Trulicity

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

Trulicity is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with a diet and exercise program.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Trulicity is part of the drug class:

• Other blood glucose lowering drugs, excl. insulins

Take Trulicity exactly as prescribed.

Trulicity comes as an injectable form to be given just under the skin, once a week. Trulicity can be administered at any time of day, with or without food.

Trulicity should be injected subcutaneously in the abdomen, thigh, or upper arm.

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

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.

Administration Techniques:

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.

When using Trulicity with insulin, patients should administer as separate injections and 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, patients should use a different injection site each week.
Do not administer Trulicity intravenously (vein) or intramuscularly (muscle). 

Always inspect Trulicity solution for particulate matter and discoloration prior to administration.

General Information:

Follow your healthcare provider's instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with Trulicity, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.

Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.

If you take too much Trulicity, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Storage

Parenteral

2–8°C in original carton; do not freeze.1

After dispensing, may be stored at room temperature up to 30°C for up to 14 days.1

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dulaglutide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dulaglutide injection in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetohexamide
• Chlorpropamide
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Lanreotide
• Octreotide
• Pasireotide
• Thioctic Acid
• Tolazamide
• Tolbutamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Esmolol
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic ketoacidosis (ketones in the blood) or
• Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.

• Gastroparesis (stomach does not empty food normally), severe or
• Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
• Medullary thyroid carcinoma (a type of thyroid cancer), personal or family history of or
• Stomach or bowel disease, severe—Should not be used in patients with these conditions.

• Kidney disease or
• Thyroid tumor—Use with caution. May make these conditions worse.

• Pancreatitis (inflammation of the pancreas), history of—It is not known if this medicine will be safe in patients with this condition.

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

1.1 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 [see Warnings and Precautions (5.1)].
• Trulicity has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. 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 [see Warnings and Precautions (5.6)].

Oral Medications

Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered 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 [see Clinical Pharmacology (12.3)].

Pregnancy

Risk Summary

Limited data with Trulicity 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 [see Clinical Considerations]. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 14-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 13-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see Data].

The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7 and has been reported to be as high as 20–25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

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

Data

Animal Data

Pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 4-, 14-, and 44-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week, respectively, based on plasma area under the time-concentration curve (AUC) comparison. Reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. Irregular skeletal ossifications and increases in post implantation loss also were observed at 4.89 mg/kg.

In pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 1-, 4-, and 13-times human exposure at the MRHD, based on plasma AUC comparison. Fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg.

In a prenatal-postnatal study in F0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 2-, 4-, and 16-times human exposure at the MRHD, based on plasma AUC comparison. F1 pups from F0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through post-natal day 63 for males and postnatal day 84 for females. F1 offspring from F0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. Females had decreased startle response. These physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. F1 female offspring of the F0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the Biel water maze. These findings occurred in conjunction with decreased F0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. The human relevance of these memory deficits in the F1 female rats is not known.

Lactation

Risk Summary

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 presence of dulaglutide in milk of treated lactating animals was not determined. 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 in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years.

Geriatric Use

In the pool of placebo- and active-controlled trials [see Adverse Reactions (6.1)], 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) patients were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment

There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations.

In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].

Renal Impairment

In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicity-treated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2). No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed [see Clinical Pharmacology (12.3)].

There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored [see Dosage and Administration (2.3), Warning and Precautions (5.5), Clinical Pharmacology (12.3)].

Gastroparesis

Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with preexisting gastroparesis.

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.

Fasting and Postprandial Glucose

In a clinical pharmacology study in adults with type 2 diabetes mellitus, treatment with once weekly Trulicity resulted in a reduction of fasting and 2-hour PPG concentrations, and postprandial serum glucose incremental AUC, when compared to placebo (-25.6 mg/dL,-59.5 mg/dL, and -197 mg h/dL, respectively); these effects were sustained after 6 weeks of dosing with the 1.5 mg dose.

First- and Second-Phase Insulin Secretion 

Both first-and second-phase insulin secretion were increased in patients with type 2 diabetes treated with Trulicity compared with placebo.

