Rybelsus (semaglutide)
RYBELSUS 3 MG Oral Tablet
Dosage & Administration
Dosage & Administration
drug label
Rybelsus Prescribing Information
samples
Request Rybelsus Samples
financial assistance
Rybelsus Financial Assistance Options
patient education
Rybelsus Patient Education
To share resource; ask patient to:
1.Pull out phone
2.Open camera
3.Scan QR code with camera
4.Tap link
Patient toolkit
people also ask
Rybelsus FAQs
What is the risk of using RYBELSUS® during pregnancy?The available data with RYBELSUS® use in pregnant women are insufficient to evaluate the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Clinical considerations should be noted regarding the risks of poorly controlled diabetes during pregnancy.
How should RYBELSUS® be used during pregnancy?RYBELSUS® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What animal reproduction studies have been conducted with RYBELSUS®?In pregnant rats, embryofetal mortality, structural abnormalities, and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. Similar findings were observed in rabbits and cynomolgus monkeys at exposures below the MRHD.
What is the estimated background risk of major birth defects and miscarriage?The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7, and has been reported to be as high as 20–25% in women with a HbA1c >10. In the general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
What are the clinical considerations for poorly controlled diabetes during pregnancy?Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. It also increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
Is there any information on RYBELSUS® use during lactation?There are no data on the presence of semaglutide (active ingredient in RYBELSUS®) in human milk, its effects on the breastfed infant, or milk production. Semaglutide was detected in the milk of lactating rats. Due to species-specific differences, the clinical relevance of these data is not clear.
What should be considered regarding lactation and RYBELSUS®?Breastfeeding is not recommended during treatment with RYBELSUS® due to potential accumulation of certain substances (such as SNAC) in breast milk. There are alternative formulations of semaglutide that can be used during lactation.
When should RYBELSUS® be discontinued in relation to a planned pregnancy?RYBELSUS® should be discontinued in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.
Is RYBELSUS® safe for pediatric use?The safety and effectiveness of RYBELSUS® have not been established in pediatric patients (younger than 18 years).
How is RYBELSUS® affected by renal impairment?The safety and effectiveness of RYBELSUS® was evaluated in patients with moderate renal impairment, showing no clinically relevant change in semaglutide pharmacokinetics. No dose adjustment of RYBELSUS® is recommended for patients with renal impairment.
How is RYBELSUS® affected by hepatic impairment?In subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics was observed. No dose adjustment of RYBELSUS® is recommended for patients with hepatic impairment.
FAQ Data Source