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TRULICITY (Dulaglutide) Injection, for Subcutaneous Use Hypersensitivity Reaction to TRULICITY Or Any of the Product Initial U.S

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TRULICITY (Dulaglutide) Injection, for Subcutaneous Use Hypersensitivity Reaction to TRULICITY Or Any of the Product Initial U.S 1 HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------------- CONTRAINDICATIONS -----------------------------­ • TRULICITY is contraindicated in patients with a personal or family These highlights do not include all the information needed to use history of medullary thyroid carcinoma or in patients with Multiple TRULICITY safely and effectively. See full prescribing information Endocrine Neoplasia syndrome type 2 (4.1, 5.1, 13.1). for TRULICITY. • TRULICITY is contraindicated in patients with a prior serious TRULICITY (dulaglutide) injection, for subcutaneous use hypersensitivity reaction to TRULICITY or any of the product Initial U.S. Approval: 2014 components (4.2, 5.4). ------------------------ WARNINGS AND PRECAUTIONS ----------------------­ WARNING: RISK OF THYROID C-CELL TUMORS • Thyroid C-cell Tumors: See Boxed Warning (5.1). See full prescribing information for complete boxed warning. • Pancreatitis: Has been reported in clinical trials. Discontinue • Dulaglutide causes thyroid C-cell tumors in rats. It is unknown promptly if pancreatitis is suspected. Do not restart if pancreatitis is whether TRULICITY causes thyroid C-cell tumors, including confirmed. Consider other antidiabetic therapies in patients with medullary thyroid carcinoma (MTC), in humans as the human history of pancreatitis (5.2). relevance of dulaglutide-induced rodent thyroid C-cell tumors • Hypoglycemia: When TRULICITY is used with an insulin has not been determined (5.1, 13.1). secretagogue (e.g., a sulfonylurea) or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk of • TRULICITY is contraindicated in patients with a personal or hypoglycemia (5.3). family history of MTC and in patients with Multiple Endocrine • Hypersensitivity Reactions: Discontinue TRULICITY if suspected. Neoplasia syndrome type 2 (MEN 2). Counsel patients Monitor and treat promptly per standard of care until signs and regarding the potential risk of MTC and symptoms of thyroid symptoms resolve (5.4). tumors (4.1, 5.1). • Renal Impairment: Monitor renal function in patients with renal --------------------------- RECENT MAJOR CHANGES -------------------------­ impairment reporting severe adverse gastrointestinal reactions (5.5). • Severe Gastrointestinal Disease: Use may be associated with INDICATIONS AND USAGE gastrointestinal adverse reactions, sometimes severe. Has not been Limitations of Use (1.1) 01/2017 studied in patients with severe gastrointestinal disease and is not ---------------------------- INDICATIONS AND USAGE --------------------------­ recommended in these patients (5.6). ® • Macrovascular outcomes: There have been no studies establishing TRULICITY is a glucagon-like peptide 1 (GLP-1) receptor agonist conclusive evidence of macrovascular risk reduction with indicated as an adjunct to diet and exercise to improve glycemic TRULICITY (5.7). control in adults with type 2 diabetes mellitus. ------------------------------- ADVERSE REACTIONS -----------------------------­ Limitations of Use: • Not recommended as first-line therapy for patients inadequately The most common adverse reactions, reported in ≥5% of patients controlled on diet and exercise (1.1, 5.1). treated with TRULICITY are: nausea, diarrhea, vomiting, abdominal • Has not been studied in patients with a history of pancreatitis. pain, and decreased appetite (6.1). Consider another antidiabetic therapy (1, 5.2). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. and Company at 1-800-LillyRx (1-800-545-5979) or FDA at • Not for patients with pre-existing severe gastrointestinal disease. 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------ DOSAGE AND ADMINISTRATION ----------------------­ ------------------------------- DRUG INTERACTIONS ------------------------------ • Administer once weekly at any time of day (2.1). Dulaglutide slows gastric emptying and may impact absorption of • Inject subcutaneously in the abdomen, thigh, or upper arm (2.1). concomitantly administered oral medications (7.1, 12.3). • Initiate at 0.75 mg subcutaneously once weekly. Dose can be increased to 1.5 mg once weekly for additional glycemic control -----------------------USE IN SPECIFIC POPULATIONS---------------------­ (2.1). • Pregnancy: TRULICITY should be used during pregnancy only if the • If a dose is missed administer within 3 days of missed dose (2.1). potential benefit justifies the potential risk to fetus (8.1). • Renal Impairment: No dosage adjustment recommended. Monitor ----------------------DOSAGE FORMS AND STRENGTHS --------------------­ renal function in patients with renal impairment reporting severe • Injection: 0.75 mg/0.5 mL solution in a single-dose pen (3) adverse gastrointestinal reactions (5.5, 8.7). • Injection: 1.5 mg/0.5 mL solution in a single-dose pen (3) • Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe See 17 for PATIENT COUNSELING INFORMATION and FDA- (3) approved Medication Guide • Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe Revised: 01/2017 (3) FULL PRESCRIBING INFORMATION: CONTENTS* 5.5 Renal Impairment WARNING: RISK OF THYROID C-CELL TUMORS 5.6 Severe Gastrointestinal Disease 1 INDICATIONS AND USAGE 5.7 Macrovascular Outcomes 1.1 Limitations of Use 6 ADVERSE REACTIONS 2 DOSAGE AND ADMINISTRATION 6.1 Clinical Studies Experience 2.1 Dosage 7 DRUG INTERACTIONS 2.2 Concomitant Use with an Insulin Secretagogue (e.g., 7.1 Oral Medications Sulfonylurea) or with Insulin 8 USE IN SPECIFIC POPULATIONS 2.3 Dosage in Patients with Renal Impairment 8.1 Pregnancy 2.4 Important Administration Instructions 8.2 Lactation 3 DOSAGE FORMS AND STRENGTHS 8.4 Pediatric Use 4 CONTRAINDICATIONS 8.5 Geriatric Use 4.1 Medullary Thyroid Carcinoma 8.6 Hepatic Impairment 4.2 Hypersensitivity 8.7 Renal Impairment 5 WARNINGS AND PRECAUTIONS 8.8 Gastroparesis 5.1 Risk of Thyroid C-cell Tumors 10 OVERDOSAGE 5.2 Pancreatitis 11 DESCRIPTION 5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 5.4 Hypersensitivity Reactions 12.2 Pharmacodynamics Reference ID: 4047562 2 12.3 Pharmacokinetics 16 HOW SUPPLIED/STORAGE AND HANDLING 13 NONCLINICAL TOXICOLOGY 16.1 How Supplied 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility 16.2 Storage and Handling 13.2 Animal Toxicology and/or Pharmacology 17 PATIENT COUNSELING INFORMATION 14 CLINICAL STUDIES 14.1 Monotherapy *Sections or subsections omitted from the full prescribing information 14.2 Combination Therapy are not listed FULL PRESCRIBING 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 [see Warnings and Precautions (5.1), and Nonclinical Toxicology (13.1)]. • 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 (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 treated with TRULICITY [see Contraindications (4.1) and Warnings and Precautions (5.1)]. 1 INDICATIONS AND USAGE 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)] 2 DOSAGE AND ADMINISTRATION 2.1 Dosage The recommended initiating dose of TRULICITY is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly. Administer TRULICITY once weekly, any time of day, with or without food. TRULICITY should be injected subcutaneously in the abdomen, thigh, or upper arm. 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
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