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

GLUMETZA should be taken once daily. However, there is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with GLUMETZA or any other pharmacologic agent. Dosage of GLUMETZA must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of GLUMETZA is 2000 mg. GLUMETZA therapy should generally be initiated with 1000 mg daily which should be taken with food preferably in the evening. Gradual dose escalation from this low dose is recommended both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control. During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to GLUMETZA and identify the minimum effective dose. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of GLUMETZA, either when used as monotherapy or in combination with sulfonylurea or insulin.

Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness. Short-term administration of GLUMETZA may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. GLUMETZA tablets must be swallowed whole and never split, crushed or chewed. Occasionally, the inactive ingredients of GLUMETZA 500 mg may be eliminated in the feces as a soft, hydrated mass, while the 1000 mg may leave an insoluble shell. (See PATIENT INFORMATION.)

Recommended Dosing Schedule

Adults — In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The starting dose of GLUMETZA is 1000 mg once daily which in order to maximize therapeutic efficacy must be taken with food preferably in the evening. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on GLUMETZA 2000 mg once daily, a trial of GLUMETZA 1000 mg twice daily should be considered. (See CLINICAL PHARMACOLOGY, Clinical Studies).

In one trial, patients treated with immediate release metformin were switched to GLUMETZA. Results of this trial suggest that patients receiving immediate release metformin treatment can be switched to GLUMETZA once daily at the same total daily dose, up to 2000 mg once daily. Following a switch from immediate release metformin to GLUMETZA, glycemic control should be closely monitored and dosage adjustments made accordingly. (See CLINICAL PHARMACOLOGY, Clinical Studies).

Pediatrics — GLUMETZA has been studied in adult patients only.

Transfer From Other Antidiabetic Therapy

When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to GLUMETZA, no transition period is generally necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant GLUMETZA and Oral Sulfonylurea Therapy in Adult Patients

If patients have not responded to four weeks of the maximum dose of GLUMETZA monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing GLUMETZA at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant GLUMETZA and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug.

However, attempts should be made to identify the minimum effective dose. With concomitant GLUMETZA and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.) If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of GLUMETZA and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without GLUMETZA.

Concomitant GLUMETZA and Insulin Therapy in Adult Patients

The current insulin dose should be continued upon initiation of GLUMETZA. GLUMETZA therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of GLUMETZA should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose of GLUMETZA is 2000 mg.

It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and GLUMETZA. Further adjustment should be individualized based on glucose-lowering response.

Specific Patient Populations

GLUMETZA is not recommended for use in pregnancy. GLUMETZA is not recommended in pediatric patients (below the age of 18 years). The initial and maintenance dosing of GLUMETZA should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of GLUMETZA. Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)

GLUMETZA tablets-500 mg are available as blue, film coated, oval-shaped tablets debossed with "GMZ" on one side and "500" on the other side.

GLUMETZA tablets 1000 mg are available as white, film coated, oval-shaped tablets with "M1000" on one side.

They are supplied as follows:

Storage

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F); see [USP Controlled Room Temperature.]

Depomed, Inc. Menlo Park, CA (866) 458-6389. www.GlumetzaXR.com. Issued December, 2007. FDA rev date: 12/04/2007

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