Melitide®

Description

Melitide^® contains liraglutide, an analog of human glucagon-like peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34.

Indications

Melitide^® (liraglutide) multidose pen injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established CV disease.

• Melitide^® is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
• Concurrent use with prandial insulin has not been studied.

Important safety information

WARNING: RISK OF THYROID C-CELL TUMORS

• Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
• Melitide^® 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 for MTC with the use of Melitide^® and inform them of symptoms of thyroid tumors (e.g. a 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 Melitide^®.
• In 5 placebo-controlled clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 8 liraglutide-treated patients (7.5 events per 1000 patient-years). Of these 8 liraglutide-treated patients, 7 patients were concomitantly using a sulfonylurea.

In the pool of 5 placebo-controlled clinical trials, withdrawals due to gastrointestinal adverse reactions occurred in 4.3% of liraglutide-treated patients and 0.5% of placebo-treated patients. Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2 to 3 months of the trials.