RYBELSUS Tablet Ref.[27432] Active ingredients: Semaglutide

Source: FDA, National Drug Code (US)  Revision Year: 2021 

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 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 [see Warnings and Precautions (5.1)].
  • RYBELSUS has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].
  • RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus.

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 water only [see Clinical Pharmacology (12.3)]. Waiting less than 30 minutes, or taking RYBELSUS 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.
  • Swallow tablets whole. Do not split, crush, or chew tablets.

2.2 Recommended Dosage

  • Start RYBELSUS with 3 mg once daily for 30 days. The 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
  • After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
  • 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.
  • Taking two 7 mg RYBELSUS tablets to achieve a 14 mg dose is not recommended.
  • If a dose is missed, the missed dose should be skipped, and the next dose should be taken the following day.

2.3 Switching Patients between OZEMPIC and RYBELSUS

  • Patients treated with RYBELSUS 14 mg daily can be transitioned to OZEMPIC subcutaneous injection 0.5 mg once weekly. Patients can start OZEMPIC the day after their last dose of RYBELSUS.
  • Patients treated with once weekly OZEMPIC 0.5 mg subcutaneous injection can be transitioned to RYBELSUS 7 mg or 14 mg. Patients can start RYBELSUS up to 7 days after their last injection of OZEMPIC. There is no equivalent dose of RYBELSUS for OZEMPIC 1 mg.

10. Overdosage

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s 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 RYBELSUS of approximately 1 week.

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 until use to protect tablets from moisture. Store product in a dry place away from moisture.

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