Trulicity

— THERAPEUTIC DISORDERS TREATED —
  • CHF and arrhythmias
  • Diabetes

Trulicity Generic Name & Formulations

General Description

Dulaglutide 0.75mg/0.5mL, 1.5mg/0.5mL, 3mg/0.5mL, 4.5mg/0.5mL; per pen; soln for SC inj.

Pharmacological Class

Glucagon-like peptide-1 (GLP-1) receptor agonist.

How Supplied

Single-dose pen—4

Manufacturer

Generic Availability

NO

Mechanism of Action

Dulaglutide activates the GLP-1 receptor, thereby increasing intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Additionally, it also decreases glucagon secretion and slows gastric emptying.

Trulicity Indications

Indications

To reduce the risk of major cardiovascular (CV) events (eg, CV death, non-fatal MI or non-fatal stroke) in adults with type 2 diabetes mellitus (T2DM) who have established CV disease or multiple CV risk factors. 

Trulicity Dosage and Administration

Adult

Give by SC inj in the abdomen, thigh, or upper arm any time of the day, with or without food. Initially 0.75mg once weekly; increase to 1.5mg once weekly if inadequate response. If additional glycemic control is needed, increase in 1.5mg increments after ≥4 weeks on the current dose; max 4.5mg once weekly.

Children

Not established.

Trulicity Contraindications

Contraindications

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

Trulicity Boxed Warnings

Boxed Warning

Risk of thyroid C-cell tumors.

Trulicity Warnings/Precautions

Warnings/Precautions

Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of diabetic retinopathy; monitor for progression. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Monitor renal function when initiating or escalating dose, and in renally-impaired patients reporting severe GI reactions. ESRD. Hepatic impairment. Pregnancy. Nursing mothers.

Trulicity Pharmacokinetics

Metabolism

Protein catabolism pathways.

Elimination

Half-life: ~5 days.

Trulicity Interactions

Interactions

Concomitant insulin: administer as separate injections not adjacent to each other. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need lower dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); monitor drugs with narrow therapeutic index.

Trulicity Adverse Reactions

Adverse Reactions

Nausea, diarrhea, vomiting, abdominal pain, decreased appetite; pancreatitis, hypersensitivity reactions (discontinue if occur), acute kidney injury.

Trulicity Clinical Trials

See Literature

Trulicity Note

Not Applicable

Trulicity Patient Counseling

See Literature

Trulicity Generic Name & Formulations

General Description

Dulaglutide 0.75mg/0.5mL, 1.5mg/0.5mL, 3mg/0.5mL, 4.5mg/0.5mL; per pen; soln for SC inj.

Pharmacological Class

Glucagon-like peptide-1 (GLP-1) receptor agonist.

How Supplied

Single-dose pen—4

Manufacturer

Generic Availability

NO

Mechanism of Action

Dulaglutide activates the GLP-1 receptor, thereby increasing intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Additionally, it also decreases glucagon secretion and slows gastric emptying.

Trulicity Indications

Indications

As adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus (T2DM). 

Limitations of Use

Not studied in patients with history of pancreatitis. Not for treating type 1 diabetes mellitus. Not recommended in patients with severe GI disease (including severe gastroparesis).

Trulicity Dosage and Administration

Adult

Give by SC inj in the abdomen, thigh, or upper arm any time of the day, with or without food. ≥18yrs: initially 0.75mg once weekly; increase to 1.5mg once weekly if inadequate response. If additional glycemic control is needed, increase in 1.5mg increments after ≥4 weeks on the current dose; max 4.5mg once weekly.

Children

<10yrs: not established. Give by SC inj in the abdomen, thigh, or upper arm any time of the day, with or without food. ≥10yrs: initially 0.75mg once weekly. If additional glycemic control is needed, may increase to max 1.5mg once weekly after ≥4 weeks on the 0.75mg dose.

Trulicity Contraindications

Contraindications

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

Trulicity Boxed Warnings

Boxed Warning

Risk of thyroid C-cell tumors.

Trulicity Warnings/Precautions

Warnings/Precautions

Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of diabetic retinopathy; monitor for progression. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Monitor renal function when initiating or escalating dose, and in renally-impaired patients reporting severe GI reactions. ESRD. Hepatic impairment. Pregnancy. Nursing mothers.

Trulicity Pharmacokinetics

Metabolism

Protein catabolism pathways.

Elimination

Half-life: ~5 days.

Trulicity Interactions

Interactions

Concomitant insulin: administer as separate injections not adjacent to each other. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need lower dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); monitor drugs with narrow therapeutic index.

Trulicity Adverse Reactions

Adverse Reactions

Nausea, diarrhea, vomiting, abdominal pain, decreased appetite; pancreatitis, hypersensitivity reactions (discontinue if occur), acute kidney injury.

Trulicity Clinical Trials

See Literature

Trulicity Note

Not Applicable

Trulicity Patient Counseling

See Literature