Exenatide

Serious side effects may occur including:

Heart attack or stroke. It is not known whether exenatide, or other anti-diabetes medications, increase your risk of a heart attack or stroke.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take exenatide with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while you use exenatide. Signs and symptoms of low blood sugar may include:

• headache
• drowsiness
• weakness
• dizziness
• confusion
• irritability
• hunger
• fast heart beat
• sweating
• feeling jittery

Talk with your healthcare provider about how to treat low blood sugar.

Kidney problems. Exenatide may cause new or worse problems with kidney function, including kidney failure. Dialysis or kidney transplant may be needed. While taking exenatide: Call your healthcare provider right away if you have:

• nausea
• vomiting
• diarrhea that will not go away
• or if you cannot take liquids by mouth. You may be at increased risk for kidney problems. 

Severe allergic reactions can happen with exenatide. Stop taking exenatide, and get medical help right away if you have any symptom of a severe allergic reaction. Do not use exenatide if you have had an allergic reaction to exenatide or any of the other ingredients in it. 

Symptoms of a severe allergic reaction with exenatide may include:

• swelling of your face, lips, tongue, or throat
• problems breathing or swallowing
• severe rash or itching
• fainting or feeling dizzy
• very rapid heartbeat

Pancreatitis. Exenatide may cause inflammation of the pancreas (pancreatitis), a potentially life-threatening condition. Tell your doctor right away if you have severe stomach pain and vomiting.

Do not use exenatide if:

• you or any of your family members have a history of medullary thyroid cancer
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.
• you have type I diabetes (insulin-dependent). Exenatide is not a form of insulin.
• if you have severe kidney disease, or severe digestive tract conditions.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of exenatide there are no specific foods that you must exclude from your diet when receiving this medication.

It is not known if exenatide crosses into human milk.

Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using exenatide.

Exenatide Pen

• Store your new, unused exenatide pen in the original carton in a refrigerator at 36 °F to 46 °F (2 °C to 8 °C).
• After first use, keep your pen at a temperature cooler than 77 °F (25 °C). Do not freeze.
• Protect exenatide from light.
• Use a exenatide pen for only 30 days. Throw away a used pen after 30 days, even if there is some medicine left in the pen.
• Do not use exenatide after the expiration date printed on the label.
• Do not store the exenatide pen with the needle attached. If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge.
• Keep your exenatide pen, pen needles, and all medicines out of the reach of children.

Exenatide Trays

• Store exenatide in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not use exenatide past the expiration date. The expiration date is labeled EXP and can be found on the paper cover of the single-dose tray.
• Do not freeze exenatide trays. Do not use exenatide if it has been frozen.
• Protect exenatide from light until you are ready to prepare and use your dose.
• If needed, you can keep your exenatide tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.
• See the Instructions for Use for information about how to throw away your used exenatide parts.
• Keep this and all medications out of the reach of children.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe nausea and vomiting, or signs of low blood sugar (headache, hunger, irritability, dizziness, feeling shaky).

Antidiabetic agent; synthetic, human glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic).1 2 3 4 38

Storage

Parenteral

Exenatide: Before use, 2–8°C in original carton.1 After first use, ≤25ºC.1 Do not freeze; protect from light.1 Discard pen 30 days after first use.1

Extended-release exenatide: 2–8°C up to the expiration date or until preparation for use.38 May store at temperature ≤25°C for 4 weeks, if necessary.38 Do not freeze; protect from light.38

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Hypersensitivity to exenatide or any component of the formulation; history of or family history of medullary thyroid carcinoma (exenatide ER only); patients with multiple endocrine neoplasia syndrome type 2 (exenatide ER only)

Canadian labeling: Additional contraindications (not in US labeling):

Bydureon: End-stage renal disease (ESRD) or severe renal impairment (CrCl <30 mL/minute) including dialysis patients

Byetta: Diabetic ketoacidosis, diabetic coma/precoma or type 1 diabetes mellitus; end-stage renal disease (ESRD) or severe renal impairment (CrCl <30 mL/minute) including dialysis patients

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, the need for dosage adjustment is unlikely as hepatic dysfunction is not expected to affect exenatide pharmacokinetics.

Bydureon: Store under refrigeration at 2°C to 8°C (36°F to 46°F); vials may be stored at ≤25°C (≤77°F) for up to 4 weeks. Do not freeze (discard if freezing occurs). Protect from light.

Byetta: Prior to initial use, store under refrigeration at 2°C to 8°C (36°F to 46°F); after initial use, may store at ≤25°C (≤77°F). Do not freeze (discard if freezing occurs). Protect from light. Pen should be discarded 30 days after initial use.

Adverse events were observed in some animal reproduction studies. Based on in vitro data, exenatide has a low potential to cross the placenta (Hiles 2003).

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008). Agents other than exenatide are currently recommended to treat diabetes in pregnant women (ACOG 2013; ADA 2017c; Blumer 2013).

Health care providers are encouraged to enroll women exposed to exenatide during pregnancy in the pregnancy registry (800-633-9081).