Ziagen is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Ziagen is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Ziagen is for adults and children who are at least 3 months old. This medicine is not a cure for HIV or AIDS.

Ziagen may also be used for purposes not listed in this medication guide.

You should not take Ziagen if you have ever had an allergic reaction to any medicine that contains Ziagen, if you have moderate to severe liver disease, or if you have a gene variation called HLA-B*5701 allele.

Stop using Ziagen 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.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Ziagen can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have pain or swelling in your upper stomach, tiredness, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ziagen comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

Ziagen doses are based on weight in children and/or teenagers. Your child's dose needs may change if the child gains or loses weight.

Ziagen can be taken with or without food.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

You may store the oral solution (liquid) in the refrigerator but do not let it freeze.

You should not use Ziagen if:

• you have moderate or severe liver disease;

• you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or

• you have had an allergic reaction to any medicine that contains Ziagen (such as Ziagen, Epzicom, Triumeq, or Trizivir).

Many combination HIV medicines have Ziagen as an ingredient. Ziagen should not be taken together with any other medicine that contains this medicine.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a risk factor for heart disease such as smoking, diabetes, or high cholesterol;

• liver disease; or

• if you have used any other HIV medication in the past.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking Ziagen again.

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

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

Taking Ziagen 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.

Stop using Ziagen 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 had an allergic reaction to Ziagen, you must never use it again. If you stop taking this medicine for any reason, talk to your doctor before you start taking the medication again.

Ziagen can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:

• severe upper stomach pain, nausea, vomiting, loss of appetite;

• swelling around your midsection;

• dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes);

• unusual tiredness; or

• chest pain or pressure, pain spreading to your jaw or shoulder.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Ziagen affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of Ziagen may include:

• feeling tired;

• sleep problems, strange dreams;

• headache, tiredness, fever, chills, general ill feeling;

• nausea or vomiting;

• rash; or

• (in children) stuffy nose, sneezing, sore throat, ear pain.

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.

Tell your doctor about all your other medicines, especially:

• riociguat;

• methadone; or

• any other HIV medicines.

This list is not complete. Other drugs may affect Ziagen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.