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Bydureon

(exenatide extended-release)

How does this medication work? What will it do for me?

Exenatide extended-release belongs to a group of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It is used alone or with other medications (e.g., metformin, glyburide, gliclazide, or insulin glargine) to improve blood glucose (sugar) levels for people with type 2 diabetes. It works by helping your body release more insulin and control blood glucose levels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

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

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 this medication on your own until you completely understand how to inject a dose.

This medication 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 this medication. If you have questions about how to use this medication, 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 this medication 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 this medication 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.

What form(s) does this medication come in?

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 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.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to 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

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is used in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • cold symptoms
  • constipation
  • cough
  • decreased appetite
  • diarrhea
  • dizziness
  • headache
  • joint pain
  • muscle pain
  • nausea
  • pain, swelling, burning, or bruising at the place of injection
  • rash
  • vomiting
  • weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, swelling of the ankles or feet)
  • symptoms of an abnormal heart rhythm (e.g., dizziness, seizures, fainting, or a fast or pounding heartbeat)
  • symptoms of low blood sugar (e.g., anxiety, blurred vision, confusion, difficulty concentrating, difficulty speaking, dizziness, drowsiness, fast heartbeat, feeling jittery, headache, hunger, irritability, nausea, weakness, nervousness, numbness or tingling lips or tongue, sweating, tiredness, trembling, weakness)
  • symptoms of thyroid cancer (e.g., a lump or swelling in the neck, trouble swallowing, hoarseness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the mouth, face, tongue, or throat)
  • symptoms of pancreatitis (inflammation of the pancreas) such as abdominal pain and vomiting

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

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 this medication.

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

Low blood sugar (hypoglycemia): This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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): 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 this medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stomach and intestinal problems: The safety and effectiveness of using this medication 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 this medication.

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 this medication.

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

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

Children: The safety and effectiveness of using this medication 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 this medication and be more likely to experience side effects.

What other drugs could interact with this medication?

There may be an interaction between exenatide extended-release and any of the following:

  • acetylsalicylic acid (ASA)
  • amiodarone
  • androgens (e.g., methyltestosterone, nandrolone, testosterone)
  • 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, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • digoxin
  • disopyramide
  • epinephrine
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • glucagon
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • lanreotide
  • loop diuretics (e.g., bumetanide, furosemide)
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
  • mifepristone
  • nasal decongestants (e.g., phenylpropanolamine, pseudoephedrine)
  • nateglinide
  • niacin
  • octreotide
  • pasireotide
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • sirolimus
  • somatostatin
  • somatropin
  • sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
  • sunitinib
  • tacrolimus
  • testosterone
  • thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
  • 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 this medication. 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.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Bydureon

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