dulaglutide (Rx)

Brand and Other Names:Trulicity
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC solution

  • Available in single-dose pen
  • 0.75mg/0.5mL
  • 1.5mg/0.5mL
  • 3mg/0.5mL
  • 4.5mg/0.5mL

Diabetes Mellitus Type 2

Indicated as once-weekly SC injection adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM)

It is also indicated to reduce risk of major adverse cardiovascular (CV) events (CV death, nonfatal MI, or nonfatal stroke) in adults with T2DM who have established CV disease or multiple CV risk factors

Initial: 0.75 mg SC once weekly

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

If additional glycemic control needed, increase to 3 mg once weekly after at least 4 weeks on the 1.5-mg dose

If additional glycemic control needed, increase to maximum dose of 4.5 mg once weekly after at least 4 weeks on the 3-mg dose

Dosage Modifications

Renal impairment (any severity): No dosage adjustment required

Hepatic impairment (any severity): No dosage adjustment required; owing to limited data, caution advised

Dosing Considerations

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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    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 (7-12.6%)

            1-10%

            Abdominal pain (6.5-9.4%)

            Vomiting (5.6-9.3%)

            Decreased appetite (4.9-8.6%)

            Fatigue (4.2-5.6%)

            Dyspepsia (2.3-5.8%)

            Constipation (3.7-3.9%)

            Severe hypoglycemia with prandial insulin (2.7-3.4%)

            Flatulence (1.4-3.4%)

            Sinus tachycardia (2.8-3%)

            Abdominal distension (2.3-2.9%)

            Gastroesophageal reflux disease (1.7-2%)

            AV block (0.9-1.7%)

            Eructation (0.6-1.6%)

            <1%

            Hypersensitivity, sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling)

            Injection-site reactions

            Pancreatitis

            Cholelithaisis and cholecystitis

            Postmarketing Reports

            Anaphylactic reactions, angioedema

            Acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis

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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)

            Cautions

            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

            Diabetic retinopathy complications

            • The REWIND CV outcomes trial (n = 9901; median follow up 5.4 yr) was conducted in patients with T2DM with established CV disease or multiple CV risk factors
            • Secondary composite endpoints showed diabetic retinopathy complications occurred in 1.9% of patients treated with dulaglutide compared with 1.5% treated with placebo
            • Diabetic retinopathy complications were higher among patients with history of diabetic retinopathy at baseline (dulaglutide 8.5%, placebo 6.2%) compared with those without baseline history (dulaglutide 1%, placebo 1%)
            • Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy
            • Monitor for diabetic retinopathy progression in patients who have a history of diabetic retinopathy

            Medullary thyroid carcinoma (MTC)

            • 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; evaluate patient further if serum calcitonin elevated
            • Evaluate patients with thyroid nodules noted on physical examination or neck imaging

            Pancreatitis

            • Acute pancreatitis reported (rare); after initiation of therapy
            • Observe 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
            • Therapy has not been evaluated in patients with a prior history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis

            Drug interaction overview

            • Insulin secretagogues (eg, sulfonylureas) or insulin
              • When initiating dulaglutide, consider reducing dosage of concomitantly administered insulin or insulin secretagogues to reduce risk of hypoglycemia
            • Oral medications
              • Dulaglutide delays gastric emptying and, thus has potential to reduce rate of absorption of concomitantly administered oral medications
              • Delay in gastric emptying is dose-dependent, but is attenuated with the recommended dose escalation to higher dulaglutide
              • Delay is largest after the first dose and diminishes with subsequent doses
              • In clinical pharmacology studies, dulaglutide 1.5 mg did not affect the absorption of the tested orally administered medications to a clinically relevant degree
              • Limited experience with use of concomitant medications in clinical trials with 3-mg and 4.5-mg doses
              • Monitor drug levels of oral medications with a narrow therapeutic index (eg, warfarin) when concomitantly administered
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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

            Clinical considerations

            • Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
            • Poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity

            Lactation

            There are no data on presence of dulaglutide in human milk, the effects on breastfed infant, or effects on milk production

            Consider developmental and health benefits of breastfeeding 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

            Peak plasma concentration: 114 ng/mL

            AUC: 14,000 ng•h/mL

            Absolute bioavailability

            • 65% (0.75 mg/dose)
            • 47% (1.5 mg/dose)
            • Absolute SC bioavailability for 3 mg and 4.5 mg doses estimated to be similar to 1.5 mg, although not been specifically studied
            • Concentrations increased approximately proportional to dose from 0.75-4.5 mg

            Distribution

            Vd: 3.09 L (central); 5.98 L (peripheral)

            Metabolism

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

            Elimination

            Half-life: ~5 days

            Clearance: 0.142 L/hr

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            Administration

            SC Preparation

            Inspect visually before use; solution should appear clear and colorless; do not use if particulate matter or coloration observed

            SC Administration

            Administer once weekly at any time of day

            May take with or without food

            Inject SC in abdomen, thigh, or upper arm; rotate injection site with each dose

            If needed, can change day of weekly administration if last dose was administered ≥3 days before

            Coadministration with insulin

            • When using with insulin, administer as separate injections and never mix
            • May inject dulaglutide and insulin in same body region, but injections should not be adjacent to each other

            Missed dose

            • ≥3 days until next scheduled dose: Administer as soon as possible
            • <3 days until next scheduled dose: Skip missed dose; administer next dose on regularly scheduled day
            • In each case, patients can then resume their regular once weekly dosing schedule

            Storage

            Refrigerate at 36-46ºF (2-8ºC)

            May be kept at room temperature, not to exceed 86ºF (30ºC) for total of 14 days

            Do not freeze; do not use if it has been frozen

            Protect from light

            Storage in original carton recommended until time of administration

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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.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            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.