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The Avandia-Rosiglitazone Medicines Access Program website is currently under development and is scheduled to be live within 60 days. If you have questions regarding the program and would like to speak to someone immediately, please contact the GSK Response Center at 1-888-825-5249, between the hours of 8:00am and 6:00pm ET. If you have questions regarding the program outside of those hours, please leave a message at the Avandia-Rosiglitazone Medicines Access Program Coordinating Center at 1-800-AVANDIA and someone will return your call within the next business day.

Important Safety Information about AVANDIA® (rosiglitazone maleate),
AVANDAMET® (rosiglitazone maleate/metformin hydrochloride) and
AVANDARYL® (rosiglitazone maleate and glimepiride)

AVANDIA, AVANDAMET and AVANDARYL may increase your risk of a heart attack (myocardial infarction). This risk may be higher in people who are also taking insulin.

Because of the potential increased risk of myocardial infarction, AVANDIA, AVANDAMET, and AVANDARYL are available only through the AVANDIA-Rosiglitazone Medicines Access Program.

AVANDIA, AVANDAMET and AVANDARYL can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on AVANDIA, AVANDAMET or AVANDARYL. AVANDIA, AVANDAMET and AVANDARYL are also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe.

Taking AVANDIA, AVANDAMET or AVANDARYL with insulin is not recommended.

Call your doctor right away or go to the nearest hospital emergency room if you have chest pain, a feeling of chest pressure or discomfort, pain in the arm, back, neck, jaw or stomach, shortness of breath and you think you are having a heart attack.
Tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Additional information about AVANDAMET

A small number of people who have taken metformin, one of the medicines in AVANDAMET, have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood) that can cause death. You have a higher chance of getting lactic acidosis if you have kidney problems; have liver problems; drink alcohol very often or excessively; get dehydrated, as when you are sick with a fever, vomiting or diarrhea; or you are going to have surgery. Tell your doctor if you have any of these problems before or while taking AVANDAMET. You should not take AVANDAMET if you have kidney problems or metabolic acidosis. Tests should be used to check your kidneys and liver before and while taking AVANDAMET. If you are taking medicines for heart failure, you may be at increased risk of lactic acidosis.

Call your doctor right away if you feel any of the following, which may be signs of lactic acidosis: very weak or tired; you have unusual (not normal) muscle pain; you have stomach pains; you have trouble breathing; you feel dizzy or lightheaded; or you have a slow or irregular heartbeat.

Additional information about AVANDARYL

AVANDARYL may cause low blood sugar. Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. If you have kidney problems, you may need a lower dose of AVANDARYL to reduce problems with low blood sugar. Talk to your doctor if low blood sugar is a problem for you.

Before taking AVANDIA, AVANDAMET or AVANDARYL, ask your doctor about what the choices are for diabetes medicines and what the expected benefits and possible risks are for you in particular. Tell your doctor if you:

Women taking AVANDIA, AVANDAMET or AVANDARYL should know that AVANDIA, AVANDAMET and AVANDARYL may increase the risk of pregnancy. Other possible side effects of AVANDIA, AVANDAMET and AVANDARYL include fractures, anemia and hypoglycemia; other possible side effects of AVANDAMET include diarrhea, nausea, and upset stomach. Your doctor should do blood tests to check your liver before you start AVANDIA, AVANDAMET or AVANDARYL and during treatment as needed.

Prescription AVANDIA, AVANDAMET and AVANDARYL, along with diet and exercise, help improve blood sugar control in adults with type 2 diabetes who are:

AVANDAMET is a combination of two drugs – rosiglitazone maleate and metformin hydrochloride. AVANDARYL is a combination of two drugs – rosiglitazone maleate and glimepiride.

AVANDIA is available in 2 mg, 4 mg and 8 mg tablets.
AVANDAMET is available in 2 mg/500 mg, 4 mg/500 mg, 2 mg/1000 mg and 4 mg/1000 mg tablets.
AVANDARYL is available in 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg and 8 mg/4 mg tablets.

For more information about AVANDIA, please see Medication Guide and full
Prescribing Information, including Boxed WARNING.

For more information about AVANDAMET, please see Medication Guide and
full Prescribing Information, including Boxed WARNING.

For more information about AVANDARYL, please see Medication Guide and
full Prescribing Information, including Boxed WARNING.

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