Exenatide injection suspension, extended-release

What is this medicine?

EXENATIDE (ex EN a tide) is used to improve blood sugar control in adults with type 2 diabetes. This medicine may be used with other oral diabetes medicines.

How should I use this medicine?

This medicine is for injection under the skin of your upper leg, stomach area, or upper arm. It is usually given once every week (every 7 days). You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

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 healthcare provider 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 drug comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this drug. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• diarrhea that continues or is severe

• lump or swelling on the neck

• severe nausea

• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

• trouble swallowing

• unusual bleeding or bruising

• unusual stomach upset or pain

• vomiting

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

• constipation

• diarrhea

• dizziness

• headache

• nausea

• pain, redness, or irritation at site where injected

• stomach upset

What may interact with this medicine?

• acetaminophen

• birth control pills

• digoxin

• insulin and other medicines for diabetes

• lisinopril

• lovastatin

• warfarin

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

• alcohol containing beverages

• antiviral medicines for HIV or AIDS

• aspirin and aspirin-like drugs

• certain medicines 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

• medicines for weight loss

• medicines for allergies, asthma, cold, or cough

• medicines for depression, anxiety, or psychotic disturbances

• niacin

• nicotine

• NSAIDs, medicines 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 medicines 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

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. If you have questions about a missed dose, contact your health care provider for advice.

Where should I keep my medicine?

Keep out of the reach of children.

Store this medicine in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Do not use if the medicine has been frozen. Protect from light and excessive heat. Each single-dose tray can be kept at a room temperature not to exceed 25 degrees C (77 degrees F) for no more than a total of 4 weeks, if needed. Throw away any unused medicine after the expiration date on the label.

What should I tell my health care provider before I take this medicine?

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 or if you are on dialysis

• low blood counts, like platelets

• stomach or intestine problems

• thyroid cancer or if someone in your family had thyroid cancer

• an unusual or allergic reaction to exenatide, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

A test called the 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. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional 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. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.