Linagliptin
Regulatory sources consulted
- EMA/H/C/002110
- https://www.ema.europa.eu/en/medicines/human/EPAR/trajenta
- https://cima.aemps.es/cima/dochtml/ft/11707004/FT_11707004.html
- AEMPS CIMA · nº registro 11707004 ↗
- EMA EPAR · EMEA/H/C/002110 ↗
- RxNorm rxcui 1100699 ↗
Approved indications
- Monotherapy: in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
- Combination therapy: in combination with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Major warning · Acute pancreatitis has been observed in patients taking linagliptin. If pancreatitis is suspected, the treatment should be discontinued. — EMA
- Major warning · Bullous pemphigoid has been reported in patients taking linagliptin. If bullous pemphigoid is suspected, the treatment should be discontinued. — EMA
Drug interactions
- HighRifampicinJ04AB02
Mechanism: Potent induction of P-gp and CYP3A4, which reduces linagliptin exposure and may decrease its efficacy.
Recommendation: Co-administration may require the use of an alternative anti-diabetic therapy if strict glycaemic control is needed.
EMA SPC
Adverse events
Common (≥1%)
hypoglycaemia (in combination therapy) · nasopharyngitis · cough
Rare but serious
acute pancreatitis · angioedema · bullous pemphigoid
Pregnancy and lactation
Pregnancy: The use of linagliptin has not been studied in pregnant women. As a precautionary measure, it is preferable to avoid its use. Lactation: It is unknown whether it is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue therapy.