Epzicom (generic: abacavir/lamivudine) is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults. Epzicom belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help decrease the amount of HIV in your blood.
This medication comes in tablet form and is taken once a day, with or without food.
Common side effects of Epzicom include trouble sleeping, depression, and headache.
Epzicom is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
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 immune system. 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. 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.
Some HIV medicines including Epzicom may increase your risk of heart attack. If you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes, tell your doctor.
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.
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 any of the following medicines:
Serious Allergic Reaction to Abacavir. 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 than if you do not. Your doctor can determine with a blood test if you have this gene variation.
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 doctor 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 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.
- Lactic Acidosis. Some human immunodeficiency virus (HIV) medicines, including Epzicom, can cause a rare but serious condition called lactic acidosis with liver enlargement (hepatomegaly). Nausea and tiredness that don't get better may be symptoms of lactic acidosis. In some cases this condition can cause death. Women, overweight people, and people who have taken HIV medicines like Epzicom for a long time have a higher chance of getting lactic acidosis and liver enlargement. Lactic acidosis is a medical emergency and must be treated in the hospital.
- Worsening of hepatitis B virus (HBV) infection. Patients with HBV infection, who take Epzicom and then stop it, may get “flare-ups” of their hepatitis. “Flare-up” is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping Epzicom. You may need to take anti-HBV medicines.
- 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 doctor.
Epzicom can have other serious side effects.
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).
- have a liver that does not function properly.
- are less than 18 years of age.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Epzicom there are no specific foods that you must exclude from your diet when receiving Epzicom.
Before starting Epzicom tell your doctor about all of your medical conditions, including if you:
Tell your doctor if you are pregnant. It is not known if Epzicom will harm your unborn baby.
Tell your doctor if you are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers not breastfeed their infants to avoid risk of HIV-1 transmission. Both medicines in Epzicom may be excreted in human breast milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, your doctor advise you not to breastfeed while taking Epzicom.
Take Epzicom exactly as your doctor prescribes it. Follow the directions on your prescription label carefully.
The recommended dose of Epzicom in adults is one tablet daily, along with other antiretroviral medicines.
If you take too much Epzicom seek emergency medical attention or call your local Poison Control Center right away.
Epzicom tablets contain 600 mg of abacavir sulfate and 300 mg of lamivudine.
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.
- 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.
WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS
Epzicom contains 2 nucleoside analogues (abacavir sulfate and lamivudine) and is intended only for patients whose regimen would otherwise include these 2 components.
Hypersensitivity Reactions: Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of Epzicom. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups:
(3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain),
(4) constitutional (including generalized malaise, fatigue, or achiness), and
(5) respiratory (including dyspnea, cough, or pharyngitis).
- Discontinue Epzicom as soon as a hypersensitivity reaction is suspected.
Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients.
Regardless of HLA-B*5701 status, permanently discontinue Epzicom if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
Following a hypersensitivity reaction to abacavir, NEVER restart Epzicom or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
Reintroduction of Epzicom or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours.
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir, lamivudine, and other antiretrovirals
Exacerbations of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, which is one component of Epzicom. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Epzicom and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.