Rybelsus is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
It should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis.
2. DOSAGE AND ADMINISTRATION
The recommended starting dose of Rybelsus is 3 mg once daily, with or without food, for 30 days. After 30 days, the dose should be increased to 7 mg once daily.
Swallow the tablet whole. Do not split, crush, or chew the tablet.
3. 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).
4. WARNINGS AND PRECAUTIONS
Pancreatitis: Inform patients of the potential risk for pancreatitis while using Rybelsus.
Diabetic Retinopathy Complications: Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
5. ADVERSE REACTIONS
Common side effects may include nausea, diarrhea, vomiting, decreased appetite, and constipation.
6. DRUG INTERACTIONS
Inform your healthcare provider of all the medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
7. USE IN SPECIFIC POPULATIONS
Pregnancy: There is limited data on the use of Rybelsus in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether Rybelsus is excreted in human milk. Use caution when administering Rybelsus to a nursing woman.
8. OVERDOSAGE
In case of an overdose, contact a healthcare professional, poison control center, or emergency room immediately for advice.
This medication guide does not include all the information needed to use Rybelsus safely and effectively. For more comprehensive details, please consult your healthcare provider or pharmacist. Be sure to read the full prescribing information for Rybelsus, including the boxed warning.