See important safety information, including boxed warning, in the attached prescribing information.

The use of dulaglutide in patients undergoing surgical procedures or hospitalization has not been evaluated.

Dulaglutide is a GLP-1 receptor agonist indicated

• as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes, and
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.1
  

Health care providers should use patient medical records and their clinical judgement to make a treatment recommendation. The additional considerations below may be helpful to determine what is best for their patient (Pharmacokinetics and Pharmacodynamics, Drug Interactions, and Precautions).

Inject dulaglutide

• once weekly on the same day every week
• at any time of day, and
• with or without food.1,2

Dulaglutide should be injected subcutaneously in the abdomen, thigh, or upper arm.1

Following subcutaneous administration, the time to maximum plasma concentration of dulaglutide at steady state ranges from 24 to 72 hours, with a median of 48 hours.1

Steady-state plasma dulaglutide concentrations were achieved between 2 and 4 weeks following once-weekly administration.1

The mean absolute bioavailability of dulaglutide following subcutaneous administration of single 0.75 mg and 1.5 mg doses was 65% and 47%, respectively.1

Absolute subcutaneous bioavailability for 3 mg and 4.5 mg doses were estimated to be similar to 1.5 mg, although this has not been specifically studied.1

The apparent population mean clearance of dulaglutide was 0.142 L/h. The elimination half-life of dulaglutide was approximately 5 days.1

For full information on pharmacokinetics, please refer to the enclosed prescribing information.1

Caution should be exercised when oral medications are concomitantly administered with dulaglutide.1

Dulaglutide delays gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Monitor drug levels of oral medications with a narrow therapeutic index when concomitantly administered with dulaglutide.1

In clinical pharmacology studies, dulaglutide 1.5 mg did not affect the absorption, to any clinically relevant degree, of the tested orally administered medications that included 

• lisinopril
• metoprolol
• digoxin
• norelgestromin
• ethinylestradiol
• atorvastatin
• metformin
• acetaminophen
• S-warfarin
• R-warfarin, and
• sitagliptin.1

There is limited experience with the use of concomitant medications in clinical trials with dulaglutide doses of 3 mg and 4.5 mg.1

For full information on drug interactions, please refer to the enclosed prescribing information.1

Dulaglutide is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).1

Dulaglutide is contraindicated in patients with a serious hypersensitivity reaction to dulaglutide or to any of the product components.1

If pancreatitis is suspected, promptly discontinue dulaglutide and initiate appropriate management. Do not restart if pancreatitis is confirmed. Dulaglutide has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.1

Patients receiving dulaglutide in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin.1

No dose adjustment is recommended in patients with renal impairment, including end-stage renal disease, when using dulaglutide. In patients treated with glucagon-like peptide-1 receptor agonists, including dulaglutide, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal function, use caution when initiating or escalating doses of dulaglutide in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.1

Use of dulaglutide has be associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving dulaglutide (0.75 mg, 2.2%; 1.5 mg, 4.3%) than placebo (1.4%). Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.1

Dulaglutide delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.1

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking dulaglutide, including whether modifying preoperative fasting recommendations or temporarily discontinuing dulaglutide could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking dulaglutide.1

For full information on precautions, please refer to the enclosed prescribing information.1

TRULICITY® (dulaglutide) injection, for subcutaneous use, Lilly