WARNINGS
What is the most important information I should know about AVANDIA?
AVANDIA is available only through the AVANDIA-Rosiglitazone Medicines Access 1Program. Both you and your doctor must be enrolled in the program so that you can get AVANDIA. To enroll, you must:
• talk to your doctor,
• understand the risks and benefits of AVANDIA, and
• agree to enroll in the program.
AVANDIA may cause serious side effects, including:
New or worse heart failure
• AVANDIA can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
• If you have severe heart failure, you cannot start AVANDIA.
• If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, AVANDIA may not be right for you.
Call your doctor right away if you have any of the following:
• swelling or fluid retention, especially in the ankles or legs
• shortness of breath or trouble breathing, especially when you lie down
• an unusually fast increase in weight
• unusual tiredness
Myocardial Infarction (“Heart Attack”)
AVANDIA may raise the risk of a heart attack. The risk of having a heart attack may be higher in people who take AVANDIA with insulin. Most people who take insulin should not also take AVANDIA.
Symptoms of a heart attack can include the following:
• chest discomfort in the center of your chest that lasts for more than a few minutes, or that goes away or comes back chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
• pain or discomfort in your arms, back, neck, jaw or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.
People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.
AVANDIA can have other serious side effects. Be sure to read the section SIDE EFFECTS.
USES
What is AVANDIA?
AVANDIA is a prescription medicine used with diet and exercise to treat certain adults with type 2 (“adult-onset” or “non-insulin dependent”) diabetes mellitus (“high blood sugar”) who are:
• already taking AVANDIA or
• unable to control their blood sugar on other diabetes medicines, and after talking with their doctor have decided not to take pioglitazone (ACTOS)
AVANDIA helps to control high blood sugar. AVANDIA may be used alone or with other diabetes medicines. AVANDIA can help your body respond better to insulin made in your body. AVANDIA does not cause your body to make more insulin.
AVANDIA is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis. It is not known if AVANDIA is safe and effective in children under 18 years old.
Who should not take AVANDIA?
Many people with heart failure should not start taking AVANDIA. See “What should I tell my doctor before taking AVANDIA?”.
What should I tell my doctor before taking AVANDIA?
Before starting AVANDIA, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular. Before taking AVANDIA, tell your doctor about all your medical conditions, including if you:
• have heart problems or heart failure.
• have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis. These conditions should be treated with insulin.
• have a type of diabetic eye disease called macular edema (swelling of the back of the eye).
• have liver problems. Your doctor should do blood tests to check your liver before you start taking AVANDIA and during treatment as needed.
• had liver problems while taking REZULIN (troglitazone), another medicine for diabetes.
• are pregnant or plan to become pregnant. AVANDIA should not be used during pregnancy. It is not known if AVANDIA can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the “change of life”) who does not have regular monthly periods, AVANDIA may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDIA.
Tell your doctor right away if you become pregnant while taking AVANDIA.
• are breast-feeding or planning to breast-feed. It is not known if AVANDIA passes into breast milk. You should not use AVANDIA while breast-feeding.
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins or herbal supplements. AVANDIA and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Especially tell your doctor if you take:
• insulin.
• any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take AVANDIA with other medicines.
HOW TO USE
How should I take AVANDIA?
• Take AVANDIA exactly as prescribed. Your doctor will tell you how many tablets to take and how often.
The usual daily starting dose is 4 mg a day taken one time each day or 2 mg taken two times each day. Your doctor may need to adjust your dose until your blood sugar is better controlled.
• AVANDIA may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
• Take AVANDIA with or without food.
• It can take 2 weeks for AVANDIA to start lowering blood sugar. It may take 2 to 3 months to see the full effect on your blood sugar level.
• If you miss a dose of AVANDIA, take it as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take double doses to make up for a missed dose.
• If you take too much AVANDIA, call your doctor or poison control center right away.
• Test your blood sugar regularly as your doctor tells you.
• Diet and exercise can help your body use its blood sugar better.
It is important to stay on your recommended diet, lose extra weight, and get regular exercise while taking AVANDIA.
• Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed. Your doctor should also do regular blood sugar tests (for example, “A1C”) to monitor your response to AVANDIA.
What are possible side effects of AVANDIA?
AVANDIA may cause serious side effects including:
• New or worse heart failure. See the section WARNINGS.
• Heart attack. See the section WARNINGS.
• Swelling (edema). AVANDIA can cause swelling due to fluid retention. See the section WARNINGS.
• Weight gain. AVANDIA can cause weight gain that may be due to fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. See the section WARNINGS.
• Liver problems. It is important for your liver to be working normally when you take AVANDIA. Your doctor should do blood tests to check your liver before you start taking AVANDIA and during treatment as needed.
Call your doctor right away if you have unexplained symptoms such as:
• nausea or vomiting
• stomach pain
• unusual or unexplained tiredness
• loss of appetite
• dark urine
• yellowing of your skin or the whites of your eyes.
• Macular edema (a diabetic eye disease with swelling in the back of the eye).
Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly. Very rarely, some people have had vision changes due to swelling in the back of the eye while taking AVANDIA.
• Fractures (broken bones), usually in the hand, upper arm or foot. Talk to your doctor for advice on how to keep your bones healthy.
• Low red blood cell count (anemia).
• Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, if you use another medicine that lowers blood sugar, or if you have certain medical problems. Call your doctor if low blood sugar levels are a problem for you.
• Ovulation (release of egg from an ovary in a woman) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy. See “What should I tell my doctor before taking AVANDIA?”.
The most common side effects of AVANDIA reported in clinical trials included coldlike symptoms and headache. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about AVANDIA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AVANDIA for a condition for which it was not prescribed. Do not give AVANDIA to other people, even if they have the same symptoms you have. It may harm them
What are the ingredients in AVANDIA?
Active Ingredient: Rosiglitazone maleate.
Inactive Ingredients: Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: Synthetic red and yellow iron oxides and talc.
Always check to make sure that the medicine you are taking is the correct one.
AVANDIA tablets are triangles with rounded corners and look like this:
2 mg – pink with “SB” on one side and “2” on the other.
4 mg – orange with “SB” on one side and “4” on the other.
8 mg – red-brown with “SB” on one side and “8” on the other.
OVERDOSE
If you take too much AVANDIA, call your doctor or poison control center right away.
MISSED DOSE
If you miss a dose of AVANDIA, take it as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take double doses to make up for a missed dose.
STORAGE
How should I store AVANDIA?
• Store AVANDIA at room temperature, 59-degrees to 86-degrees F (15-degrees to 30-degrees C).
Keep AVANDIA in the container it comes in.
• Safely, throw away AVANDIA that is out of date or no longer needed.
Keep AVANDIA and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 11/2020
Prescribing Information: revision date 11/2020
DRUG INTERACTIONS
1 CYP2C8 Inhibitors and Inducers An inhibitor of CYP2C8 (e.g., gemfibrozil) may increase the AUC of rosiglitazone and an inducer of CYP2C8 (e.g., rifampin) may decrease the AUC of rosiglitazone. Therefore, if an inhibitor or an inducer of CYP2C8 is started or stopped during treatment with rosiglitazone, changes in diabetes treatment may be needed based upon clinical response.
See the section WARNINGS above.
