Bydureon

The usual adult dose of Bydureon (Exenatide) is 2 mg of extended release suspension, injected subcutaneously (under the skin) in the thigh, abdomen, or upper arm once a week.

Bydureon (Exenatide) extended-release is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Bydureon (Exenatide) on your own until you completely understand how to inject a dose.

Bydureon (Exenatide) is provided in a pen injector that contains a glass cartridge with 2 compartments. One compartment contains the medication in a powder form, while the other compartment contains the diluent that, when mixed with the medication powder, creates a suspension that is injected. Read the user manual for instructions on how to properly use Bydureon (Exenatide). If you have questions about how to use Bydureon (Exenatide), contact your doctor or pharmacist.

Rotate the injection sites (arms, thighs, upper buttocks, or stomach) to minimize injection site skin irritation.

The diluent is clear and colourless and should not contain particles. After it has been mixed with the medication powder, the mixture will be white-to-off-white and cloudy. Inject the medication immediately after mixing the solution and powder.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that Bydureon (Exenatide) be used exactly as prescribed by your doctor. If you miss a dose, and it is less than 3 days since the missed dose, inject it as soon as possible. If it is more than 3 days since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Bydureon (Exenatide) in the refrigerator, protect it from light, and keep it out of the reach of children. Do not allow it to freeze. If necessary, your pen may be stored at room temperature for up to 4 weeks.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each pen injector contains a dual chamber glass cartridge injector with a bypass channel and injection needle.

• The front chamber of the glass cartridge contains a white-to-off-white powder containing 2 mg of Bydureon (Exenatide). Nonmedicinal ingredients: poly (D,L-lactide-co-glycolide) and sucrose.
• The rear chamber of the glass cartridge injector pen contains sufficient diluent to deliver 0.65 mL after reconstitution. Nonmedicinal ingredients: carboxymethylcellulose sodium, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, polysorbate 20, sodium chloride, and water for injection.

Do not use Bydureon (Exenatide) if you:

• are allergic to Bydureon (Exenatide) or any ingredients of the medication
• have or have had a family member with medullary Thyroid cancer
• have multiple endocrine neoplasia syndrome type 2 (a disease where people have tumours in more than one gland in their body)
• have severe or end-stage Kidney Disease

There may be an interaction between Bydureon (Exenatide) extended-release and any of the following:

• acetylsalicylic acid (Asa)
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• beta-blockers (e.g., Metoprolol, Atenolol)
• birth control pills
• calcium channel blockers (e.g., Verapamil, Diltiazem)
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, Nateglinide, Rosiglitazone)
• Digoxin
• Disopyramide
• diuretics (e.g., Furosemide, Hydrochlorothiazide)
• Epinephrine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Glucagon
• Hepatitis C antivirals (e.g., daclatasvir, ledipasvir, paritaprevir, sofosbuvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lanreotide
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, Tranylcypromine)
• mifepristone
• Niacin
• Octreotide
• Pasireotide
• Pegvisomant
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• somatostatin
• Somatropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• testosterone
• Vorinostat
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Bydureon (Exenatide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Bydureon (Exenatide).

Bleeding: Bydureon (Exenatide) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.

Blood sugar control: Fever, infection, surgery, or trauma may cause a loss of blood sugar control and you may need to change to insulin temporarily, until you recover. Your doctor will recommend when this is needed.

If you regularly experience uncontrolled blood glucose levels, contact your doctor.

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking medication to manage your blood glucose levels.

Heart problems: Bydureon (Exenatide) extended-release may increase your heart rate and may affect how electrical impulses travel through the heart muscle. If you have heart disease (e.g., recent Heart Attack, Angina, heart failure) or an abnormal heart rhythm (e.g., heart block or fast heart rate), discuss with your doctor how Bydureon (Exenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bydureon (Exenatide), and whether any special monitoring is needed.

If you experience dizziness, palpitations (a rapid, pounding, or irregular heartbeat), fainting, or seizures, get immediate medical attention.

Kidney problems: Bydureon (Exenatide) may cause kidney problems. Your doctor will monitor your kidney function with blood tests while you are using Bydureon (Exenatide). If you have had a kidney transplant or have reduced kidney function, discuss with your doctor how Bydureon (Exenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bydureon (Exenatide), and whether any special monitoring is needed. If you are on dialysis or have severely reduced kidney function, you should not use Bydureon (Exenatide).

Low blood sugar (Hypoglycemia): Bydureon (Exenatide) may cause low blood sugar when it is used with sulfonylureas (e.g., glyburide, gliclazide) or insulin. If you are taking any of these types of medications, discuss with your doctor how Bydureon (Exenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bydureon (Exenatide), and whether any special monitoring is needed.

If you experience symptoms of hypoglycemia such as a cold sweat, nervousness, or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling of the tongue or lips, contact your doctor. Your doctor may need to adjust the dose of your medication(s).

Pancreatitis (inflammation of the pancreas): Bydureon (Exenatide) extended-release may cause pancreatitis that can be serious or life threatening. If you experience symptoms of pancreatitis such as severe and persistent abdominal pain that may move to your back and may be accompanied by vomiting, stop taking Bydureon (Exenatide) and contact your doctor or get immediate medical attention.

If you have previously had pancreatitis, gallstones, or alcohol use problems, discuss with your doctor how Bydureon (Exenatide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bydureon (Exenatide), and whether any special monitoring is needed.

Stomach and intestinal problems: The safety and effectiveness of using Bydureon (Exenatide) have not been established for people who have inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or slowed movement through the intestinal tract due to diabetes. If you have either of these conditions, you should not use Bydureon (Exenatide).

Thyroid cancer: It is not clear whether Bydureon (Exenatide) increases the risk of developing certain types of thyroid cancer. If you or a family member have ever had medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN 2), you should not use Bydureon (Exenatide).

If you experience possible symptoms of thyroid cancer, such as difficulty swallowing, hoarseness, trouble breathing or a mass in the neck, contact your doctor as soon as possible.

Pregnancy: Bydureon (Exenatide) should not be used during pregnancy unless the benefits outweigh the risks. If you are planning to become pregnant, Bydureon (Exenatide) should be stopped at least 3 months before becoming pregnant. If you become pregnant while using Bydureon (Exenatide), contact your doctor immediately.

Breast-feeding: It is not known if Bydureon (Exenatide) extended-release passes into breast milk. If you are a breast-feeding mother and are taking Bydureon (Exenatide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Bydureon (Exenatide) have not been established for children and adolescents less than 18 years of age.

Seniors: If you are a senior, you may be more sensitive to the effects of Bydureon (Exenatide) and be more likely to experience side effects.