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.