Ziagen

Generic Name: abacavir (a-BAK-a-vir)
Brand Name: Ziagen

Ziagen has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough, sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take Ziagen again or take any other medicine that contains abacavir if you have had an allergic reaction to Ziagen. You may be at risk for an even more severe allergic reaction.

Patients who have a certain gene type called HLA-B*5701 have an increased risk of allergic reaction. A lab test may be performed before you start Ziagen to see if you have this gene type. Discuss any questions or concerns with your doctor.

Ziagen may cause severe and sometimes fatal high blood acid levels (lactic acidosis) and liver problems. The risk of these problems may be greater if you are a woman, are very overweight, or have a history of liver problems. It may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; fast or irregular heartbeat; unusual weakness or tiredness; unusual muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); shortness of breath; sluggishness; or severe or unusual drowsiness, dizziness, or light-headedness.


Ziagen is used for:

Treating HIV infection with other medications.

Ziagen is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.

Do NOT use Ziagen if:

  • you are allergic to any ingredient in Ziagen
  • you have moderate to severe liver problems
  • you take another medicine that contains abacavir

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Ziagen:

Some medical conditions may interact with Ziagen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding or thinking about breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems (eg, heart attack), high blood pressure, liver problems (eg, hepatitis B), high cholesterol, or diabetes
  • if you smoke, drink alcohol, or are very overweight
  • if you have a history of autoimmune problems (eg, Graves disease, Guillain-Barré syndrome)
  • if you have been tested and know whether or not you have a gene type called HLA-B*5701
  • if you have ever taken another medicine that contains abacavir

Some MEDICINES MAY INTERACT with Ziagen. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Methadone because its effectiveness may be decreased by Ziagen

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ziagen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ziagen:

Use Ziagen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ziagen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ziagen refilled.
  • Ziagen comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Ziagen.
  • Take Ziagen by mouth with or without food.
  • Taking Ziagen at the same time(s) each day will help you remember to take it.
  • Take Ziagen on a regular schedule to get the most benefit from it.
  • Continue to take Ziagen even if you feel well. Do not miss any doses.
  • If you miss a dose of Ziagen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ziagen.

Important safety information:

  • Ziagen may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ziagen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Tell your doctor or dentist that you take Ziagen before you receive any medical or dental care, emergency care, or surgery.
  • Check with your doctor before you drink alcohol while you are using Ziagen.
  • If you must stop taking Ziagen for any reason other than a serious allergic reaction, do not start taking Ziagen again without talking with your health care provider. If your health care provider decides that you may take Ziagen again, you should do so only in a setting with other people in case you need immediate access to a doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Ziagen, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Ziagen. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Ziagen may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Ziagen.
  • Ziagen does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Ziagen is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Do NOT take more than the recommended dose, change the dose, or stop taking Ziagen without checking with your doctor.
  • Lab tests, including liver function and monitoring for hypersensitivity reactions, may be performed while you use Ziagen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ziagen should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ziagen while you are pregnant. It is not known if Ziagen is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Ziagen to the baby.

Possible side effects of Ziagen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; lack of energy; loss of appetite; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; change in the amount of urine produced; chest, jaw, or arm pain; ear pain; eye pain, redness, or swelling; fainting; fever or chills; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; fast or irregular heartbeat; unusual muscle pain or tenderness; unusual cold feeling in the arms or legs; sluggishness; severe or unusual drowsiness, dizziness, or light-headedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite); unusual achiness, sweating, or swelling; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ziagen:

Store Ziagen at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ziagen out of the reach of children and away from pets.

General information:

  • If you have any questions about Ziagen, please talk with your doctor, pharmacist, or other health care provider.
  • Ziagen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Ziagen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ziagen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ziagen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ziagen.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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