WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.5MG/0.5ML

Catalent Belgium SA (Formulation and filling) (BELGIUM)🇸🇬 Health Sciences Authority

Approval Date: Feb 22, 2023
Approval ID: c8fa47c074875bef
Company: Catalent Belgium SA (Formulation and filling) (BELGIUM)
Type: Therapeutic

Approval Details

Approval Id: c8fa47c074875bef
Drug Name: WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.5MG/0.5ML
Product Name: WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.5MG/0.5ML
Approval Number: SIN16705P
Approval Date: 2023-02-22
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: 4.2 Posology and method of administration Posology Adults The maintenance dose of semaglutide 2.4 mg once-weekly is reached by starting with a dose of 0.25 mg. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated over a 16-week period to a maintenance dose of 2.4 mg once weekly (see Table 2). In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved. Weekly doses higher than 2.4 mg are not recommended. <img src="/TGIF/Wegovy-Table2.png" alt="Wegovy Dosage Table 2" /> Adolescents For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied (see Table 2). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended. Patients with type 2 diabetes When initiating semaglutide in patients with type 2 diabetes, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. 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. If more doses are missed, reducing the starting dose for re-initiation should be considered. Special populations Elderly (≥65 years old) No dose adjustment is required based on age. Therapeutic experience in patients ≥85 years of age is limited. Patients with renal impairment No dose adjustment is required for patients with mild or moderate 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 severe renal impairment (eGFR <30 mL/min/1.73m2) including patients with end-stage renal disease (see sections 4.4, 4.8 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients with hepatic impairment No dose adjustment is required for patients with mild or moderate hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment is limited. Semaglutide is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population No dose adjustment is required for adolescents ages 12 years and above. The safety and efficacy of semaglutide in children below 12 years of age have not been established. Method of administration Subcutaneous use. Wegovy® 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. 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. When administering Wegovy®, the pen should be pressed firmly against the skin until the yellow bar has stopped moving. The injection takes about 5–10 seconds. Patients should be advised to read the ‘Instructions on how to use Wegovy® pen’ on the other side of this leaflet carefully before administering the medicinal product – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. For further information before administration see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Route Of Administration: SUBCUTANEOUS
Indication Info: 4.1 Therapeutic indications Adults Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of <ul> <li>≥30 kg/m2 (obesity), or</li> <li>≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.</li> <li>to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight (see Section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul> Adolescents (≥12 years) Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with <ul> <li>obesity* and</li> <li>body weight above 60 kg.</li> </ul> Treatment with Wegovy® should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1). <img src="/TGIF/Wegovy-Table1_280225.png" alt="Wegovy Indications Table 1" />
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – 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

Active Ingredients

Semaglutide

0.5mg/0.5ml

SEMAGLUTIDE

0.5 MG/0.5 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 22, 2023

Approval ID

c8fa47c074875bef

Type

Therapeutic

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