Bydureon and Victoza Comparison

Bydureon®(exenatide)	Victoza®(liraglutide)
Prescription Only Bydureon BCise injection is used together with diet and exercise to treat type 2 diabetes. This medicine is available by prescription...	Prescription Only Victoza is a medication that mimics a natural hormone in the body to regulate blood sugar, insulin, and digestion. It is used in conjunction with diet and exercise to enhance...
Administration
Subcutaneous . Learn more.	Subcutaneous. Learn more.
Dosing
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.	Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg daily. If needed ↑ to 1.8 mg daily after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed ↑ to 1.2 mg daily; if further needed, ↑ to 1.8 mg daily after ≥ 1 wk at 1.2 mg dose.. Learn more.
Latin Shorthand
2 mg SC q7d any time, with/without meals. Administer immediately after preparation.. Learn more.	Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg qd. If needed, ↑ to 1.8 mg qd after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed, ↑ to 1.2 mg qd; if further needed, ↑ to 1.8 mg qd after ≥ 1 wk at 1.2 mg dose.. Learn more.
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$25. Learn more.
Annual Cap
$150 per monthly script. Learn more.	$150 for 1 month supply; $300 for a 2 month supply; $450 for a 3 month supply. Learn more.
Assistance Expiration
Learn more.	24 months from activation. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
Most common (≥5%) in clinical trials: injection-site nodule, nausea.. Learn more.	Most common adverse reactions (incidence ≥5%) in clinical trials are nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation. Immunogenicity-related events, including urticaria, were more common among VICTOZA®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. Learn more.
Mechanism of Actions (MoA)
GLP-1 Receptor Agonists. Learn more.	Diabetes Mellitus, Type 2. 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.	What are the considerations regarding the use of VICTOZA® during pregnancy? Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA® during pregnancy. VICTOZA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes is 6 to 10%. Clinical considerations include the increased risk of maternal and fetal complications associated with poorly controlled diabetes. What are the considerations regarding the use of VICTOZA® during lactation? There are no data on the presence of VICTOZA® in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in the milk of lactating rats. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VICTOZA® and any potential adverse effects on the breastfed infant from VICTOZA® or from the underlying maternal condition. What is known about the safety and effectiveness of VICTOZA® in pediatric patients? The safety and effectiveness of VICTOZA® as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. Use of VICTOZA® for this indication is supported by clinical trials. The risk of hypoglycemia was higher with VICTOZA® in pediatric patients. VICTOZA® has not been established in pediatric patients less than 10 years of age. Are there any age-related differences in the safety and effectiveness of VICTOZA®? In clinical trials, no overall differences in safety or effectiveness for VICTOZA® have been observed between patients 65 years of age and older and younger patients. How should VICTOZA® be used in patients with renal impairment? No dose adjustment of VICTOZA® is recommended for patients with renal impairment. The safety and efficacy of VICTOZA® was evaluated in patients with moderate renal impairment. In clinical trials, no overall differences in safety or efficacy were seen in patients with renal impairment compared to patients with normal renal function. Use caution in patients who experience dehydration. What are the recommendations for using VICTOZA® in patients with hepatic impairment? There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, VICTOZA® should be used with caution in this patient population. No dose adjustment of VICTOZA® is recommended for patients with hepatic impairment. How does VICTOZA® affect patients with gastroparesis? VICTOZA® slows gastric emptying. VICTOZA® has not been studied in patients with pre-existing gastroparesis.

Bydureon®(exenatide)

Victoza®(liraglutide)

Prescription Only

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

Prescription Only

Victoza is a medication that mimics a natural hormone in the body to regulate blood sugar, insulin, and digestion. It is used in conjunction with diet and exercise to enhance...

Dosage & Administration

Administration

Subcutaneous . Learn more.

Subcutaneous. Learn more.

Dosing

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.

Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg daily. If needed ↑ to 1.8 mg daily after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed ↑ to 1.2 mg daily; if further needed, ↑ to 1.8 mg daily after ≥ 1 wk at 1.2 mg dose.. Learn more.

Latin Shorthand

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

Adult: Initiate: 0.6 mg SC qd x 1wk, then ↑ to 1.2 mg qd. If needed, ↑ to 1.8 mg qd after 1 wk at 1.2 mg dose. Pediatrics: Initiate: 0.6 mg SC qd x ≥ 1 wk. If needed, ↑ to 1.2 mg qd; if further needed, ↑ to 1.8 mg qd after ≥ 1 wk at 1.2 mg dose.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

$25. Learn more.

Annual Cap

$150 per monthly script. Learn more.

$150 for 1 month supply; $300 for a 2 month supply; $450 for a 3 month supply. Learn more.

Assistance Expiration

Learn more.

24 months from activation. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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

Most common adverse reactions (incidence ≥5%) in clinical trials are nausea, diarrhea, vomiting, decreased appetite, dyspepsia, constipation. Immunogenicity-related events, including urticaria, were more common among VICTOZA®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. Learn more.

Mechanism of Actions (MoA)

GLP-1 Receptor Agonists. Learn more.

Diabetes Mellitus, Type 2. 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.

What are the considerations regarding the use of VICTOZA® during pregnancy?

Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA® during pregnancy. VICTOZA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes is 6 to 10%. Clinical considerations include the increased risk of maternal and fetal complications associated with poorly controlled diabetes.

What are the considerations regarding the use of VICTOZA® during lactation?

There are no data on the presence of VICTOZA® in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in the milk of lactating rats. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VICTOZA® and any potential adverse effects on the breastfed infant from VICTOZA® or from the underlying maternal condition.

What is known about the safety and effectiveness of VICTOZA® in pediatric patients?

The safety and effectiveness of VICTOZA® as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. Use of VICTOZA® for this indication is supported by clinical trials. The risk of hypoglycemia was higher with VICTOZA® in pediatric patients. VICTOZA® has not been established in pediatric patients less than 10 years of age.

Are there any age-related differences in the safety and effectiveness of VICTOZA®?

In clinical trials, no overall differences in safety or effectiveness for VICTOZA® have been observed between patients 65 years of age and older and younger patients.

How should VICTOZA® be used in patients with renal impairment?

No dose adjustment of VICTOZA® is recommended for patients with renal impairment. The safety and efficacy of VICTOZA® was evaluated in patients with moderate renal impairment. In clinical trials, no overall differences in safety or efficacy were seen in patients with renal impairment compared to patients with normal renal function. Use caution in patients who experience dehydration.

What are the recommendations for using VICTOZA® in patients with hepatic impairment?

There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, VICTOZA® should be used with caution in this patient population. No dose adjustment of VICTOZA® is recommended for patients with hepatic impairment.

How does VICTOZA® affect patients with gastroparesis?

VICTOZA® slows gastric emptying. VICTOZA® has not been studied in patients with pre-existing gastroparesis.

Bydureon® Alternatives