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Trulicity (dulaglutide) injection logo
  • Prescribing Information
  • Instructions for Use
  • Medication Guide
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Trulicity (dulaglutide) injection logo
  • Prescribing Information
  • Instructions for Use
  • Medication Guide

    Educational videos

    A few short, informational videos about Trulicity

    Pen demonstration video thumbnail

    How to Use the Pen

    Learn the key administration steps for delivering a dose of Trulicity.

    Watch how to use Trulicity Pen

    mechanism of action video thumbnail

    Mechanism of Action

    See how Trulicity was designed with patients in mind.

    Watch Mechanism of Action video

    Nursing home video thumbnail

    Trulicity in the Nursing Home Setting

    See how Trulicity impacted protocols at Four Seasons Nursing Home.

    Watch Trulicity in the Nursing Home Setting video

    Real patient video thumbnail

    Real patients- Real Experiences

    Follow along as Linda and Clayton explain how Trulicity helps them face some of the daily challenges of living with type 2 diabetes.

    Watch Real patients video

    Balancing Blood Glucose in Long-term Care video

    Balancing Blood Glucose in Long-term Care

    See how glucose-dependent Trulicity is an option for long-term care residents.

    Watch Balancing Blood Glucose in Long-term Care video

    Questions healthcare professionals often ask about Trulicity

    Trulicity patient holding Trulicity Pen

    Trulicity offers 4 efficacious* doses.1

    Dosing: Initiate at 0.75 mg subcutaneously once weekly. For additional glycemic control, dose can be increased to 1.5 mg once weekly. Then the 1.5 mg dose may be increased after ≥4 weeks to 3.0 mg once weekly. The 3.0 mg dose may be increased after ≥4 weeks to the maximum dose of 4.5 mg once weekly. *Trulicity 3.0 mg was not statistically significant vs Trulicity 1.5 mg on A1C change from baseline at 36 weeks.

    Trulicity Rx pads

    The amount to be dispensed may be written as “1 box” or “4 pens.”

    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.1

    Yes. In pooled study results, there were no overall differences in safety or efficacy between older and younger patients but greater sensitivity in some older individuals cannot be ruled out.1

    • 620 (18.6%) Trulicity-treated patients were 65 years of age or over
    • 65 (1.9%) Trulicity-treated patients were 75 years of age or over

    Basal insulin can be titrated as needed and combined with either dose of once-weekly Trulicity.1

    Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control

    Select Important Safety Information:
    Patients receiving Trulicity in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

    • Store the Trulicity Pen in the refrigerator between 36°F to 46°F (2°C to 8°C)2
    • The Trulicity Pen may be stored at room temperature below 86°F (30°C) for a total of 14 days2
    • Do not freeze the Trulicity Pen. If the pen has been frozen, throw the pen away and use a new pen2
    • Storage of the Trulicity Pen in the original carton is recommended. Protect the pen from direct heat and light2
    • The pen has glass parts. Handle it carefully. If the pen is dropped on a hard surface, do not use it. Use a new pen for the injection2
    • Keep the Trulicity Pen and all medicines out of the reach of children2

    The Trulicity molecule was designed with patients in mind

    • Prolong incretin activity to enable once‑weekly administration
      • Amino acid substitution on human GLP-1 protects against DPP 4 degradation3-6
      • Increasing the size of the molecule decreases renal clearance and extends the time-action profile4
    • Eliminate the need for reconstitution
      • Another amino acid substitution on human GLP-1 and fusion to the modified Fc portion of IgG4 improves solubility3-6

    Image description:
    GLP-1 analog
    Linker
    Modified lgG4Fc domain
    Fc - Fragment crystallization

    Trulicity mechanism of action

    Trulicity is not indicated for weight loss and in clinical studies, weight change was a secondary endpoint. On average, patients experienced weight loss. However, some patients did not lose weight.

    View Weight Loss in Clinical Trials

    Once-weekly Trulicity has a plasma half-life of approximately 5 days.1

    References

    1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
    2. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC.
    3. Glaesner W, Vick AM, Millican R, et al. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev. 2010;26(4):287-296.
    4. Umpierrez GE, Blevins T, Rosenstock J, et al. The effects of LY2189265, a long-acting glucagon-like peptide-1 analogue, in a randomized, placebo-controlled, double-blind study of overweight/obese patients with type 2 diabetes: the EGO study. Diabetes Obes Metab. 2011;13(5):418-425.
    5. Pabreja K, Mohd MA, Koole C, et al. Molecular mechanisms underlying physiological and receptor pleiotropic effects mediated by GLP-1R activation. Br J Pharmacol. 2014;171(5):1114-1128.
    6. Data on file. Eli Lilly and Company; 2014, TRU20151210A.
    7. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357.

    IMPORTANT SAFETY INFORMATION

    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 Trulicity 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.

    Trulicity 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 Trulicity 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 is of uncertain value for early detection of MTC in patients treated with Trulicity.

    Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a serious hypersensitivity reaction to dulaglutide or any of the product components.

    Risk of Thyroid C-cell Tumors: One case of MTC was reported in a patient treated with Trulicity in a clinical study. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). An additional case of C-cell hyperplasia with elevated calcitonin levels following treatment was reported in the cardiovascular outcomes trial (REWIND). If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

    Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

    Hypoglycemia: Patients receiving Trulicity in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

    Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions and angioedema) in patients treated with Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist as it is unknown whether they will be predisposed to anaphylaxis with Trulicity.

    Acute Kidney Injury: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.

    Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

    Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.

    Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In a cardiovascular outcomes trial with a median follow up of 5.4 years, cholelithiasis occurred at a rate of 0.62/100 patient-years in Trulicity-treated patients and 0.56/100 patient-years in placebo-treated patients after adjusting for prior cholecystectomy. Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on Trulicity and placebo respectively. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

    The most common adverse reactions reported in ≥5% of Trulicity-treated patients in trials were nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia, and fatigue.

    Gastric emptying: Trulicity slows gastric emptying, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

    Pregnancy: Limited data with Trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide. Use only if potential benefit justifies the potential risk to the fetus.

    Lactation: There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition.

    Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

    Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, and Medication Guide.

    Please see Instructions for Use included with the pen.

    DG HCP ISI 10JUN2022

    INDICATIONS

    Trulicity (dulaglutide) is indicated

    • 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, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

    LIMITATIONS OF USE:

    • Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients.
    • Not for the treatment of type 1 diabetes mellitus.
    • Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients.
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