RYBELSUS® TABLET 3MG [SIN16215P]

Product Info

RYBELSUS® TABLET 3MG

[SIN16215P]

4.1 Therapeutic indications

Rybelsus® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications.

• in combination with other medicinal products for the treatment of diabetes.

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

Posology

The starting dose of semaglutide is 3 mg once daily for one month. After one month, the dose should be increased to a maintenance dose of 7 mg once daily. After at least one month with a dose of 7 mg once daily, the dose can be increased to a maintenance dose of 14 mg once daily to further improve glycaemic control.

The maximum recommended single daily dose of semaglutide is 14 mg. Taking two 7 mg tablets to achieve the effect of a 14 mg dose has not been studied and is therefore not recommended.

For information on switching between oral and subcutaneous (s.c.) semaglutide, see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

When semaglutide is used in combination with metformin and/or a sodium-glucose co-transporter-2 inhibitor (SGLT2i) or thiazolidinedione, the current dose of metformin and/or SGLT2i or thiazolidinedione can be continued.

When semaglutide is used in combination with a sulfonylurea or with insulin, a reduction in the dose of sulfonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4 and 4.8 – 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 semaglutide. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when semaglutide is started and insulin is reduced. A stepwise approach to insulin reduction is recommended.

Missed dose
If a dose is missed, the missed dose should be skipped and the next dose should be taken the following day.

Special populations

Elderly
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited (see section 5.2 – 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 in patients with end-stage renal disease (see section 5.2 – 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of Rybelsus® in children and adolescents below 18 years have not been established. No data are available.

Method of administration

Rybelsus® is a tablet for once-daily oral use.

• This medicinal product should be taken on an empty stomach at any time of the day.

• It should be swallowed whole with a sip of water (up to half a glass of water equivalent to 120 ml). Tablets should not be split, crushed or chewed, as it is not known whether this impacts absorption of semaglutide.

• Patients should wait at least 30 minutes before eating or drinking or taking other oral medicinal products. Waiting less than 30 minutes decreases the absorption of semaglutide (see sections 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.