Clinical Information
Gen. Code and Des.
80228 semaglutide ORAL TABLET 3 MG
GCN and Des.
46964 semaglutide ORAL TABLET 3 MG
Strength
3MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200600 INCRETIN MIMETICS
Active Ingredients
17424 semaglutide 910463682
Inactive Ingredients
2537 povidone 9003398
These highlights do not include all the information needed to use RYBELSUS® safely and effectively. See full prescribing information for RYBELSUS.
RYBELSUS (semaglutide) tablets, for oral use
Initial U.S. Approval: 2017
WARNING: RISK OF THYROID C-CELL TUMORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
•
In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether RYBELSUS causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined (5.1, 13.1).
•
RYBELSUS is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1).
INDICATIONS AND USAGE
RYBELSUS is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
Limitations of Use
•
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (1, 5.1).
•
Has not been studied in patients with a history of pancreatitis (1, 5.2).
•
Not indicated for use in patients with type 1 diabetes mellitusor treatment of diabetic ketoacidosis (1).
DOSAGE AND ADMINISTRATION
•
Instruct patients to take RYBELSUS at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of RYBELSUS. Waiting more than 30 minutes to eat may increase the absorption of RYBELSUS (2.1).
•
Swallow tablets whole. Do not cut, crush, or chew tablets (2.1).
•
Start RYBELSUS with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily (2.2).
•
Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose (2.2).
•
See the Full Prescribing Information for instructions on switching between OZEMPIC® and RYBELSUS (2.3).
DOSAGE FORMS AND STRENGTHS
Tablets: 3 mg, 7 mg and 14 mg (3).
CONTRAINDICATIONS
•
Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4).
•
Known hypersensitivity to semaglutide or any of the components in RYBELSUS (4).
WARNINGS AND PRECAUTIONS
•
Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2).
•
Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored (5.3).
•
Hypoglycemia: When RYBELSUS is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia (5.4).
•
Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5).
•
Hypersensitivity Reactions: Discontinue RYBELSUS if suspected and promptly seek medical advice (5.6).
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 (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-457-7455 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Oral Medications: RYBELSUS delays gastric emptying. When coadministering oral medications instruct patients to closely follow RYBELSUS administration instructions. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring (7.2).
USE IN SPECIFIC POPULATIONS
•
Pregnancy: May cause fetal harm (8.1).
•
Lactation: Breastfeeding not recommended (8.2).
•
Females and Males of Reproductive Potential: Discontinue RYBELSUS in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide (8.3).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2019
CLOSE