What’s the most important information I should know about taking EPZICOM?

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

If you get a symptom from 2 or more of the following groups while taking EPZICOM, stop taking EPZICOM and call your doctor 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, or sore throat

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

If you stop EPZICOM because you have had an allergic reaction to abacavir, NEVER take EPZICOM or another abacavir-containing medicine (ZIAGEN^® and TRIZIVIR^®) again. If you take EPZICOM 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 EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your healthcare professional before taking it again. Taking EPZICOM again can cause a serious or life-threatening reaction, even if you never had an allergic reaction before. If your healthcare professional tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a doctor if you need one.

What other safety information should I know about EPZICOM™ (abacavir sulfate and lamivudine)?

EPZICOM, 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.
Patients with hepatitis B virus (HBV) infection, who take EPZICOM and then stop 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 EPZICOM. 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 EPZICOM as well as interferon with or without ribavirin and you experienc side effects, be sure to tell your doctor.
When you start taking HIV medicine, your immune system may get stronger and could 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 medicine, 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 seen with EPZICOM were allergic reaction, trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams, and anxiety. Most of these side effects did not cause people to stop taking this combination of medicines in clinical studies.

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 with EPZICOM.