Exenatide Solution for injection

What is this medicine?

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

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

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

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

• kidney disease or if you are on dialysis
• stomach problems
• an unusual or allergic reaction to exenatide, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin of your upper leg, stomach area, or upper arm. 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 patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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

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. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• gatifloxacin

This medicine may also interact with the following medications:

• acetaminophen
• birth control pills
• digoxin
• lisinopril
• lovastatin
• sulfonylureas
• warfarin

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

• alcohol containing beverages
• aspirin and aspirin-like drugs
• chloramphenicol
• chromium
• diuretics
• female hormones, such as estrogens or progestins, birth control pills
• heart medicines
• isoniazid
• male hormones or anabolic steroids
• medications for weight loss
• medicines for allergies, asthma, cold, or cough
• medicines for mental problems
• medicines called MAO inhibitors - Nardil, Parnate, Marplan, Eldepryl
• niacin
• NSAIDS, such as ibuprofen
• pentamidine
• phenytoin
• probenecid
• quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin
• some herbal dietary supplements
• steroid medicines such as prednisone or cortisone
• 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 medicine?

Visit your doctor or health care professional for regular checks on your progress. To control your diabetes, you must use this medicine regularly and follow a diet and exercise schedule. Checking and recording your blood sugar and urine ketone levels regularly is important. Use a blood sugar measuring device before you treat high or low blood sugar.

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 family members 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.

Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.

Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.

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
• low blood sugar (ask your doctor or healthcare professional for a list of these symptoms)
• severe stomach pain

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

• heartburn
• mild dizziness, weakness, or headaches
• mild nausea
• reduced appetite or a slight weight loss
• temporary diarrhea
• 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 medicine?

Keep out of the reach of children.

Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medicine has been frozen. Protect from light and excessive heat. After you first use the pen, it should be kept at a temperature not to exceed 25 degrees C (77 degrees F). Throw away your used pen after 30 days or after the expiration date, whichever comes first.

Do not store your pen with the needle attached. If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.