Frequently asked questions about RYBELSUS® (semaglutide)
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
How do you pronounce RYBELSUS®?
What is RYBELSUS®?
RYBELSUS® is the first type 2 diabetes pill in its class (GLP-1 RA).1,2 It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.1
Can RYBELSUS® be used as a first-line treatment option for glycemic control in adult patients with T2D?
Yes, RYBELSUS®, along with diet and exercise, is NOW a first-line option for adult patients with T2D who need A1C reduction.1
How does RYBELSUS® work?
RYBELSUS® is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that mimics the body’s native GLP-1 hormone to respond to elevated levels of blood glucose. GLP-1 RAs reduce blood glucose by stimulating insulin secretion and lowering glucagon secretion, both in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.1
The RYBELSUS® molecule is stabilized against degradation by DPP-4, prolongs incretin activity, and is coformulated with an absorption enhancer that enables once-daily oral administration.1,a
aSNAC: Sodium-N-[8-(2-hydroxybenzoyl) amino] caprylate: a small fatty-acid derivative.
Was RYBELSUS® compared to other oral antidiabetic medications in head-to-head clinical trials?
RYBELSUS® showed superior A1C reduction (as a primary endpoint) and superior weight reduction (as a confirmatory secondary endpoint) vs Januvia®.1,3 See how RYBELSUS® measured up in phase 3 clinical trials vs Januvia® and Jardiance®.
RYBELSUS® is not indicated for weight loss.
Will RYBELSUS® help my patients lose weight?
RYBELSUS® is not indicated for weight loss.
While the primary endpoint in the majority of RYBELSUS® clinical trials was mean change in A1C, mean change in body weight was generally evaluated as a confirmatory secondary endpoint. Review some of these studies for additional information and see the Prescribing Information.
What are the side effects of RYBELSUS®?
The most frequently reported adverse reactions, excluding hypoglycemia, in clinical trials that occurred in at least 5% of patients treated with RYBELSUS® were GI related, including nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and/or diarrhea occurred mostly during dose escalation. 4% and 8% of patients discontinued RYBELSUS® 7 mg and 14 mg, respectively, due to GI adverse reactions, compared to 1% of patients receiving placebo.1
How do you take RYBELSUS®?
For RYBELSUS® to work as intended, proper administration is important.1 See full dosing instructions.
How often is RYBELSUS® taken?
RYBELSUS® should be taken orally once daily, the same way every day. Patients should understand and follow all of the administration instructions for it to work as intended. Read about the proper way to take RYBELSUS®.
Does RYBELSUS® need to be refrigerated?
Unlike other GLP-1 RA therapies, RYBELSUS® should not be refrigerated. It should be stored at room temperature between 68°F–77°F (20°C–25°C) in a dry place away from moisture.1 You should discuss all the important storage information with your patients for RYBELSUS® to work as intended. See key storage information.
How long is RYBELSUS® active?
RYBELSUS® is a once-daily oral tablet. Following administration, the maximum concentration is reached after 1 hour, and the half-life is approximately 1 week. Steady-state exposure is achieved following 4 to 5 weeks of administration.
How is RYBELSUS® packaged and supplied?
RYBELSUS® tablets are available in bottles as a 30-day supply of RYBELSUS® 3 mg (green label), 7 mg (red label), or 14 mg (blue label) dosages. Read more about dosing and prescribing RYBELSUS® and find more on supplying and storage in Section 16 of the Prescribing Information.
Where can I send my patients for savings information?
Eligible patients may pay as little as $10 for a 30-, 60-, or 90-day supply of RYBELSUS®.b They can take advantage of this offer by texting READY to 21848 or by downloading a savings card at SaveOnR.com.c
bOffer available only to commercially insured patients with RYBELSUS® coverage. Maximum savings of $300 per 30-day supply, $600 per 60-day supply, or $900 per 90-day supply. RYBELSUS® 3 mg strength is limited to a 30-day supply only. Eligibility and restrictions apply.
cMessage and data rates may apply. Check with your mobile service provider. See Terms and Conditions of Use at RYBELSUS.com.
Are there other support programs available?
Signing up for savings automatically enrolls your patients in patient support. If they sign up for savings via text, they will receive text message support. If they sign up for savings online, they will receive email support. At any time, patients can call 1-833-ASK-A-CDE (1-833-275-2233) for one-on-one support from a Certified Diabetes Educator (CDE).
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Important Safety Information for RYBELSUS® (semaglutide) tablets 7 mg or 14 mg
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
- RYBELSUS® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of RYBELSUS® and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS®
Indication and Usage
RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Limitations of Use
- RYBELSUS® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis
- RYBELSUS® is not indicated for use in patients with type 1 diabetes
Important Safety Information
- RYBELSUS® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with RYBELSUS®
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
- Pancreatitis: Has been reported in clinical trials. Observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue RYBELSUS® and initiate appropriate management; if confirmed, do not restart RYBELSUS®
- Diabetic Retinopathy Complications: In a pooled analysis of glycemic control trials with RYBELSUS®, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with RYBELSUS® and 3.8% with comparator). In a 2-year trial with semaglutide injection involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with semaglutide injection (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy
- Hypoglycemia: Patients receiving RYBELSUS® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia
- Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists, including semaglutide. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of RYBELSUS® in patients reporting severe adverse gastrointestinal reactions
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with RYBELSUS®. If hypersensitivity reactions occur, discontinue use of RYBELSUS®, treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist
- Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1% of patients treated with RYBELSUS® 7 mg. Cholelithiasis was not reported in RYBELSUS® 14 mg or placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
- Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation
- RYBELSUS® stimulates insulin release in the presence of elevated blood glucose concentrations. When initiating RYBELSUS®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia
- RYBELSUS® delays gastric emptying and has the potential to impact the absorption of other oral medications. Closely follow RYBELSUS® administration instructions when coadministering with other oral medications and consider increased monitoring for medications with a narrow therapeutic index, such as levothyroxine
Use in Specific Populations
- Pregnancy: Available data with RYBELSUS® are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to RYBELSUS®. Use only if the potential benefit justifies the potential risk to the fetus
- Lactation: There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS®, from breastfeeding and because there are alternative formulations of semaglutide that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with RYBELSUS®
- Discontinue RYBELSUS® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Pediatric Use: Safety and effectiveness of RYBELSUS® have not been established in pediatric patients
Please click here for Prescribing Information, including Boxed Warning.
- RYBELSUS® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; January 2023.
- Rodbard HW, Dougherty T, Taddei-Allen P. Efficacy of oral semaglutide: overview of the PIONEER clinical trial program and implications for managed care. Am J Manag Care. 2020;26(suppl 16):S335-S343.
- 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;321(15):1466-1480.