ZIAGEN® (abacavir sulfate)

ZIAGEN Tablets and Oral Solution, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. ZIAGEN is one of three medicines containing abacavir. Before starting ZIAGEN, your healthcare professional will review your medical history in order to avoid the use of abacavir if you have experienced a hypersensitivity reaction to abacavir in the past. In one study, more patients had a severe hypersensitivity reaction in the abacavir once-daily group than in the abacavir twice-daily group. ZIAGEN should not be used as part of a triple-nucleoside regimen. ZIAGEN does not cure HIV infection/AIDS or prevent passing HIV to others.

Important Safety Information

ZIAGEN 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 ZIAGEN because you have an allergic reaction to abacavir, NEVER take ZIAGEN or another abacavir-containing medicine again. If you take ZIAGEN or another abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that 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 healthcare professional before taking it again. Taking abacavir 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 abacavir again, start taking it when you are around medical help or people who can call a healthcare professional if you need one.

Other Important Safety Information

ZIAGEN, 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
If you have less serious liver problems (including hepatitis B), or kidney problems, talk to your doctor about whether or not you should take ZIAGEN
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 ZIAGEN 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. The cause and long-term health effects of these conditions are not known at this time
The most common side effects with ZIAGEN were nausea, headache, weakness or tiredness, nausea and vomiting, allergic reaction, diarrhea, stomach pain, depression, fever/chills, muscle pain, rashes, and nervousness
These are not all the side effects you could have when taking this medicine. Your healthcare professional can talk to you about these and other side effects with ZIAGEN
Tell your doctor promptly about any side effects or other unusual symptoms you may experience

See the full Prescribing Information for ZIAGEN