Oral Semaglutide (RYBELSUS)

US NDC LINE: 0169-4303

Trade Name: RYBELSUS

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Novo Nordisk

Presentation: TABLET

Strength: 3 mg/1

Storage and handling

SEMAGLUTIDE GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

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  • 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 (, ).
  • 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 (, ).
  • RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus .
  • Limitations of Use
  • 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 ().
  • Limitations of Use
  • 1n- 5.1
  • 1n- 5.2
  • Array
  • No data
  • RYBELSUS tablets are available as:
  • Tablets: 3 mg, 7 mg and 14 mg ().
  • RYBELSUS is contraindicated in patients with:
  • No data
  • Pancreatitis:
  • Diabetic Retinopathy Complications:
  • Hypoglycemia:
  • Acute Kidney Injury:
  • Hypersensitivity Reactions:
  • The following serious adverse reactions are described below or elsewhere in the prescribing information:
  • The most common adverse reactions, reported in u22655% of patients treated with RYBELSUS are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation ().
  • Oral Medications:
  • 7.2
  • No data
  • Pregnancy:
  • Lactation:
  • Females and Males of Reproductive Potential
  • In the event of overdose, appropriate supportive treatment should be initiated according to the patientu2019s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of RYBELSUSof approximately 1 week.
  • RYBELSUS tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is CHNO and the molecular weight is 4113.58 g/mol.
  • Structural formula:
  • Semaglutide is a white to almost white hygroscopic powder. Each tablet of RYBELSUS contains 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).
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  • RYBELSUS tablets are available as follows:
  • Arrayn- Storage and Handling
  • Store at 68u00b0 to 77u00b0F (20 to 25u00b0C); excursions permitted to 59u00b0 to 86u00b0F (15u00b0 to 30u00b0C) [see USP Controlled Room Temperature]. Store and dispense in the original carton.
  • Store tablet in the original blister card until use to protect tablets from moisture. Store product in a dry place away from moisture.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Risk of Thyroid C-cell Tumors
  • Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician .
  • Pancreatitis
  • Inform patients of the potential risk for pancreatitis. Instruct patients to discontinue RYBELSUS promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting) n
  • Diabetic Retinopathy Complications
  • Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS n
  • Dehydration and Renal Failure
  • Advise patients treated with RYBELSUS of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs .
  • Hypersensitivity Reactions
  • Inform patients to stop taking RYBELSUS and seek medical advice promptly if symptoms of hypersensitivity reactions occur.
  • Pregnancy
  • Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant n n
  • Lactation
  • Advise females not to breastfeed during treatment with RYBELSUS .
  • Females and Males of Reproductive Potential
  • Discontinue RYBELSUS at least 2 months before a planned pregnancy due to the long washout period for semaglutide .
  • Manufactured by:Novo Nordisk A/S
  • DK-2880 Bagsvaerd
  • Denmark
  • For information about RYBELSUS contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536
  • 1-833-457-7455
  • Date of Issue: January 2020
  • Version: 2
  • RYBELSUSn- and OZEMPICare registered trademarks of Novo Nordisk A/S.
  • PATENT INFORMATION
  • u00a9 2020 Novo Nordisk
  • No data
  • NDC 0169--13List 430313
  • 3mg
  • RYBELSUSn
  • (semaglutide) Tablets
  • 3 mg
  • Once daily
  • Each tablet contains 3 mg semaglutide
  • Oral use only
  • Rx only
  • Dispense the Enclosed Medication Guide to Each Patient
  • 30 tablets
  • 3 blister packs. Each pack contains 10 tablets.
  • Open
  • Here
  • NDC 0169--13 List 430313
  • 7mg
  • RYBELSUSn
  • (semaglutide) Tablets
  • 3 mg
  • Once daily
  • Each tablet contains 7 mg semaglutide
  • Oral use only
  • Rx only
  • Dispense the Enclosed Medication Guide to Each Patient
  • 30 tablets
  • 3 blister packs. Each pack contains 10 tablets.
  • Open
  • Here
  • NDC 0169--13 List 431413
  • 14mg
  • RYBELSUSn
  • (semaglutide) Tablets
  • 14 mg
  • Once daily
  • Each tablet contains 14 mg semaglutide
  • Oral use only
  • Rx only
  • Dispense the Enclosed Medication Guide to Each Patient
  • 30 tablets
  • 3 blister packs. Each pack contains 10 tablets.
  • Open
  • Here

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oral Semaglutide (RYBELSUS) which is also known as RYBELSUS and Manufactured by Novo Nordisk. It is available in strength of 3 mg/1 per ml.

Oral Semaglutide (RYBELSUS) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.Click to know price.

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