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|Dosage & Administration|
Start RYBELSUS® with 3 mg once daily for 30 days. The 3 mg dosage is intended for treatment initiation. •After 30 days on the 3 mg dosage, increase the dosage to 7 mg once daily. •The dosage may be increased to 14 mg.. Learn more.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Mechanism of Actions (MoA)
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.
What is the risk of using BYDUREON BCISE during pregnancy?
Limited data with exenatide, the active ingredient in BYDUREON BCISE, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to BYDUREON BCISE during pregnancy. BYDUREON BCISE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What were the findings of animal reproduction studies with exenatide during pregnancy?
Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy or from exposure to exenatide during pregnancy and lactation, in association with maternal effects. In rats, exenatide extended-release, administered during the period of organogenesis, reduced fetal growth and produced skeletal ossification deficits at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 2 mg/week. In mice, exenatide administered during gestation and lactation, caused increased neonatal deaths at doses that approximate clinical exposures at the MRHD.
What is the estimated background risk of birth defects and miscarriage in women with diabetes?
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 HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
What maternal and fetal risks are associated with poorly controlled diabetes in pregnancy?
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.
What is the risk of using BYDUREON BCISE during lactation?
There is no information regarding the presence of exenatide, in human milk, the effects of exenatide on the breastfed infant, or the effects of exenatide on milk production. Exenatide, the active ingredient in BYDUREON BCISE was present in the milk of lactating mice. However, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear.
What is the recommended use of BYDUREON BCISE in pediatric patients?
The safety and effectiveness of BYDUREON BCISE as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients aged 10 years and older. Use of BYDUREON BCISE for this indication is supported by clinical studies. Safety and effectiveness of BYDUREON BCISE have not been established in pediatric patients less than 10 years of age.
What are the considerations for using BYDUREON BCISE in geriatric patients?
In two comparator-controlled trials, BYDUREON BCISE was studied in older patients, with no meaningful differences in safety and effectiveness observed between patients ≥65 years of age and younger adults. However, caution is advised when initiating BYDUREON BCISE in geriatric patients due to potential decreased kidney function.
How does renal impairment affect the use of BYDUREON BCISE?
Pharmacokinetic studies indicate an increase in exenatide exposure in patients with mild and moderate renal impairment compared to those with normal kidney function. BYDUREON BCISE may induce adverse reactions leading to hypovolemia in patients with renal impairment. It is not recommended for use in patients with eGFR below 45 mL/min/1.73 m2 or end-stage renal disease.
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