HIGHLIGHT
Rybelsus

Rybelsus Dosage/Direction for Use

semaglutide

Manufacturer:

Novo Nordisk

Distributor:

Zuellig Pharma

Marketer:

Novo Nordisk
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Dosage/Direction for Use
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 Pharmacology: Pharmacokinetics under Actions.
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 Precautions and Adverse Reactions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Interactions and Pharmacology: Pharmacokinetics under Actions).
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