Semaglutide 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 and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular ... Read moreSemaglutide 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 and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.An adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: 30 kg/m2 or greater (Obesity) or 27 kg/m2 or greater (Overweight) in the presence of at least one weight-related comorbid condition (e g. hypertension, type 2 diabetes mellitus or dyslipidemia).

Initiating Semaglutide concomitant with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. In clinical pharmacology trials, Semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree. Nonetheless, caution should be exercised when oral medications are concomitantly administered with Semaglutide.

Semaglutide is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) and hypersensitivity to Semaglutide. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Semaglutide.

It is not known if Semaglutide will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Risk of Thyroid C-Cell Tumors: It is unknown whether Semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.Pancreatitis: After initiation of Semaglutide, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Semaglutide should be discontinued and appropriate management initiated; if confirmed, Semaglutide should not be restarted.Diabetic Retinopathy Complications: The effect of long-term glycemic control with Semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for the progression of diabetic retinopathy.Never Share Semaglutide Pen Between Patients: Semaglutide pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for the transmission of blood-borne pathogens.Hypoglycemia with Concomitant Use of Insulin: Secretagogues or Insulin Patients receiving Semaglutide in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or another concomitantly administered insulin secretagogue) or insulin.Acute Kidney Injury: There have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptoragonists.Hypersensitivity: Do not use in patients with previous hypersensitivity to Semaglutide. If hypersensitivity reactions occur, discontinue the use of Semaglutide; treat promptly per standard of care, and monitor until signs and symptoms resolve.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

Store your Semaglutide in the refrigerator at 2°C to 8°C. After the first use of the Semaglutide, the pen can be stored for 56 days in a refrigerator (2°C to 8°C). Do not freeze Semaglutide. Do not use Semaglutide if it has been frozen. Unused Semaglutide cartridges may be used until the expiration date printed on the label, if kept in the refrigerator (2°C to 8°C). Keep Semaglutide away from heat and out of the light. Keep the pen cap on when not in use.

GLP-1 receptor agonists

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

There are limited data with semaglutide use in pregnant women. Semaglutide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no data on the presence of Semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Discontinue Semaglutide in women at least 2 months before a planned pregnancy due to the long washout period for Semaglutide.