IMPORTANT SAFETY INFORMATION

TRIZIVIR does not cure HIV infection/AIDS or prevent passing HIV to others.

TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) contains abacavir, which is also contained in ZIAGEN® (abacavir sulfate) and EPZICOM® (abacavir sulfate and lamivudine). Patients taking TRIZIVIR may have a serious allergic reaction (hypersensitivity reaction), which can be fatal.

If you get a symptom from 2 or more of the following groups while taking TRIZIVIR, stop taking TRIZIVIR and call your healthcare professional right away.

	Symptom(s)
Group 1	Fever
Group 2	Rash
Group 3	Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
Group 4	Generally ill feeling, extreme tiredness, or achiness
Group 5	Shortness of breath, cough, or sore throat

Read the list of potential problems on the Warning Card that your pharmacist gives you. Carry this Warning Card with you.

If you stop TRIZIVIR because you had an allergic reaction to abacavir, NEVER take TRIZIVIR (or ZIAGEN or EPZICOM) or another abacavir-containing medicine again. If you take TRIZIVIR or another abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may experience life-threatening symptoms, including very low blood pressure or death.

If you stop TRIZIVIR for any reason, even for a few days, and you are not allergic to TRIZIVIR, talk with your healthcare professional before taking it again. Taking TRIZIVIR again can cause a serious or life-threatening reaction, even if you have never had an allergic reaction before. If your healthcare professional tells you that you can take TRIZIVIR again, start taking it when you are around medical help or someone you know who can call a healthcare professional if you need one.

What Other Safety Information Should I Know About TRIZIVIR?

• TRIZIVIR, like other HIV medicines, can cause a condition called lactic acidosis and severe liver problems. Lactic acidosis occurs when acid builds up in the blood, which can affect how the body functions. In some cases, lactic acidosis can cause death. Nausea and tiredness that don't get better may be symptoms of lactic acidosis. Women are more likely than men to get this serious side effect
• Make sure to see your doctor regularly because other serious side effects can occur, such as muscle damage and a decrease in red and/or white blood cells, especially in patients with advanced HIV or AIDS
• Patients with hepatitis B virus (HBV) who take TRIZIVIR and then stop it may get "flare-ups" of their hepatitis. A "flare-up" occurs when the disease suddenly returns in a worse way than before. If you have HBV, your doctor should closely monitor your liver function for several months after stopping TRIZIVIR. You may need to take anti-HBV medicines
• Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking TRIZIVIR as well as interferon with or without ribavirin, and you experience side effects, be sure to tell your doctor
• When you start taking HIV medicines, your immune system may get stronger and may begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor
• Changes in body fat may occur in some patients taking antiretroviral therapy. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also occur. At this time, the cause and long-term health effects of these conditions are unknown
• The most common side effects with TRIZIVIR should be the same as those of ZIAGEN® (abacavir sulfate), EPIVIR® (lamivudine), and RETROVIR® (zidovudine) taken together. The most common adverse events (≥5%) of at least moderate intensity associated with the use of TRIZIVIR include nausea, headache, weakness or tiredness, vomiting, hypersensitivity reaction, diarrhea, fever and/or chills, depression, muscle and joint pain, skin rashes, ear/nose/throat infections, cold symptoms, and nervousness. In clinical studies, most of these side effects did not cause people to stop taking this combination of medicines

These are not all the side effects you could have when taking this medicine. Your healthcare professional can discuss a full list of side effects that may occur while taking TRIZIVIR.

Who Should Not Take TRIZIVIR?

• Do not take TRIZIVIR if you've ever had a serious allergic reaction to any of the medicines that make up TRIZIVIR, such as ZIAGEN® (abacavir sulfate) or EPZICOM® (abacavir sulfate and lamivudine)
• Do not take TRIZIVIR with COMBIVIR® (lamivudine and zidovudine), ZIAGEN, EPIVIR® (lamivudine), EPZICOM, or RETROVIR® (zidovudine) because these medicines contain the same drugs as TRIZIVIR
• If you weigh less than 90 pounds, you should not take TRIZIVIR because it may be too much medicine for your body to handle
• If you have a serious liver problem and your liver does not function properly, you should not take TRIZIVIR
• If you have less serious liver problems (including hepatitis B), or kidney problems, talk to your doctor about whether or not you should take TRIZIVIR

For more information about HIV and TRIZIVIR, read our patient education brochure

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