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Bydureon BCise® Alternatives

Bydureon BCise®(exenatide)
Ozempic®(semaglutide)
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
Ozempic (semaglutide) is a once-weekly injection that helps improve blood sugar levels in adults with type 2 diabetes mellitus. It also reduces the risk of major cardiovascular...
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.
0.25 mg SC injection q/week for 4 weeks. After 4 weeks, increase to 0.5 mg SC q/week. • If more control needed after 4 weeks on 0.5 mg, increase to 1 mg SC q/week • If further control needed after 4 weeks on 1 mg, increase to 2 mg SC q/week (max dose). . Learn more.
Latin Shorthand
2 mg SC q7d any time, with/without meals. Administer immediately after preparation.. Learn more.
0.25 mg SC injection q/week for 4 weeks. After 4 weeks, increase to 0.5 mg SC q/week. • If more control needed after 4 weeks on 0.5 mg, increase to 1 mg SC q/week • If further control needed after 4 weeks on 1 mg, increase to 2 mg SC q/week (max dose). . Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
Annual Cap
$150 per monthly script. Learn more.
$150 for 1 month supply; $300 for 2 month supply; $450 for 3 month supply. Learn more.
Assistance Expiration
24 months. Learn more.
Generics
No lower-cost generic available
No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common (≥5%) in clinical trials: injection-site nodule, nausea.. Learn more.
The most common adverse reactions, reported in ≥5% of patients treated with OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation.. Learn more.
Mechanism of Actions (MoA)
GLP-1 Receptor Agonists. 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.

What is the risk of using OZEMPIC® during pregnancy?

Limited data exist on the use of semaglutide in pregnant women, making it challenging to determine the potential drug-associated risk for adverse developmental outcomes. Poorly controlled diabetes during pregnancy poses risks for both the mother and fetus. OZEMPIC® should be used during pregnancy only if the potential benefits outweigh the potential risks.

What are the potential risks to the fetus from exposure to semaglutide during pregnancy?

Based on animal studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. In pregnant rats, exposure to semaglutide during organogenesis led to embryofetal mortality, structural abnormalities, and growth alterations. Similar findings were observed in rabbits and cynomolgus monkeys.

What is the estimated background risk of birth defects and miscarriage in pregnant women?

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. For women with pre-gestational diabetes, the estimated background risk of major birth defects is 6 to 10% with a peri-conceptional HbA1c >7 and can be as high as 20 to 25% with a peri-conceptional HbA1c >10.

What are the disease-associated risks for pregnant women with poorly controlled diabetes?

Poorly controlled diabetes during pregnancy increases the risk of hypoglycemia, hyperglycemia, diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. It also increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

What do the animal data reveal about the effects of semaglutide exposure during pregnancy?

Animal data indicate that exposure to semaglutide during pregnancy in rats, rabbits, and cynomolgus monkeys can result in embryofetal mortality, structural abnormalities, and alterations in growth. These effects were observed at various dose levels and exposures in different animal species.

What is known about semaglutide exposure during lactation?

There is no information available regarding the presence of semaglutide in human milk or its effects on breastfed infants or milk production. Semaglutide was detected in the milk of lactating rats, but the clinical relevance of these findings is not clear.

Should OZEMPIC® be discontinued in women planning a pregnancy?

OZEMPIC® should be discontinued in women at least 2 months before planning a pregnancy due to the long washout period required for semaglutide.

Is OZEMPIC® safe for pediatric use?

Safety and efficacy of OZEMPIC® have not been established in pediatric patients (younger than 18 years).

Is OZEMPIC® safe for geriatric use?

No overall differences in safety or efficacy have been detected between older and younger patients in clinical trials. However, caution should be exercised in geriatric patients.

Is OZEMPIC® safe for patients with renal impairment?

No dose adjustment of OZEMPIC® is recommended for patients with renal impairment. Semaglutide pharmacokinetics have not shown clinically relevant changes in subjects with renal impairment, including end-stage renal disease.

Is OZEMPIC® safe for patients with hepatic impairment?

No dose adjustment of OZEMPIC® is recommended for patients with hepatic impairment. Semaglutide pharmacokinetics have not shown clinically relevant changes in subjects with varying degrees of hepatic impairment.