Bydureon BCise: 7 things you should know

Medically reviewed by Carmen Pope, BPharm. Last updated on April 19, 2023.

1. How it works

• Bydureon BCise is a brand (trade) name for a long-acting form of exenatide which may be used to improve blood glucose control in adults and children over the age of 10 with type 2 diabetes.
• Bydureon BCise works by mimicking the effects of a naturally occurring human incretin, called GLP-1. Incretins are gut-derived hormones, similar to glucagon, that are released in response to food ingestion, mainly when we eat glucose or fat. When GLP-1 binds to the GLP-1 receptor it causes an increase in our body’s production of insulin in response to food. When Bydureon is given by injection into the upper thigh once a week, it binds to the GLP-1 receptor, stimulating insulin release from the beta cells of the pancreas whenever food is eaten.
• Bydureon BCise belongs to the class of medicines known as incretin mimetics.

2. Upsides

• May be used to help manage blood glucose (sugar) control in adults and children over the age of 10 with type 2 diabetes. Used in addition to diet control and exercise.
• Available as an autoinjector which is given under the skin (subcutaneously [SC]). The recommended dose is 2mg SC once a week (every 7 days).
• Can be administered at any time of the day. Does not need to be given at the same time as eating food.
• Bydureon BCise can be left out of the refrigerator for up to 4 weeks (28 days) as long as the temperature in the room does not exceed 86°F (30°C). This allows people to take their weekly dose with them, especially if they are traveling.
• Bydureon BCise replaced Bydureon (which was discontinued in March 2021). Bydureon BCise contains the same active ingredient as the Bydureon pen.
• Is an extended-release formulation which means one dose lasts for one week.
• Bydureon BCise does not require premixing and is available as an auto-injector with a pre-attached hidden needle.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Hypoglycemia (low blood sugar levels), injection site reactions including nodules, nausea, headache, diarrhea, vomiting, dizziness, and constipation are the most common side effects reported with Bydureon BCise. The risk of hypoglycemia is significantly increased when Bydureon BCise is used in combination with insulin or sulfonylureas.
• Animal studies have reported thyroid C-cell tumors in rats given exenatide and other incretin mimetics. Bydureon BCise is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Because of the uncertainty about the association between Bydureon BCise and thyroid C-cell tumors, it is not recommended as first-line treatment.
• Do not use it for people with type 1 diabetes.
• Avoid other medications that also contain exenatide or are incretin mimetics. When changing from an immediate-release injection (such as Byetta) to Bydureon, a short-term increase in blood glucose levels may be noted.
• Do not use in people with previous hypersensitivity reactions to exenatide or with a history of drug-induced immune-mediated thrombocytopenia (may increase the risk of serious bleeding).
• Bydureon may increase the risk of pancreatitis. Monitor patients carefully for signs and symptoms including persistent severe abdominal pain that may radiate to the back, with or without vomiting. Discontinue Bydureon and do not restart it if pancreatitis confirmed. Do not use in people with a history of pancreatitis.
• There have also been reports of kidney damage, which may require hemodialysis, in people treated with GLP-1 receptor agonists (RA), such as Rybelsus. Anaphylaxis and angioedema have also been reported with GLP-1 RAs such as Rybelsus.
• Bydureon may cause nausea and vomiting and may worsen renal function. The risk may be higher in those taking other medications that also reduce renal function. Do not use in people with ClCR of < 45 mL/min/1.73m².
• Not recommended in people with severe gastrointestinal disease because Bydureon BCise may exacerbate symptoms such as nausea, vomiting, and diarrhea. Acute gallbladder disease has also been reported, monitor and discontinue if necessary.
• A small percentage of people receiving Bydureon may develop antibodies to it. If there is worsening glycemic control or a failure to achieve glycemic targets then stop Bydureo and use alternative antidiabetic treatment. Drug-induced thrombocytopenia may also develop.
• Bydureon BCise has not been adequately studied in pregnant women and should not be used unless the perceived benefits outweigh the risks of uncontrolled diabetes, which include preeclampsia, spontaneous abortions, and preterm delivery. There is no information regarding the presence of Bydureon BCise in human milk.
• There is no generic Bydureon BCise.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

• Bydureon BCise is the brand name for a long-acting form of exenatide that is given by injection once weekly for type 2 diabetes. It is available as an autoinjector which is easy to administer and the main side effects are low blood glucose levels, nodules at the injection site, and nausea. It should not be given to people with a history of pancreatitis or thyroid cancer.

