Reglutide SC Injection

Semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Semaglutide 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. Semaglutide has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Semaglutide is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis, as it would not be effective in these settings.

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.

Instruct patients to take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking Semaglutide with food, beverages (other than plain water) or other oral medications will lessen the effect of Semaglutide by decreasing its absorption. Waiting more than 30 minutes to eat may increase the absorption of Semaglutide. Swallow tablets whole. Do not split, crush, or chew tablets.

• Start Semaglutide with 3 mg once daily for 30 days. The 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
• After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
• Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.
• Taking two 7 mg Semaglutide tablets to achieve a 14 mg dose is not recommended.
• If a dose is missed, the missed dose should be skipped, and the next dose should be taken the following day.

Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin: The risk of hypoglycemia is increased when Semaglutide is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin.

Oral Medications: Semaglutide causes a delay of gastric emptying, and thereby has the potential to impact the absorption of other oral medications. Levothyroxine exposure was increased 33% when administered with Semaglutide in a drug interaction study. When coadministering oral medications instruct patients to closely follow Semaglutide administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.

Semaglutide is contraindicated in patients with:

• A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Known hypersensitivity to semaglutide or to any of the components in Semaglutide.

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumors
• Pancreatitis
• Diabetic Retinopathy Complications
• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
• Acute Kidney Injury
• Hypersensitivity

Available data with Semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy. There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats.

• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.
• Hypoglycemia: When semaglutide is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia.
• Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
• Hypersensitivity Reactions: Discontinue semaglutide if suspected and promptly seek medical advice.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Semaglutide of approximately 1 week.

GLP-1 receptor agonists.

Pediatric Use: Safety and efficacy of Semaglutide have not been established in pediatric patients (younger than 18 years).

Geriatric Use: No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment: The safety and efficacy of Semaglutide was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2). In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of Semaglutide is recommended for patients with renal impairment.

Hepatic Impairment: In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed. No dose adjustment of semaglutide is recommended for patients with hepatic impairment.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.