Trizivir contains a combination of abacavir, lamivudine, and zidovudine. Abacavir, lamivudine, and zidovudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Trizivir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Trizivir is used alone or in combination with other antiviral medicines.

You should not take Trizivir if you have ever had an allergic reaction to any medicine that contains abacavir, or if you have a gene variation called HLA-B*5701 allele. Also, you should not use this medicine if you have moderate or severe liver disease.

Stop taking Trizivir and call your doctor at once if you have signs of an allergic reaction to this medicine: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you've ever had hepatitis B, it may become active or get worse after you stop using Trizivir. You may need frequent liver function tests for several months.

Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking Trizivir once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking the medication again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Take Trizivir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Trizivir with or without food.

Trizivir comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Trizivir. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Usual Adult Dose for HIV Infection:

1 tablet orally twice a day

Use: In combination with other antiretroviral agents or alone, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally twice a day
Duration of therapy: 28 days

Comments:
-Recommended as an alternative regimen for nonoccupational postexposure prophylaxis of HIV infection; this triple NRTI regimen is recommended only when a NNRTI-based or a protease inhibitor-based regimen cannot or should not be used.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, as an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

At least 40 kg: 1 tablet orally twice a day

Comments: Use of the individual components is recommended for patients less than 40 kg; the manufacturer product information for Trizivir should be consulted.

Use: In combination with other antiretroviral agents or alone, for the treatment of HIV-1 infection

You should not use Trizivir if you are allergic to abacavir, lamivudine, or zidovudine, or if:

• you have moderate or severe liver disease;

• you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or

• you have a history of allergic reaction to Combivir, Epivir, Epzicom, Retrovir, or Ziagen.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

To make sure Trizivir is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);

• other liver problems (especially if you also use ribavirin or interferon alfa);

• bone marrow suppression;

• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or

• kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Trizivir should not be used to treat HIV in adolescents weighing less than 88 pounds (40 kilograms).

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medication again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking Trizivir will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

• Group 1 - fever;

• Group 2 - rash;

• Group 3 - nausea, vomiting, diarrhea, stomach pain;

• Group 4 - general ill feeling, extreme tiredness, body aches;

• Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to Trizivir, you must never use it again. If you stop taking Trizivir for any reason, talk to your doctor before you start taking it again.

Also call your doctor at once if you have:

• other signs of allergic reaction - skin blisters or peeling, eye redness, swelling in your face or throat, trouble breathing;

• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• liver problems - swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Trizivir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Trizivir side effects may include:

• headache;

• weakness or tiredness;

• nausea, vomiting; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with abacavir, lamivudine, and zidovudine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.