IMPORTANT: 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.
EXENATIDE - INJECTION
COMMON BRAND NAME(S): Byetta
WARNING: 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.
HOW TO USE:
Read the Medication Guide and the Pen User Manual provided by your pharmacist before you start using exenatide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist.
Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.
Inject this medication under the skin in the thigh, abdomen, or upper arm 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.
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.
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.
The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Carefully follow your diabetes management plan, including medications, diet, and exercise.
Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are often too high or too low. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
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. Learn how to store and discard medical supplies safely.
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 persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she 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 all your diabetes medication(s).
Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, 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, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction right away. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Talk with your doctor or pharmacist about what to do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication(s).
Stop taking exenatide and tell your doctor right away if any of these very serious side effects occur: signs of pancreatitis (such as persistent nausea/vomiting, loss of appetite, severe stomach/abdominal/back pain), signs of kidney problems (such as change in the amount of urine).
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), stones in your gallbladder (gallstones).
You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires 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 breast-feeding.
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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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.
Keep all regular medical and laboratory appointments. Laboratory and/or medical tests (such as kidney function, blood glucose, hemoglobin A1c) should be performed before you start treatment and periodically to monitor your progress or check for side effects.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
Store the new, unused pen injector in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. After first use, store at room temperature at or below 77 degrees F (25 degrees C). Protect from light. Discard 30 days after first use, even if some drug remains in the pen. 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.