The Generic
Equivalent
for Byetta®
COMING SOON:
Exenatide Injection from Amneal Pharmaceuticals
An FDA-approved generic equivalent for Byetta®
- Contains the same active ingredient
- Provides the same therapeutic effect
- Offered in the same dosage strengths
Using Exenatide Injection
The Amneal exenatide injection pen is available in 2 dose strengths: 5 micrograms (mcg) and 10 mcg. Your healthcare provider will prescribe the dose that is right for you. They should also help you learn how to inject exenatide before your first use.
Each pen contains enough medicine for 30 days.*
It is recommended that exenatide be started at 5 mcg twice daily to reduce the incidence and severity of gastrointestinal side effects. Based on your clinical response after one month of treatment, your healthcare provider may increase the dosage.
*Based on standard dosage regimen of one injection twice a day.
Instructions for Use for Exenatide Injection
Before you use the pen for the first time, please read the full Instructions for Use.
See below for resources on using the Amneal exenatide injection pen*
*This information does not replace talking with your doctor about your medical condition or your treatment .
When To Take
Exenatide is injected two times each day, at any time within 60 minutes (1 hour) before your morning and eventing meals (or before the two main meals of the day, approximately 6 hours or more apart). Do not take exenatide injection after your meal.
- If you miss a dose of exenatide, skip that dose and take your next dose at the next prescribed time. Do not take an extra dose or increase the amount of your next dose to make up for a missed dose.
- If you use too much exenatide, call your healthcare provider or poison control center at 1-800-222-1222 right away. Too much exenatide can cause your blood sugar to drop quickly, and you may have symptoms of low blood sugar. You may need medical treatment right away. Too much exenatide can also cause severe nausea and vomiting.
Remember
The Exenatide injection pen is for single patient use only.
- Do not share your injection 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.
- Do not reuse or share needles with another person.
- Be sure to read the Instructions for Use that comes with your injection pen for more complete instructions.
- Follow your healthcare provider’s instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with exenatide, talk to your healthcare provider; you may need to adjust your current diabetes treatment plan.
- Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.
Important Safety Information for Exenatide Injection
- Do not take Exenatide Injection if you have had an allergic reaction to exenatide or any of the other ingredients in Exenatide Injection. Severe allergic reactions can happen with Exenatide Injection. 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 Exenatide Injection and get medical help right away.
- Do not share your Exenatide Injection 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 Exenatide Injection, tell your healthcare provider if you have had pancreatitis. Stop using Exenatide Injection and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Your risk for getting low blood sugar (hypoglycemia) is higher if you take Exenatide Injection 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 Exenatide Injection. Signs and symptoms of low blood sugar may include headache; drowsiness; weakness; hunger; fast heart beat; dizziness; confusion; anxiety, irritability, or mood change; sweating; feeling jittery; blurred vision; slurred speech.
- Tell your healthcare provider if you have or have had kidney problems or a kidney transplant. Exenatide Injection 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. Other medicines like Exenatide Injection may cause severe stomach problems. It is not known if Exenatide Injection will cause or worsen stomach problems.
- The most common side effects with Exenatide Injection include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness. Nausea is most common when first starting Exenatide Injection, but may decrease over time.
- Before using Exenatide Injection, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as taking them with Exenatide Injection 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, a blood pressure medicine, water pill, pain medicine, or lovastatin. Take your birth control pills or antibiotics at least one hour before injecting Exenatide Injection.
- Before using Exenatide Injection, tell your healthcare provider if you are pregnant, nursing, or plan to become pregnant or nurse. Exenatide Injection may harm your unborn baby.
Approved Uses
Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
- Exenatide injection is not indicated for use in patients with type 1 diabetes.
- Exenatide injection contains exenatide and should not be used with other products containing the active ingredient exenatide.
- Exenatide injection has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
You may report adverse events, product quality complaints and request medical information in the United States from Amneal: Call (877) 835-5472, option 1 or email DrugSafety@amneal.com.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide for Exenatide injection 5 mcg and 10 mcg.