Xultophy and Bydureon BCise Comparison

Xultophy®(insulin degludec / liraglutide)	Bydureon BCise®(exenatide)
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 Bydureon BCise injection is used together with diet and exercise to treat type 2 diabetes. This medicine is available by prescription...
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 2 mg by subcutaneous injection once every seven days (weekly), at any time of day and with or without meals. Administer immediately after the dose is prepared.. 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.	2 mg SC q7d any time, with/without meals. Administer immediately after preparation.. Learn more.
Out-Of-Pocket Costs With Copay Card
Insurance Specific Copay. Learn more.	$0. Learn more.
Annual Cap
Learn more.	$150 per monthly script. Learn more.
Assistance Expiration
Learn more.	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.	Most common (≥5%) in clinical trials: injection-site nodule, nausea.. 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.	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.

Xultophy®(insulin degludec / liraglutide)

Bydureon BCise®(exenatide)

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

Bydureon BCise injection is used together with diet and exercise to treat type 2 diabetes. This medicine is available by prescription...

Dosage & Administration

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 2 mg by subcutaneous injection once every seven days (weekly), at any time of day and with or without meals. Administer immediately after the dose is prepared.. 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.

2 mg SC q7d any time, with/without meals. Administer immediately after preparation.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

Insurance Specific Copay. Learn more.

$0. Learn more.

Annual Cap

Learn more.

$150 per monthly script. Learn more.

Assistance Expiration

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.

Most common (≥5%) in clinical trials: injection-site nodule, nausea.. 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.

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.

Xultophy® Alternatives