Talking to your patients about RYBELSUS® (semaglutide) at the pharmacy
RYBELSUS® is the first type 2 diabetes pill in its class (GLP-1 RA).1,2 Here is some important information to be sure to discuss with your patients when they come to pick up their prescription.
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Dosing and administration
Dosing and administration
Tell patients about proper dosing, storage, and administration for intended efficacy
Savings and
support
Help your commercially insured patients find savings
Trade product information
Get information on ordering and dispensing in your pharmacy
Get updates
Don't miss out on important updates
Dosing and administration
Tell patients about proper dosing, storage, and administration for intended efficacy
Savings and support
Help your commercially insured patients find savings
Trade product information
Get information on ordering and dispensing in your pharmacy
Get updates
Don't miss out on important updates
What is RYBELSUS®? (reb-EL-sus)
- RYBELSUS® is the world’s first and only oral glucagon-like peptide-1 (GLP-1) receptor agonist.1 It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Gradual dose escalation is designed to help patients adjust to therapy1
For once-daily RYBELSUS® to work as planned, patients should take as directed. If a patient misses a dose, the missed dose should be skipped, and the next dose should be taken the following day.1
aThe 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
Storing RYBELSUS®1
Store tablets in the closed RYBELSUS® bottle until ready to take one.
Do not use a pill organizer or other container to store RYBELSUS® tablets.
Swallow tablet whole.
Do not split, crush, or chew
Important note: The RYBELSUS® blue cap is equipped with a drying agent to help protect the tablets from moisture, which helps preserve RYBELSUS®. Tablets should be kept in the RYBELSUS® bottle with the blue cap whenever the patient is not taking one.
Store at room temperature 68°F–77°F (20°C–25°C).
Store in a dry place away from moisture.
Taking RYBELSUS®1
Take RYBELSUS® upon waking
Patients must take RYBELSUS® on an empty stomach
Take with no more than 4 oz of water
Patients should take RYBELSUS® with a sip of plain water
Wait 30 minutes before the first food, beverage, or other oral medications of the day
Waiting less than 30 minutes or taking with food, beverages (other than plain water), or other oral medications will lessen the effect of RYBELSUS® by decreasing its absorption. Waiting more than 30 minutes to eat may increase the absorption of RYBELSUS®.
We’re committed to patient savings and support
Patients can get the savings offer in 2 ways:
Signing up for savings allows patients to enroll in patient support—either by text if they texted for savings, or by email if they downloaded a savings card online.
aOffer 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.
bMessage and data rates may apply. Check with your mobile service provider. See Terms and Conditions of Use at RYBELSUS.com.
Have questions about processing the RYBELSUS® savings offer?
Call the Change Healthcare Pharmacy Help desk at 1-800-433-4893 to get answers.
Available Monday to Friday, 8:00 A.M. – 8:00 P.M. ET, except holidays.
How to dispense RYBELSUS®
All the information you need to order RYBELSUS® for your pharmacy
STARTER DOSE
STRENGTH
3 mga
NDC NUMBER
0169-4303-30
BOTTLE QUANTITY
30 x 3 mg per bottle
THERAPUTIC DOSE
STRENGTH
7 mg
NDC NUMBER
0169-4307-30
BOTTLE QUANTITY
30 x 7 mg per bottle
THERAPUTIC DOSE
STRENGTH
14 mg
NDC NUMBER
0169-4314-30
BOTTLE QUANTITY
30 x 14 mg per bottle
aThe 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
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Change Healthcare Pharmacy Help desk
1-800-433-4893
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® 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 (cont'd)
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. 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
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:
- RYBELSUS® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2022.
- 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.