Trulicity (dulaglutide) PFP

Trulicity is a clear, colorless, sterile solution. Each 0.5 mL of Trulicity solution contains 0.75 mg or 1.5 mg of dulaglutide. Each single-dose pen or prefilled syringe contains 0.5 mL of solution and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg), trisodium citrate dihydrate (1.37 mg), in water for injection.

Indications

Trulicity® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations Of Use

• Trulicity is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk.
• Trulicity has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• Trulicity should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Trulicity is not a substitute for insulin.
• Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of Trulicity is not recommended in patients with pre-existing severe gastrointestinal disease.

Dosage and administration

Dosage

The recommended initiating dose of Trulicity is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly. Administer Trulicity once weekly, any time of day, with or without food. Trulicity should be injected subcutaneously in the abdomen, thigh, or upper arm.

If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.

Concomitant Use With An Insulin Secretagogue (e.g., Sulfonylurea) Or With Insulin

• When initiating Trulicity, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Dosage In Patients With Renal Impairment

• No dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Important Administration Instructions

• Prior to initiation of Trulicity, patients should be trained by their healthcare professional on proper injection technique. Training reduces the risk of administration errors such as improper injection site, needle sticks, and incomplete dosing. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.trulicity.com.
• When using Trulicity with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject Trulicity and insulin in the same body region but the injections should not be adjacent to each other.
• When injecting in the same body region, advise patients to use a different injection site each week. Trulicity must not be administered intravenously or intramuscularly. Trulicity solution should be visually inspected for particulate matter and discoloration prior to administration.

How its supplied

Dosage Forms And Strengths

• Injection: 0.75 mg/0.5 mL solution in a single-dose pen
• Injection: 1.5 mg/0.5 mL solution in a single-dose pen
• Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe
• Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe

Each TRULICITY single-dose pen or prefilled syringe is packaged in a cardboard outer carton.

Carton Of 4 Single-Dose Pens

• 0.75 mg/0.5 mL solution in a single-dose pen 
• 1.5 mg/0.5 mL solution in a single-dose pen 

Carton Of 4 Prefilled Syringes

• 0.75 mg/0.5 mL solution in a single-dose prefilled syringe 
• 1.5 mg/0.5 mL solution in a single-dose prefilled syringe 

Storage And Handling

• Store Trulicity in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not use Trulicity beyond the expiration date.
• 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.
• Do not freeze Trulicity. Do not use TRULICITY if it has been frozen.
• Trulicity must be protected from light. Storage of Trulicity in the original carton is recommended until time of administration.
• Discard the Trulicity single-dose pen or prefilled syringe after use in a puncture-resistant container.

Side effects

The following serious reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumors 
• Pancreatitis 
• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
• Hypersensitivity reactions
• Renal impairment
• Severe Gastrointestinal Disease

Contraindications

Medullary Thyroid Carcinoma

• Trulicity is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2.

Hypersensitivity

Trulicity is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Trulicity.

Mechanism Of Action

Trulicity contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.

Pharmacodynamics

Trulicity lowers fasting glucose and reduces postprandial glucose (PPG) concentrations in patients with type 2 diabetes mellitus. The reduction in fasting and postprandial glucose can be observed after a single dose.

References

https://diatribe.org/lilly-launches-trulicity-us-first-ever-ready-use-once-weekly-glp-1-receptor-agonist

https://www.trulicity.com

https://www.trulicity.com/about-trulicity/

http://www.diabetes.co.uk/diabetes-medication/trulicity.html

https://www.drugs.com/trulicity.html

http://www.rxlist.com/trulicity-drug.htm

http://reference.medscape.com/drug/trulicity-dulaglutide-999965