Adult Dosing
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Individualize the starting dose 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
- Limit initial dose of pioglitazone to 15 mg/day with NYHA Class 1 or II heart failure
- May take with or without food
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Mild impairment: No dose adjustments
- Moderate impairment (CrCl >30 to <60 mL/min): Not to exceed 12.5 mg/day alogliptin
- Severe impairment (CrCl <30 mL/min or ESRD): Use not recommended
Hepatic Dose Adjustment
- Mild-moderate impairment (Child-Pugh Grade A and B): No dose adjustments
- Severe impairment (Child-Pugh Grade C): Dose adjustments not defined
Use with strong CYP2C8 inhibitors
- Such as gemfibrozil, the maximum recommended dose of pioglitazone is 15 mg once daily
See Supplemental Patient Information
- Thiazolidinediones including pioglitazone may cause or exacerbate congestive heart failure in some patients (US black box warning)
- After initiation and dose increases, monitor patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain; dyspnea; and/or edema). If these signs or symptoms develop, the heart failure should be managed according to the current standards of care. Discontinuation or dose reduction of thiazolidinedione must be considered (US black box warning)
- Therapy is not recommended in patients with symptomatic heart failure (US black box warning)
- Initiation in patients with established NYHA class III or IV heart failure is contraindicated (US black box warning)
- Alogliptin component has been associated with reports of acute pancreatitis, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue the therapy and initiate appropriate management
- Alogliptin may lead to hypersensitivity reactions such as anaphylaxis, angioedema, and severe cutaneous adverse reactions including Stevens-Johnson syndrome. If a serious hypersensitivity reaction is suspected, discontinue therapy, assess for other potential causes for the event, and institute alternative treatment for diabetes
- Fatal and nonfatal hepatic failure has been reported; patients may have fatty liver disease and liver enzyme elevation; monitor carefully and interrupt treatment if LFTs is elevated
- Pioglitazone can cause dose-related fluid retention that may lead to or exacerbate CHF. Patients should be observed for signs and symptoms of congestive heart failure
- Use cautiously in patients with edema
- Pioglitazone therapy may increased fracture risk in females, attention should be given to assessing and maintaining bone health according to current standards of care
- Insulin and insulin secretagogues (eg, sulfonylureas) are known to cause hypoglycemia; therefore, a lower dose of insulin of insulin secretagogue may be needed to minimize hypoglycemia risk
- Macular edema has been reported with thiazolidinediones. Patients with diabetes should have regular eye exams by an ophthalmologist according to current standards of care
- Pioglitazone may result in ovulation in premenopausal anovulatory women
- Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users. Do not use in patients with active bladder cancer. Use caution when using in patients with history of bladder cancer
Supplemental Patient Information
- Patients who experience increase in weight or edema or who develop shortness of breath or other symptoms of heart failure should immediately report these symptoms to their physician
- Patients should be informed that acute pancreatitis has been reported during use of alogliptin. If persistent severe abdominal pain occurs, patients should be instructed to promptly discontinue therapy and contact their physician
- If symptoms of allergic reactions such as skin rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing occur, patients should be instructed to discontinue therapy and seek medical advice promptly
- Inform patients to promptly report any sign of macroscopic hematuria or other symptoms such as dysuria or urinary urgency that develop or increase during treatment as these may be due to bladder cancer
Pregnancy Category:C
Breastfeeding: Safety unknown; It is not known whether alogliptin and/or pioglitazone are secreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue therapy, taking into account the importance of drug to the mother
US Trade Name(s)
US Availability
Oseni (alogliptin/pioglitazone)
- TABS
- 12.5 mg/15 mg
- 12.5 mg/30 mg
- 12.5 mg/45 mg
- 25 mg/15 mg
- 25 mg/30 mg
- 25 mg/45 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]