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Soliqua®(insulin glargine / lixisenatide)
|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
The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.. 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.
1. What are the pregnancy risks associated with SOLIQUA 100/33?
Based on animal studies, there may be fetal risks from exposure to lixisenatide during pregnancy. SOLIQUA 100/33 should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Limited data are available, and there is no clear association with major birth defects or miscarriage risk.
2. What is the risk of major birth defects and miscarriage in pregnant women with diabetes?
The estimated background risk of major birth defects is 6%–10% in women with pregestational diabetes and HbA1c >7, and it can be as high as 20%–25% with HbA1c >10. The background risk of miscarriage for this population is unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage is 2%–4% and 15%–20%, respectively.
3. What are the maternal and fetal risks associated with 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. The fetal risk includes major birth defects, stillbirth, and macrosomia-related morbidity.
4. What fetal risks are associated with lixisenatide exposure during pregnancy?
Lixisenatide exposure in pregnant rats and rabbits was associated with visceral closure and skeletal defects. These effects were observed at exposures higher than the highest clinical dose. Decreases in maternal food intake and weight gain were also observed. However, the relevance of these findings to human risk assessment is confounded by concurrent maternal effects.
5. Is there any information about lixisenatide and insulin glargine in human milk?
There is no information about the presence of lixisenatide and insulin glargine in human milk, their effects on the breastfed infant, or their effects on milk production. Lixisenatide is present in rat milk.
6. Is SOLIQUA 100/33 safe and effective for pediatric patients?
Safety and effectiveness of SOLIQUA 100/33 have not been established in pediatric patients.
7. What should be considered for geriatric patients using SOLIQUA 100/33?
While no overall differences in effectiveness and safety were observed in geriatric patients, caution should be exercised. In elderly patients with diabetes, dosing should be conservative to avoid hypoglycemic reactions, as hypoglycemia may be difficult to recognize in the elderly.
8. What are the considerations for patients with renal impairment using SOLIQUA 100/33?
Frequent glucose monitoring and dose adjustment may be necessary for SOLIQUA 100/33 in patients with renal impairment. Patients with severe renal impairment should be closely monitored for adverse reactions and changes in renal function.
9. How does hepatic impairment affect the use of SOLIQUA 100/33?
The effect of hepatic impairment on the pharmacokinetics of SOLIQUA 100/33 has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for patients with hepatic impairment.
10. Can SOLIQUA 100/33 be used in patients with gastroparesis?
SOLIQUA 100/33 is not recommended for patients with severe gastroparesis. Lixisenatide, a component of SOLIQUA 100/33, slows gastric emptying.
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