Insulin and Glucagon Secretion

Trulicity stimulates glucose-dependent insulin secretion and reduces glucagon secretion. Treatment with Trulicity 0.75 mg and 1.5 mg once weekly increased fasting insulin from baseline at Week 26 by 35.38 and 17.50 pmol/L, respectively, and C-peptide concentration by 0.09 and 0.07 nmol/L, respectively, in a Phase 3 monotherapy study. In the same study, fasting glucagon concentration was reduced by 1.71 and 2.05 pmol/L from baseline with Trulicity 0.75 mg and 1.5 mg, respectively.

Gastric Motility

Dulaglutide causes a delay of gastric emptying. The delay is largest after the first dose and diminishes with subsequent doses.

Cardiac Electrophysiology (QTc)

The effect of dulaglutide on cardiac repolarization was tested in a thorough QTc study. Dulaglutide did not produce QTc prolongation at supratherapeutic doses of 4 and 7 mg.

Pharmacokinetics

The pharmacokinetics of dulaglutide is similar between healthy subjects and patients with type 2 diabetes mellitus. Following subcutaneous administration, the time to maximum plasma concentration of dulaglutide at steady-state ranges from 24 to 72 hours, with a median of 48 hours. After multiple-dose administration of 1.5 mg to steady state, the mean peak plasma concentration (Cmax) and total systemic exposure (AUC) of dulaglutide were 114 ng/mL (range 56 to 231 ng/mL) and 14,000 ng*h/mL (range 6940 to 26,000 ng*h/mL), respectively; accumulation ratio was approximately 1.56. Steady-state plasma dulaglutide concentrations were achieved between 2 and 4 weeks following once weekly administration. Site of subcutaneous administration (abdomen, upper arm, and thigh) had no statistically significant effect on the exposure to dulaglutide.

Absorption – The mean absolute bioavailability of dulaglutide following subcutaneous administration of single 0.75 mg and 1.5 mg doses was 65% and 47%, respectively.

Distribution – The mean volumes of distribution after subcutaneous administration of Trulicity 0.75 mg and 1.5 mg to steady state were approximately 19.2 L (range 14.3 to 26.4 L) and 17.4 L (range 9.3 to 33 L), respectively.

Metabolism – Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.

Elimination – The mean apparent clearance at steady state of dulaglutide is approximately 0.111 L/h for the 0.75 mg dose, and 0.107 L/h for the 1.5 mg dose. The elimination half-life of dulaglutide for both doses is approximately 5 days.

Specific Populations

No dose adjustment of dulaglutide is needed based on age, gender, race, ethnicity, body weight, or renal or hepatic impairment. The effects of intrinsic factors on the PK of dulaglutide are shown in Figure 1.

Figure 1: Impact of intrinsic factors on dulaglutide pharmacokinetics.

Renal – Dulaglutide systemic exposure was increased by 20, 28, 14 and 12% for mild, moderate, severe, and ESRD renal impairment sub-groups, respectively, compared to subjects with normal renal function. The corresponding values for increase in Cmax were 13, 23, 20 and 11%, respectively (Figure 1). [see Dosage and Administration (2.3), Warning and Precautions (5.5), Use in Specific Population (8.7)].

Hepatic - Dulaglutide systemic exposure decreased by 23, 33 and 21% for mild, moderate and severe hepatic impairment groups, respectively, compared to subjects with normal hepatic function, and Cmax was decreased by a similar magnitude (Figure 1). [see Use in Specific Population (8.6)].

Drug Interactions

The potential effect of co-administered medications on the PK of dulaglutide and vice-versa was studied in several single- and multiple-dose studies in healthy subjects, patients with type 2 diabetes mellitus, and patients with hypertension.

Potential for Dulaglutide to Influence the Pharmacokinetics of Other Drugs

Dulaglutide slows gastric emptying and, as a result, may reduce the extent and rate of absorption of orally co-administered medications. In clinical pharmacology studies, dulaglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree.

Pharmacokinetic (PK) measures indicating the magnitude of these interactions are presented in Figure 2. No dose adjustment is recommended for any of the evaluated co-administered medications.

Figure 2: Impact of dulaglutide on the pharmacokinetics of co-administered medications.

