Abacavir, lamivudine, and zidovudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Abacavir, lamivudine, and zidovudine (Trizivir) is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). abacavir, lamivudine, and zidovudine is not a cure for HIV or AIDS.

Trizivir may also be used for purposes not listed in this medication guide.

You should not take abacavir, lamivudine, and zidovudine 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 this medicine and call your doctor at once if you have signs of an allergic reaction: 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 abacavir, lamivudine, and zidovudine 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 abacavir, lamivudine, and zidovudine 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.

Tell your doctor if you have ever had:

• 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Taking this medicine 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 this medicine, 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).

Abacavir, lamivudine, and zidovudine 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 side effects of abacavir, lamivudine, and zidovudine 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 affect 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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to abacavir, lamivudine, and zidovudine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of abacavir, lamivudine, and zidovudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Trizivir® (containing Abacavir, Lamivudine, and Zidovudine)