dulaglutide (Rx)

Brand and Other Names:Trulicity
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC solution

  • Available in single-dose prefilled syringe or pen
  • 0.75mg/0.5mL
  • 1.5mg/0.5mL

Diabetes Mellitus Type 2

Indicated as once-weekly SC injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Initial: 0.75 mg SC once weekly

May increase dose to 1.5 mg once weekly for additional glycemic control

Dosage Modifications

Renal impairment (any severity): No dosage adjustment required

Dosing Considerations

Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin: When initiating dulaglutide, consider reducing the dosage of concomitantly administered insulin or insulin secretagogues to reduce risk of hypoglycemia

Not recommended as first-line therapy for patients inadequately controlled on diet and exercise

Has not been studied with a history of pancreatitis; consider another antidiabetic therapy

Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis

Not for patients with preexisting severe GI disease

Safety and efficacy not established

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Interactions

Interaction Checker

and dulaglutide

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (12.4-21.1%)

            Increased amylase (20%)

            Increased lipase (14%)

            Diarrhea (8.9-12.6%)

            Vomiting (6-12.7%)

            1-10%

            Abdominal pain (6.5-9.4%)

            Decreased appetite (4.9-8.6%)

            Dyspepsia (4.1-5.8%)

            Fatigue (4.2-5.6%)

            Severe/symptomatic hypoglycemia

            • Add-on to metformin (2.6-5.6%); placebo 1.1%
            • Add-on to metformin and pioglitazone (4.5-5%); placebo 1.4%

            <1%

            Severe hypersensitivity (eg, severe urticaria, systemic rash, facial edema, lip swelling)

            Injection-site reactions

            Pancreatitis

            Postmarketing Reports

            Severe gastrointestinal disease

            Angioedema

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            Warnings

            Black Box Warnings

            Risk of thyroid C-cell tumors

            • Causes thyroid C-cell tumors in rodents; human risk could not be determined
            • Contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN-2)
            • Counsel patients regarding potential risk of MTC with therapy and inform them of symptoms of thyroid tumors (e.g., 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 receiving therapy

            Contraindications

            Hypersensitivity

            Personal or family history of medullary thyroid carcinoma (MTC)

            Multiple endocrine neoplasia type 2 (MEN-2)

            Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide

            Cautions

            Nonclinical studies in rodents showed increased incidence of thyroid C-cell tumors (see Black Box Warnings and Contraindications); routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide; significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; if serum calcitonin is measured and found to be elevated, evaluate patient further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated

            Acute pancreatitis reported (rare); after initiation of therapy, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting; discontinue if pancreatitis suspected and do not restart if confirmed

            Hypoglycemia may occur when used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; consider lowering sulfonylurea or insulin dosage when starting dulaglutide

            Systemic hypersensitivity reactions reported; anaphylaxis and angioedema reported with other GLP-1 receptor agonists; use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist; unknown whether such patients will be predisposed to anaphylaxis with drug; discontinue if such reactions occur

            Acute renal failure and worsening of chronic renal failure (some requiring hemodialysis) reported with treatment with glucagonlike peptide-1 (GLP-1) receptor agonists

            May be associated with GI adverse reactions, sometimes severe; counsel patients to take precautions to avoid fluid depletion; has not been studied in patients with severe GI disease, including severe gastroparesis

            Clinical trials have not established conclusive evidence of macrovascular risk reduction with GLP-1 agonists or any other antidiabetic drug

            Slows gastric emptying and may affect absorption of concomitantly administered PO drugs

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            Pregnancy & Lactation

            Pregnancy

            Limited data in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage

            There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (eg, diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, delivery complications)

            Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

            Animal studies

            • Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy
            • In pregnant rats and rabbits administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 13 to 14-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week

            Lactation

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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Incretin mimetic; analogue of human glucagonlike peptide-1 (GLP-1); acts as GLP-1 receptor agonist to increase insulin secretion in the presence of elevated blood glucose; delays gastric emptying to decrease postprandial glucose; also decreases glucagon secretion

            Absorption

            Absolute bioavailability: 65% (0.75 mg/dose); 47% (1.5 mg/dose)

            Peak plasma concentration: 114 ng/mL

            AUC: 14,000 ng•h/mL

            Distribution

            Vd: 19.2 L (0.75 mg/dose); 17.4 L (1.5 mg/dose)

            Metabolism

            Thought to be degraded into its component amino acids by general protein catabolism pathways

            Elimination

            Half-life: 5 days

            Clearance: ~0.1 L/hr

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            Administration

            SC Administration

            Administer once weekly at any time of day

            Inject SC in abdomen, thigh, or upper arm

            If a dose is missed, administer within 3 days of missed dose

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

            Missed 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
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.