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Is GLUMETZA right for you?

If you were diagnosed with type 2 diabetes, you and your doctor will decide an appropriate treatment for you. For many patients, metformin is an effective treatment option to help control blood sugar and manage type 2 diabetes.

Reaching your treatment goals

By measuring the amount of hemoglobin A1c (HbA1c) in your blood, your doctor can see how well controlled your glucose (sugar) has been over the past few months. You and your doctor may have talked about a "treatment goal" of keeping the HbA1c in your blood below 7%, the level most doctors agree is appropriate for someone with type 2 diabetes.

Because GLUMETZA is an extended-release tablet, it delivers meformin slowly and steadily over several hours,1 providing consistent control over 24 hours. That also may help minimize stomach-related side effects, such as nausea, during the 1st week of taking GLUMETZA.

GLUMETZA may help you reach your HbA1c goal by helping you manage type 2 diabetes with fewer stomach-related side effects, such as nausea, in the 1st week you take your medication.2

GLUMETZA is designed to be taken once a day for convenience, or as prescribed by your doctor.

Possible side effects

As with all metformins, GLUMETZA can cause a rare, but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death.

Like all medications, GLUMETZA can cause side effects. In clinical trials, side effects included gastrointestinal or stomach-related side effects, such as:

  • Diarrhea
  • Nausea or vomiting
  • Gas
  • Indigestion/heartburn
  • Abdominal or stomach discomfort 3

Learn more about possible side effects of GLUMETZA.

GLUMETZA is not for everyone. You should not take GLUMETZA if you:

  • have kidney problems
  • have heart failure that is treated with medicines
  • have a condition called metabolic acidosis, including diabetic ketoacidosis; diabetic ketoacidosis should be treated with insulin
  • are allergic to GLUMETZA or to any of its ingredients.4

Before starting treatment with GLUMETZA, you should also tell your doctor about any medical conditions you have, including:

  • If you have kidney, liver, or heart problems
  • If you drink alcohol
  • If you are pregnant, planning to become pregnant, or if you are breastfeeding

You should also tell your doctor about all prescription and non-prescription medicines, vitamins and other supplements you take, since they may interact with GLUMETZA.4

Indication

GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Safety Information

Boxed Warnings

There is a black box warning associated with metformin products. Lactic acidosis due to metformin accumulation during treatment with GLUMETZA is a rare but potentially fatal occurrence. Lactic acidosis may also occur in association with a number of pathophysiologic conditions and whenever there is significant tissue hypoperfusion and hypoxemia. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The onset of lactic acidosis often is subtle, and can be accompanied only by nonspecific symptoms. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. Treatment should not be initiated in patients = 80 years of age unless renal function is not reduced. The risk of lactic acidosis while on GLUMETZA therapy may be significantly decreased by: Initial and regular monitoring of renal and liver function; using the minimum effective dose of GLUMETZA; promptly withholding GLUMETZA in the presence of any condition associated with hypoxemia, dehydration, or sepsis; avoidance of GLUMETZA in patients with hepatic disease; cautioning patients against excessive alcohol intake, either acute or chronic; and temporarily discontinuing GLUMETZA prior to any intravascular radiocontrast study or surgical procedure. Lactic acidosis is a medical emergency requiring immediate discontinuation of GLUMETZA and prompt institution of general supportive measures. Because metformin is dialyzable, prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin.

For the Full Prescribing Information, including Black Box Warning, please click here. Please consult with your healthcare professional to see if GLUMETZA is right for you.

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GLUMETZA is contraindicated in patients with renal dysfunction, known hypersensitivity to metformin HCl or metabolic acidosis, including diabetic ketoacidosis. Use of concomitant medications that affect renal function or hemodynamic change may interfere with the disposition of metformin and should be used with caution.

Hypoglycemia does not occur in patients receiving GLUMETZA alone but could occur with deficient caloric intake or during concomitant use with other glucose-lowering agents or ethanol. Loss of glycemic control may occur when a stabilized patient is exposed to stress.

In clinical trials, the most common side effects with GLUMETZA monotherapy were diarrhea, nausea, dyspepsia, and upper abdominal pain. In a clinical trial of GLUMETZA combined with a sulfonylurea, the most common side effects included hypoglycemia, diarrhea, and nausea.

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References

  1. Foster RH, Keam SJ. Metformin extended release. Am J Drug Deliv. 2006;4:1-11.
  2. Schwartz S, Fonseca V, Berner B, Cramer M, Chiang Y-K, Lewin A. Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with type 2 diabetes. Diabetes Care. 2006;29:759-764.
  3. Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997;102:491-497.
  4. GLUMETZA [package insert]. Menlo Park, CA: Depomed, Inc; 2008.

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