RYBELSUS Tablet (2021)

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Novo Nordisk

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BOXED WARNING SECTION

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 ...

1. Indications and Usage

RYBELSUS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)]. Limitations of Use: RYBELSUS ...

2. Dosage and Administration

2.1 Important Administration Instructions 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 ...

3. Dosage Forms and Strengths

RYBELSUS tablets are available as: 3 mg: white to light yellow, oval shaped debossed with 3 on one side and novo on the other side. 7 mg: white to light yellow, oval shaped debossed with 7 on one side ...

4. 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) [see Warnings ...

5. Warnings and Precautions

5.1 Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after ...

6. Adverse Reactions

The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)] Pancreatitis [see ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Immunogenicity

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with RYBELSUS may develop anti-semaglutide antibodies. The detection of antibody formation ...

6.3. Postmarketing Experience

The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of RYBELSUS. Because these reactions are reported voluntarily from a population of uncertain ...

7. Drug Interactions

7.1 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When initiating RYBELSUS, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) ...

8.1. Pregnancy

Risk Summary Available data with RYBELSUS use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats. ...

8.3. 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 [see Use in Specific Populations (8.1)].

8.4. Pediatric Use

Safety and efficacy of RYBELSUS have not been established in pediatric patients (younger than 18 years).

8.5. Geriatric Use

In the pool of glycemic control trials, 1229 (29.9%) RYBELSUS-treated patients were 65 years of age and over and 199 (4.8%) RYBELSUS-treated patients were 75 years of age and over. In PIONEER 6, the cardiovascular ...

8.6. Renal Impairment

The safety and efficacy of RYBELSUS was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73m²) [see Clinical Studies (14.1)] ...

8.7. Hepatic Impairment

In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. No dose ...

10. Overdosage

In the event of overdose, appropriate supportive treatment should be initiated according to the patients clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms ...

11. Description

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, ...

12.1. Mechanism of Action

Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native ...

12.2. Pharmacodynamics

All pharmacodynamic evaluations were performed after 12 weeks of treatment (including dose escalation) at steady state semaglutide injection 1 mg. Fasting and Postprandial Glucose Semaglutide reduces fasting ...

12.3. Pharmacokinetics

Absorption Semaglutide is co-formulated with salcaprozate sodium which facilitates the absorption of semaglutide after oral administration. The absorption of semaglutide predominantly occurs in the stomach. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113-fold the maximum recommended human dose (MRHD) of RYBELSUS 14 mg, based on AUC] were administered ...

13.2. Animal Toxicology and/or Pharmacology

Increase in lactate levels and decrease in glucose levels in the plasma and cerebrospinal fluid (CSF) were observed in mechanistic studies with SNAC in rats. Small but statistically significant increases ...

14. Clinical Studies

14.1 Overview of Clinical Studies RYBELSUS has been studied as monotherapy and in combination with metformin, sulfonylureas, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulins, and thiazolidinediones ...

16.1. How Supplied

RYBELSUS tablets are available as follows: Tablet Strength Description Package Configuration NDC No. 3 mg White to light yellow, oval shaped debossed with 3 on one side and novo on the other side ...

16.2. Storage and Handling

Store at 68° to 77°F (20 to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [see USP Controlled Room Temperature]. Store and dispense in the original bottle. Store tablet in the original bottle ...

17. Patient Counseling Information

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 ...