alogliptin/pioglitazone
Incresync · ATC code A10BD09
Also known as: Alogliptin/Pioglitazon, Alogliptin / Pioglitazone
- Key facts
- Active substance
- alogliptin/pioglitazone (INN: alogliptin / pioglitazone)
- Drug class
- Anti-diabetic medication
- ATC code
- A10BD09
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Incresync 12.5 mg/30 mg film-coated tablets / Incresync 25 mg/30 mg film-coated tablets / Incresync 25 mg/45 mg film-coated tablets
- Marketing authorisation holder
- Takeda Pharma A/S
- Information as of
- 2026-10-28
Key facts
Alogliptin/pioglitazone (Incresync) is a fixed combination of a DPP-4 inhibitor and a thiazolidinedione used to lower blood glucose in type 2 diabetes.
What it is used for
- Type 2 diabetes in adults aged 18 years and older as second- or third-line treatment, adjunct to diet and exercise: when inadequately controlled on pioglitazone alone and metformin is inappropriate, or in combination with metformin (triple therapy).
- Replacement of separate alogliptin and pioglitazone tablets in patients already on this combination.
- Response (e.g. HbA1c) should be reviewed after 3 to 6 months and treatment discontinued if inadequate.
Dosing
- One tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the pioglitazone dose already being taken; when combined with metformin, the metformin dose is maintained.
- Maximum daily dose 25 mg alogliptin and 45 mg pioglitazone.
- Moderate renal impairment (CrCl ≥30 to ≤50 mL/min): one tablet of 12.5 mg/30 mg once daily; not recommended in severe renal impairment (CrCl < 30 mL/min) or dialysis.
- Must not be used in hepatic impairment. In advanced age, alogliptin dosing should be conservative because of possible reduced renal function.
- Once daily with or without food; a missed dose should be taken when remembered, but not a double dose on the same day.
Contraindications
- Hypersensitivity to the active substances or excipients, or a serious hypersensitivity reaction (e.g. anaphylaxis, angioedema) to any DPP-4 inhibitor.
- Cardiac failure or history of cardiac failure (NYHA stages I to IV).
- Hepatic impairment.
- Diabetic ketoacidosis.
- Current or past bladder cancer; uninvestigated macroscopic haematuria.
Important warnings
- Pioglitazone can cause fluid retention and may exacerbate or precipitate heart failure; watch for weight gain and oedema, especially in combination with insulin.
- Bladder cancer was reported more frequently with pioglitazone; macroscopic haematuria should be investigated before starting, and patients should report blood in the urine or urinary urgency.
- Acute pancreatitis: discontinue if suspected and do not restart if confirmed.
- Periodic monitoring of liver enzymes; hepatic dysfunction including hepatic failure has been reported.
- Increased hypoglycaemia risk in triple therapy with metformin; increased bone fracture rate in women; bullous pemphigoid can occur with DPP-4 inhibitors.
- Not for use in type 1 diabetes.
Side effects
- Common: upper respiratory tract infections, sinusitis, headache, hypoglycaemia, nausea, weight increase, oedema, pruritus, bone fracture.
- Serious (alogliptin component): acute pancreatitis and hypersensitivity reactions such as Stevens-Johnson syndrome, anaphylaxis and angioedema.
- Women taking pioglitazone had more fractures (2.6% vs 1.7% with comparator).
Interactions
- Gemfibrozil (a CYP2C8 inhibitor) increases pioglitazone AUC 3-fold; the pioglitazone dose may need to be decreased.
- Concomitant insulin or NSAIDs may increase the risk of oedema and heart failure.
Pregnancy and breastfeeding
- Should not be used during pregnancy.
- A risk to the breast-fed child cannot be excluded; a decision on breast-feeding or therapy is required.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- IncresyncTakeda Pharma A/S · EMEA/H/C/002178
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Incresync
- Liechtenstein
- Incresync
- Norway
- Incresync
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- European Medicines Agency. Incresync – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/incresync-epar-product-information_en.pdf
- Wikidata (CC0): ATC A10BD.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.