Bydureon

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

What is Bydureon?

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

Description

Bydureon (exenatide extended-release) for injectable suspension is a GLP-1 receptor agonist supplied as a sterile powder to be suspended in diluent and administered by subcutaneous injection. 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-IleGlu- Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH₂

Bydureon is a white to off-white powder that is available in a dosage strength of 2 mg exenatide per vial or per pen. 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). The powder must be suspended in the diluent prior to injection.

The diluent for the Bydureon vial is supplied in a prefilled syringe within each single-dose tray. The diluent for the Bydureon Pen is contained within each single-dose pen. Each configuration contains sufficient diluent to deliver 0.65 mL. The diluent is a clear, colorless to pale-yellow solution composed of carboxymethylcellulose sodium (19 mg), polysorbate 20 (0.63 mg), sodium phosphate monobasic monohydrate (0.61 mg), sodium phosphate dibasic heptahydrate (0.51 mg), sodium chloride (4.1 mg), and water for injection. Sodium hydroxide may be added during manufacture of Bydureon Pen for pH adjustment.

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

Bydureon 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 or mice, Bydureon and medicines that work like Bydureon caused thyroid tumors, including thyroid cancer. It is not known if Bydureon will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Bydureon 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 use Bydureon?

Do not use Bydureon 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 are allergic to exenatide or any of the ingredients in Bydureon. See the end of this Medication Guide for a complete list of ingredients in Bydureon.

What should I tell my healthcare provider before using Bydureon?

Before using Bydureon, 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 may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Bydureon. 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 passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Bydureon.

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

Before using Bydureon, 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 use Bydureon?

• Read the instructions for use that comes with Bydureon.
• Use Bydureon exactly as your healthcare provider tells you to.
• Bydureon should be injected right away after you prepare your dose.
• Your healthcare provider should show you how to use Bydureon before you use it for the first time.
• Bydureon is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Bydureon into a muscle (intramuscularly) or vein (intravenously).
• Use Bydureon 1 time each week on the same day each week at any time of the day.
• Bydureon may be taken with or without food.
• If you miss a dose of Bydureon, 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 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.
• Do not mix insulin and Bydureon together in the same injection.
• You may give an injection of Bydureon 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.
• Do not share your Bydureon pen, prefilled syringe, or needles with another person. You may give another person an infection or get an infection from them.
• Your dose of Bydureon and 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.

What are the possible side effects of Bydureon?

Bydureon may cause serious side effects, including:

• See “What is the most important information I should know about Bydureon?”.
• inflammation of your pancreas (pancreatitis). Stop using Bydureon 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 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 may cause severe stomach problems. It is not known if Bydureon causes or worsens stomach problems.
• serious allergic reactions. Stop using Bydureon, 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,
  • your skin or the white part of your eyes turns yellow.

The most common side effects of Bydureon may include:

• nausea,
• diarrhea,
• headache,
• vomiting,
• constipation,
• itching at the injection site,
• a small bump (nodule) at the injection site,
• indigestion.

Nausea is most common when you first start using Bydureon, 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. For more information, ask your healthcare provider or pharmacist.

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

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

General information about the safe and effective use of Bydureon.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bydureon for a condition for which it was not prescribed. Do not give your Bydureon 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 that is written for health professionals.

How do I store Bydureon?

• Bydureon 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 should not be used past the expiration date. The expiration date can be found on the carton, on the cover of the single-dose tray, or on the pen label.
• Do not freeze Bydureon. Do not use Bydureon if it has been frozen. Protect from light.
• Bydureon can be kept at room temperature not to exceed 77°F (25°C) for no more than a total of 4 weeks, if needed.
• Use the diluent only if it is clear and free of particulate matter.
• After suspension, the mixture should be white to off-white and cloudy.
• Bydureon must be administered immediately after the exenatide powder is suspended in the diluent.
• Use a puncture-resistant container to discard Bydureon with the needle still attached. Do not reuse or share needles or syringes.
• Keep out of the reach of children.

What are the ingredients in Bydureon?

Contents of the powder:

Active Ingredient: exenatide

Inactive Ingredients: polylactide-co-glycolide and sucrose

Contents of liquid (diluent):

Inactive Ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, water for injection. Sodium hydroxide may be added during manufacture of Bydureon Pen for pH adjustment.

SRC: NLM .