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TRAJENTA®
Linagliptin
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 |
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
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).
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
Footnotes
- *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).
- †Adverse reaction observed in combination with metformin plus sulphonylurea.
- ‡Based on lipase elevations >3 x ULN observed in clinical trials.
Helping a broad range of adult patients
How does TRAJENTA® work?
The long-term cardiovascular (CV) and kidney safety profile
References
- TRAJENTA® (linagliptin) Summary of Product Characteristics. SmPCs available at EMC: www.medicines.org.uk (GB) and https://www.emcmedicines.com/en-GB/northernireland/ (NI).
- Cooper M, et al. Diabetes Obes Metab. 2020;22(7):1062-1073
- Espeland MA, et al. Diabetes Obes Metab 2021;23(2):569-580
PC-GB-105689 V2
September 2022