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IMPORTANT SAFETY INFORMATION Prescribing Information, including Boxed WARNINGS and Medication Guide
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. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not.
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EPZICOM: Screening test
See if EPZICOM is right for you before you take it.
Before starting EPZICOM, your doctor will do a blood test to check for HLA-B*5701 to see if you are at high risk for an allergic reaction to abacavir – one of the main ingredients of EPZICOM. This simple, one-time test will tell you and your doctor whether EPZICOM may be right for you before you even take it. In fact, this test is clinically proven to help you reduce the chance of experiencing a potentially serious allergic reaction.
Learn more about the HLA-B*5701 test.
Who is at risk?
While an allergic reaction to abacavir can cause death, the reaction will usually go away if it is identified quickly and the medicine is stopped. Only about 8 in 100 people who take EPZICOM would experience an allergic reaction without the use of HLA-B*5701 testing.
What do your HLA-B*5701 test results mean?
Testing positive
- The screening test for EPZICOM (also know as HLA-B*5701) is clinically proven to help you reduce the chance of experiencing a potentially serious allergic reaction. By testing positive, you are at a higher risk of having an allergic reaction to abacavir. HIV treatment with abacavir is therefore not recommended.
Testing negative
- By testing negative for HLA-B*5701, you are at a lower risk of having an allergic reaction to abacavir. Therefore you may be a candidate for an HIV medicine that contains abacavir, such as EPZICOM.
Who should take the test?
The one-time screening test for EPZICOM is recommended for most people with HIV as one of their routine lab tests. People who should be tested include:
- People who have not yet started HIV treatment
- People who have started HIV treatment, but have never taken an HIV medicine containing abacavir
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Important Safety Information
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. 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 doctor 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, call your doctor right away to determine if you should stop taking this medicine.
- Fever
- Rash
- Nausea, vomiting, diarrhea, abdominal (stomach area) pain
- Generally ill feeling, extreme tiredness, or achiness
- Shortness of breath, cough, or sore throat
Indication
- 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 provider will review your medical history in order to avoid the use of abacavir if you have experienced an allergic 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.
Carefully read the Warning Card that your pharmacist gives you and carry it with you at all times.
If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM (abacavir sulfate and lamivudine) or any other abacavir-containing medicine (ZIAGEN and 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 allergic or life-threatening reaction, even if you never had an allergic reaction before. If your healthcare provider tells you that you can take EPZICOM 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 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 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 these side effects did not cause people to stop taking EPZICOM.