- Approval Id
- 9612940865b1273b
- Drug Name
- OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML
- Product Name
- OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML
- Approval Number
- SIN16165P
- Approval Date
- 2021-04-21
- Registrant
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Licence Holder
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **Posology and method of administration**
Posology
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 glycaemic control.
Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher than 1 mg are not recommended.
When Ozempic® is added to existing metformin and/or thiazolidinedione therapy or to a sodium-glucose cotransporter 2 (SGLT2) inhibitor, the current dose of metformin and/or thiazolidinedione or SGLT2 inhibitor can be continued unchanged.
When Ozempic® 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 hypoglycaemia (see _Special warnings and precautions for use_ and _Undesirable effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Self-monitoring of blood glucose is not needed in order to adjust the dose of Ozempic®. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Ozempic® is started and insulin is reduced. A stepwise approach to insulin reduction is recommended.
_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 regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
Special populations
_Elderly_
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited (see _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Renal impairment_
No dose adjustment is required for patients with mild, moderate or severe renal impairment. Experience with the use of semaglutide in patients with severe renal impairment is limited. Semaglutide is not recommended for use in patients with end-stage renal disease (see _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Hepatic impairment_
No dose adjustment is required for patients with hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment is limited. Caution should be exercised when treating these patients with semaglutide (see _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Paediatric population_
The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established. No data are available.
Method of administration
Ozempic® is to be administered once weekly at any time of the day, with or without meals.
Ozempic® is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed without dose adjustment. Ozempic® 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).
For further information on administration, see _Special precautions for disposal and other handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **Therapeutic indications**
Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes.
To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( _see Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Contraindications
- **Contraindications**
Hypersensitivity to the active substance or to any of the excipients listed in _List of excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Atc Code
- A10BJ06
- Atc Item Name
- semaglutide
- Pharma Manufacturer Name
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/877c4bac80747145/novo-nordisk-pharma-singapore-pte-ltd
