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 * Important Safety Information
 * Prescribing Information
 * Medical Info
 * Patient Site
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 * Novo Nordisk Sites


RYBELSUS®


(SEMAGLUTIDE) TABLET 7 MG OR 14 MG

For US Health Care Professionals Only



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   * Cardiovascular Outcomes Trial
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View Indication and Limitations of Use

View Indication and Limitations of Use



FOR ADULTS WITH TYPE 2 DIABETES AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE
GLYCEMIC CONTROL





WAKE UP TO THE POSSIBILITIES






RYBELSUS®—THE WORLD’S FIRST AND ONLY ORAL GLP-1 RA1



FOR ADULTS WITH TYPE 2 DIABETES AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE
GLYCEMIC CONTROL




WAKE UP TO THE POSSIBILITIES








SUPERIOR A1C REDUCTION VS JANUVIA® AND JARDIANCE®1‑3



In two separate studies, RYBELSUS® went head-to-head vs the most prescribed
DPP-4i and SGLT-2i for A1C reduction.4 Also, mean change in body weight was a
confirmatory secondary endpoint in these studies.1-3

View results »





SUPERIOR A1C REDUCTION VS JANUVIA® AND JARDIANCE®1‑3



In two separate studies, RYBELSUS® went head-to-head vs the most prescribed
DPP-4i and SGLT-2i for A1C reduction.4 Also, mean change in body weight was a
confirmatory secondary endpoint in these studies.1-3

View results »





FINALLY! A GLP-1 RA IN A ONCE-DAILY PILL1



Find out how to accurately prescribe, store, and dose RYBELSUS®. The time is
now!

Get patients started »






FINALLY! A GLP-1 RA IN A ONCE-DAILY PILL1



Find out how to accurately prescribe, store, and dose RYBELSUS®. The time is
now!

Get patients started »






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WAITING FOR?



Learn about our tool that allows you to find a patient’s coverage status and get
an estimated prescription cost in minutes.

Check patient costs »




WHAT ARE YOU
WAITING FOR?



Learn about our tool that allows you to find a patient’s coverage status and get
an estimated prescription cost in minutes.

Check patient costs »




STAY IN THE KNOW ABOUT RYBELSUS®




Get email updates about the world’s first and only oral GLP-1 RA.1

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WONDERING ABOUT RYBELSUS® COVERAGE?


RYBELSUS® IS WIDELY AVAILABLE AND ALREADY COVEREDA BY THE TOP 5 BIGGEST PAYERSB

aCoverage status and tier varies by plan. Please check directly with the health
plan to confirm coverage for individual patients.
bPlan data based on number of pharmacy lives as reported by Fingertip Formulary®
(current as of May 2020). Applies to commercial business only. Formulary status
is subject to change. Because formularies do change, and many health plans offer
more than one formulary, please check directly with the health plan to confirm
coverage for individual patients. 2020 Fingertip Formulary®. All rights
reserved.



Check local coverage »



Please see Indication and Important Safety Information on the website.

Proceed to site »


SELECTED IMPORTANT SAFETY INFORMATION

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®


INDICATIONS 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® is not recommended as a first-line therapy for patients who have
   inadequate glycemic control on diet and exercise because of the uncertain
   relevance of rodent C-cell tumor findings to humans
 * 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

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®

CONTRAINDICATIONS

 * 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. The risk of hypoglycemia may be
   lowered by a reduction in the dose of sulfonylurea (or other concomitantly
   administered insulin secretagogue) or insulin. 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

ADVERSE REACTIONS

 * The most common adverse reactions, reported in ≥5% of patients treated with
   RYBELSUS® are nausea, abdominal pain, diarrhea, decreased appetite, vomiting
   and constipation

DRUG INTERACTIONS

 * 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 efficacy of RYBELSUS® have not been established in
   pediatric patients (younger than 18 years)

Please click here for Prescribing Information, including Boxed Warning.

References:

 1. RYBELSUS® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; April 2021.
 2. 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.
 3. 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. doi:10.2337/dc19-0883.
 4. Data on file. Novo Nordisk Inc; Plainsboro, NJ.

Return to top ▴

Novo Nordisk®
 * Home
 * Starting Patients
   * About RYBELSUS®
   * Dosing & Prescribing
   * Storage & Administration
 * Efficacy & Safety
   * A1C & Weight Data
   * RYBELSUS® vs Januvia®
   * Cardiovascular Outcomes Trial
   * Specific Populations
   * Safety Data
   * Mechanism of Action
 * Savings & Coverage
 * For Pharmacists
 * Stay in the Know
   * Get Updates
   * FAQs
 * Samples

RYBELSUS® is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

All other trademarks, registered or unregistered, are the property of their
respective owners.

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© 2021 Novo Nordisk All rights reserved. US21RYB00058 May 2021



SELECTED IMPORTANT SAFETY INFORMATION

Show More

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®


INDICATIONS 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® is not recommended as a first-line therapy for patients who have
   inadequate glycemic control on diet and exercise because of the uncertain
   relevance of rodent C-cell tumor findings to humans
 * 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

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®

CONTRAINDICATIONS

 * 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. The risk of hypoglycemia may be
   lowered by a reduction in the dose of sulfonylurea (or other concomitantly
   administered insulin secretagogue) or insulin. 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

ADVERSE REACTIONS

 * The most common adverse reactions, reported in ≥5% of patients treated with
   RYBELSUS® are nausea, abdominal pain, diarrhea, decreased appetite, vomiting
   and constipation

DRUG INTERACTIONS

 * 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 efficacy of RYBELSUS® have not been established in
   pediatric patients (younger than 18 years)

Please click here for Prescribing Information, including Boxed Warning.





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