Bydureon Bcise

Generic name: exenatide (Bydureon)
Brand names: Bydureon BCise, Bydureon Pen
Drug class: Incretin mimetics

Medically reviewed by A Ras MD.

What is Bydureon Bcise?

Bydureon Bcise is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus and should be used along with diet and exercise. Bydureon Bcise is not recommended as the first choice of medicine for treating diabetes. Bydureon Bcise is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.

It is not known if Bydureon Bcise can be used with mealtime insulin. Bydureon Bcise and Bydureon are long-acting forms of the medicine in Byetta (exenatide). Bydureon Bcise should not be used at the same time as Byetta or Bydureon. It is not known if Bydureon Bcise can be used in people who have had pancreatitis. It is not known if Bydureon Bcise is safe and effective for use in children.

Description

BYDUREON BCISE (exenatide extended-release) injectable suspension is a GLP-1 receptor agonist supplied as a sterile suspension of exenatide extended-release microspheres in an oil-based vehicle of medium chain triglycerides (MCT), in a single-dose autoinjector. Redispersion by mixing provides a white to off-white, opaque suspension to be administered by subcutaneous injection. Each autoinjector contains sufficient suspension to deliver 2 mg of exenatide extended-release in a volume of 0.85 mL.

Exenatide is a 39-amino acid synthetic peptide amide with an empirical formula of C184H282N50O60S and a molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below.

H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2

Exenatide is incorporated in an extended-release microsphere formulation containing the 50:50 poly(D,L-lactide-co-glycolide) polymer (37.2 mg per dose) along with sucrose (0.8 mg per dose), suspended in the vehicle, MCT (774.4 mg per dose).

Mechanism of Action

Incretins, such as glucagon-like peptide-1 (GLP-1), enhance glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following their release into the circulation from the gut. Exenatide is a GLP-1 receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.

The amino acid sequence of exenatide partially overlaps that of human GLP-1. Exenatide is a GLP-1 receptor agonist that has been shown to bind and activate the human GLP-1 receptor in vitro. This leads to an increase in both glucose-dependent synthesis of insulin and in vivo secretion of insulin from pancreatic beta-cells, by mechanisms involving cyclic AMP and/or other intracellular signaling pathways. Exenatide promotes insulin release from pancreatic beta-cells in the presence of elevated glucose concentrations.

What is the most important information I should know about Bydureon Bcise?

Bydureon Bcise may cause serious side effects, including:

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. These may be symptoms of thyroid cancer. In studies with rats, Bydureon and medicines that work like Bydureon caused thyroid tumors, including thyroid cancer. It is not known if Bydureon Bcise will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Bydureon Bcise if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Who should not take Bydureon Bcise?

Do not use Bydureon Bcise if:

you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you have a history of low blood platelet count from using exenatide medicines (drug-induced thrombocytopenia).
you are allergic to exenatide or any of the ingredients in Bydureon Bcise. See the end of this Medication Guide for a complete list of ingredients in Bydureon Bcise.

What should I tell my healthcare provider before taking Bydureon Bcise?

Before using Bydureon Bcise, tell your healthcare provider about all of your medical conditions, including if you:

have or have had problems with your pancreas or kidneys.
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are pregnant or plan to become pregnant. Bydureon Bcise may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Bydureon Bcise. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
are breastfeeding or plan to breastfeed. It is not known if Bydureon Bcise passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Bydureon Bcise.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bydureon Bcise may affect the way some medicines work and some medicines may affect the way Bydureon Bcise works.

Before using Bydureon Bcise, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Bydureon Bcise?

