Some people have an allergic reaction to abacavir, a medicine in EPZICOM
All medicines may have some side effects, such as headache, tiredness, upset stomach, fever, and rash. Abacavir, one of the medicines in EPZICOM, sometimes causes an allergic reaction. This happens to fewer than 1 in 10 people who take EPZICOM.
The allergic reaction caused by abacavir is called hypersensitivity, and it can cause any or all of the following symptoms:
- Fever
- Rash
- Nausea, vomiting, diarrhea, abdominal (stomach area) pain
- Generally ill feeling, extreme tiredness, achiness
- Shortness of breath, cough, sore throat
If you are taking EPZICOM and you get a symptom from two or more of the groups listed above, call your healthcare provider immediately. Hypersensitivity can be dangerous if it is not caught early.
Managing your risk of having a hypersensitivity reaction
Before you start taking EPZICOM, there is a specific test you can take to find out if you have a higher chance of having hypersensitivity. If you test positive, you are at higher risk of having a serious and potentially fatal allergic reaction to abacavir, which is a medicine contained in EPZICOM. Talk to your healthcare provider about this specific test and your result. Your healthcare provider and you can then decide if EPZICOM is right for you.
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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 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.
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.
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, 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 of an allergic reaction, NEVER take
EPZICOM or any other 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 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.
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 doctor. If you have both HBV and HIV and stop treatment with EPZICOM, you should be closely monitored by your doctor 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 doctor.
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 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 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.
