Type 2 Diabetes (T2D) Treatments

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Generic Name

Pioglitazone

Brand Names

Alogliptin, OSENI

FDA approval date: July 15, 1999

Classification: Peroxisome Proliferator Receptor alpha Agonist

Form: Tablet

What is Alogliptin (Pioglitazone)?

Alogliptin and pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin and pioglitazone tablets are a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Alogliptin and pioglitazone tablets are not recommended for use in patients with type 1 diabetes mellitus. Limitations of Use Alogliptin and pioglitazone tablets are not recommended for use in patients with type 1 diabetes mellitus.

Approved To Treat

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Brand Information

Alogliptin and Pioglitazone (Alogliptin Benzoate and Pioglitazone hydrochloride)

WARNING: CONGESTIVE HEART FAILURE

Thiazolidinediones, including pioglitazone, which is a component of alogliptin and pioglitazone tablets, cause or exacerbate congestive heart failure in some patients
After initiation of alogliptin and pioglitazone tablets 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 alogliptin and pioglitazone tablets, consider discontinuation of alogliptin and pioglitazone tablets or dosage reduction of pioglitazone in alogliptin and pioglitazone tablets
Alogliptin and pioglitazone tablets are not recommended in patients with symptomatic heart failure
Initiation of alogliptin and pioglitazone tablets in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated

1INDICATIONS AND USAGE

Alogliptin and pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

2CONTRAINDICATIONS

Alogliptin and pioglitazone tablets are contraindicated in patients with:

Established NYHA Class III or IV heart failure at the time of alogliptin and pioglitazone tablets initiation
A history of serious hypersensitivity reaction to alogliptin, pioglitazone, or any of the excipients in alogliptin and pioglitazone tablets. 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.

4OVERDOSAGE

In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract.

Alogliptin is minimally dialyzable; over a three-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if alogliptin is dialyzable by peritoneal dialysis.

In the event of an overdose, contact the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

5DESCRIPTION

Alogliptin and pioglitazone tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone.

6CLINICAL STUDIES

The effectiveness of alogliptin and pioglitazone tablets 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.

7HOW SUPPLIED/STORAGE AND HANDLING

Alogliptin and pioglitazone 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:

8PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Congestive Heart Failure: Inform patients of the signs and symptoms of heart failure. Instruct patients who experience an unusually rapid increase in weight or edema, shortness of breath, or other symptoms of heart failure while on alogliptin and pioglitazone tablets to immediately report these symptoms to their healthcare provider [see .
Pancreatitis: Inform patients that acute pancreatitis has been reported during use of alogliptin and pioglitazone tablets. Educate patients that persistent, severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to promptly discontinue alogliptin and pioglitazone tablets and contact their healthcare provider if persistent severe abdominal pain occurs [see .
Hypersensitivity Reactions: Inform patients that allergic reactions have been reported during use of alogliptin and pioglitazone. Instruct patients if symptoms of allergic reactions (including skin rash, hives and swelling of the face, lips, tongue and throat that may cause difficulty in breathing or swallowing) occur, patients should discontinue alogliptin and pioglitazone tablets and seek medical advice promptly [see .
Hepatic Effects: Instruct patients to promptly stop taking alogliptin and pioglitazone tablets and seek immediate medical advice if they experience signs or symptoms of liver injury (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia or dark urine) [see .
Edema: Inform patients that alogliptin and pioglitazone tablets use can lead to new-onset or worsening of edema. Instruct patients to immediately report symptoms of rapid weight increase or worsening edema to their healthcare provider [see .
Fractures: Inform female patients about the risk of fractures while taking alogliptin and pioglitazone tablets. Provide them with information on factors that may contribute to fracture risk [see .
Urinary Bladder Tumors: Advise patients to promptly report any hematuria, dysuria, or urinary urgency that develops or increases during treatment, as these may be due to bladder cancer [see .
Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues: Inform patients that the risk of hypoglycemia is increased when alogliptin and pioglitazone tablets are used with insulin or insulin secretagogues (such as a sulfonylurea). Educate patients on the signs and symptoms of hypoglycemia [see .
Macular Edema: Educate patients on the signs and symptoms of macular edema and advise them to seek medical attention from an ophthalmologist if they experience symptoms of macular edema [see .
Severe and Disabling Arthralgia: Inform patients that severe and disabling joint pain may occur with alogliptin and pioglitazone tablets. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see .
Bullous Pemphigoid: Inform patients that bullous pemphigoid may occur with this alogliptin and pioglitazone tablets. Instruct patients to seek medical advice if blisters or erosions occur [see .
Females of Reproductive Age: Inform female patients that treatment with alogliptin and pioglitazone tablets may result in an unintended pregnancy in some premenopausal anovulatory females due to its effect on ovulation [see .
Dosage and Administration: Instruct patients to take alogliptin and pioglitazone tablets with or without meals. Instruct patients if a dose is missed, not to double their next dose. Instruct patients that the tablets must never be split.