HIGHLIGHTS OF PRESCRIBING INFORMATION ...

1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to use TRULICITY safely and effectively. See full PRESCRIBING INFORMATION for (dulaglutide) injection, forsubcutaneous useInitial Approval: 2014 WARNING: RISK OF THYROID C-CELL TUMORSSee full PRESCRIBING INFORMATION for complete boxed warning. Dulaglutidecauses thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humansas the human relevance of dulaglutide-induced rodent thyroid C-cell tumorshas not been determined( , ). TRULICITYis contraindicated in patients with a personal or family history of MTC and in patients withMultipleEndocrine Neoplasia syndrome type 2 (MEN 2).

2 Counselpatients regarding thepotentialrisk of MTC and symptoms of thyroid tumors(4, ).---------------------------RECENT MAJOR CHANGES--------------------------Indicat ions and Usage (1)2/2020 Warnings and Precautions, Diabetic Retinopathy ( )2/2020 Dosage and Administration ( )9/2020----------------------------INDIC ATIONS AND USAGE---------------------------TRULICIT Y is a glucagon-like peptide-1 (GLP-1) receptor agonist 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 in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk Use: Has not been studied in patients with a history of pancreatitis.

3 Consider other antidiabetic therapies in these patients(1, ). Not for treatment of type 1 diabetes mellitus (1). Not recommended inpatients with severe gastrointestinal disease, including severe gastroparesis(1, ).------------------------DOSAGE AND ADMINISTRATION----------------------- Initiate at subcutaneouslyonce the doseto mg once weekly for additional glycemic control. If additionalglycemic controlis needed, increase thedose to 3 mg once weekly after at least 4 weeks on the dose( ). If additionalglycemic controlis needed,increase to the maximum dose of once weekly after at least4 weeks on the 3mg dose.( ). If a dose is missed, administer the missed dose as soon as possibleif there are at least 3 days (72 hours) until the next scheduleddose ( ).

4 Administer once weekly at any time of daywith or without food( ). Inject subcutaneously in the abdomen, thigh, or upper arm ( ).----------------------DOSAGE FORMS AND STRENGTHS--------------------- Injection: solution in a single-dose pen(3) Injection: solutionin a single-dose pen (3) Injection: 3 solutionin a single-dose pen(3) Injection: solutionin a single-dose pen(3)-------------------------------CON TRAINDICATIONS-------------------------- ---- Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4, ). Patients with a priorserioushypersensitivityreactionto TRULICITYor any of the product components (4, ).

5 ------------------------WARNINGS AND PRECAUTIONS----------------------- Thyroid C-cell Tumors: See Boxed Warning( ). Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed( ). Hypoglycemia: When TRULICITYis used with an insulin secretagogue or insulin, consider lowering the dose of the sulfonylureaor insulin to reducethe risk of hypoglycemia ( ). Hypersensitivity Reactions: Serious hypersensitivity reactions ( , anaphylactic reactions and angioedema)have occurred. Discontinue TRULICITY and promptly seek medical advice( ). Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions( ).

6 Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied inpatients with severe gastrointestinal disease and is not recommended in these patients ( ). Diabetic Retinopathy Complications:Have been reported in a cardiovascularoutcomes trial. Monitor patients with a history of diabetic retinopathy( ).-------------------------------ADVERSE REACTIONS------------------------------T he most common adverse reactions, reported in 5% of patients treated with TRULICITYare: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite ( ).To report SUSPECTED ADVERSE REACTIONS, contact EliLilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or INTERACTIONS---------------------------- --TRULICITY delaysgastric emptying and has the potential to reduce the rateof absorption of concomitantly administered oral medications( , ).

7 -----------------------USE IN SPECIFIC POPULATIONS---------------------- Pregnancy:TRULICITY should beused during pregnancyonly if the potential benefit justifies the potential risk to fetus ( ).See 17 for PATIENT COUNSELING INFORMATION and FDA-approved Medication : 09/2020 FULL PRESCRIBING INFORMATION : CONTENTS*WARNING: RISK OF THYROID C-CELL TUMORS1 INDICATIONS AND USAGE2 DOSAGE AND Administration Instructions3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND of Thyroid C-cell with Concomitant Use of Insulin Secretagogues or Kidney Gastrointestinal Retinopathy Complications in Patients with a History of Diabetic Retinopathy6 ADVERSE Postmarketing Experience7 DRUG Oral Use with an Insulin Secretagogue ( , Sulfonylurea)

8 Or with Insulin8 USE IN SPECIFIC OVERDOSAGE11 DESCRIPTION12 CLINICAL Mechanism of NONCLINICAL , Mutagenesis, and Impairment of Toxicology and/or Pharmacology14 CLINICAL Control Trials in Adults with Type 2 Diabetes Outcomes Trial in Adults with Type 2 Diabetes Mellitus and Cardiovascular Disease or Multiple Cardiovascular Risk Factors16 HOW SUPPLIED/STORAGE AND Handling17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full PRESCRIBING INFORMATION are not PRESCRIBING INFORMATIONWARNING:RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutidecauses a dose-relatedand treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetimeexposure.

9 It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humansas human relevance of dulaglutide-induced rodent thyroid C-cell tumorshas notbeen determined [see Warnings and Precautions ( ), and Nonclinical Toxicology ( )]. TRULICITYis contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counselpatients regarding the potentialrisk of MTC with use of TRULICITY and inform them ofsymptoms of thyroid tumors ( , mass in the neck, dysphagia, dyspnea, persistenthoarseness).Routine monitoring ofserum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTCin patients treated with TRULICITY[see Contraindications (4)and Warnings and Precautions ( )].

10 1 INDICATIONS AND USAGETRULICITY 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, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk of Use TRULICITYhas not been studied in patients with a history of pancreatitis[see Warnings and Precautions ( )].Consider other antidiabetic therapiesin patients with a history of pancreatitis. TRULICITY should not be used in patients with type 1 diabetes mellitus. TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesisand is therefore not recommended in these patients[see Warnings and Precautions ( )].