Skip to Content

Dulaglutide

Medically reviewed by Drugs.com. Last updated on Jul 20, 2020.

Pronunciation

(doo la GLOO tide)

Index Terms

  • LY2189265

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous [preservative free]:

Trulicity: 0.75 mg/0.5 mL (0.5 mL); 1.5 mg/0.5 mL (0.5 mL); 3 mg/0.5 mL (0.5 mL); 4.5 mg/0.5 mL (0.5 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Trulicity

Pharmacologic Category

  • Antidiabetic Agent, Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Pharmacology

Dulaglutide is an agonist of human glucagon-like peptide-1 (GLP-1) receptor and augments glucose dependent insulin secretion and slows gastric emptying.

Distribution

Central volume, mean: 3.09 L; peripheral volume, mean: 5.98 L.

Metabolism

Degradation to amino acids by protein catabolism pathways.

Time to Peak

Plasma: 24 to 72 hours

Half-Life Elimination

~5 days

Special Populations: Renal Function Impairment

Renal impairment: Dulaglutide systemic exposure increased by 20%, 28%, 14%, and 12% for mild, moderate, and severe renal impairment, and ESRD, respectively.

Special Populations: Hepatic Function Impairment

Dulaglutide systemic exposure decreased by 23%, 33%, and 21% for mild, moderate, and severe hepatic impairment, respectively.

Use: Labeled Indications

Diabetes mellitus, type 2, treatment: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Contraindications

Serious hypersensitivity to dulaglutide or any component of the formulation; personal or family history of medullary thyroid carcinoma (MTC); patients with multiple endocrine neoplasia syndrome type 2 (MEN2)

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy; breast-feeding

Dosing: Adult

Note: Due to lack of additive glycemic benefit, avoid concomitant use with a dipeptidyl peptidase-4 inhibitor (ADA/EASD [Davies 2018]). May require a dose reduction of insulin and/or insulin secretagogues to avoid hypoglycemia.

Diabetes mellitus, type 2, treatment:

Note: May be used as an adjunctive agent or alternative monotherapy for patients who fail initial therapy with lifestyle intervention and metformin or who cannot take metformin. May be preferred in patients who have or are at risk for atherosclerotic cardiovascular disease, when weight loss is desired, and/or in patients with an HbA1c relatively far from goal (eg, HbA1c 9% to 10%) and type 1 diabetes is not likely (ADA 2020; Gerstein 2019; Wexler 2020).

SubQ: Initial: 0.75 mg once weekly; may increase to 1.5 mg once weekly after 4 to 8 weeks if needed to achieve glycemic goals (Dungan 2020; Umpierrez 2014; Weinstock 2015). If additional glycemic control is needed, may further increase to 3 mg once weekly after at least 4 weeks on the 1.5 mg weekly dose and then to a maximum of 4.5 mg once weekly after at least 4 weeks on the 3 mg weekly dose.

Missed doses: Missed dose should be administered as soon as possible within 3 days; resume usual schedule thereafter. If there are <3 days until next scheduled dose, omit the missed dose and resume administration at the next scheduled weekly dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Administration

SubQ: Do not inject intravenously or intramuscularly. Inject subcutaneously into the upper arm, thigh, or abdomen; when administering within the same body region, use a different injection site each week. Administer once weekly on the same day each week, without regard to meals or time of day. The day of weekly administration may be changed, as long as the last dose was administered ≥3 days before. If using concomitantly with insulin, administer as separate injections (do not mix); may inject in the same body region as insulin, but not adjacent to one another.

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Protect from light. If needed, each single-dose pen or prefilled syringe can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days.

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Insulins: Glucagon-Like Peptide-1 Agonists may enhance the hypoglycemic effect of Insulins. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Consider therapy modification

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification

Sulfonylureas: Glucagon-Like Peptide-1 Agonists may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Endocrine & metabolic: Hypoglycemia (≤77%; highest incidence seen with adjunctive use of insulin glargine, prandial insulin, and sulfonylurea; severe: ≤3%; highest incidence seen with adjunctive use of prandial insulin)

Gastrointestinal: Diarrhea (9% to 13%), nausea (12% to 21%), vomiting (6% to 13%)

1% to 10%:

Cardiovascular: First degree atrioventricular block (2%), prolongation P-R interval on ECG (3%), sinus tachycardia (6%), sustained tachycardia (2%)

Gastrointestinal: Abdominal distension (2% to 3%), abdominal pain (7% to 9%), constipation (4%), decreased appetite (5% to 9%), dyspepsia (4% to 6%), eructation (2%), flatulence (3%), gastroesophageal reflux disease (2%)

Immunologic: Antibody development (2%; neutralizing: <1%)

Nervous system: Fatigue (4% to 6%)

<1%:

Hypersensitivity: Hypersensitivity reaction

Local: Injection site reaction

Frequency not defined:

Gastrointestinal: Increased serum amylase, increased serum lipase, pancreatitis

Postmarketing:

Hypersensitivity: Anaphylaxis, angioedema

Renal: Acute renal failure, exacerbation of renal failure

ALERT: U.S. Boxed Warning

Risk of thyroid C-cell tumors:

In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether dulaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

Dulaglutide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of dulaglutide and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide.

