Side Effects of This Medicine

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

Stop taking this medicineand get emergency help immediately if the following side effect occurs:

Less 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 discomfortor illness; unusual tiredness or weakness; or vomiting

Check with your doctor assoon as possible if any of the following side effects occur:

More common

Chills

Less common

Muscle weakness; pale skin; yellow eyes or skin

Rare

Black tarry stools; blood in urine orstools; pinpoint red spots on skin; unusual bleeding or bruising

Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome:

More common

Bone pain; loss of appetite; sleeplessness; trouble sleeping

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