Short answer: Oseni is taken by mouth once daily, with or without food, and tablets are not split. The starting dose depends on current medicines, usually 25 mg alogliptin with 15 mg or 30 mg pioglitazone, raised gradually up to 25 mg/45 mg. With moderate kidney impairment the dose is 12.5 mg/30 mg, and with mild heart failure the start is 25 mg/15 mg. The label says not to double the next dose after a missed one.
This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.
What Oseni is approved for: Oseni combines alogliptin, a DPP-4 inhibitor, with pioglitazone, a thiazolidinedione. It is approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes (section 1). It is not recommended for type 1 diabetes.
Source
OSENI (alogliptin and pioglitazone) tablets, for oral use, prescribing information and Medication Guide. Takeda Pharmaceuticals America. DailyMed, version published March 24, 2025. DailyMed setid 4c619ed9-fe3e-4158-9938-80c6c3493d55
Oseni is a tablet taken by mouth once daily, with or without food. Tablets are not split (section 2.1).
Liver tests (ALT, AST, alkaline phosphatase and total bilirubin) are taken before starting (section 2.1).
It comes as alogliptin/pioglitazone 12.5 mg/30 mg, 25 mg/15 mg, 25 mg/30 mg and 25 mg/45 mg (section 3).
The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.
| Current Regimen | Starting Dosage of OSENI (alogliptin/pioglitazone) |
|---|---|
| Not treated with either alogliptin or pioglitazone | 25 mg/15 mg or 25 mg/30 mg |
| Alogliptin | 25 mg/15 mg or 25 mg/30 mg |
| Pioglitazone | 25 mg/15 mg, 25 mg/30 mg, or 25 mg/45 mg |
| Alogliptin and pioglitazone | Select a dosage that is as close as possible to the current dosage of alogliptin and pioglitazone |
Doses are alogliptin/pioglitazone. Kidney impairment and heart failure change the dose (sections 2.3 and 2.4).
| Situation | Oseni dosage |
|---|---|
| Maximum dosage | 25 mg of alogliptin and 45 mg of pioglitazone once daily |
| Moderate renal impairment (CrCl ≥30 to <60 mL/min) | 12.5 mg of alogliptin and 30 mg of pioglitazone once daily |
| Severe renal impairment (CrCl ≥15 to <30 mL/min) or ESRD | Not recommended |
| Preexisting NYHA Class I or II congestive heart failure | Starting dosage 25 mg of alogliptin and 15 mg of pioglitazone |
| With gemfibrozil or other strong CYP2C8 inhibitors | Maximum 25 mg of alogliptin and 15 mg of pioglitazone once daily |
The dose is raised gradually, as needed, after checking response and tolerability, up to the maximum.
Kidney function is assessed before starting and periodically after. With mild impairment (CrCl 60 mL/min or more) the dose is the same as with normal kidney function.
After starting or a dose increase, people are watched for fluid retention, weight gain, swelling and heart failure. If heart failure develops, stopping Oseni or lowering the pioglitazone dose is considered.
With insulin or a sulfonylurea, a lower dose of those medicines may be needed to reduce the risk of low blood sugar.
Tablets are stored at 25 C (77 F), with excursions from 15 to 30 C allowed.
If a dose is missed, the next dose is not doubled. The Medication Guide adds: if you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of Oseni at the same time.
More on this: missed a dose of Oseni.
From alogliptin, Oseni starts at 25 mg/15 mg or 25 mg/30 mg. From pioglitazone, it starts at 25 mg/15 mg, 25 mg/30 mg or 25 mg/45 mg. From both, the strength closest to the current doses is chosen.
In Dose Track you set up Oseni as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.