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What is GLUMETZA?

GLUMETZA is a medication to be used in addition to diet and exercise to improve blood sugar control in adults (18 years and older) with type 2 diabetes. GLUMETZA contains metformin, a medication to help manage type 2 diabetes.1

GLUMETZA helps control your blood sugar in a number of ways, including:

  • Helping your body respond better to the insulin it makes naturally
  • Decreasing the amount of sugar your liver makes
  • Decreasing the amount of sugar your intestines absorb

If you have been diagnosed with type 2 diabetes, GLUMETZA may be an appropriate treatment for you. Only your doctor can prescribe it, so ask if GLUMETZA could be right for you.

GLUMETZA Advanced Polymer Technology1-3

Unlike immediate-release metformin, GLUMETZA uses a special advanced polymer technology that delivers the medicine slowly and steadily over several hours.5 This delay in the release of the medicine may result in fewer stomach-related side effects, such as nausea, in the 1st week of taking the medication.4

Controlled Release

As with any medication for type 2 diabetes, GLUMETZA should be used along with diet and exercise to help you control blood sugar levels. Be sure to talk to your doctor before beginning any diet or exercise program.

Don't take GLUMETZA if you have kidney problems, are allergic to metformin HCl, or have metabolic acidosis or diabetic ketoacidosis. Metabolic acidosis and diabetic ketoacidosis result from the build-up of certain acids in your blood. Both must be treated in the hospital. Use of medications that affect the function of your kidneys or change the way your blood flows may interfere with the way metformin works and should be used with caution.

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. GLUMETZA [package insert]. Menlo Park, CA: Depomed, Inc; 2008.
  2. Foster RH, Keam SJ. Metformin extended release. Am J Drug Deliv. 2006;4:1-11.
  3. Depomed™, Inc. Patent Summary. US patent 6,488,962.
  4. 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.

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