abacavir and lamivudine

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Pronunciation: a BAK a veer and la MIV yoo deen

Brand: Epzicom

Epzicom

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What is the most important information I should know about abacavir and lamivudine?

Abacavir and lamivudine can cause severe or fatal side effects. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not take this medicine if you have liver disease, or if you have ever tested positive for a gene variation called HLA-B*5701. Do not take this medicine if you have ever had an allergic reaction to any medicine that contains abacavir or lamivudine.

Stop taking abacavir and lamivudine and call your doctor at once if you have signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine.

What is abacavir and lamivudine?

Abacavir and lamivudine are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Abacavir and lamivudine is a combination medicine used to treat HIV, which can cause the acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

Abacavir and lamivudine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking abacavir and lamivudine?

You should not use this medicine if you are allergic to abacavir or lamivudine, or:

  • if you have liver disease;
  • if you have ever tested positive for a gene variation called HLA-B*5701; or
  • if you have ever had an allergic reaction to any medicine that contains abacavir or lamivudine (Combivir, Epivir, Triumeq, Trizivir, Ziagen).

Once you have had an allergic reaction to abacavir, you must never use it again.

Some people taking lamivudine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

To make sure abacavir and lamivudine is safe for you, tell your doctor if you have:

  • hepatitis C (especially if you are treated with interferon and/or ribavirin);
  • a history of hepatitis or other liver problems (especially hepatitis B);
  • kidney disease;
  • heart disease or high blood pressure;
  • a risk factor for heart disease (such as smoking, diabetes, high cholesterol); or
  • if you drink alcohol daily.

You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medicine after stopping for reasons not related to an allergic reaction.

It is not known whether abacavir and lamivudine will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of this medication on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Abacavir and lamivudine should not be given to a child who weighs less than 55 pounds.

How should I take abacavir and lamivudine?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Abacavir and lamivudine may be taken with or without food. Tell the doctor if a child taking this medicine has trouble swallowing the tablet.

This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abacavir and lamivudine. Visit your doctor regularly.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medication again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking abacavir and lamivudine?

Avoid drinking alcohol. It may increase your risk of liver damage or lactic acidosis.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of abacavir and lamivudine?

Stop using this medicine and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

  • Group 1 - fever;
  • Group 2 - rash;
  • Group 3 - nausea, vomiting, diarrhea, stomach pain;
  • Group 4 - general ill feeling, extreme tiredness, body aches;
  • Group 5 - shortness of breath, cough, sore throat.

Once you have an allergic reaction to abacavir, you must never use it again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Abacavir and lamivudine can also cause serious or fatal side effects on the liver. Call your doctor at once if you have:

  • swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Abacavir and lamivudine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with abacavir and lamivudine. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • cold sores, sores on your genital or anal area;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects include:

  • sleep problems (insomnia);
  • headache, dizziness, tiredness, depression;
  • nausea, diarrhea; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect abacavir and lamivudine?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • interferon or ribavirin (to treat hepatitis C);
  • methadone; or
  • any other HIV medicines.

This list is not complete. Other drugs may interact with abacavir and lamivudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about abacavir and lamivudine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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