Dosing and uses of Trulicity (dulaglutide)
Adult dosage forms and strengths
SC solution
- Available in single-dose prefilled syringe or pen
- 0.75mg/0.5mL
- 1.5mg/0.5mL
Diabetes Mellitus Type 2
Indicated as once-weekly SC injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Initial: 0.75 mg SC once weekly
May increase dose to 1.5 mg once weekly for additional glycemic controL
Dosage modifications
Renal impairment (any severity): No dosage adjustment required
Dosing Considerations
Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin: When initiating dulaglutide, consider reducing the dosage of concomitantly administered insulin or insulin secretagogues to reduce risk of hypoglycemia
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
Has not been studied with a history of pancreatitis; consider another antidiabetic therapy
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
Not for patients with preexisting severe GI disease
Has not been studied in combination with basal insulin
Pediatric dosage forms and strengths
Safety and efficacy not established
Trulicity (dulaglutide) adverse (side) effects
>10%
Nausea (12.4-21.1%)
Increased amylase (20%)
Increased lipase (14%)
Diarrhea (8.9-12.6%)
Vomiting (6-12.7%)
1-10%
Abdominal pain (6.5-9.4%)
Decreased appetite (4.9-8.6%)
Dyspepsia (4.1-5.8%)
Fatigue (4.2-5.6%)
Severe/symptomatic hypoglycemia
- Add-on to metformin (2.6-5.6%); placebo 1.1%
- Add-on to metformin and pioglitazone (4.5-5%); placebo 1.4%
<1%
Severe hypersensitivity (eg, severe urticaria, systemic rash, facial edema, lip swelling)
Injection-site reactions
Pancreatitis
Warnings
Black box warnings
Risk of thyroid C-cell tumors
- Causes thyroid C-cell tumors in rodents; human risk could not be determined
- 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)
Contraindications
Hypersensitivity
Personal or family history of medullary thyroid carcinoma (MTC)
Multiple endocrine neoplasia type 2 (MEN-2)
Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide
Cautions
Nonclinical studies in rodents showed increased incidence of thyroid C-cell tumors (see Black box warnings and Contraindications); routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide; significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; if serum calcitonin is measured and found to be elevated, evaluate patient further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated
Acute pancreatitis reported (rare); discontinue if pancreatitis suspected and do not restart if confirmed
Hypoglycemia may occur when used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; consider lowering sulfonylurea or insulin dosage when starting dulaglutide
Systemic hypersensitivity reactions reported; discontinue if such reactions occur
Acute renal failure and worsening of chronic renal failure (some requiring hemodialysis) reported with treatment with glucagonlike peptide-1 (GLP-1) receptor agonists
May be associated with GI adverse reactions, sometimes severe; counsel patients to take precautions to avoid fluid depletion; has not been studied in patients with severe GI disease, including severe gastroparesis
Clinical trials have not established conclusive evidence of macrovascular risk reduction with GLP-1 agonists or any other antidiabetic drug
Slows gastric emptying and may affect absorption of concomitantly administered PO drugs
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in human breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Trulicity (dulaglutide)
Mechanism of action
Incretin mimetic; analogue of human glucagonlike peptide-1 (GLP-1); acts as GLP-1 receptor agonist to increase insulin secretion in the presence of elevated blood glucose; delays gastric emptying to decrease postprandial glucose; also decreases glucagon secretion
Absorption
Absolute bioavailability: 65% (0.75 mg/dose); 47% (1.5 mg/dose)
Peak plasma concentration: 114 ng/mL
AUC: 14,000 ng•h/mL
Distribution
Vd: 19.2 L (0.75 mg/dose); 17.4 L (1.5 mg/dose)
Metabolism
Thought to be degraded into its component amino acids by general protein catabolism pathways
Elimination
Half-life: 5 days
Clearance: ~0.1 L/hr
Administration
SC Administration
Administer once weekly at any time of day
Inject SC in abdomen, thigh, or upper arm
If a dose is missed, administer within 3 days of missed dose
The day of weekly administration can be changed if necessary as long as the last dose was administered ≥3 days before
Missed dose
- If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day; in each case, patients can then resume their regular once weekly dosing schedule
