RYBELSUS efficacy and safety

No dosage adjustment for mild, moderate, or severe renal impairment (GFR ≥15 ml/min per 1.73 m²).^1,2*

Use is not recommended in end-stage renal disease.¹

No dose adjustment is required based on age.¹

The efficacy and safety of RYBELSUS^® were not impacted by age.¹

No dose adjustment is required for patients with hepatic impairment.¹

In a study of patients with mild, moderate, or severe hepatic impairment, no clinically relevant change in RYBELSUS^® pharmacokinetics was observed.^1,3

*Proven efficacy and safety in patients with type 2 diabetes and moderate renal impairment.^1,4 No clinically relevant changes in pharmacokinetics were observed in patients with mild, moderate, or severe renal disease or in patients with end-stage renal disease on dialysis.^1,4

GFR: glomerular filtration rate.

Gastrointestinal (GI) tolerability

RYBELSUS^® led to a treatment discontinuation of only 4%¹

CV safety demonstrated in a pre-approval trial

21% reduced risk of MACE confirms CV safety and non-inferiority of RYBELSUS^® vs placebo (Nonsignificant)^1,5

Low risk of hypoglycaemia

Due to the glucose-dependent mode of action of GLP-1 RAs, RYBELSUS^® has an inherently low risk of hypoglycaemia¹

Most GI events were mild and transient, consistent with the GLP-1 RA class

For full details of RYBELSUS^® safety profile, take a look a the Summary of Product Characteristics.

Patients should be informed that nausea can happen when taking a GLP-1 RA but this usually occurs early in treatment, is usually mild to moderate in severity and generally reduces after dose escalation.¹

As a result, GI events with RYBELSUS^® led to a treatment discontinuation of only 4%¹

Educate and set the expectations for patients

Decrease food intake and avoid fatty meals

Keep a food diary to identify foods that worsen nausea

In the PIONEER 6 trial, fewer patients experienced a major adverse CV event (MACE) with RYBELSUS^® compared with placebo (3.8% n=61/1591 for RYBELSUS^® vs 4.8% n=76/1592; p<0.001 for non-inferiority).^1,5

In this study, patients were randomly assigned 1:1 to receive once-daily RYBELSUS^® (target dose 14 mg) or placebo, both in addition to standard-of-care treatment, with a median observation of 16 months.⁵

This helped to establish that there is no increased risk of MACE with RYBELSUS^® vs placebo.^1,5

Components of the primary composite outcome

In phase 3 trials, no increased risk of hypoglycaemia was observed with Rybelsus^® versus comparator groups, including other GLP-1 RAs.^1,9–11

Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia.¹

The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with semaglutide.¹

The glucose-dependent action of GLP-1RAs translate into a low risk of hypoglycaemia

ADA and EASD guidelines now recommend GLP-1 RAs early on, either as monotherapy or in combination, for glycaemic control and weight loss, instead of metformin or DPP4is¹³

Can be initiated early in the continuum of care, including oral formulations^13–15

Can be started after prescribing metformin or after starting lifestyle modifications

Can be prescribed as part of a holistic approach after starting lifestyle modifications^13–15

May be prescribed independent of
baseline HbA_1c ^13,14

Over 3 million patients worldwide have been treated with semaglutide

In the Phase 3 programme, acute pancreatitis confirmed by adjudication was reported in RYBELSUS^® (<0.1%) and comparator (0.2%). Acute pancreatitis has been observed with the use of GLP-1 RAs. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, RYBELSUS^® should be discontinued.¹

In patients with diabetic retinopathy treated with insulin and Ozempic^® (s.c. semaglutide), an increased risk of developing diabetic retinopathy complications has been observed, a risk that cannot be excluded for RYBELSUS^®. Caution should be exercised when using semaglutide in patients with diabetic retinopathy. These patients should be monitored closely and treated according to clinical guidelines.¹

RYBELSUS - The only type 2 diabetes pill of its kind

RYBELSUS^® can deliver HbA_1c reduction with added benefit of weight loss, helping your patients reduce the risk of long-term complications associated with type 2 diabetes

Find out more about the Phase 3 clinical trial programme investigating RYBELSUS^® (oral semaglutide).

By combining semaglutide with the SNAC absorption enhancer, we found a way to deliver a GLP-1 RA in a tablet.

RYBELSUS^® [summary of product characteristics]. Bagsværd, Denmark: Novo Nordisk A/ S; March 2024.

CKD Work Group. Kidney Disease: Improving Global Outcomes (KDIGO). 2012 Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease. Kidney Inter. 2013;3(suppl):1-150.

Bækdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, safety, and tolerability of oral semaglutide in subjects with hepatic impairment.) Clin Pharm. 2018;58(10):1314-1323.

Mosenzon O, Blicher TM, Signe Rosenlund S, et al. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Lancet Diabetes Endocinol. 2019;7(7):515-527.

Husain M, Birkenfeld AL, Donsmark M, et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2019;381(9):841-851.

Data on file. PIONEER 1 data. Novo Nordisk A/S Bagsværd, Denmark.

Rasalam R, Barlow J, Kennedy M, et al. GLP-1 Receptor Agonists for Type 2 Diabetes and Their Role in Primary Care: An Australian Perspective. Diabetes Ther. 2019;10(4):1205–1217.

Cornell S. A review of GLP-1 receptor agonists in type 2 diabetes: a focus on the mechanism of action of once-weekly agents. Journal of Clinical Pharmacy and Therapeutics. 2020;45(51):17-27.

Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial.JAMA. 2019;42(12):2272-2281.

10.

Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: the PIONEER 2 trial. Diabetes Care. 2019;42(12):2272-2281.

11.

Pratley R, Amod A, Hoff ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet. 2019;394(10192):39-50.

12.

Data on file. IQVIA MIDAS^® monthly volume sales data, ATC3 A10S, for the time period 01.2005 to 11.2023; IQVIA LAAD data (US) for the time period 01.2016 to 11.2023, and IQVIA LRx data (UK, CANADA) for the time period 01.2019 to 10.2023

13.

Davies MJ, Aroda VR, Collins BS, et al. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786.

14.

American Diabetes Association. 1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021;44:S7–S14.

15.

Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J 2020;41:255–323.

16.

Based on internal analysis by Novo Nordisk using IQVIA MIDAS^® monthly volume sales data, ATC3 A10S, for the rolling 12-month time period ending 12.2023 (41 countries***) reflecting estimates of real-world activity. *MAT time period is M1 2023 to M12 2023. ** Semaglutide® is included under A10S.

17.

Data on file. Novo Nordisk A/S Bagsværd, Denmark. 2016-2021.

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The Summary of Product Characteristics (SmPC) is based on the EU SmPC as of March 2024. Registration conditions differ internationally. Always refer to the full local SmPC before prescribing.

HQ24RYB00041, April 2024

For healthcare professionals only