Epzicom (abacavir sulfate and lamivudine)

Brand name: Epzicom

Generic: abacavir sulfate and lamivudine

Epzicom is a prescription medicine used with other HIV-1 medicines to treat HIV-1 infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Epzicom contains the prescription medicines abacavir and lamivudine. Epzicom should not be used in children weighing less than 55 pounds (25 kg).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with Epzicom. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with Epzicom.
• Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Epzicom with other medicines.

What are the serious side effects of Epzicom?

Epzicom may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• unexplained weight loss,
• severe tiredness,
• muscle aches,
• weakness,
• severe headaches,
• joint pain,
• numbness or tingling of the hands, feet, arms, legs,
• vision changes,
• fever,
• chills,
• swollen lymph nodes,
• cough,
• non-healing skin sores,
• irritability,
• nervousness,
• heat intolerance,
• fast, pounding, or irregular heartbeat,
• bulging eyes,
• unusual growth in the neck or thyroid (goiter),
• trouble swallowing,
• difficulty moving your eyes,
• drooping face,
• paralysis,
• difficulty speaking,
• mental or mood changes,
• depression,
• anxiety,
• easy bruising,
• unusual bleeding,
• unusual tiredness,
• fast breathing,
• pale skin,
• nausea,
• vomiting,
• stomach pain,
• back pain,
• fever,
• loss of appetite,
• yellowing of the eyes and skin (jaundice),
• dark urine,
• deep or rapid breathing, and
• drowsiness

Get medical help right away, if you have any of the symptoms listed above.

Epzicom can cause serious side effects, including:

• Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with Epzicom and other abacavir-containing products. 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.

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 and lamivudine) or any other abacavir-containing medicine (Triumeq, Trizivir, or Ziagen) again.

• If you have an allergic reaction, dispose of any unused Epzicom. Ask your pharmacist how to properly dispose of medicines.
• 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.

• Worsening of hepatitis B virus (HBV) infection. If you have HBV infection and take Epzicom, your HBV may get worse (flare-up) if you stop taking Epzicom. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
  • Do not run out of Epzicom. Refill your prescription or talk to your healthcare provider before your Epzicom is all gone.
  • Do not stop Epzicom without first talking to your healthcare provider.
  • If you stop taking Epzicom, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat HBV. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Epzicom.
• Resistant HBV. If you have human immunodeficiency virus-1 (HIV-1) and HBV, the HBV can change (mutate) during your treatment with Epzicom and become harder to treat (resistant).

What are the common side effects of Epzicom?

The most common side effects of Epzicom include:

• headache,
• nausea,
• diarrhea,
• dizziness,
• tiredness, and
• trouble sleeping

Tell the doctor 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. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

No information provided

Methadone

• In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg of Ziagen twice daily (twice the currently recommended dose), oral methadone clearance increased.
• This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.

Sorbitol

• Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures.
• When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines.

Riociguat

• Coadministration with fixed-dose abacavir/dolutegravir/lamivudine resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions. The riociguat dose may need to be reduced. See full prescribing information for ADEMPAS (riociguat).

Screening For HLA-B*5701 Allele Prior To Starting Epzicom

• Screen for the HLA-B*5701 allele prior to initiating therapy with Epzicom.

Recommended Dosage For Adult Patients

• The recommended dosage of Epzicom for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food.

Recommended Dosage For Pediatric Patients

• The recommended oral dose of Epzicom for pediatric patients weighing at least 25 kg is one tablet daily in combination with other antiretroviral agents. Before prescribing Epzicom tablets, pediatric patients should be assessed for the ability to swallow tablets.

Not Recommended Due To Lack Of Dosage Adjustment

Because Epzicom is a fixed-dose tablet and cannot be dose adjusted, Epzicom is not recommended for:

• patients with creatinine clearance less than 50 mL per minute.
• patients with mild hepatic impairment. Epzicom is contraindicated in patients with moderate or severe hepatic impairment.

Use of Epivir (lamivudine) oral solution or tablets and Ziagen (abacavir) oral solution may be considered.

Do not take Epzicom if you:

• have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with Epzicom.
• are allergic to abacavir, lamivudine, 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.

Before you take Epzicom tell your healthcare provider about all of your medical conditions, including if you:

• have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
• have or have had liver problems, including hepatitis B or C virus infection.
• have kidney problems.
• have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
• are pregnant or plan to become pregnant.
  • Pregnancy Registry. There is a pregnancy registry for women who take HIV-1 medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take Epzicom.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.