Semaglo OB SC Injection

Semaglutide is a GLP-1 analogue with 94% sequence as same as to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor. Semaglutide reduces blood glucose in a glucose dependent manner by stimulating insulin secretion and lowering glucagon secretion when blood glucose is high. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying. During hypoglycemia, Semaglutide diminishes insulin secretion and does not impair glucagon secretion. Semaglutide reduces body weight and body fat mass by an overall reduced appetite.

For Diabetes:

Semaglutide Tablet: Take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces (118 ml) of plain water only.

• Starter Dose: Start Semaglutide with 3 mg once daily for 30 days
• Maintenance Dose: After 30 days on the 3 mg dose, increase the dose to 7 mg once daily
• For Additional Glycemic Control: If additional glycemic control is needed after at least 30 days on the 7 mg dose, the dose can be increased to 14 mg once daily

Semaglutide injection: The starting dose is 0.25 mg Semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycemic control. Weekly doses higher than 1 mg are not recommended. Semaglutide is to be administered once weekly at any time of the day with or without meals. Semaglutide is to be injected subcutaneously in the abdomen, thigh or in upper arm. The injection site can be changed without dose adjustment. Semaglutide should not be administered intravenously or intramuscularly. The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once weekly dosing should be continued.

Switching patients between Semaglutide injection and Semaglutide tablet-

• Patients treated with once weekly Semaglutide injection 0.5 mg subcutaneous injection can be transitioned to Semaglutide 7 mg or 14 mg tablet. Patients can start Semaglutide tablet up to 7 days after their last injection of Semaglutide injection. There is no equivalent dose of Semaglutide tablet for Semaglutide injection 1 mg
• Patients treated with Semaglutide 14 mg tablet daily can be transitioned to Semaglutide subcutaneous injection 0.5 mg once weekly. Patients can start Semaglutide injection the day after their last dose of Semaglutide tablet.

For Obesity: The starting dose is 0.25 mg Semaglutide once weekly for 4 weeks subcutaneously. If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks. If patients do not tolerate the maintenance dose 2.4 mg, the dose can be temporarily decreased to 1.7 mg once weekly for maximum 4 weeks. After 4 weeks increase the dose to 2.4 mg. Weekly doses higher than 2.4 mg is not recommended. Semaglutide is to be administered once weekly at any time of the day with or without meals. Semaglutide is to be injected subcutaneously in the abdomen, thigh or in upper arm. The injection site can be changed without dose adjustment. Semaglutide should not be administered intravenously or intramuscularly. The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours). After selecting a new dosing day, once weekly dosing should be continued.

Semaglo OB delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Semaglo OB should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption.

Hypersensitivity to the active substance or to any of the excipients.

Sometimes hypoglycemia can occur when used with insulin or sulfonylurea. The most frequent adverse reactions are gastrointestinal disorder, nausea, diarrhea, vomiting, abdominal pain and constipation. In general these reactions are mild or moderate in severity and of short duration. Beside these allergic reaction, injection site reaction, lipodystropy, pruritus and rash may occur.

Semaglutide should not be used during pregnancy. If a patient wishes to become pregnant Semaglutide should be discontinued at least 2 months before a planned pregnancy. As a risk to a breast-fed child cannot be excluded, Semaglutide should not be used during breast-feeding.

Diabetic ketoacidosis: Semaglo OB should not be used in type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Pancreatitis: Semaglo OB should be discontinued promptly if pancreatitis is suspected and it should not be restart if pancreatitis is confirmed.

Diabetic Retinopathy: Patient with diabetic retinopathy should be monitored.

Pediatric population: The safety and efficacy of Semaglo OB in children and adolescents below 18 years have not yet been established. No data are available.

Elderly: No dose adjustment is required based on age.

Renal impairment: No dose adjustment is required for patients with mild moderate or severe renal impairment. Semaglo OB is not recommended for use in patients with end-stage renal disease.

Hepatic impairment: No dose adjustment is required for patients with hepatic impairment. Caution should be exercised when treating these patients with Semaglo OB.

Overdose: Overdose of up to 4 mg in a single dose and up to 4 mg in a week have been reported in clinical trials. The most commonly reported adverse reaction was nausea. There is no specific antidote for overdose with Semaglo OB. In the event of overdose appropriate supportive treatment should be initiated according to the patients clinical sign and symptoms.

Dose adjustment: When Semaglo OB is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued unchanged. When Semaglo OB is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycemia. Self-monitoring in blood glucose is not needed in order to adjust the dose of Semaglo OB. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin particularly when Semaglo OB is started and insulin is reduced.

Missed dose: If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped and the next dose should be administered on the regular scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

GLP-1 receptor agonists

Store at 2 °C to 8 °C (in a refrigerator). Do not freeze. Keep out of reach of children.