Dulaglutide
Regulatory sources consulted
- ema-epar-EMEA/H/C/002825
- aemps-cima-114956002
- https://www.ema.europa.eu/en/documents/product-information/trulicity-epar-product-information_en.pdf
- https://www.ema.europa.eu/es/documents/product-information/trulicity-epar-product-information_es.pdf
- https://www.ema.europa.eu/fr/documents/product-information/trulicity-epar-product-information_fr.pdf
- RxNorm rxcui 1551291 ↗
Approved indications
- Treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Clinical warnings
- Major warning · Acute pancreatitis has been reported. Patients should be informed of the characteristic symptoms. If pancreatitis is suspected, Trulicity should be discontinued. — EMA SPC
- Major warning · Risk of Thyroid C-cell Tumors. Thyroid C-cell tumors have been observed in rodents, but the relevance to humans is unknown. It is not recommended in patients with a personal or family history of MTC or MEN2. — EMA SPC
Drug interactions
- ModerateOral medications
Mechanism: Dulaglutide-induced delay in gastric emptying, which may alter the rate and extent of absorption of concomitantly administered oral medications.
Recommendation: Administer with caution medications that require rapid gastrointestinal absorption or have a narrow therapeutic index. Monitor as needed.
EMA SPC
Adverse events
Common (≥1%)
nausea · diarrhea · vomiting · abdominal pain · decreased appetite
Rare but serious
acute pancreatitis · anaphylactic reactions · angioedema · intestinal obstruction
Pregnancy and lactation
Use during pregnancy is not recommended due to reproductive toxicity in animals. Should not be used during breast-feeding as it is unknown if it is excreted in human milk.