Warnings/Precautions

Concerns related to adverse effects:

• Gallbladder disease: Use of glucagon-like peptide-1 (GLP-1) agonists may increase risk of gallbladder and bile duct disease, including cholelithiasis and cholecystitis (Faillie 2016; Gerstein 2019; Monami 2017).

• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported; discontinue therapy in the event of a hypersensitivity reaction. Use with caution in patients with a history of angioedema or anaphylaxis to other GLP-1 receptor agonists; potential for cross-sensitivity is unknown.

• Pancreatitis: Cases of pancreatitis have been reported; monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain). If pancreatitis is suspected, discontinue use. Do not resume therapy if pancreatitis is confirmed. Consider antidiabetic therapies other than dulaglutide in patients with a history of pancreatitis.

• Thyroid tumors:[US Boxed Warning] Thyroid C-cell tumors have developed in animal studies with GLP-1 receptor agonists; it is not known if dulaglutide causes thyroid C-cell tumor, including medullary thyroid carcinoma (MTC) in humans. Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide. Patients should be counseled on the potential risk of MTC with the use of dulaglutide and informed of symptoms of thyroid tumors (eg, neck mass, dysphagia, dyspnea, persistent hoarseness). Use is contraindicated in patients with a personal or a family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2. Once case of MTC has been reported in a patient treated with dulaglutide and cases have also been reported in patients treated with the GLP-1 receptor agonist liraglutide; data is insufficient to establish or exclude a causal relationship. Consultation with an endocrinologist is recommended in patients with thyroid nodules on physical examination or neck imaging and in patients who develop elevated calcitonin concentrations.

Disease-related concerns:

• Bariatric surgery:

- Dehydration: Evaluate, correct, and maintain postsurgical fluid requirements and volume status prior to initiating therapy, and closely monitor the patient for the duration of therapy; acute and chronic kidney failure exacerbation may occur. A majority of cases occurred in patients with nausea, vomiting, diarrhea, and/or dehydration. Nausea is common and fluid intake may be more difficult after gastric bypass, sleeve gastrectomy, and gastric band (Mechanick 2013).

- Excessive glucagon-like peptide-1 exposure: Closely monitor for efficacy and assess for signs and symptoms of pancreatitis if therapy is initiated after surgery; gastric bypass and sleeve gastrectomy (but not gastric band) significantly increase endogenous postprandial GLP-1 concentrations (Korner 2009; Peterli 2012). Administration of exogenous GLP-1 agonists may be redundant to surgery effects.

• Diabetic retinopathy: Increased complications associated with diabetic retinopathy have been observed with dulaglutide compared to placebo; risk may be increased in patients with a history of diabetic retinopathy. Monitor for worsening of diabetic retinopathy in patients with a prior history.

• GI disease: Use is not recommended in patients with preexisting severe GI disease, including severe gastroparesis.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment, particularly during initiation of therapy and dose escalation. Acute renal failure and chronic renal failure exacerbation (sometimes requiring hemodialysis) have been reported; some cases have been reported in patients with no known preexisting renal disease. A majority of reported cases occurred in patients with nausea/vomiting/diarrhea or dehydration.

Other warnings/precautions:

• Appropriate use: Diabetes mellitus: Not recommended for first-line therapy in patients inadequately controlled on diet and exercise alone. Do not use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; not a substitute for insulin.

• Patient education: Diabetes self-management education is essential to maximize the effectiveness of therapy.

Monitoring Parameters

Plasma glucose, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2020]), renal function (in patients reporting severe GI reactions), signs/symptoms of pancreatitis

Pregnancy Considerations

Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major birth defects, stillbirth, and macrosomia (ACOG 201 2018). To prevent adverse outcomes, prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2020; Blumer 2013).

Agents other than dulaglutide are currently recommended to treat diabetes mellitus in pregnancy (ADA 2020).

Patient Education

What is this drug used for?

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

• It is used to lower the chance of heart attack, stroke, and death in some people.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Lack of appetite

• Diarrhea

• Nausea

• Vomiting

• Abdominal pain

• Loss of strength and energy

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Thyroid cancer like new lump or swelling in the neck, pain in the front of the neck, persistent cough, persistent change in voice like hoarseness, or trouble swallowing or breathing

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting

• Vision changes

• Low blood sugar like dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating.

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions