Generic Name
Pioglitazone
Brand Names
OSENI, Alogliptin
FDA approval date: July 15, 1999
Classification: Peroxisome Proliferator Receptor alpha Agonist
Form: Tablet
What is OSENI (Pioglitazone)?
Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. Important Limitations of Use Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [ see Warnings and Precautions.
Approved To Treat
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Brand Information
OSENI (alogliptin and pioglitazone)
WARNING: CONGESTIVE HEART FAILURE
- Thiazolidinediones, including pioglitazone, which is a component of OSENI
- 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 congestive heart failure develops while taking OSENI, consider discontinuation of OSENI or dosage reduction of pioglitazone in OSENI
- 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
1INDICATIONS AND USAGE
OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
2CONTRAINDICATIONS
OSENI is contraindicated in patients with:
- Established NYHA Class III or IV heart failure at the time of OSENI initiation
- A history of serious hypersensitivity reaction to alogliptin, pioglitazone, or any of the excipients in OSENI. Reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported
3ADVERSE REACTIONS
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Congestive Heart Failure
- Pancreatitis
- Hypersensitivity Reactions
- Hepatic Effects
- Edema
- Fractures
- Urinary Bladder Tumors
- Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues
- Macular Edema
- Severe and Disabling Arthralgia
- Bullous Pemphigoid
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4DESCRIPTION
OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone.
5CLINICAL STUDIES
The effectiveness of OSENI has been established based on four adequate and well-controlled Phase 3 trials of alogliptin and pioglitazone as adjunct to diet to improve glycemic control in adult patients with type 2 diabetes mellitus.
In patients with type 2 diabetes mellitus, treatment with alogliptin and pioglitazone produced clinically meaningful and statistically significant improvements in A1C compared to either alogliptin or pioglitazone alone. As is typical for trials of agents to treat type 2 diabetes mellitus, the mean reduction in A1C with alogliptin and pioglitazone appears to be related to the degree of A1C elevation at baseline.
6HOW SUPPLIED/STORAGE AND HANDLING
OSENI tablets are available in the following strengths and packages:
25 mg/15 mg tablet: yellow, round, biconvex and film-coated with both “A/P” and “25/15” printed on one side, available in:
25 mg/30 mg tablet: peach, round, biconvex and film-coated with both “A/P” and “25/30” printed on one side, available in:
25 mg/45 mg tablet: red, round, biconvex, film-coated and with both “A/P” and “25/45” printed on one side, available in:
12.5 mg/30 mg tablet: pale peach, round, biconvex and film-coated with both “A/P” and “12.5/30” printed on one side, available in:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).