INDICATION AND USAGE

EPZICOM is a prescription antiretroviral medicine that is used with certain other antiretroviral medicines to treat HIV-1 infection in adults. It contains 2 nucleoside analog reverse transcriptase inhibitor (NRTI) medicines, abacavir (ZIAGEN) and lamivudine or 3TC (EPIVIR). EPZICOM should not be used with other NRTI medicines.

EPZICOM is one of 3 medicines containing abacavir. Before starting EPZICOM, your healthcare provider will review your medical history to see if you have experienced an allergic reaction to abacavir in the past.

EPZICOM does not cure HIV-1 infection/AIDS and you may still experience HIV-related illnesses.

It is not known if EPZICOM is safe or effective in children under the age of 18.

IMPORTANT SAFETY INFORMATION FOR EPZICOM

  • 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, call your healthcare provider right away to determine if you should stop taking this medicine.
    • Fever
    • Rash
    • Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
    • Generally ill feeling, extreme tiredness, or achiness
    • Shortness of breath, cough, or sore throat
  • A list of these symptoms is on the Patient Warning Card. You will receive a Patient Warning Card with each new prescription and refill of EPZICOM®. Carefully read the Warning Card and always carry it with you.
  • 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 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 to it 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 for medical help.
  • EPZICOM, which contains abacavir, is taken once a day. In one study, more patients had severe allergic reaction when abacavir was taken once a day than if it was taken twice a day.
  • A buildup of lactic acid (lactic acidosis) in the blood and an enlarged liver, including fatal cases, has been reported. This serious medical emergency must be treated in the hospital. Call your healthcare provider right away if you have any of the following symptoms: feel very weak or tired; have muscle pain that isn't normal; trouble breathing; stomach pain with nausea and vomiting; feel cold, especially in your arms and legs; are dizzy or light-headed; or have a fast heartbeat.
  • Serious liver problems have been reported that can cause death. Call your healthcare provider right away if you get any of the following symptoms: your skin or white part of eyes turns yellow; your urine turns dark; your bowel movements turn light in color; you don't feel like eating for several days; or you have nausea or lower stomach pain.
  • You are more likely to have lactic acid buildup or serious liver problems if you are female, overweight, or taking nucleoside analogue HIV medicines for a long time.
  • Do not take EPZICOM if your liver does not function normally, are allergic to abacavir, or have the HLA-B*5701 gene.
  • Some patients with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (part of EPZICOM). Discuss any change in treatment with your healthcare provider. If you have HBV and HIV and stop using 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 also being treated for hepatitis C with interferon with or without ribavirin. Tell your healthcare provider if you are taking EPZICOM and interferon with or without ribavirin and you experience side effects.
  • 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, or tuberculosis. Tell your healthcare provider if you have new or worsening infection symptoms after starting EPZICOM.
  • Changes in body fat may occur in some patients taking antiretroviral therapy, including EPZICOM. These may include more fat in the upper back and neck ("buffalo hump"), chest, breast, and around the trunk, and loss of fat from the legs, arms, and face. The cause and long-term health effects of these changes are unknown.
  • Some HIV medicines, including those containing abacavir (ZIAGEN, EPZICOM, and TRIZIVIR), may increase your risk of heart attack.
  • Before taking EPZICOM, tell your healthcare provider if you:
    • have been tested and know if you have or don't have the HLA-B*5701 gene.
    • have or had hepatitis B, other liver problems, or kidney problems; or have any other health problems.
    • have or had heart problems, diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes, or if you smoke, because some HIV medicines, including those containing abacavir (ZIAGEN, EPZICOM, and TRIZIVIR) may increase your risk of heart attack.
    • are pregnant or plan to become pregnant, because it is not known if EPZICOM will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. Do NOT breastfeed. HIV-1 can be passed to your baby in breast milk. EPZICOM can pass into your breast milk, and it is not known if it will harm your baby.
  • It is important to tell your healthcare provider about all HIV medicines you take because EPZICOM should not be used with other medicines that contain abacavir or lamivudine, or with any medicines containing emtricitabine. Tell your healthcare provider if you take alcohol, medicines to treat hepatitis (like interferon or ribavirin), methadone, ATRIPLA®, COMBIVIR®, COMPLERA®, EMTRIVA®, EPIVIR® or EPIVIR-HBV®, STRIBILD®, TRIZIVIR, TRUVADA® or ZIAGEN.
  • The most common side effects of EPZICOM were allergic reaction, trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, and fever. These are not all the possible side effects of EPZICOM or its components. Ask your healthcare provider or pharmacist for more information.

COMBIVIR, EPIVIR, EPZICOM, TRIZIVIR, and ZIAGEN are registered trademarks of ViiV Healthcare.

The brands listed are trademarks of their respective owners and are not trademarks of ViiV Healthcare. The makers of these brands are not affiliated with and do not endorse ViiV Healthcare or its products.