Singledose pen which contains 2 mg of exenatide white to offwhite powder, diluent, and. The new bydureon device is a prefilled, singleuse pen injector, which eliminates the need for the user to transfer the medication between a vial and syringe during the selfinjection process and reduces some of the hassle factor of taking bydureon. The new autoinjector features a simpler mixing process, a hidden needle, and a viewing window for users to confirm that theyve received the medication. Do not use bydureon after the expiration date printed on the product packaging carton and pen injector. Bydureon is not a substitute for insulin and has not been studied in combination with insulin.
Bydureon bcise causes thyroid ccell tumors, including medullary thyroid carcinoma mtc in humans, as the human relevance of exenatide extendedreleaseinduced rodent thyroid ccell tumors has not been determined. Bydureon bcise has a unique, continuousrelease microsphere delivery system designed to provide consistent therapeutic levels of exenatide. How to use bydureon bcise bydureon bcise exenatide. Dr eggitt explains how to use the new bydureon pen device the oakwood surgery, doncaster uk. Bydureon bcise is expected to launch in early 2018. Bydureon is a longacting form of the medication in byetta exenatide injection so both drugs should not be used together. New bydureon pen for diabetes now available goodrx. Bydureon singledose tray which contains one vial of 2 mg exenatide, one vial connector, one prefilled diluent syringe, and two needles one provided as a spare. Do not give your bydureon bcise to other people, even if they have the same symptoms you have.
To use the pen, set the needle on top and turn the knob on the. Medication guide bydureon bydureeon for injectable. The dose can be administered at any time of day, with or without meals. Refer to the user manual each time you inject this medicine. This drug has four hundred and seventysix patent family members in fortyseven countries. Bydureon medicare coverage and copay details goodrx. Goodrx has partnered with inside rx and astrazeneca to reduce the price for this prescription. Bydureon exenatide extendedrelease for injectable suspension. Bydureon can be used with or without food and given at any time of the day. Bydureon exenatide extendedrelease and bydureon bcise may cause serious side effects, including. This bydureon price guide is based on using the drugs. Fda approves bydureon bcise new autoinjector to launch. We also recommend that you view the video below before using the bydureon pen. Most peoplein fact 85% who were part of a studyagreed that onceweekly bydureon bcise is easy or very easy to use its a noninsulin medicine in an injectable device holding just one dose.
The bydureon pen contains the same formulation and dose as the original bydureon singledose tray, providing the same continuous release of exenatide. Bydureon is the first onceweekly treatment option for adults with type 2 diabetes, and bydureon pen now offers the same continuous release of exenatide in a prefilled device, said john yee, m. Please click here for medication guide, and click here for full prescribing information for bydureon pen. Bydureon 2 mg powder and solvent for prolongedrelease suspension for injection in prefilled pen. Capitals indicate lifethreatening, underlines indicate most frequent. Bydureon pen is designed to be patientfriendly and can be used any time of day, with or without meals. Your 1st injection bydureon exenatide extendedrelease for. Possible thyroid tumors, including cancer tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. The bydureon pen requires the needle to be assembled to the pen. Bydureon pen should be trained on proper mixing and injection. Us fda approves new easytouse, onceweekly bydureon. Learn more about bydureon bcise, an enhanced formulation in a simplified device. Astrazeneca launches the new bydureon pen in the us diatribe. You can keep a pen at room temperature for 28 days.
The european medicines agency noted that the benefits of bydureon, such as its effect on reducing the levels of hba1c, compare well with those of comparator medicines and that its side effects are manageable. This medication guide provides information about the bydureon brand of exenatide. Before using bydureon bcise, talk to your healthcare provider about how to use it the right way. Highlights of prescribing information history of drug. The recommended dose of bydureon is 2 mg subcutaneously once every 7 days weekly. Bydureon is covered by some medicare and insurance plans. Home conditions diabetes type 2 diabetes drug bydureon gets a makeover. Us fda approves new easytouse, onceweekly bydureon bcise injectable medicine for patients with type2 diabetes. Bydureon 2 mg powder and solvent for prolongedrelease suspension for injection in prefilled pen how to use bydureon prefilled pen cover knob orange label striped label needle top of pen mixing window inspection window green label prior to use of the pen, it is recommended that you should be trained by a doctor or diabetes nurse on its proper. Exenatide exenatide extendedrelease storing your pens store your pens in the refrigerator until you use them. After mixing, check the window to see if the medicine is cloudy with no clumps.
