exenatide 10 mcg/dose(250 mcg/mL)2.4 mL subcutaneous pen injector

Generic name:
Exenatide - injection

Pronunciation
(ex-EN-a-tide)

Brand name(s)
Byetta

This medication can cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats. It is unknown if this medication can cause similar tumors in humans. Talk with your doctor about the benefits and risks of treatment with this medication. Do not use this medication if you have a personal/family history of a certain type of cancer (medullary thyroid carcinoma) or a certain inherited disease (multiple endocrine neoplasia syndrome type 2 or MEN 2). While using this medication, tell your doctor right away if you notice any signs of thyroid tumors, including an unusual growth or lump in the neck, difficulty swallowing, shortness of breath, unusual/lasting hoarseness.

Exenatide is used with a proper diet and exercise program to control high blood sugar. It is used by people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Exenatide is a diabetes drug that is similar to a natural hormone in your body (incretin). It works by increasing insulin release (especially after a meal) and decreasing the amount of sugar your liver makes. It also slows down food digestion in your stomach, decreases the amount of sugar absorbed from food, and may help decrease your appetite.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using exenatide and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually twice a day. Injection should be done within 60 minutes before the morning and evening meals (or before the two main meals of the day, at least 6 hours apart). Exenatide should not be used after a meal since it will not work as well. The injection is given in the thigh, abdomen, or upper arm. The dosage is based on your medical condition and response to treatment.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. If you are also using insulin, give exenatide and insulin as separate injections. Do not mix them. You may inject these medications in the same area of the body, but the injection sites should not be next to each other. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Since exenatide slows down digestion of food/drugs in your stomach, certain medications (such as birth control pills, antibiotics taken by mouth) may not work as well if you take them at the same time. Take birth control pills or antibiotics at least 1 hour before using exenatide. If you must take these medications with food, take them with a meal or snack when you do not also take exenatide. Ask your doctor or pharmacist if you have any questions about when to take your medications.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.

Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

See also Warning section.

Nausea, vomiting, diarrhea, nervousness, or upset stomach may occur as your body adjusts to the medication. Nausea usually lessens as you continue to use exenatide. Other side effects include decreased appetite or weight loss. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although exenatide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, headache, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine)
• easy bruising/bleeding

Get medical help right away if you have any very serious side effects, including:

• signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• stomach/intestinal disorders (such as gastroparesis, digestion problems)
• kidney disease
• disease of the pancreas (pancreatitis)
• gallbladder disease
• a certain blood disorder from exenatide (drug-induced thrombocytopenia)

You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Attend a diabetes education program to learn more about diabetes and the important parts of its treatment, including medications, diet, exercise, and having regular eye/foot/medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

Lab and/or medical tests (such as kidney function, blood glucose, hemoglobin A1c) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store the unused pen injector in the refrigerator. Do not freeze. Once used, this product may be stored in the refrigerator or at room temperature away from light. Discard the used pen injector after 30 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.