Xultophy and Soliqua Comparison

Xultophy®(insulin degludec / liraglutide)	Soliqua ®(insulin glargine / lixisenatide)
Prescription Only Xultophy is an injection pen combining insulin degludec and liraglutide. Insulin degludec provides long-acting glucose control, while liraglutide assists in regulating blood...	Prescription Only Soliqua 100/33 is a combination medication featuring insulin glargine and lixisenatide. Insulin glargine offers prolonged blood glucose reduction, while lixisenatide enhances...
Administration
Subcutaneous. Learn more.	Subcutaneous. Learn more.
Dosing
Administer XULTOPHY® 100/3.6 by subcutaneous injection once-daily at the same time each day with or without food. See complete table for starting dose and titration schedule in the PI.. 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
Administer XULTOPHY® 100/3.6 by SC injection qd at the same time each day with or without food.. 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.
Out-Of-Pocket Costs With Copay Card
Insurance Specific Copay. 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
Adverse Reactions
• Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection. • Immunogenicity-related events, including urticaria, were more common among liraglutide-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. 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)
GLP-1 Receptor Agonists. Learn more.	GLP-1 Receptor Agonists. Learn more.
Special Populations
Is there a risk to the fetus from exposure to liraglutide during pregnancy? Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. XULTOPHY® 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Are there available data on the use of XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women? There are no available data with XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy. What are the findings from animal reproduction studies for insulin degludec during pregnancy? For insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. No adverse outcomes were observed for pregnant animals and offspring. What are the findings from animal reproduction studies for liraglutide during pregnancy? For liraglutide, 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 in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. What is the estimated background risk of major birth defects and miscarriage in the general population and in women with pre-gestational diabetes? In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20 to 25% in women with a peri-conceptional HbA1c >10. What are the disease-associated maternal and/or embryo/fetal risks related to poorly controlled diabetes in pregnancy? Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. Are there data on the presence of liraglutide or insulin degludec in human milk, their effects on the breastfed infant, or effects on milk production? There are no data on the presence of liraglutide or insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production. In lactating rats, insulin degludec and liraglutide, the two components of XULTOPHY® 100/3.6, were present in milk. What are the safety and effectiveness considerations for pediatric use of XULTOPHY® 100/3.6? Safety and effectiveness of XULTOPHY® 100/3.6 have not been established in pediatric patients. Are there age-related differences in safety and effectiveness for geriatric patients using XULTOPHY® 100/3.6? No overall differences in safety or effectiveness of XULTOPHY® 100/3.6 were observed between patients 65 years of age and older and younger patients. Age had no clinically relevant effect on the pharmacokinetics of XULTOPHY® 100/3.6. What are the considerations for XULTOPHY® 100/3.6 use in patients with renal impairment? There is limited experience with XULTOPHY® 100/3.6 in patients with mild and moderate kidney impairment and when used in these patients, additional glucose monitoring and XULTOPHY® 100/3.6 dose adjustments may be required on an individual basis. XULTOPHY® 100/3.6 has not been studied in patients with severe kidney impairment. Are there any differences in insulin degludec pharmacokinetics in patients with kidney impairment? No clinically relevant difference in the pharmacokinetics of insulin degludec was identified in a study comparing healthy subjects and subjects with kidney impairment, including subjects with end stage kidney disease. What is the effect of liraglutide on kidney impairment? The safety and efficacy of liraglutide was evaluated in a 26-week clinical study that included patients with moderate kidney impairment. There is limited experience with liraglutide in patients with end stage kidney disease. Are there considerations for XULTOPHY® 100/3.6 use in patients with hepatic impairment? XULTOPHY® 100/3.6 has not been studied in patients with hepatic impairment. Are there any differences in insulin degludec pharmacokinetics in patients with hepatic impairment? No clinically relevant difference in the pharmacokinetics of insulin degludec, one of the components of XULTOPHY® 100/3.6, was identified in a study comparing healthy subjects and subjects with hepatic impairment. What is the effect of liraglutide on hepatic impairment? There is limited experience in patients with mild, moderate, or severe hepatic impairment with liraglutide, one of the components of XULTOPHY® 100/3.6. Does liraglutide, a component of XULTOPHY® 100/3.6, have an impact on gastric emptying? Liraglutide, one of the components of XULTOPHY® 100/3.6, slows gastric emptying. XULTOPHY® 100/3.6 has not been studied in patients with pre-existing gastroparesis.	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.