It was previously available only in the kit with syringe. Your doctor has most likely explained about your new treatment plan, but when starting a new. Bydureon prices, coupons and patient assistance programs. Bcise for a condition for which it was not prescribed.
The agency therefore decided that bydureon s benefits are greater than its risks and recommended that it be given marketing authorisation. Bydureon is currently available as a pen and a singledose tray formulation, both which require assembly. Bydureon exenatide is a member of the incretin mimetics drug class and is commonly used for diabetes type 2. Byetta is another brand of exenatide that is not covered in this medication guide bydureon pen is an injectable diabetes medicine that helps control blood sugar levels. Bydureon is provided in a pen injector consisting of a dual. Though it isnt insulin, it is injected in a similar way. A bydureon pen is a userfriendly way to lower blood sugar in people with type 2 diabetes. Chinese, simplified mandarin dialect bilingual pdf. You may change your weekly dosing day, but do not inject on your new dosing day if it has been less than 3 days since your last dose. Byetta exenatide injection and bydureontm exenatide. Bydureon exenatide extendedrelease for injectable suspension is available as. Bydureon bcise is a onceweekly, noninsulin prescription medicine used along with diet and exercise to help improve blood sugar in adults with type 2 diabetes.
Check our savings tips for copay cards, assistance programs, and other ways to reduce your cost. Each singledose pen contains 2 mg of exenatide and diluent, and includes one needle. Read the user manual for information on how to use the bydureon kit, pen or autoinjector before use. Bydureon is a glp1 analogue, the first weekly treatment for type 2 diabetes. If a dose is missed, administer the dose as soon as noticed, provided the next regularly scheduled dose is. Dispose of your pen, with the needle attached, in a punctureresistant container. Bydureon bcise exenatide extendedrelease new formulation. Roni shye, pharmd bcgp bcacp, is a licensed pharmacist in the states of florida, ohio, and pennsylvania. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Advise patient that new pen setup should be done only. Learn how to use bydureon bcise exenatide extendedrelease. Type 2 diabetes drug bydureon gets a makeover goodrx. The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before the new day of administration.
For subcutaneous use only singledose autoinjector once weekly. Bydureon bcise autoinjector must be injected immediately after mixing the suspension. Bydureon is not recommended as the first medication to treat diabetes. Read the user manual each time you get a new kit or pen, in case something has changed. The main differences between the old bydureon pen and the new bydureon bcise are as follows. The design of the new device incorporates user and healthcare provider feedback on the previous bydureon dualchambered pen. Information for the user bydureon 2 mg powder and solvent for prolongedrelease suspension for injection in prefilled pen exenatide read all of this leaflet carefully before you start using this medicine because it contains important information for you. The fda recently approved a new pen form of diabetes injection bydureon exenatide, which is gaining popularity and causing mixups at the pharmacy the existing bydureon vial and the new pen contain the same medication, but the two forms are not interchangeableyour pharmacist will need to fill the form your doctor has prescribed. Bydureon is a drug marketed by astrazeneca ab and is included in two ndas. Bydureon may cause serious side effects, including. Im not a fan of bydureon because it has statistically less a1c lowering compared to once daily victoza duration6 trial. You can ask your pharmacist or healthcare provider for information about bydureon bcise that is written for health professionals. New formulation of onceweekly exenatide in an improved device provides significant hba1c reduction with added benefit of weight loss. When do bydureon patents expire, and what generic alternatives are available.
Read the instructions for use before you start using bydureon bcise. The recommended dose of bydureon bcise is 2 mg subcutaneously once every 7 days weekly. The bydureon pen requires the needle to be assembled to the pen and the single dose tray requires assembly of the syringe, vial and vial. Please refer to your supplemental new drug application snda dated august 29, 20. Take out one pen and let it sit at room temperature for at least 15 minutes.
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