Glyxambi and Bydureon BCise Comparison

Glyxambi®(empagliflozin / linagliptin)	Bydureon BCise®(exenatide)
Prescription Only Glyxambi is a medication that combines empagliflozin and linagliptin, both of which are oral drugs designed to manage blood sugar levels. Empagliflozin operates by aiding the...	Prescription Only Bydureon BCise injection is used together with diet and exercise to treat type 2 diabetes. This medicine is available by prescription...
Administration
Oral . Learn more.	Subcutaneous . Learn more.
Dosing
The recommended dose of GLYXAMBI is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.. 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
Recommended GLYXAMBI dose: 10mg empagliflozin + 5mg linagliptin qd in the AM, with or without food. May increase to 25mg empagliflozin + 5mg linagliptin qd.. Learn more.	2 mg SC q7d any time, with/without meals. Administer immediately after preparation.. Learn more.
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$0. Learn more.
Annual Cap
$175 per month. 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 (5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections.. Learn more.	Most common (≥5%) in clinical trials: injection-site nodule, nausea.. Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	GLP-1 Receptor Agonists. Learn more.
Special Populations
	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.

Glyxambi®(empagliflozin / linagliptin)

Bydureon BCise®(exenatide)

Prescription Only

Glyxambi is a medication that combines empagliflozin and linagliptin, both of which are oral drugs designed to manage blood sugar levels. Empagliflozin operates by aiding the...

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

Oral . Learn more.

Subcutaneous . Learn more.

Dosing

The recommended dose of GLYXAMBI is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.. 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

Recommended GLYXAMBI dose: 10mg empagliflozin + 5mg linagliptin qd in the AM, with or without food. May increase to 25mg empagliflozin + 5mg linagliptin qd.. 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

$10. Learn more.

$0. Learn more.

Annual Cap

$175 per month. 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 (5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections.. Learn more.

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

Mechanism of Actions (MoA)

SGLT2 Inhibitors. Learn more.

GLP-1 Receptor Agonists. Learn more.

Special Populations

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.

Glyxambi® Alternatives