Usual Adult Dose for Diabetes Type 2

Initial dose: 0.75 mg subcutaneously once a week

• Dose may be increased in 1.5 mg increments for additional glycemic control; patients should remain on 1.5 mg once a week dose for at least 4 weeks prior to increasing dose to 3 mg once a week; patients should remain on 3 mg once a week dose for at least 4 weeks prior to increasing dose to 4.5 mg once a week

Maintenance dose: 0.75 to 4.5 mg subcutaneously once a week
Maximum dose: 4.5 mg weekly

Comments:

• This drug should not be used in patients with type 1 diabetes mellitus.
• This drug has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is not recommended in these patients.
• This drug has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in these patients.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 0.75 mg subcutaneously once a week

• Dose may be increased in 1.5 mg increments for additional glycemic control; patients should remain on 1.5 mg once a week dose for at least 4 weeks prior to increasing dose to 3 mg once a week; patients should remain on 3 mg once a week dose for at least 4 weeks prior to increasing dose to 4.5 mg once a week

Maintenance dose: 0.75 to 4.5 mg subcutaneously once a week
Maximum dose: 4.5 mg weekly

Comments:

• This drug should not be used in patients with type 1 diabetes mellitus.
• This drug has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is not recommended in these patients.
• This drug has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in these patients.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Renal Dose Adjustments

No adjustment recommended; monitor renal function closely in patients with renal impairment who experience severe adverse gastrointestinal reactions
ESRD: Use caution

Liver Dose Adjustments

Caution is recommended as this drug has not been studied in subjects with hepatic impairment

Dose Adjustments

Elderly: A greater sensitivity of some older adults cannot be ruled out; use with caution

Concomitant Use with Insulin or Insulin Secretagogue:

• The dose of concomitantly administered insulin or insulin secretagogue may need to be reduced to avoid hypoglycemia

Concomitant Use of Oral Medications:

• This drug delays gastric emptying in a dose-dependent manner; the delay is greatest after the first dose and diminishes with subsequent doses.
• Due to limited experience with use of higher doses (e.g., 3 mg and 4.5 mg), caution is advised with concomitant use of oral medications with a narrow therapeutic index.

Precautions

US BOXED WARNING: Risk of Thyroid C-Cell Tumors

• In male and female rats, this drug 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 this drug causes thyroid C-cell tumor, including medullary thyroid carcinoma (MTC) in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.
• This drug is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection. Patients should be counseled regarding the risk factors and symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness).

CONTRAINDICATIONS:

• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Personal or family history of medullary thyroid carcinoma (MTC)
• Prior serious hypersensitivity reaction to this drug or product excipients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer subcutaneously in the abdomen, thigh, or upper arm, once a week at any time of day, with or without food
• Do not share pens, needles or syringes with another person due to risk of infection(s)
• Patients should be trained on proper injection technique and instructed to rotate injection site each week
• If concurrently using insulin, administer as separate injections; may inject in same body region, but not adjacent to each other

MISSED DOSE:

• Administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose; resume weekly dosing on scheduled day
• If there is less than 3 days (72 hours) until the next dose, skip the missed dose and resume weekly dosing on scheduled day

CHANGE DAY OF ADMINISTRATION: The scheduled day of weekly administration can be changed if the last dose was administered 3 or more days earlier

Storage requirements:

• Refrigerate at 2C to 8C (36F to 46F); do not use if drug has been frozen
• Single-dose pen or prefilled syringe can be kept at room temperature (not to exceed 30C [86F] for 14 days
• Protect from light; store in original carton until time of administration

Reconstitution/preparation techniques: The manufacturer product information should be consulted

General:

• Use in patients with a severe gastrointestinal disease has not been studied and is not recommended.
• Use in patients with a history of pancreatitis has not been studied; consider other antidiabetic therapies.
• This drug is not a substitute for insulin; it should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Monitoring:

• Monitor renal function in patients with renal impairment experiencing severe gastrointestinal reactions
• Observe for signs and symptoms of pancreatitis
• Monitor for progression of diabetic retinopathy in patients with a history of diabetic retinopathy

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients should be instructed to report symptoms of thyroid tumors such as a lump in neck, persistent hoarseness, dysphagia, or dyspnea.
• Patients should be aware of the potential for gastrointestinal (GI) reactions; they should be instructed to take measures to ensure adequate fluid intake to avoid dehydration and to seek medical advice for persistent and severe GI events.
• Patients should be instructed to seek medical advice during periods of stress as medical management of diabetes may change.
• Patients should understand that serious hypersensitivity reactions may occur and if they occur, they should seek immediate medical assistance.

Frequently asked questions

• Does Trulicity cause weight loss?
• Does Trulicity need to be refrigerated?
• How do you use/inject Trulicity?
• Can Trulicity be injected cold?
• Can Trulicity be used with insulin?
• How does Trulicity work?
• Is Trulicity a form of insulin?
• Does dulaglutide cause weight loss?
• What is dulaglutide used for and how does it work?