Abacavir, lamivudine, and zidovudine

Stop using this medicine and call your doctor at once if you have any of these 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. Once you have had an allergic reaction to this medicine, you must never use it again.

Trizivir can weaken your immune system. Your blood may need to be tested often.

This medicine may also cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Trizivir with or without food.

Trizivir comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

If you have ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.

Store at room temperature away from moisture and heat.

Stop using Trizivir and 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.

Trizivir can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• low white blood cells--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, trouble concentrating; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Trizivir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Trizivir. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

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

Common 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 in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with abacavir, lamivudine, and zidovudine. Give a list of all your medicines to any healthcare provider who treats you.

• 3TC, Abacavir, and Zidovudine
• Abacavir/Lamivudine/Zidovudine
• Azidothymidine, Abacavir, and Lamivudine
• AZT, Abacavir, and Lamivudine
• Compound S, Abacavir, and Lamivudine
• Lamivudine, Abacavir, and Zidovudine
• ZDV, Abacavir, and Lamivudine
• Zidovudine, Abacavir, and Lamivudine

• Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)

The combination of abacavir, lamivudine, and zidovudine is believed to act synergistically to inhibit reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue as well as to delay the emergence of mutations conferring resistance.

HIV infection: Treatment of HIV-1 infection alone or in combination with other antiretroviral agents.

Limitations of use: Limited data exist on use alone in patients with higher baseline viral load levels (>100,000 copies/mL).

HIV-1 infection, treatment: Children and Adolescents ≥40 kg: Refer to adult dosing. Note: Not recommended for pediatric patients <40 kg.

Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele.

Abacavir/lamivudine/zidovudine is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir/lamivudine/zidovudine or reinitiation of therapy with abacavir/lamivudine/zidovudine, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir/lamivudine/zidovudine immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible.

Following a hypersensitivity reaction to abacavir, never restart abacavir/lamivudine/zidovudine or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patient who have no history of abacavir hypersensitivity.

Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease.

Prolonged use of zidovudine has been associated with symptomatic myopathy.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue abacavir/lamivudine/zidovudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of abacavir/lamivudine/zidovudine. Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months in patients who discontinue abacavir/lamivudine/zidovudine and are coinfected with HIV-1 and HBV. If appropriate, initiation of anti-HBV therapy may be warranted.