Insulina degludec
Regulatory sources consulted
- EMA EPAR for Tresiba (EMEA/H/C/002498)
- AEMPS CIMA Ficha Técnica (112807004)
- AEMPS CIMA · nº registro 112807004 ↗
- EMA EPAR · EMEA/H/C/002498 ↗
- RxNorm rxcui 1670007 ↗
Approved indications
- Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Major warning · Hypoglycaemia: This is the most frequent adverse reaction. Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Patients whose blood glucose control is greatly improved may experience a change in their usual warning symptoms of hypoglycaemia. — EMA SPC
- Medication errors: Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Tresiba and other insulin products. — EMA SPC
Drug interactions
- ModerateBeta-blockersC07
Mechanism: May mask the symptoms of hypoglycaemia (e.g., tachycardia).
Recommendation: Monitor blood glucose more closely. Educate the patient on atypical symptoms of hypoglycaemia (e.g., sweating, confusion) that may still occur.
EMA SPC
- LowThiazidesC03A
Mechanism: May increase insulin requirements by inducing hyperglycaemia.
Recommendation: Monitor blood glucose and adjust insulin dose as needed when starting or stopping the diuretic.
EMA SPC
Adverse events
Common (≥1%)
hypoglycaemia · injection site reactions
Rare but serious
severe hypoglycaemia · anaphylactic reaction
Pregnancy and lactation
Pregnancy: There is no clinical experience with the use of Tresiba in pregnant women. Its use may be considered if the clinical benefit outweighs the potential risks. Lactation: It is unknown whether insulin degludec is excreted in human milk. No metabolic effects are anticipated in the breastfed newborn/infant.