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Abbreviated prescribing information (and not full package insert)
Generic Name: Semaglutide Injection 0.25 mg (r-DNA Origin), solution for injection in pre-filled pen, Semaglutide Injection 0.5 mg (r-DNA Origin),
solution for injection in pre-filled pen, Semaglutide Injection 1 mg (r-DNA Origin), solution for injection in pre-filled pen Brand Name: Ozempic^®.
Presentation: Ozempic^® is available in 0.25 mg, 0.5 mg and 1 mg.
Indication: Semaglutide injection is indicated as; an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease, To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. Description: Ozempic® is a clear and colorless or almost colorless solution for injection in a pre-filled pen.
Posology: The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks, the dose should be in-creased 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 glycaemic control.
Method of administration: Subcutaneous use. Ozempic^® is administered once weekly at any time of the day, with or without meals. It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly. If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. 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). Patients should be advised to read the instructions for use included in the package leaflet carefully before administering Ozempic^®.
Special Population: No dose adjustment is required based on age. No dose adjustment is required for patients with mild, moderate or severe renal impairment. Experience with the use of semaglutide in patients with end-stage kidney disease is limited. No dose adjustment is required for patients with hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment is limited. The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients, with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function. Increased risk of residual gastric content due to delayed gastric emptying should be considered prior to performing procedures with general anaesthesia or deep sedation. Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide should be discontinued. Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with semaglutide. In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Caution should be exercised when using semaglutide in patients with diabetic retinopathy treated with insulin. Use in special populations (Fertility, pregnancy and lactation): Women of child-bearing potential are rec-ommended to use contraception when treated with semaglutide. There are limited data regarding the use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life. Semaglutide should not be used during breast-feeding. The effect of semaglutide on fertility in humans is unknown.
Drug Interaction: Semaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Semaglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption.
Paracetamol: Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a standardized meal test. No clinically relevant effect on paracetamol was observed with semaglutide. No dose adjustment of paracetamol is necessary when administered with semaglutide.
Oral contraceptives: Semaglutide is not anticipated to decrease the effectiveness of oral contraceptives as semaglutide did not change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree, when an oral contraceptive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) was co-administered with semaglutide.
Atorvastatin: Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg). Digoxin: Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin (0.5 mg).
Metformin: Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days.
Warfarin: Semaglutide did not change the overall exposure or Cmax of R- and S-warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner.
Effects on ability to drive and use machines: Semaglutide has no or negligible influence on the ability to drive or use machines. When it is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Undesirable effects: In 8 phase 3a trials, 4792 patients were exposed to semaglutide up to 1 mg. The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea (very common) and vomiting (common). In general, these reactions were mild or moderate in severity and of short duration. Overdose: Overdoses 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. All patients recovered without complicate-tions. There is no specific antidote for overdose with semaglutide. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Shelf-life: Before first use: 36 months. After first opening: 6 weeks. Store below 30 °C or in a refrigerator (2 °C–8 °C). Storage: Store in a refrigerator (2 °C–8 °C). Keep away from the cooling element. Do not freeze. Keep the pen cap on in order to protect from light.Disclaimer: The abbreviated package insert is updated from the CDSCO approved package insert (File No. BIO/IMP/25/000051 dated 19 Sep 2025 and subsequent approval vide File No. r-DNA-11011/13/2025-eoffice dated 23 Oct 2025).

Ozempic^®, NovoFine^® and Apis bull logo are registered trademarks owned by Novo Nordisk A/S and registered in Denmark.. Imported by: Novo Nordisk India Private Limited, Bangalore. *For full prescribing information, please contact +91-8040303200 or write to us at INAgree@novonordisk.com or reach us at Novo Nordisk India Pvt Ltd, NXT Tower-2, Floor 1&2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore – 560 045, India.

Note: For detailed information on this product, please refer to full package insert*.

This material is developed by: Novo Nordisk India, Private Limited, NXT Tower -2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore-560 045, India.
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