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

January 4, 2015

Epzicom

Brand Name: Epzicom
Other Name(s): abacavir sulfate/lamivudine, ABC/3TC
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection

Chemical Images:

abacavir sulfate

abacavir sulfate
Molecular Weight: 670.7522

lamivudine

lamivudine
Molecular Weight: 229.2589


WARNING:

Epzicom can cause serious, life-threatening side effects. These include allergic reactions, lactic acidosis (buildup of lactic acid in the blood), and liver problems.

People who take abacavir, an HIV medicine included in 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 health care provider can determine with a blood test if you have this gene variation. If you get a symptom from two or more of the following groups while taking Epzicom, contact your health care provider right away to find out if you should stop taking Epzicom.

Your pharmacist will give you a Warning Card with a list of these symptoms. Carry this Warning Card with you at all times. If you stop Epzicom because of an allergic reaction, never take Epzicom or any other abacavir-containing medicine 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 health care 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 health care provider tells you that you can take Epzicom again, start taking it when you are around medical help or people who can call a health care provider if you need one.

Contact your health care provider right away if you have any of the following symptoms that may be signs of lactic acidosis:

Contact your health care provider right away if you have any of the following symptoms that may be signs of serious liver problems:

Epzicom is not approved for the treatment of hepatitis B virus (HBV) infection. If you have both HIV and HBV infection and take Epzicom, your HBV infection may get worse (flare up) if you stop taking Epzicom.

Worsening of liver disease (sometimes resulting in death) has occurred in people infected with both HIV and hepatitis C virus (HCV) who are taking HIV medicines and are also being treated for HCV with interferon with or without ribavirin. If you are taking Epzicom as well as interferon with or without ribavirin and you experience side effects, tell your health care provider.

Epzicom may increase the risk of heart attack (myocardial infarction).

While taking Epzicom, it is important to keep all of your appointments with your health care provider.


What Is Epzicom?

Epzicom is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults. Epzicom is always used in combination with other HIV medicines.

Epzicom contains the following two different HIV medicines combined in one pill:

Both of the medicines in Epzicom (abacavir and lamivudine) belong to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, the two drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.


What Should I Tell My Health Care Provider Before Taking Epzicom?

Before taking Epzicom, tell your health care provider:


How Should I Take Epzicom?

Epzicom comes in tablet form. Each tablet contains:

Take Epzicom according to your health care provider's instructions.

Take Epzicom with or without food. Do not skip doses.

Always take Epzicom in combination with other HIV medicines.

If you take too much Epzicom, contact your health care provider or local poison control center (1-800-222-1222) right away or go to the nearest hospital emergency room.

For more information on how to take Epzicom, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)


What Should I Do if I Forget a Dose?

If you miss a dose of Epzicom, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.


What Side Effects Can Epzicom Cause?

Epzicom can cause serious, life-threatening side effects. These include allergic reactions, lactic acidosis (buildup of lactic acid in the blood), liver problems, and heart attack. (See the WARNING above.)

Other possible side effects of Epzicom include:

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Epzicom. To learn more about possible side effects of Epzicom, read the drug or package insert or talk to your health care provider or pharmacist.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to Epzicom.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088), or online at www.accessdata.fda.gov/scripts/medwatch/.


How Should Epzicom Be Stored?


Where Can I Find More Information About Epzicom?

More information about Epzicom is available:


Manufacturer Information

ViiV Healthcare
877-844-8872

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).




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