Trulicity Dulaglutide Injection

1. Indications and Usage
Glycemic Control in Type 2 Diabetes:
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Cardiovascular Risk Reduction:
Indicated to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors.
Limitations of Use:
Not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Has not been studied in patients with a history of pancreatitis. Not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY. Must be administered once weekly, at any time of day, without regard to meals.
Recommended Dosage:
Initial Dose: 0.75 mg administered subcutaneously once weekly.
Titration: After a minimum of 4 weeks, the dose may be increased to 1.5 mg once weekly to further improve glycemic control. Higher doses (e.g., 3 mg or 4.5 mg) may also be used based on clinical need and tolerability.
Administration Instructions:
Administer into the abdomen, thigh, or upper arm. Injection sites and timing can be changed without dose adjustment.
Missed Dose: If a dose is missed, administer as soon as possible if the next scheduled dose is more than 3 days (72 hours) away. Otherwise, skip the missed dose and resume the regular schedule. Do not administer two doses within 3 days of each other.
3. Mechanism of Action
GLP-1 Receptor Agonist:
Dulaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that binds to and activates the human GLP-1 receptor.
Glucose-Dependent Insulin Secretion:
It stimulates glucose-dependent insulin secretion from pancreatic beta cells and suppresses elevated glucagon secretion. Because its insulinotropic action is glucose-dependent, the risk of hypoglycemia is low when used as monotherapy.
Delayed Gastric Emptying:
It delays gastric emptying, which contributes to reduced postprandial glucose excursions and promotes satiety.
4. Safety and Warnings
Risk of Thyroid C-Cell Tumors:
Contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.
Acute Pancreatitis:
Monitor for signs and symptoms of pancreatitis (e.g., persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). Discontinue promptly if pancreatitis is suspected.
Hypoglycemia:
The risk of hypoglycemia is increased when dulaglutide is used concomitantly with insulin secretagogues (e.g., sulfonylureas) or insulin. A lower dose of the concomitant medication should be considered.
Diabetic Retinopathy Complications:
Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression.
Renal Impairment:
Gastrointestinal adverse reactions (nausea, vomiting, diarrhea) may lead to dehydration and acute kidney injury. Use with caution in patients with renal impairment.
5. Adverse Reactions
Most Common:
Nausea, diarrhea, vomiting, abdominal pain, decreased appetite, and dyspepsia. These gastrointestinal events are typically mild to moderate, occur primarily during dose escalation, and decrease over time.
Other Reported Reactions:
Injection site reactions (erythema, rash), hypersensitivity reactions (rash, pruritus, urticaria, angioedema), and increased heart rate.
6. Drug Interactions
Oral Medications:
Due to delayed gastric emptying, dulaglutide may impact the absorption of concomitantly administered oral medications. Caution is advised when administering drugs with a narrow therapeutic index that require rapid gastrointestinal absorption.
Insulin Secretagogues and Insulin:
Concomitant use increases the risk of hypoglycemia. Consider reducing the dose of sulfonylureas or insulin upon initiation of dulaglutide.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Dulaglutide (a recombinant human GLP-1 receptor agonist).
Available Strengths: Prefilled single-dose pens containing 0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3 mg/0.5 mL, or 4.5 mg/0.5 mL.
Storage:
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. If stored at room temperature (up to 30°C/86°F), it must be used within 14 days.