FAQs about EPZICOM

Learn more about the test for hypersensitivity

Q. What is EPZICOM?
Q. Who should not take EPZICOM?
Q. How should I take EPZICOM?
Q. What should I avoid while taking EPZICOM?
Q. What are the possible side effects of EPZICOM?
Q. How should I store EPZICOM?
Q. What are the ingredients in EPZICOM?

Q. What is EPZICOM?

A. EPZICOM is a prescription medicine used to treat HIV infection. EPZICOM includes 2 medicines: abacavir (Ziagen) and lamivudine or 3TC (Epivir^®). Both of these medicines are called nucleoside analogue reverse transcriptase inhibitors (NRTIs). When used together, they help lower the amount of HIV in your blood. This helps to keep your immune system as healthy as possible so that it can help fight infection.

Different combinations of medicines are used to treat HIV infection. You and your doctor should discuss which combination of medicines is best for you.

EPZICOM does not cure HIV infection or AIDS. We do not know if EPZICOM will help you live longer or have fewer of the medical problems that people get with HIV or AIDS. It is very important that you see your doctor regularly while you are taking EPZICOM.
EPZICOM does not lower the risk of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles.

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Q. Who should not take EPZICOM?

A. Do not take EPZICOM if you:

have ever had a serious allergic reaction (a hypersensitivity reaction) to EPZICOM or any other medicine that has abacavir as one of its ingredients (Trizivir and Ziagen). If you have had such a reaction, return all of your unused EPZICOM to your doctor or pharmacist.
have a liver that does not function properly.
are less than 18 years of age.

Before starting EPZICOM, tell your doctor about all your medical conditions, including if you:

are pregnant or planning to become pregnant. We do not know if EPZICOM will harm your unborn child. You and your doctor will need to decide if EPZICOM is right for you. If you use EPZICOM while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry for EPZICOM.
are breastfeeding. Some of the ingredients in EPZICOM can be passed to your baby in your breast milk. It is not known if they could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk.
have liver problems, including hepatitis B virus infection.
have kidney problems.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

methadone
Hivid® (zalcitabine, ddC)
Epivir or Epivir-HBV (lamivudine, 3TC), Ziagen (abacavir sulfate), Combivir® (lamivudine and zidovudine), or Trizivir (abacavir sulfate, lamivudine, and zidovudine).

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Q. How should I take EPZICOM?

Take EPZICOM by mouth exactly as your doctor prescribes it. The usual dose is 1 tablet once a day. Do not skip doses.
You can take EPZICOM with or without food.
If you miss a dose of EPZICOM, take the missed dose right away, then take the next dose at the usual time.
Do not let your EPZICOM run out.
Starting EPZICOM again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If you run out of EPZICOM, even for a few days, you must ask your doctor if you can start EPZICOM again. If your doctor 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.
If you stop your anti-HIV drugs, even for a short time, the amount of virus in your blood may increase and the virus may become harder to treat.
If you take too much EPZICOM, call your doctor or poison control center right away.

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Q. What should I avoid while taking EPZICOM?

Do not take Epivir (lamivudine, 3TC) , Combivir (lamivudine and zidovudine) , Ziagen (abacavir sulfate) , or Trizivir (abacavir sulfate, lamivudine, and zidovudine) while taking EPZICOM. Some of these medicines are already in EPZICOM.
Do not take zalcitabine (Hivid, ddC) while taking EPZICOM.

Avoid doing things that can spread HIV infection, as EPZICOM does not stop you from passing the HIV infection to others.

Do not share needles or other injection equipment.
Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Do not breastfeed. EPZICOM can be passed to babies in breast milk and could harm the baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk.

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Q. What are the possible side effects of EPZICOM?

A. EPZICOM can cause the following serious side effects:

Serious allergic reaction that can cause death.
Lactic acidosis with liver enlargement (hepatomegaly) that can cause death.
Worsening of HBV infection.
Changes in body fat. These changes have happened in patients taking antiretroviral medicines like EPZICOM. The changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.

The most common side effects with EPZICOM are 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.

This list of side effects is not complete. Ask your doctor or pharmacist for more information.

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Q. How should I store EPZICOM?

Store EPZICOM at room temperature between 59° to 86°F (15° to 30°C).
Keep EPZICOM and all medicines out of the reach of children.

General information for safe and effective use of EPZICOM

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use EPZICOM for a condition for which it was not prescribed. Do not give EPZICOM to other people, even if they have the same symptoms that you have. It may harm them.

This is a summary of the most important information about EPZICOM. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for the information that is written for healthcare professionals, or call 1-888-825-5249.

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Q. What are the ingredients in EPZICOM?

A. Active ingredients: abacavir sulfate and lamivudine

Inactive ingredients: Each film-coated EPZICOM Tablet contains the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (Opadry® orange YS-1-13065-A) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

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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.