Pronunciation:

a-BAK-a-veer SUL-fate, la-MI-vyoo-deen, zye-DOE-vyoo-deen

Brand Names:

• Trizivir

Dosage Forms:

• Tablet

Warnings:

The three nucleoside analogue combination (abacavir sulfate/lamivudine/zidovudine) is intended only for patients whose regimen would otherwise include these 3 components.

Hypersensitivity reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: fever, rash, gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), constitutional (including generalized malaise, fatigue, or achiness), and respiratory (including dyspnea, cough, or pharyngitis). Discontinue abacavir sulfate/lamivudine/zidovudine as soon as a hypersensitivity reaction is suspected. Permanently discontinue abacavir sulfate/lamivudine/zidovudine if hypersensitivity cannot be ruled out, even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir, never restart abacavir sulfate/lamivudine/zidovudine or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.

Reintroduction of abacavir sulfate/lamivudine/zidovudine or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours.

Hematologic toxicity: Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV) disease. Prolonged use of zidovudine has been associated with symptomatic myopathy.

Lactic acidosis and severe hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir, lamivudine, zidovudine, and other antiretrovirals.

Exacerbations of hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV) and have discontinued lamivudine, which is one component of abacavir sulfate/lamivudine/zidovudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue abacavir sulfate/lamivudine/zidovudine and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Fatal hypersensitivity reactions have been reported with abacavir sulfate; discontinue if hypersensitivity reaction suspected and do not restart. Neutropenia, severe anemia, and symptomatic myopathy has been associated with zidovudine use, particularly in patients with advanced HIV disease. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogs alone or in combination with other antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients co-infected with HBV and HIV who have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Abacavir

Uses of This Medicine:

Abacavir , lamivudine , and zidovudine combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir, lamivudine, and zidovudine 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, lamivudine, and zidovudine 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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Abacavir, lamivudine, and zidovudine combination contains 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 in this product cannot be adjusted for smaller body sizes.

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, lamivudine, and zidovudine combination in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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.

• Dapsone
• Doxorubicin Hydrochloride
• Flucytosine
• Ganciclovir
• Interferon Alfa
• Pyrazinamide
• Pyrimethamine
• Ribavirin
• Stavudine
• Vinblastine
• Vincristine
• Vincristine Liposome
• Zalcitabine

Other interactions—

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.

Other medical problems—

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:

• 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 have more side effects

Proper Use of This Medicine:

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. Also, do not stop taking abacavir, lamivudine, and zidovudine combination without checking 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 with your health care professional.

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

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.

Abacavir, lamivudine, and zidovudine combination contains 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—Use is not recommended.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Abacavir, lamivudine, and zidovudine 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 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.

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, lamivudine, and zidovudine 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.

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 may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

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 discomfort or illness; unusual tiredness or weakness; or vomiting

Check with your doctor as soon 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 or stools

pinpoint red spots on skin

unusual bleeding or bruising

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. Also, your health care professional may be able to tell you about 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

Bone pain

loss of appetite

sleeplessness

trouble sleeping

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