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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.
Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg daily. If needed ↑ to 1.8 mg daily after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed ↑ to 1.2 mg daily; if further needed, ↑ to 1.8 mg daily after ≥ 1 wk at 1.2 mg dose.. Learn more.
Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg qd. If needed, ↑ to 1.8 mg qd after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed, ↑ to 1.2 mg qd; if further needed, ↑ to 1.8 mg qd after ≥ 1 wk at 1.2 mg dose.. Learn more.
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Most common adverse reactions (incidence ≥5%) in clinical trials are nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation. Immunogenicity-related events, including urticaria, were more common among VICTOZA®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. Learn more.
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 are the considerations regarding the use of VICTOZA® during pregnancy?
Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA® during pregnancy. VICTOZA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities. The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes is 6 to 10%. Clinical considerations include the increased risk of maternal and fetal complications associated with poorly controlled diabetes.
What are the considerations regarding the use of VICTOZA® during lactation?
There are no data on the presence of VICTOZA® in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in the milk of lactating rats. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VICTOZA® and any potential adverse effects on the breastfed infant from VICTOZA® or from the underlying maternal condition.
What is known about the safety and effectiveness of VICTOZA® in pediatric patients?
The safety and effectiveness of VICTOZA® as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. Use of VICTOZA® for this indication is supported by clinical trials. The risk of hypoglycemia was higher with VICTOZA® in pediatric patients. VICTOZA® has not been established in pediatric patients less than 10 years of age.
Are there any age-related differences in the safety and effectiveness of VICTOZA®?
In clinical trials, no overall differences in safety or effectiveness for VICTOZA® have been observed between patients 65 years of age and older and younger patients.
How should VICTOZA® be used in patients with renal impairment?
No dose adjustment of VICTOZA® is recommended for patients with renal impairment. The safety and efficacy of VICTOZA® was evaluated in patients with moderate renal impairment. In clinical trials, no overall differences in safety or efficacy were seen in patients with renal impairment compared to patients with normal renal function. Use caution in patients who experience dehydration.
What are the recommendations for using VICTOZA® in patients with hepatic impairment?
There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, VICTOZA® should be used with caution in this patient population. No dose adjustment of VICTOZA® is recommended for patients with hepatic impairment.
How does VICTOZA® affect patients with gastroparesis?
VICTOZA® slows gastric emptying. VICTOZA® has not been studied in patients with pre-existing gastroparesis.
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