The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Generic Name: exenatide (ex-EN-a-tide)
Brand Name: Bydureon
Bydureon extended-release has been shown to cause thyroid cancer in rats. The risk increased with high doses and prolonged use. It is not known if Bydureon extended-release may cause thyroid cancer in humans. If thyroid cancer happens, it may be deadly if not found and treated early.
Do not use Bydureon extended-release if you or a family member have had medullary thyroid carcinoma (MTC) (a certain type of thyroid cancer), or if you have multiple endocrine neoplasia syndrome type 2 (MEN 2) (another type of cancer). Lab tests, including calcitonin levels or thyroid ultrasound, may be performed while you are using Bydureon extended-release. It is not known if having these tests decreases the risk of thyroid cancer. Discuss any questions or concerns with your doctor.
Contact your doctor immediately if you have a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
Bydureon extended-release is used for:
Treating type 2 diabetes. It is used along with diet and exercise.
Bydureon extended-release is a glucagon-like peptide-1 (GLP-1) receptor agonist. It lowers blood sugar by increasing the release of insulin from the pancreas. It also mimics the actions of certain hormones that lower blood sugar levels.
Do NOT use Bydureon extended-release if:
- you are allergic to any ingredient in Bydureon extended-release
- you or a family member has a history of MTC
- you have MEN 2
- you have type 1 diabetes
- you have diabetic ketoacidosis (high blood acid levels)
- you have severe kidney problems or severe stomach or bowel problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Bydureon extended-release:
Some medical conditions may interact with Bydureon extended-release. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of stomach or bowel problems (eg, trouble digesting food, slowed emptying of the stomach), gallbladder problems (eg, gallstones), inflammation of the pancreas (pancreatitis), high blood triglyceride levels, alcohol abuse, kidney problems or kidney transplant, or if you receive dialysis
- if you have never taken another medicine for type 2 diabetes
- if you are also using insulin or if you use another exenatide medicine ( Byetta)
Some MEDICINES MAY INTERACT with Bydureon extended-release. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Insulin, meglitinides (eg, repaglinide), sulfonylureas (eg, glipizide), or thiazolidinediones (eg, pioglitazone) because the risk of low blood sugar may be increased
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), diuretics (eg, furosemide, hydrochlorothiazide), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or other medicines that may affect kidney function (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; cyclosporine; tacrolimus; vancomycin) because the risk of kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might affect kidney function
- Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Bydureon extended-release
This may not be a complete list of all interactions that may occur. Ask your health care provider if Bydureon extended-release may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Bydureon extended-release:
Use Bydureon extended-release as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Bydureon extended-release comes with an extra patient information sheet called a Medication Guide and Instructions for Use. Read them carefully. Read them again each time you get Bydureon extended-release refilled.
- Use Bydureon extended-release with or without food once every 7 days (weekly).
- A health care provider will teach you how to use Bydureon extended-release. Be sure you understand how to use Bydureon extended-release. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Before giving the injection, let this product stand in room temperature for at least 15 minutes. Do not heat this drug.
- Use Bydureon extended-release immediately after it has been mixed.
- Use the proper technique taught to you by your health care provider. Inject deep under the skin, in the stomach area (abdomen), upper leg (thigh), or upper arm, as directed by your doctor. Do NOT inject Bydureon extended-release into a vein or muscle.
- Do not use Bydureon extended-release if it contains particles, is discolored, or if the pen is cracked or damaged.
- Do not share Bydureon extended-release with another person even if the needle is changed. Sharing your pen may pass infections from one person to another. This includes infections you may not know you have.
- Remove the needle after each injection. Store this device without a needle on it.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse or share needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Use Bydureon extended-release on a regular schedule to get the most benefit from it.
- If you miss a dose of Bydureon extended-release, use it as soon as possible if your next scheduled dose is due at least 3 days later. If you miss a dose and your next scheduled dose is due 1 or 2 days later, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Bydureon extended-release.
Important safety information:
- Bydureon extended-release may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Bydureon extended-release with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose without checking with your doctor.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Bydureon extended-release exactly as prescribed, tell your doctor.
- Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Bydureon extended-release.
- The risk of low blood sugar may be increased when Bydureon extended-release is used with certain other diabetes medicines (eg, insulin, meglitinides, sulfonylureas, thiazolidinediones). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Patients taking Bydureon extended-release have developed a severe and sometimes fatal pancreas problem (pancreatitis). Contact your doctor right away if you develop severe or persistent stomach pain that may radiate to the back (with or without nausea or vomiting).
- Serious skin problems at the injection site have happened with Bydureon extended-release. Sometimes, surgery was needed for these reactions. Call your doctor right away if you have an area that feels hard, blisters, dark scab, lumps, open wound, pain, swelling, or other very bad skin irritation where the injection was given.
- Bydureon extended-release may change the way that medicines taken by mouth are absorbed into your body. Be sure your doctor knows about all the medicines you take. Discuss any questions or concerns with your doctor.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Tell your doctor or dentist that you take Bydureon extended-release before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including hemoglobin A1c levels, blood sugar levels, and kidney function, may be performed while you use Bydureon extended-release. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Bydureon extended-release with caution in the ELDERLY; they may be more sensitive to its effects.
- Bydureon extended-release should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bydureon extended-release while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Bydureon extended-release, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Bydureon extended-release:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; headache; indigestion; itching or small bump at the injection site; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; fainting; fast heartbeat; lump or swelling in the neck; pain, swelling, redness, or severe irritation at the injection site; persistent hoarseness; severe or persistent headache, diarrhea, nausea, or vomiting; severe or persistent stomach pain that may radiate to the back (with or without nausea or vomiting); shortness of breath; symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, unusual or persistent pain in the mid to lower back, unexplained swelling); symptoms of low blood sugar (eg, chills, confusion, dizziness, drowsiness, increased hunger, increased sweating, irritability, nervousness, shakiness, tremor, blurred vision, weakness); trouble swallowing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Bydureon extended-release:
Store Bydureon extended-release in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use Bydureon extended-release if it has been frozen. Keep the cap on the pen when not in use. Protect from light. Do not store in the bathroom. Do not use past the expiration date. Keep Bydureon extended-release out of the reach of children and away from pets.
- If you have any questions about Bydureon extended-release, please talk with your doctor, pharmacist, or other health care provider.
- Bydureon extended-release is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Bydureon extended-release or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bydureon extended-release. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Bydureon extended-release. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Bydureon extended-release.