Exenatide Extended-Release Suspension for Injection

What is this medication?

EXENATIDE (ex EN a tide) treats type 2 diabetes. It works by increasing insulin levels in your body, which decreases your blood sugar (glucose). It also reduces the amount of sugar released into your blood and slows down your digestion. Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Bydureon

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Endocrine tumors (MEN 2) or if someone in your family had these tumors
• History of pancreatitis
• Kidney disease
• Low blood counts (platelets)
• On dialysis
• Stomach or intestine problems
• Thyroid cancer or if someone in your family had thyroid cancer
• An unusual or allergic reaction to exenatide, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label at the same time every 7 days. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can, provided your next usual scheduled dose is due at least 3 days later. If you miss a dose and your next usual scheduled dose is due 1 or 2 days later, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

• Acetaminophen
• Birth control pills
• Digoxin
• Insulin and other medications for diabetes
• Lisinopril
• Lovastatin
• Warfarin

Many medications may cause changes in blood sugar, these include:

• Alcohol-containing beverages
• Antiviral medications for HIV or AIDS
• Aspirin and aspirin-like medications
• Certain medications for blood pressure, heart disease, irregular heart beat
• Chromium
• Diuretics
• Female hormones, such as estrogens or progestins, birth control pills
• Fenofibrate
• Gemfibrozil
• Isoniazid
• Lanreotide
• Male hormones or anabolic steroids
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications for weight loss
• Medications for allergies, asthma, cold, or cough
• Medications for depression, anxiety, or psychotic disturbances
• Niacin
• Nicotine
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Octreotide
• Pasireotide
• Pentamidine
• Phenytoin
• Probenecid
• Quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin
• Some herbal dietary supplements
• Steroid medications such as prednisone or cortisone
• Sulfamethoxazole; trimethoprim
• Thyroid hormones

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

• Beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
• Clonidine
• Guanethidine
• Reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

A test called HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. Get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you may need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Pens should never be shared. Sharing may result in passing of viruses like hepatitis or HIV.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Thyroid cancer—new mass or lump in the neck, pain or trouble swallowing, trouble breathing, hoarseness
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• Diarrhea
• Nausea
• Pain, redness, or irritation at injection site
• Upset stomach
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator. Do not freeze. This medication may be stored at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 4 weeks. Protect from light. Keep this medication in the original carton until you are ready to take it. Remove the dose from the carton 15 minutes before it is time for you to take it. Use it immediately after you mix it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.