The long-term effects of treatment with Ziagen are not known at this time.

Special Warning(s) with Ziagen:

If you experience signs or symptoms of a hypersensitivity reaction, (severe allergic reaction) at any time while you are taking Ziagen, you must stop taking Ziagen and contact your health care provider immediately. If you have a skin rash or two or more of the following symptoms you may be having a hypersensitivity reaction:

• Fever
• Nausea, vomiting, diarrhea, or stomach pain
• Severe tiredness, achiness, or a general ill feeling
• Sore throat, cough, or shortness of breath

If you experience a hypersensitivity reaction, at any time while taking Ziagen you must never take Ziagen again. If you take Ziagen again, more severe symptoms will reappear within hours, which may include life-threatening low blood pressure and death.

A medication guide for patients comes with every Ziagen prescription. Read the medication guide carefully. In addition, your pharmacist will give you a warning card listing the symptoms of a Ziagen allergy. Carry this card with you.

Ziagen can cause a condition called lactic acidosis (accumulation of lactic acid in the body) together with an enlarged liver, which can be a serious and sometimes fatal.

If you have a history of liver problems, your health care provider will evaluate and decide if Ziagen is right for you.

General Precautions with Ziagen:

• Because resistance to the HIV virus can occur quickly with single-drug treatment, Ziagen should always be taken in combination with other antiretroviral medications. Ziagen should not be taken alone to treat HIV. If your current treatment is failing, Ziagen should not be added as a single agent.

• Ziagen is not a cure for HIV infection. At present, there are no results from studies evaluating long term suppression of HIV or disease progression. You may continue to experience illnesses associated with HIV infection, including opportunistic infections.

• You should remain under the care of a physician when using Ziagen. If you stopped taking Ziagen for reasons other than a severe allergic reaction, it is possible to begin taking Ziagen again with continued monitoring by your doctor for such a reaction.

• Ziagen has not been shown to reduce the risk of transmission to others through sexual contact or blood contamination.

What should I tell my doctor or health care provider?

Tell your health care provider if you are:

• trying to become pregnant, or are pregnant.
• breast-feeding or thinking about breast-feeding while taking Ziagen.

What are some possible side effects of Ziagen? (This is NOT a complete list of side effects reported with Ziagen. Your health care provider can discuss with you a more complete list of side effects.)   Carry the warning card of Ziagen allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Ziagen. Serious and life threatening allergic reactions have been associated with Ziagen (See "Special Warnings").

Side effects of Ziagen include:

• Fever
• Rash
• Nausea
• Vomiting
• Feeling tired
• Diarrhea
• Loss of appetite
• Trouble sleeping
• Joint pain
• Swelling
• Shortness of breath

For more detailed information about Ziagen, ask your health care provider.

Link to Ziagen's approved label and patient information 

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Date Posted: 2/23/99
Updated: 3/20/01, 4/18/00, 4/16/01
Revised: 7/25/00