5. Tips

• Bydureon BCise is a prefilled, ready-mixed, autoinjector that is designed to be self-injected at home once a week. If you have trouble injecting the pen yourself, you could ask a family member, friend, caregiver, or your health provider to do it for you.
• Bydureon BCise is injected subcutaneously (this means just under the skin) and there are 3 main areas where Bydureon can be injected: your stomach area (belly) except for a 2-inch circle around your navel (belly button); the top and outer part of your thighs, but not your inner thighs or anywhere close to your knee; the outer back of your upper arm where there is a pocket of fatty tissue (this is usually easier if somebody else is injecting the pen for you).
• To keep your skin from thickening or getting lumpy, try not to inject in the same spot. Instead, rotate injection sites.
• Do not share your Bydureon autoinjector with anyone. Each pen is for single use only.
• Never leave your Bydureon autoinjector in the sun or a hot place, like your car's jockey box, because it will become too hot. And do not put it back in the refrigerator if it has been out of the refrigerator for longer than an hour. It can stay out of the refrigerator for up to 4 weeks (28 days) at room temperature. If it stays out longer than this, throw it away.
• When you get a new packet of Bydureon, store it flat in the refrigerator between 36°F and 46°F (2°C to 8°C). Keeping Bydureon BCise flat makes it easier to mix. If you store it vertically, it makes take longer than 15 seconds of shaking to mix it.
• Do not freeze Bydureon or use it past its expiration date. Protect it from light until you are ready to prepare and use your dose.
• To inject Bydureon, take one autoinjector out of the refrigerator and rest it flat on a bench for 15 minutes, to allow it to warm up to room temperature. Do not try to speed up this process by warming it in any other way, like putting it in hot water or the microwave as this may destroy the pen or the medicine
• Wash your hands with soap and warm water and dry them with a clean towel. Check the expiration date on the autoinjector, and if it has passed, do not use it, contact your pharmacist. Mix the autoinjector by shaking vigorously for at least 15 seconds. After mixing, the liquid inside should be opaque, cloudy, white to off-white suspension, with no residual medicine along the side, bottom, or top of the viewing window visible.
• Administer Bydureon BCise immediately after you have mixed it do not keep it for later. It is given as a subcutaneous injection in the abdomen, thigh, or upper arm region. Use a different injection site each week when injecting in the same region.
• Hold the autoinjector straight up with the orange cap pointing upwards and unlock it by turning the knob from the lock to unlock position, until you hear a click. Remove the orange cap. A green shield will pop up that protects the needle.
• Push the autoinjector against your preferred injection site. You will hear a click as the injection begins. Keep holding it against the skin for 15 seconds to make sure you get the full dose. This will show as an orange rod in the viewing window. Throw away the used autoinjector in a sharps container.
• If you miss a weekly dose, administer it as soon as you remember, as long as it is at least 3 days before your next scheduled dose. Then resume your weekly schedule of once a week.
• Tell your doctor if you or a family member has ever had thyroid cancer, Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or pancreatitis.
• Bydureon BCise may cause side effects such as low blood glucose levels, diarrhea, or nausea. Tell your doctor if you experience any side effects that you can't tolerate or are worried about, including persistent abdominal pain, yellowing of your skin or eyes, fever, clay-colored stools, easy bruising or bleeding, or serious injection site reactions.
• Tell your doctor if you are pregnant or intend to become pregnant, or if you are breastfeeding as Bydureon may not be right for you.
• Tell your doctor about all the medications you take including those that require a prescription or brought from a drug store or supermarket and herbal remedies.
• Do not use Bydureon with any other product containing exenatide, such as Byetta.
• If you need any help, ring 1-800-236-9933.

6. Response and effectiveness

• Bydureon Bcise starts working as soon as you inject the first dose but it may take two or more weeks before it has a noticeable effect on your blood sugar levels, and longer before it decreases your HbA1c levels.
• Bydureon Bcise builds up gradually in your body with each weekly dose and reaches its optimal level after 10 weeks of dosing. The extended-release delivery system keeps a consistent level of medicine in your body.

7. Interactions

Medicines that interact with Bydureon Bcise may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Bydureon Bcise. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

More than 340 medications interact with Bydureon Bcise. Common medicines that interact include:

• acetazolamide
• albuterol
• anticonvulsants such as phenytoin
• antipsychotics, such as aripiprazole
• bendroflumethiazide
• bexarotene
• ciprofloxacin or gatifloxacin
• corticosteroids, such as prednisone or cortisone
• diuretics, such as bumetanide, HCTZ, furosemide, and bendroflumethiazide
• Heart medications such as enalapril, losartan,
• HIV medications, such as amprenavir, atazanavir, and fosamprenavir
• hormones, such as ethinylestradiol and hydroxyprogesterone
• insulin (may increase the risk of hypoglycemia)
• isoniazid
• methamphetamine
• methotrexate
• nalidixic acid
• orally administered medicines (may slow gastric emptying)
• other medications that affect blood sugar levels or are used for diabetes, such as sulfonylureas (may increase the risk of hypoglycemia)
• pain-relieving medications (such as acetaminophen) because Bydureon may delay the onset of their pain-relieving effect
• promethazine
• pseudoephedrine
• urea
• vancomycin
• warfarin (monitor INR more frequently on initiation until stable again)
• zoledronic acid.

Alcohol may affect blood glucose levels in people with diabetes, increasing the risk of hypoglycemia. This effect may be compounded by Bydureon BCise.

Note that this list is not all-inclusive and includes only common medications that may interact with Bydureon BCise. You should refer to the prescribing information for Bydureon BCis for a complete list of interactions.

References

• Bydureon Bcise Package Insert (long-acting exenatide). Updated 05/2023. AstraZeneca Pharmaceuticals LP https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/df5ddbd6-546b-43da-b794-56f711189aba/df5ddbd6-546b-43da-b794-56f711189aba_viewable_rendition__v.pdf

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Bydureon BCise only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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