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EPZICOM® (abacavir sulfate and lamivudine)

See the full Prescribing Information for EPZICOM

Details on Use of EPZICOM

  • EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults.
  • EPZICOM is one of 3 medicines containing abacavir. Before starting EPZICOM, 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.
  • EPZICOM should not be used as part of a triple-nucleoside regimen.
  • EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.
    •

Important Safety Information

EPZICOM contains abacavir, which is also contained in ZIAGEN® (abacavir sulfate) and TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine).

Patients taking abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking EPZICOM, stop taking EPZICOM and call your healthcare provider 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

Carefully read the Warning Card that your pharmacist gives you and carry it with you at all times.

If you stop EPZICOM because you have an allergic reaction to abacavir, NEVER take EPZICOM or another abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If you take EPZICOM or any other 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 provider before taking it again. Taking EPZICOM again can cause a serious or life-threatening reaction, even if you have never had an allergic reaction before. If your healthcare provider tells you that you can take abacavir again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.

A buildup of lactic acid in the blood and an enlarged liver, including fatal cases, have been reported.

Do not take EPZICOM if your liver does not function normally.

Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of EPZICOM). Discuss any change in treatment with your healthcare provider. If you have both HBV and HIV and stop treatment with EPZICOM, you should be closely monitored by your healthcare provider for at least several months.

Worsening of liver disease (sometimes resulting in death) has occured 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 experience side effects, be sure to tell your healthcare provider.

When you start taking HIV medicines, 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 medicines, be sure to tell your healthcare provider.

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.

Some HIV medicines, including those containing abacavir (ZIAGEN, EPZICOM, and TRIZIVIR), may increase your risk of heart attack. If you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes, tell your healthcare provider.

The most common side effects seen with the drugs in EPZICOM dosed once-daily were allergic reaction, trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams, and anxiety. Most of the side effects do not cause people to stop taking EPZICOM.

See the full Prescribing Information for EPZICOM, including boxed warnings

Visit the Web site for EPZICOM