See Supplemental Patient Information
- Dulaglutide causes thyroid C-cell tumors in rodents; risk to humans could not be determined from clinical or nonclinical studies
- Dulaglutide is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2 syndrome [US Black Box Warning]
- It is unknown whether routine serum calcitonin or thyroid ultrasound monitoring will reduce the potential risk of MTC, in fact such monitoring may increase the risk of unnecessary procedures, because of low test specificity for serum calcitonin and a high background incidence of thyroid disease [US Black Box Warning]
- In clinical trials, there were more cases of pancreatitis among dulaglutide treated patients. Observe patients carefully for signs and symptoms of pancreatitis including persistent severe abdominal pain after initiation of therapy and after dose increment; if pancreatitis is suspected, discontinue therapy and start other antidiabetic therapies. Do not restart dulaglutide
- Risk of hypoglycemia can increase when dulaglutide is coadministered with an insulin secretagogue (e.g., sulfonylurea) or insulin; reduce dose of sulfonylurea or insulin
- If systemic hypersensitivity reactions occur, discontinue treatment and seek medical advice promptly
- Acute renal failure and worsening of chronic renal failure have been reported; use caution when initiating or escalating dulaglutide doses in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions
- Gastrointestinal adverse reactions may occur with treatment, hence dulaglutide is not recommended for patients with pre-existing GI disease including gastroparesis
- Association between GLP-1 agonist or any other antidiabetic medication and macrovascular risk reduction has not been confirmed by clinical studies
- Dulaglutide slows gastric emptying which may reduce absorption of concomitantly administered oral medications
Cautions: Use cautiously in
- Hx of pancreatitis
- Renal impairment
- Coadministration with sulfonylurea or insulin
Supplemental Patient Information
- Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of pancreatitis. If severe abdominal pain occurs persistently, discontinue dulaglutide and contact the physician
- Inform patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician
Pregnancy Category:C
Breastfeeding: Safety unknown; however as many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or therapy, taking into account the importance of drug to the mother.
3 days before