Read the Instructions for Use that comes with Bydureon Bcise.
Use Bydureon Bcise exactly as your healthcare provider tells you to.
Bydureon Bcise should be injected right away after you prepare your dose.
Your healthcare provider should show you how to use Bydureon Bcise before you use it for the first time.
Bydureon Bcise is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Bydureon Bcise into a muscle (intramuscularly) or vein (intravenously).
Use Bydureon Bcise 1 time each week on the same day each week at any time of the day.
Bydureon Bcise may be taken with or without food.
If you miss a dose of Bydureon Bcise, take the missed dose as soon as possible if there are at least 3 days (72 hours) until your next scheduled dose. If there are less than 3 days remaining, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of Bydureon Bcise within 3 days of each other.
You may change the day of the week as long as your last dose was given 3 or more days before.
If you use a different long acting exenatide medicine and your healthcare provider switches your medicine to Bydureon Bcise, you should start using Bydureon Bcise at your next scheduled dose.
Do not mix insulin and Bydureon Bcise together in the same injection.
You may give an injection of Bydureon Bcise and insulin in the same body area (such as, your stomach area), but not right next to each other.
Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
Your dose of other diabetes medicines may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.
Do not share your Bydureon Bcise pen, syringe, or needles with another person. You may give another person an infection or get an infection from them.

What are the possible side effects of Bydureon Bcise?

Bydureon Bcise may cause serious side effects, including:

See “What is the most important information I should know about Bydureon Bcise?”
inflammation of your pancreas (pancreatitis). Stop using Bydureon Bcise and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Bydureon Bcise with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
- dizziness or light-headedness
- sweating
- confusion or drowsiness
- headache
- blurred vision
- slurred speech
- shakiness
- fast heartbeat
- anxiety, irritability, or mood changes
- hunger
- weakness
- feeling jittery
kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse or kidney failure.
stomach problems. Other medicines like Bydureon Bcise may cause severe stomach problems. It is not known if Bydureon Bcise causes or worsens stomach problems.
low blood platelet count (drug-induced thrombocytopenia). Bydureon Bcise may cause the number of platelets in your blood to be reduced. When your platelet count is too low, your body cannot form blood clots. You could have serious bleeding that could lead to death. Stop using Bydureon Bcise and call your healthcare provider right away if you have unusual bleeding or bruising. Your blood platelet count may continue to be low for about 10 weeks after stopping Bydureon Bcise.
serious allergic reactions. Stop using Bydureon Bcise and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.
injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use Bydureon. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of an injection-site reaction, including severe pain, swelling, blisters, an open wound, a dark scab.
gallbladder problems. Gallbladder problems have happened in some people who take Bydureon or other medicines like Bydureon. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include: pain in the right or middle upper stomach area, nausea and vomiting, fever, or your skin or the white part of your eyes turns yellow.

The most common side effects of Bydureon Bcise may include a bump (nodule) at the injection site and nausea.

Nausea is most common when you first start using Bydureon Bcise but decreases over time in most people as their body gets used to the medicine.

Talk to your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of Bydureon Bcise.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep Bydureon Bcise and all medicines out of the reach of children.

General information about the safe and effective use of Bydureon Bcise

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bydureon Bcise for a condition for which it was not prescribed. Do not give your Bydureon Bcise to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Bydureon BciseE that is written for health professionals.

How should I store Bydureon Bcise?

Bydureon Bcise must be stored flat.
Store the autoinjector in the original package. Protect from light.
Bydureon Bcise should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C), up to the expiration date or until preparing for use. Bydureon Bcise should not be used past the expiration date. The expiration date can be found on the carton, or on the autoinjector label.
Bydureon Bcise can be kept at room temperature not to exceed 86°F (30°C) for no more than a total of 4 weeks, if needed.
Discard Bydureon Bcise after use in a puncture-resistant container.

What are the ingredients in Bydureon Bcise?

Contents of the powder:

Active Ingredient: exenatide
Inactive Ingredients: polylactide-co-glycolide and sucrose

Contents of liquid (diluent):

Inactive Ingredients: medium chain triglycerides

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 2 MG PEN LABEL

NDC 0310-6540-01
2 mg single-dose autoinjector
Medication requires mixing before use
Store FLAT in a refrigerator 36-46°F
(2-8°C)
Once-weekly
BYDUREON BCise®
(exenatide extended-release)
injectable suspension
For subcutaneous use only

Rx only AstraZeneca

SRC: NLM .

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