Alogliptin
Regulatory sources consulted
- EMA-EPAR-EMEA/H/C/002182
- AEMPS-CIMA-113844012
- AEMPS CIMA · nº registro 113844012 ↗
- EMA EPAR · EMEA/H/C/002182 ↗
- RxNorm rxcui 1368001 ↗
Approved indications
- Indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients, or a history of a severe hypersensitivity reaction, including anaphylaxis, anaphylactic shock and angioedema, to any dipeptidyl peptidase-4 (DPP-4) inhibitor.
Clinical warnings
- Major warning · Acute pancreatitis: Cases of acute pancreatitis have been observed. Patients should be informed of the characteristic symptoms (persistent, severe abdominal pain). If pancreatitis is suspected, treatment should be discontinued. — EMA
- Major warning · Bullous pemphigoid: Cases of bullous pemphigoid requiring hospitalization have been reported. If suspected, treatment should be discontinued. — EMA
Drug interactions
- ModerateSulfonylureas (e.g., Glyburide)A10BB
Mechanism: Additive pharmacodynamic effect, increasing the risk of hypoglycemia.
Recommendation: Consider a lower dose of the sulfonylurea to reduce the risk of hypoglycemia when initiating treatment with alogliptin.
EMA SPC
Adverse events
Common (≥1%)
upper respiratory tract infection · nasopharyngitis · headache · abdominal pain · pruritus
Rare but serious
acute pancreatitis · hepatic failure · bullous pemphigoid · angioedema · anaphylaxis
Pregnancy and lactation
There are no data from the use of alogliptin in pregnant women. As a precautionary measure, it is preferable to avoid its use during pregnancy. It is unknown whether it is excreted in human milk; a risk to the breastfed infant cannot be excluded.