Teva Pharmaceuticals announced US Food and Drug Administration approval and US launch of a generic version of Saxenda (liraglutide injection), the first generic glucagon-like peptide-1 receptor agonist specifically indicated for weight loss in the US.
Liraglutide injection is indicated, with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction in adults with obesity or adults with overweight plus at least one weight-related comorbidity, and in pediatric patients aged 12 to 17 years with obesity and body weight greater than 60 kg. As a glucagon-like peptide-1 (GLP-1) receptor agonist, it is not recommended for patients who also take liraglutide or other GLP-1 receptor agonists. Safety and effectiveness are unknown in children younger than 12 years and in those aged 12 to 17 years with type 2 diabetes mellitus.
The prescribing information carries a boxed warning for possible thyroid tumors. In rodent studies, liraglutide caused thyroid tumors; in humans, the risk of thyroid tumors—including medullary thyroid carcinoma—remains unknown. The drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2.
Serious risks include pancreatitis; hypoglycemia—particularly in adults with type 2 diabetes mellitus using insulin or sulfonylureas and in children without type 2 diabetes mellitus—requiring blood glucose monitoring at initiation and during therapy; increased heart rate; dehydration with potential kidney injury; severe gastrointestinal adverse reactions; serious hypersensitivity; gallbladder disease; depression or suicidal ideation; and aspiration risk during procedures requiring anesthesia or deep sedation.
Common adverse reactions in adults include nausea, diarrhea, constipation, vomiting, injection-site reactions, hypoglycemia, headache, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase; in children, additional common reactions are fever and gastroenteritis. Patients should review the Medication Guide in the full Prescribing Information and discuss all concomitant medicines—especially insulin and sulfonylureas—with a clinician.
Source: Teva Pharmaceuticals
