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Soliqua®(Insulin Glargine And Lixisenatide)

Prescription Only

Soliqua 100/33 is a combination medication featuring insulin glargine and lixisenatide. Insulin glargine offers prolonged blood glucose reduction, while lixisenatide enhances...

Dosage & Administration

Administration

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Subcutaneous. Learn more.

Dosing

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Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.

Latin Shorthand

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Administer SOLIQUA 100/33 SC qd within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

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$9. Learn more.

Annual Cap

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$365 per pack. Learn more.

Assistance Expiration

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12 months. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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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)

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GLP-1 Receptor Agonists. Learn more.

Special Populations

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.

®()	Soliqua®(Insulin Glargine And Lixisenatide)

Prescription Only	Prescription Only Soliqua 100/33 is a combination medication featuring insulin glargine and lixisenatide. Insulin glargine offers prolonged blood glucose reduction, while lixisenatide enhances...
Dosage & Administration	Dosage & Administration comparison data
Administration
Learn more.	Subcutaneous. Learn more.
Dosing
Learn more.	Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.
Latin Shorthand
Learn more.	Administer SOLIQUA 100/33 SC qd within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
Learn more.	$9. Learn more.
Annual Cap
Learn more.	$365 per pack. Learn more.
Assistance Expiration
Learn more.	12 months. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory	Physician Advisory comparison data
Adverse Reactions
Learn more.	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)
Learn more.	GLP-1 Receptor Agonists. Learn more.
Special Populations
	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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