Safety Profile
Common and very common adverse events only listed here - please refer to SmPC for complete table of adverse events.
| System organ class / Adverse reaction | Frequency of adverse reaction* |
|---|---|
| Metabolism and nutrition disorders | |
| Hypoglycaemia† | Very common |
| Investigations | |
| Lipase increased‡ | Common |
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*
The adverse reactions are listed by absolute frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data).
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†
Adverse reaction observed in combination with metformin plus sulphonylurea.
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‡
Based on lipase elevations >3 x upper limit of normal observed in clinical trials.
The most frequently reported adverse reaction was hypoglycaemia when Trajenta® was used in combination with metformin and sulphonylurea. Trajenta® alone had a comparable incidence of hypoglycaemia to placebo.1 Caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin. A dose reduction of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.
Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Trajenta® should be discontinued; if acute pancreatitis is confirmed, Trajenta® should not be restarted. Caution should be exercised in patients with a history of pancreatitis.1 The incidence of pancreatitis with Trajenta® is rare (≥1/10,000 - < 1/1000).
Bullous pemphigoid has been observed in patients taking linagliptin. If bullous pemphigoid is suspected, Trajenta® should be discontinued.1 The incidence of bullous pemphigoid with Trajenta® is rare (≥1/10,000 - 1/1,000).
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.1
Avoid use during pregnancy; a risk to the breast-fed child cannot be excluded.1
Refer to the SmPC for a full list of adverse effects, warnings and precautions.1
Helping a broad range of adult patients
How does Trajenta® work?
Abbreviations:
3P-MACE: 3-point major cardiac events; CV: cardiovascular; MI: myocardial infarction; SmPC: Summary of Product Characteristics; T2D: type 2 diabetes.
Footnotes
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#
Primary endpoint for CARMELINA® and CAROLINA®: Time to first occurrence of any of the following CV components: CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), or non-fatal stroke (3P-MACE).
References
- Trajenta® (linagliptin) Summary of Product Characteristics. SmPCs available at EMC.
- Cooper ME, et al. Diabetes Obes Metab 2020;22:1062–1073
- Espeland MA, et al. Diabetes Obes Metab 2021;23(2):569-580
Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:
monotherapy when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment
in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control
PC-GB-110498 V2 | February 2025