Bydureon BCise(exenatide)
Dosage & Administration
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Bydureon BCise Prescribing Information
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Is my patient eligible for Bydureon BCise samples?
- Your rep will communicate with you how to receive samples, when you can receive samples, the amount and more.
How do I find out who my Bydureon BCise rep is?
- Not sure who your local Bydureon BCise pharma rep is? Reach out to AstraZeneca Pharmaceuticals LP and they can help you identify your rep.
Bydureon BCise Financial Assistance Options
Copay savings program
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Overview
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Bydureon BCise PubMed™ News
Bydureon BCise Patient Education
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Patient toolkit
Bydureon BCise FAQs
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.
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.
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.
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.
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.
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.
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.
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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available