About the BYETTA Pen
Read the BYETTA (exenatide) injection Medication Guide that comes with the BYETTA Pen carton.
Read the instructions in the pen User Manual carefully BEFORE using your BYETTA Pen. It is important that you use your pen correctly. Failure to follow the instructions
in your User Manual completely may result in a wrong dose, a broken pen, or an infection.
The instructions in your User Manual do not take the place of talking with your healthcare provider about your medical condition or your treatment.
If you are having problems using your BYETTA Pen, call toll-free 1-800-868-1190.
Important information about your BYETTA Pen
- Each BYETTA Pen contains enough medicine for injection 2 times each day for 30 days. You do not have to measure any doses, the pen measures each dose for you.
- Do not transfer the medicine in the BYETTA Pen to a syringe or vial.
- If any part of your pen appears broken or damaged, do not use the pen.
- The BYETTA Pen is not recommended for use by people who are blind or have vision problems without the help of a person trained in the proper use of the pen.
- Follow the injection method explained to you by your healthcare provider.
- Follow Section 2 of the User Manual only to set up a new pen before first use.
- Section 3 of the User Manual should be used for every injection.
Important information about pen needles
- Pen needles are not included with your pen. You may need a prescription to get them from your pharmacist.
- Use 29 (thin), 30, or 31 (thinner) gauge disposable pen needles with your BYETTA Pen. Ask your healthcare provider which needle gauge and length is best for you.
- Use a new needle for each injection. Do not reuse needles.
- Remove the needle from the pen immediately after you complete each injection. This will help prevent leakage of BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
- Do not push the injection button on your pen unless a needle is attached to the pen.
- Do not throw away the pen with a needle attached.
- Place used needles in a closeable, puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Ask your healthcare provider for instructions on the right way to throw away (dispose of) your used pens and the container. There may be state and local laws about how you should throw away used pens and needles.
- Do not throw the disposal container in the household trash. Do not recycle.
- Always keep the puncture-proof container out of reach of children.
Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
IMPORTANT SAFETY INFORMATION for BYETTA® (exenatide) injection
- Do not take BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Symptoms of a severe allergic reaction include severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop taking BYETTA and get medical help right away.
- Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
- Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop taking BYETTA and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away, occurs with or without vomiting or is felt going from your abdomen through to your back. These may be symptoms of pancreatitis.
- Your risk for getting low blood sugar (hypoglycemia) is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use BYETTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
- Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYETTA may cause new or worse problems with the way your kidneys work. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids by mouth.
- Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
- The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness. Nausea most commonly happens when first starting BYETTA, but may become less over time.
- Before using BYETTA, tell your doctor about all the medicines you take, as taking them with BYETTA may affect how each medicine works. Tell your healthcare provider if you take other diabetes medicines, especially insulin or a sulfonylurea, or birth control pills, an antibiotic, warfarin sodium (Coumadin® or Jantoven®), a blood pressure medicine, water pill, pain medicine, or lovastatin (Altoprev®, Mevacor®, or Advicor®). Take your birth control pills or antibiotics at least one hour before injecting BYETTA.
- Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
WHAT IS BYETTA?
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise. BYETTA is not insulin and should not be taken instead of insulin. BYETTA can be used with Lantus® (insulin glargine), which is a long-acting insulin, but should not be taken with short- and/or rapid-acting insulin.
BYETTA should not be used in people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYETTA is not recommended for use in children. BYETTA has not been studied in people who have pancreatitis. BYETTA should not be used in people who have severe kidney problems.
Please click here for Medication Guide and click here for US Full Prescribing Information for BYETTA (exenatide) injection.