An Overview of Epzicom (Abacavir/3TC, Kivexa)

a-BAK-a-veer, la-MI-vyoo-deen

Brand Name: Epzicom
Other Name(s): ABC/3TC, Abacavir sulfate/Lamivudine
Drug Class: Nucleoside Reverse Transcriptase Inhibitors

EPZICOM^® (ep' zih com)
(abacavir sulfate and lamivudine)

What is the most important information I should know about EPZICOM?

1. Serious allergic reaction (hypersensitivity reaction). EPZICOM contains abacavir (also contained in ZIAGEN^® and TRIZIVIR^®). 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. 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 find out if you should stop taking EPZICOM.

Group 1: Fever
Group 2: Rash
Group 3: Nausea, vomiting, diarrhea, abdominal (stomach area) pain
Group 4: Generally ill feeling, extreme tiredness, or achiness
Group 5: Shortness of breath, cough, sore throat

A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card 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 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 a healthcare provider if you need one.

2. Lactic Acidosis (buildup of acid in the blood). Some human immunodeficiency virus (HIV) medicines, including EPZICOM, can cause a rare but serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death and must be treated in the hospital.

• you feel very weak or tired
• you have unusual (not normal) muscle pain
• you have trouble breathing
• you have stomach pain with nausea and vomiting
• you feel cold, especially in your arms and legs
• you feel dizzy or light-headed
• you have a fast or irregular heartbeat

3. Serious liver problems. Some people who have taken medicines like EPZICOM have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

• your skin or the white part of your eyes turns yellow (jaundice)
• your urine turns dark
• your bowel movements (stools) turn light in color
• you don't feel like eating food for several days or longer
• you feel sick to your stomach (nausea)
• you have lower stomach area (abdominal) pain

You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines for a long time.

4. Use with interferon and ribavirin-based regimens. 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.

5. If you have HIV and hepatitis B virus infection, your hepatitis B virus infection may get worse if you stop taking EPZICOM.

• Take EPZICOM exactly as prescribed.
• Do not run out of EPZICOM.
• Do not stop EPZICOM without talking to your healthcare provider.
• Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking EPZICOM.

What is EPZICOM?

EPZICOM is a prescription medicine used to treat HIV infection. EPZICOM contains 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.

• EPZICOM does not cure HIV infection or AIDS.
• It is not known 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 healthcare provider regularly while you are taking EPZICOM.
• It is not known if EPZICOM is safe or effective in children under the age of 18.

Who should not take EPZICOM?

Do not take EPZICOM if you:

• are allergic to abacavir or any of the ingredients in EPZICOM. See the end of this Medication Guide for a complete list of ingredients in EPZICOM.
• have certain liver problems