Microsoft word - duetact.doc

Duetact® (pioglitazone & glimepiride)

FDA-APPROVED INDICATION
Duetact® is indicated as an adjunct to diet and exercise as a once-daily combination therapy to improve
glycemic control in patients with type 2 diabetes who are already being treated with a combination of
pioglitazone and a sulfonylurea, or whose diabetes is not adequately controlled with a sulfonylurea alone, or for
those patients who have initially responded to pioglitazone alone and require additional glycemic control.
DOSE
Duetact® should be given once daily with the first meal of the day
Patients currently on glimepiride monotherapy: Based on the usual starting dosage of pioglitazone (15 or 30 mg
daily)pioglitazone/glimepiride may be initiated at 30 mg/2 mg or 30 mg/4 mg tablet strengths once daily, and
adjusted after assessing adequacy of therapeutic response.
Patients currently on pioglitazone monotherapy: Based on the usual starting dosage of glimepiride (1 or 2 mg
once daily)and pioglitazone 15 or 30 mg, pioglitazone/glimepiride may be initiated at 30 mg/2 mg once daily,
and adjusted after assessing adequacy of therapeutic response.
Patients switching from combination therapy of pioglitazone plus glimepiride as separate tablets:
Pioglitazone/glimepiride may be initiated with 30 mg/2 mg or 30 mg/4 mg tablet strengths based on the dose of
pioglitazone and glimepiride already being taken. Patients who are not controlled with pioglitazone 15 mg in
combination with glimepiride should be carefully monitored when switched to pioglitazone/glimepiride.
Patients currently on a different sulfonylurea monotherapy or switching from combination therapy of
pioglitazone plus a different sulfonylurea: No exact dosage relationship exists between glimepiride and the
other sulfonylurea agents. Therefore, based on the maximum starting dose of glimepiride 2 mg,
pioglitazone/glimepiride should be limited initially to a starting dosage of 30 mg/2 mg once daily and adjusted
after assessing adequacy of therapeutic response.
Note: Pioglitazone/glimepiride tablets are available as a pioglitazone 30 mg plus glimepiride 2 mg or a
pioglitazone 30 mg plus glimepiride 4 mg formulation for oral administration. The maximum recommended
daily dose for pioglitazone is 45 mg, and the maximum recommended daily dose for glimepiride is 8 mg.
Pioglitazone/glimepiride should therefore not be given more than once daily at any of the tablet strengths.
COVERAGE POLICY
Please refer to Thiazolidinediones Prior Authorization Criteria for details of coverage.

NON-COVERAGE
Duetact® is NOT covered for members with the following criteria:
A. Treatment of Type I diabetes. B. Patients with diabetic ketoacidosis, with or without coma. C. Patients with NYHA Class III or IV cardiac status.
REFERENCES
1. Duetact® (pioglitazone & glimepiride) prescribing information. Takeda Pharmaceuticals America, Inc, 2006. http://www.actos.com/pi_duetact.pdf 2. American Diabetes Association (2007) Standards of Medical Care in Diabetes-2007. Diabetes Care 3. American Diabetes Association Consensus Statement. Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care. 2007 Apr. 29(8): 1963-1972

Source: http://www.cvty.com/content/items/12531/Duetact.pdf