An Overview of Ziagen (Abacavir)

WARNING:

Abacavir can cause serious, life-threatening side effects. These include allergic reactions, lactic acidosis (buildup of acid in the blood), and liver problems.

People who take abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your health care provider can determine with a blood test if you have this gene variation. If you get a symptom from two or more of the following groups while taking abacavir, contact your health care provider right away to find out if you should stop taking abacavir.

• Group 1 Symptoms: Fever
• Group 2 Symptoms: Rash.
• Group 3 Symptoms: Nausea, vomiting, diarrhea, abdominal (stomach area) pain.
• Group 4 Symptoms: General ill feeling, extreme tiredness, or achiness.
• Group 5 Symptoms: Shortness of breath, cough, sore throat.

Your pharmacist will give you a Warning Card with a list of these symptoms. Carry this Warning Card with you at all times. If you stop abacavir because of an allergic reaction, never take abacavir or any other abacavir-containing medicine again. If you take abacavir 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 abacavir for any other reason, even for a few days, and you are not allergic to abacavir, talk with your health care provider before taking it again. Taking abacavir again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If your health care provider tells you that you can take abacavir again, start taking it when you are around medical help or people who can call a health care provider if you need one.

Contact your health care provider right away if you have any of the following symptoms that may signal lactic acidosis:

• Feeling very weak or tired.
• Unusual (not normal) muscle pain.
• Trouble breathing.
• Stomach pain with nausea and vomiting.
• Feeling cold, especially in your arms and legs.
• Feeling dizzy or lightheaded.
• Fast or irregular heartbeat.

Contact your health care provider right away if you have any of the following symptoms that may signal liver problems:

• Yellowing of your skin or the whites of your eyes (jaundice).
• Dark-colored urine.
• Light-colored bowel movements.
• Loss of appetite for several days or longer.
• Feeling sick to your stomach (nausea).
• Lower stomach area (abdominal) pain.

Abacavir may increase the risk of heart attack (myocardial infarction).

While taking abacavir, it is important to keep all of your appointments with your health care provider.