Rosiglitazone (patient information)

IMPORTANT WARNING:
[Posted 02/20/2007] Glaxo SmithKline (GSK) notified healthcare professionals of the results of a randomized, double-blind parallel group study [ADOPT] of 4,360 patients with recently diagnosed type 2 diabetes mellitus followed for 4-6 years to compare glycemic control with rosiglitazone relative to metformin and glyburide monotherapies. Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide. At GSK's request, an independent safety committee reviewed an interim analysis of fractures in another large; ongoing; controlled clinical trial and preliminary analysis was reported as being consistent with the observations from ADOPT. Healthcare professionals should consider the risk of fracture when initiating or treating female patients with type 2 diabetes mellitus with rosiglitazone. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone and http://www.fda.gov/medwatch/safety/2007/Avandia_GSK_Ltr.pdf.

Why is this medication prescribed
See the MedWatch notification at the beginning of the monograph.

Rosiglitazone is used along with a diet and exercise program and sometimes with other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Rosiglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood).

How should this medicine be used
Rosiglitazone comes as a tablet to take by mouth. It is usually taken once or twice daily with or without meals. Take rosiglitazone at about the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rosiglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of rosiglitazone and may increase your dose after 8-12 weeks, based on your body's response to rosiglitazone.

Rosiglitazone helps control type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease, and 2-3 months or longer for you to feel the full benefit of rosiglitazone. Continue to take rosiglitazone even if you feel well. Do not stop taking rosiglitazone without talking to your doctor.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow
See the MedWatch notification at the beginning of the monograph.

Before taking rosiglitazone:
 * tell your doctor and pharmacist if you are allergic to rosiglitazone or any other medications.
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: candesartan (Atacand), felodipine (Lexxel, Plendil), gemfibrozil (Lopid), insulin and other medications for diabetes,montelukast (Singulair), phenobarbital, rifampin (Rifadin, Rimactane in Rifamate), trimethoprim (in Bactrim, in Septra, others), and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor if you have or have ever had any type of heart disease including heart failure or a heart attack; high blood pressure; high cholesterol or fats in the blood; swelling of the hands, arms, feet, ankles, or lower legs; diabetic eye disease such as macular edema (swelling of the back of the eye); type 1 diabetes; diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated in a diabetic patient); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.
 * tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rosiglitazone, call your doctor. Do not breastfeed while you are taking rosiglitazone.
 * if you have not yet experienced menopause (change of life; end of monthly periods) you should know that rosiglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
 * plan to follow the exercise program recommended by your doctor. Regular exercise will help to control your diabetes.
 * talk to your doctor about how often you should test your blood sugar during your treatment with rosiglitazone. Follow these instructions carefully.

What special dietary instructions should I follow
Follow all dietary recommendations made by your doctor or dietitian. A healthy diet and weight loss will help control your diabetes and will also make rosiglitazone more effective.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while you are taking this medication.

What should I do if I forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects
This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

''You may experience hypoglycemia (low blood sugar) while you are taking this medication in combination with other medications used to treat diabetes. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:''


 * shakiness
 * dizziness or lightheadedness
 * sweating
 * nervousness or irritability
 * sudden changes in behavior or mood
 * headache
 * numbness or tingling around the mouth
 * weakness
 * pale skin
 * hunger
 * clumsy or jerky movements

''If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately:''


 * confusion
 * seizures
 * loss of consciousness

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):


 * extreme thirst
 * frequent urination
 * extreme hunger
 * weakness
 * blurred vision

''If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:''


 * dry mouth
 * upset stomach and vomiting
 * shortness of breath
 * breath that smells fruity
 * decreased consciousness

Mild side effects
''Rosiglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:''


 * headache
 * runny nose and other cold symptoms
 * sore throat
 * back pain
 * painful or irregular menstrual periods
 * flu-like symptoms

Severe side effects
''Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:''


 * stomach pain
 * excessive tiredness
 * loss of appetite
 * upset stomach
 * vomiting
 * dark urine
 * yellowing of the skin or eyes
 * blurred vision
 * difficulty seeing colors
 * difficulty seeing in the dark
 * pale skin
 * dizziness
 * chest pain or tightness
 * shortness of breath
 * wakening during the night because of difficulty breathing
 * cough
 * large or rapid weight gain
 * swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles or lower legs
 * hoarseness
 * difficulty swallowing or breathing
 * hives
 * itching

Rosiglitazone may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know
See the MedWatch notification at the beginning of the monograph.

Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to rosiglitazone. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to rosiglitazone. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully:


 * You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
 * Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Avandia®
 * Avandaryl® (as a combination product containing rosiglitazone and glimepiride)
 * Avandamet® (as a combination product containing rosiglitazone and metformin)