TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine)

TRIZIVIR treats HIV infection in combination with other HIV medicines or alone. HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.

TRIZIVIR is used in combination with other HIV medicines, or alone, for the treatment of HIV infection. TRIZIVIR is a combination of three medicines: ZIAGEN^® (abacavir sulfate), EPIVIR^® (lamivudine or 3TC), and RETROVIR^® (zidovudine, or ZDV). If you weigh less than 90 pounds, you should not take TRIZIVIR because it may be too much medicine for your body to handle
TRIZIVIR is one of several medicines containing abacavir. Before you start taking TRIZIVIR, review your medical history with your healthcare professional to make sure you have not had a severe allergic reaction to abacavir in the past
There is limited information on the use of this triple-combination therapy in patients with viral loads >100,000 c/mL. Talk to your healthcare professional about whether TRIZIVIR might be right for you

Important Safety Information

TRIZIVIR contains abacavir. Patients taking abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death.

If you get a symptom from two or more of the following groups while taking abacavir, stop taking abacavir 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 problems that can happen on the Warning Card that your pharmacist gives you. Carry this Warning Card with you.

If you stop TRIZIVIR because you have an allergic reaction to abacavir, NEVER take TRIZIVIR 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 get life-threatening symptoms that may include very low blood pressure or death.

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

Other Important Safety Information

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 disease or AIDS
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
Patients with hepatitis B virus (HBV) infection who take lamivudine, an active ingredient in TRIZIVIR, and then stop taking it, may get "flare-ups" of their hepatitis. A flare-up is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping lamivudine. 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 anti-HIV medicines. 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. The cause and long-term health effects of these conditions are not known at this time
The most common side effects 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
These are not all the side effects you could have when taking TRIZIVIR. Your healthcare professional can talk to you about these and other side effects with TRIZIVIR
Tell your doctor promptly about any side effects or other unusual symptoms you may experience

See the full Prescribing Information for TRIZIVIR

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