Adult Dosage and Administration

• The recommended starting dose of GLUMETZA is 500 mg orally once daily with the evening meal.

• Increase the dose in increments of 500 mg every 1 to 2 weeks on the basis of glycemic control and tolerability, up to

a maximum of 2,000 mg once daily with the evening meal.

• Patients receiving metformin hydrochloride (HCl) may be switched to GLUMETZA once daily at the same total

daily dose, up to 2,000 mg once daily.

• Swallow GLUMETZA whole and never crush, cut or chew.

• If a dose of GLUMETZA is missed, instruct patients not to take two doses the same day and to resume their usual

dose of GLUMETZA with the next schedule dose.

Recommendations for Use in Renal Impairment

• Assess renal function prior to initiation of GLUMETZA and periodically thereafter.

• GLUMETZA is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below

30 mL/minute/1.73 m2.

• Initiation of GLUMETZA in patients with an eGFR between 30 to 45 mL/minute/1.73 m2 is not recommended.

• In patients taking GLUMETZA whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefit risk of

continuing therapy.

• Discontinue GLUMETZA if the patient’s eGFR later falls below 30 mL/minute/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.1)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue GLUMETZA at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart GLUMETZA if renal function is stable [see Warnings and Precautions (5.1)].