HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DUETACT safely and effectively. See full prescribing information for DUETACT.
DUETACT (pioglitazone and glimepiride) tablets for oral use
Initial U.S. Approval: 2006
WARNING: CONGESTIVE HEART FAILURE
See full prescribing information for complete boxed warning.
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Thiazolidinediones, including pioglitazone, which is a component of DUETACT, cause or exacerbate congestive heart failure in some patients. ( 5.1)
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After initiation of DUETACT, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of DUETACT must be considered. ( 5.1)
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DUETACT is not recommended in patients with symptomatic heart failure. ( 5.1)
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Initiation of DUETACT in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ( 4, 5.1)
RECENT MAJOR CHANGES
Contraindications (4) 03/2015
INDICATIONS AND USAGE
DUETACT is a thiazolidinedione and a sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and glimepiride is appropriate. (1)
Important Limitations of Use:
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Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1)
DOSAGE AND ADMINISTRATION
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Individualize the starting dose of DUETACT based on the patient’s current regimen. ( 2.1)
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May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of pioglitazone 45 mg and glimepiride 8 mg. ( 2.1)
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DUETACT should be given in a single dose once daily with meals. ( 2.1)
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Obtain liver tests before starting DUETACT. If abnormal, use caution when treating with DUETACT, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on DUETACT is not recommended in patients without liver disease. ( 5.5)
DOSAGE FORMS AND STRENGTHS
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Tablets: 30 mg pioglitazone/2 mg glimepiride. ( 3)
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Tablets: 30 mg pioglitazone/4 mg glimepiride. ( 3)
CONTRAINDICATIONS
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Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see Boxed Warning]. ( 4)
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Use in patients with known hypersensitivity to pioglitazone, glimepiride or any other component of DUETACT. ( 4)
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Hypersensitivity to sulfonamide derivatives. ( 4)
WARNINGS AND PRECAUTIONS
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Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. ( 5.1)
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Hypoglycemia: May be severe. When insulin or an insulin secretagogue is used with pioglitazone, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. ( 5.2)
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Hypersensitivity Reactions: Postmarketing reports for glimepiride, a component of DUETACT, include anaphylaxis, angioedema and Stevens-Johnson Syndrome. Promptly discontinue DUETACT, assess for other cases, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. ( 5.3)
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Potential increased risk of cardiovascular mortality with sulfonylureas: Inform patients of risk, benefits, and treatment alternatives. ( 5.4)
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Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt DUETACT and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart DUETACT if liver injury is confirmed and no alternate etiology can be found. ( 5.5)
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Bladder cancer: Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users. The observational data further suggest that the risk increases with duration of use. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer ( 5.6)
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Edema: Dose-related edema may occur. ( 5.7)
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Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. ( 5.8)
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Hemolytic anemia: Can occur if glucose 6-phophate dehydrogenase (GP6D) deficient. Use with caution in patients with GP6D deficiency. ( 5.9)
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Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt eva luation for acute visual changes. ( 5.10)
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Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with DUETACT or any other antidiabetic drug. ( 5.12)
ADVERSE REACTIONS
Most common adverse reactions (≥5%) are upper respiratory tract infection, accidental injury, and combined edema/peripheral edema. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations. Limit pioglitazone dose to 15 mg daily. ( 2.3, 7.1)
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CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. ( 7.2)
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Certain medications may affect glucose metabolism, requiring DUETACT dose adjustment and close monitoring of blood glucose ( 7.3).
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Miconazole: Severe hypoglycemia can occur when DUETACT and oral miconazole are used concomitantly. ( 7.4)
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CYP2C9 interactions: Inhibitors and inducers may affect glycemic control by altering glimepiride plasma concentrations. ( 7.5)
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Colesevelam: Coadministration may reduce glimepiride absorption. DUETACT should be administered at least 4 hours prior to colesevelam. ( 2.4, 7.6)
USE IN SPECIFIC POPULATIONS
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Nursing mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother. ( 8.3)
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Pediatrics: Not recommended for use in pediatric patients. ( 8.4)
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Geriatric or renally impaired patients: At risk for hypoglycemia with DUETACT. Use caution in dose selection and titration, and monitor closely. ( 8.5, 8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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