Potential for Co-administered Drugs to Influence the Pharmacokinetics of Dulaglutide

In a clinical pharmacology study, the coadministration of a single dose of dulaglutide (1.5 mg) with steady-state sitagliptin (100 mg) caused an increase in dulaglutide AUC and Cmax of approximately 38% and 27%, which is not considered clinically relevant.

Trulicity (dulaglutide) is an injectable diabetes medicine that helps control blood sugar levels.

Trulicity is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Dulaglutide is usually given after other diabetes medicines have been tried without success.

Trulicity is not for treating type 1 diabetes.

You should not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer). Do not use Trulicity if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

In animal studies, Trulicity caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

Usual Adult Dose of Trulicity for Diabetes Type 2:

Initial dose: 0.75 mg subcutaneously once a week
Maximum dose: May increase to 1.5 mg subcutaneously once a week for additional glycemic control

Comments:
- If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Applies to dulaglutide: subcutaneous solution

General

The most common adverse reactions included nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 21.1%), diarrhea (up to 13.7%), vomiting (up to 11.5%)
Common (1% to 10%): Abdominal pain, dyspepsia, constipation, flatulence, abdominal distention, gastroesophageal reflux disease, eructation, lipase and/or pancreatic amylase increases from baseline (up to 20%)
Frequency not reported: Pancreatitis[Ref]

During clinical trials, a greater number of pancreatitis related adverse reactions were reported in patients exposed to this drug versus non-incretin comparators (12 cases vs 3 cases). Analyses of adjudicated events revealed 5 cases of confirmed pancreatitis in dulaglutide-exposed patients compared with 1 case in the non-incretin comparator group.

Gastrointestinal events occurred more frequently with the higher dose. Cases were graded as mild, moderate, or severe in 58% and 48%, 35% and 43%, and 7% and 11%, of patients receiving the 0.75 mg dose and the 1.5 mg dose, respectively. The severity of events was graded by clinical trial investigators.[Ref]

Oncologic

One case of Medullary Thyroid Carcinoma (MTC) has been reported in a patient treated with this drug. Prior to receiving treatment, this patient had calcitonin levels approximately 8 times the upper limit of normal.[Ref]

Very rare (less than 0.01%): Medullary Thyroid Carcinoma[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (up to 85% when combined with prandial insulin)
Common (1% to 10%): Decreased appetite[Ref]

Hypoglycemia occurred more frequently when this drug was used in combination with a sulfonylurea or insulin. In combination with prandial insulin, hypoglycemia occurred in 85% and 80% of patients receiving 0.75 mg and 1.5 mg; severe hypoglycemia in 2.4% and 3.4% of patients, respectively. In combination with a sulfonylurea, symptomatic hypoglycemia occurred in 39% and 40%. As add-on therapy to metformin or metformin plus pioglitazone, symptomatic hypoglycemia occurred in up to 5.6% of patients, with no reports of severe hypoglycemia.[Ref]

Cardiovascular

During clinical trials, a mean increase in heart rate of 2 to 4 beats per minute was observed. Sinus tachycardia was reported in 2.8% and 5.6% of patients receiving 0.75 mg and 1.5 mg of dulaglutide (the active ingredient contained in Trulicity) compared with 3% in placebo. Persistent sinus tachycardia defined as occurring at more than 2 visits was reported in 0.4%, 1.6%, and 0.2% of patients receiving dulaglutide 0.75 mg, 1.5 mg, or placebo. Episodes of sinus tachycardia associated with an increase of 15 or more beats per minute from baseline occurred in 1.3%, 2.2%, and 0.7% of patients, respectively.[Ref]

Common (1% to 10%): First degree AV block, sinus tachycardia, PR prolongation on ECG
Frequency not reported: Increased heart rate[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Systemic hypersensitivity including severe urticaria, systemic rash, facial edema, lip swelling[Ref]

Immunologic

In clinical studies 1.6% (n=64) of patients developed anti-drug antibodies (ADAs). Half of the patients had dulaglutide-neutralizing antibodies and half developed antibodies against native GLP-1.[Ref]

Common (1% to 10%): Anti-drug antibodies[Ref]

Local

Common (1% to 10%): Injection site reactions[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Some side effects of Trulicity may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.