Classes
DEA Class; Rx
Common Brand Names; Trulicity
- Antidiabetics, Glucagon-like Peptide-1 Agonists
Description
Incretin mimetic (GLP-1 receptor agonist) administered as a once-weekly subcutaneous injection
Used to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus (T2DM) and for the reduction of cardiovascular (CV) mortality due to major cardiovascular events (MACE) in adult T2DM patients with established CV disease or multiple CV risk factors
Not recommended as first-line therapy because of the boxed warning regarding rodent C-cell tumor findings and the uncertain relevance to humans
Indications
Indicated as once-weekly SC injection adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM)
It is also indicated to reduce risk of major adverse cardiovascular (CV) events (CV death, nonfatal MI, or nonfatal stroke) in adults with T2DM who have established CV disease or multiple CV risk factors
Contraindications
Hypersensitivity to drug or excipients
Personal or family history of medullary thyroid carcinoma (MTC)
Multiple endocrine neoplasia type 2 (MEN-2)
Adverse Effects
- Nausea (12.4-21.1%)
- Increased amylase (20%)
- Increased lipase (14%)
- Diarrhea (7-12.6%)
- Abdominal pain (6.5-9.4%)
- Vomiting (5.6-9.3%)
- Decreased appetite (4.9-8.6%)
- Fatigue (4.2-5.6%)
- Dyspepsia (2.3-5.8%)
- Constipation (3.7-3.9%)
- Severe hypoglycemia with prandial insulin (2.7-3.4%)
- Flatulence (1.4-3.4%)
- Sinus tachycardia (2.8-3%)
- Abdominal distension (2.3-2.9%)
- Gastroesophageal reflux disease (1.7-2%)
- AV block (0.9-1.7%)
- Eructation (0.6-1.6%)
- Hypersensitivity, sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling)
- Injection-site reactions
- Pancreatitis
- Cholelithaisis and cholecystitis
- Gastrointestinal: Ileus
- Hepatobiliary: Cholecystitis, cholelithiasis requiring cholecystectomy, cholestasis, elevation of liver enzymes, hepatitis
- Hypersensitivity: Anaphylactic reactions, angioedema
- Renal: Acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
Warnings
Systemic hypersensitivity reactions reported; anaphylaxis and angioedema reported with other GLP-1 receptor agonists; use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist; unknown whether such patients will be predisposed to anaphylaxis with drug; 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
Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported in GLP-1 receptor agonist trials and postmarketing; serious events of acute cholecystitis reported; if cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
Pregnancy and Lactation
Limited data in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage
There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (eg, diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, delivery complications)
Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
There are no data on presence of dulaglutide in human milk, the effects on breastfed infant, or effects on milk production
Maximum Dosage
4.5 mg/week subcutaneously.
4.5 mg/week subcutaneously.
1.5 mg/week subcutaneously.
10 to 12 years: 1.5 mg/week subcutaneously.
1 to 9 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Dulaglutide
SC solution
- Available in single-dose pen
- 0.75mg/0.5mL
- 1.5mg/0.5mL
- 3mg/0.5mL
- 4.5mg/0.5mL