| WARNING: CONGESTIVE HEART FAILURE
See full prescribing information for complete boxed warning
•Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients.
•After initiation of OSENI 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 pioglitazone in OSENI must be considered.
•OSENI is not recommended in patients with symptomatic heart failure.
•Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.
| OSENI (alogliptin and pioglitazone) tablets
Initial U.S. Approval: 2013
OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: alogliptin and pioglitazone.
Alogliptin- Alogliptin is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4).
| Mechanism of Action:
OSENI combines two antihyperglycemic agents with complementary and distinct mechanisms of action to improve glycemic control in patients with type 2 diabetes: alogliptin, a selective inhibitor of DPP-4, and pioglitazone, a member of the TZD class.
In animal models of diabetes, pioglitazone reduces the hyperglycemia, hyperinsulinemia and hypertriglyceridemia characteristic of insulin-resistant states such as type 2 diabetes. The metabolic changes produced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous animal models of insulin resistance.
Because pioglitazone enhances the effects of circulating insulin (by decreasing insulin resistance), it does not lower blood glucose in animal models that lack endogenous insulin.
| INDICATIONS AND USAGE::
OSENI is a dipeptidyl peptidase-4 inhibitor and thiazolidinedione combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.
| History of a serious hypersensitivity reaction to alogliptin or pioglitazone, components of OSENI, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.
Do not initiate OSENI in patients with established NYHA Class III or IV heart failure.
WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS
Common adverse reactions reported in 44% of patients treated with coadministration of alogliptin 25 mg and pioglitazone 15 mg, 30 mg or 45 mg were nasopharyngitis, back pain and upper respiratory tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations. (7.2)
USE IN SPECIFIC POPULATIONS
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION:
Individualize the starting dose of OSENI based on the patient’s current regimen and concurrent medical condition but do not exceed a daily dose of alogliptin 25 mg and pioglitazone 45 mg.
Can be taken with or without food.
Limit initial dose of pioglitazone to 15 mg once daily in patients with NYHA Class I or II heart failure.
Adjust dose if moderate renal impairment.
OSENI is not recommended for patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
The maximum recommended dose of pioglitazone is 15 mg once daily in patients taking strong CYP2C8 inhibitors (e.g., gemfibrozil).
| DOSAGE FORMS AND STRENGTHS
12.5 mg alogliptin and 15 mg pioglitazone, 12.5 mg alogliptin and 30 mg pioglitazone, 12.5 mg alogliptin and 45 mg pioglitazone.
| Package insert data: [Accessed: Jan 2014].
OSENI, NESINA and ACTOS are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and are used under license by Takeda Pharmaceuticals America, Inc.
©2013 Takeda Pharmaceuticals America, Inc.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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