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 may be 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:

• history of pancreatitis

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

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.

Exenatide pens and cartridges 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.

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

• 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

• swelling of the ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusual stomach pain or upset

• unusually weak or tired

• vomiting

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

• constipation

• diarrhea

• dizziness

• headache

• heartburn

• nausea

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.

Exenatide Suspension for injection, 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.

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:

• endocrine tumors (MEN 2) or if someone in your family had these tumors

• history of pancreatitis

• kidney disease or if you are on dialysis

• stomach 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

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.

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

Overdosage: If you think you've 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. If you have questions about a missed dose, contact your health care provider for advice.

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.

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.

Exenatide pens and cartridges 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.

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

• 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

• swelling of the ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusual stomach pain or upset

• unusually weak or tired

• vomiting

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

• constipation

• diarrhea

• dizziness

• headache

• heartburn

• itching, irritation, or redness at site where injected.

• nausea

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 this medicine 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. Each single-dose tray can be kept at a 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.

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.