Xultophy®(insulin degludec / liraglutide)

Soliqua ®(insulin glargine / lixisenatide)

Prescription Only

Xultophy is an injection pen combining insulin degludec and liraglutide. Insulin degludec provides long-acting glucose control, while liraglutide assists in regulating blood...

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

Subcutaneous. Learn more.

Dosing

Administer XULTOPHY® 100/3.6 by subcutaneous injection once-daily at the same time each day with or without food. See complete table for starting dose and titration schedule in the PI.. 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

Administer XULTOPHY® 100/3.6 by SC injection qd at the same time each day with or without food.. 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

Out-Of-Pocket Costs With Copay Card

Insurance Specific Copay. 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

Physician Advisory

Adverse Reactions

• Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection. • Immunogenicity-related events, including urticaria, were more common among liraglutide-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. 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)

GLP-1 Receptor Agonists. Learn more.

Special Populations

Is there a risk to the fetus from exposure to liraglutide during pregnancy?

Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. XULTOPHY® 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Are there available data on the use of XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women?

There are no available data with XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy.

What are the findings from animal reproduction studies for insulin degludec during pregnancy?

For insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. No adverse outcomes were observed for pregnant animals and offspring.

What are the findings from animal reproduction studies for liraglutide during pregnancy?

For liraglutide, 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 in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day.

What is the estimated background risk of major birth defects and miscarriage in the general population and in women with pre-gestational diabetes?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20 to 25% in women with a peri-conceptional HbA1c >10.

What are the disease-associated maternal and/or embryo/fetal risks related to poorly controlled diabetes in pregnancy?

Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

Are there data on the presence of liraglutide or insulin degludec in human milk, their effects on the breastfed infant, or effects on milk production?

There are no data on the presence of liraglutide or insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production. In lactating rats, insulin degludec and liraglutide, the two components of XULTOPHY® 100/3.6, were present in milk.

What are the safety and effectiveness considerations for pediatric use of XULTOPHY® 100/3.6?

Safety and effectiveness of XULTOPHY® 100/3.6 have not been established in pediatric patients.

Are there age-related differences in safety and effectiveness for geriatric patients using XULTOPHY® 100/3.6?

No overall differences in safety or effectiveness of XULTOPHY® 100/3.6 were observed between patients 65 years of age and older and younger patients. Age had no clinically relevant effect on the pharmacokinetics of XULTOPHY® 100/3.6.

What are the considerations for XULTOPHY® 100/3.6 use in patients with renal impairment?

There is limited experience with XULTOPHY® 100/3.6 in patients with mild and moderate kidney impairment and when used in these patients, additional glucose monitoring and XULTOPHY® 100/3.6 dose adjustments may be required on an individual basis. XULTOPHY® 100/3.6 has not been studied in patients with severe kidney impairment.

Are there any differences in insulin degludec pharmacokinetics in patients with kidney impairment?

No clinically relevant difference in the pharmacokinetics of insulin degludec was identified in a study comparing healthy subjects and subjects with kidney impairment, including subjects with end stage kidney disease.

What is the effect of liraglutide on kidney impairment?

The safety and efficacy of liraglutide was evaluated in a 26-week clinical study that included patients with moderate kidney impairment. There is limited experience with liraglutide in patients with end stage kidney disease.

Are there considerations for XULTOPHY® 100/3.6 use in patients with hepatic impairment?

XULTOPHY® 100/3.6 has not been studied in patients with hepatic impairment.

Are there any differences in insulin degludec pharmacokinetics in patients with hepatic impairment?

No clinically relevant difference in the pharmacokinetics of insulin degludec, one of the components of XULTOPHY® 100/3.6, was identified in a study comparing healthy subjects and subjects with hepatic impairment.

What is the effect of liraglutide on hepatic impairment?

There is limited experience in patients with mild, moderate, or severe hepatic impairment with liraglutide, one of the components of XULTOPHY® 100/3.6.

Does liraglutide, a component of XULTOPHY® 100/3.6, have an impact on gastric emptying?

Liraglutide, one of the components of XULTOPHY® 100/3.6, slows gastric emptying. XULTOPHY® 100/3.6 has not been studied in patients with pre-existing gastroparesis.

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.

Xultophy® Alternatives