Exenatide

Exenatide is a prescription medication that is used along with diet and exercise to treat type 2 diabetes. Exenatide belongs to a group of medications called incretin mimetics. It works by helping the pancreas to secrete insulin when blood sugar levels are high, decreases the amount of sugar the liver produces, and it slows the emptying of the stomach.

Exenatide is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes when used with a diet and exercise program. 

The brand, Bydureon, is also approved be given as an add-on therapy to basal insulin in adults with type 2 diabetes who have not reached their blood sugar goals. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Exenatide may be found in some form under the following brand names:

• Bydureon

• Byetta

Serious side effects have been reported with exenatide. See "Drug Precautions" section.

The most common side effects with exenatide include:

• nausea. Nausea most commonly happens when first starting exenatide, but may become less over time.
• vomiting
• diarrhea or constipation
• dizziness
• headache
• feeling jittery
• acid stomach or indigestion

This is not a complete list of exenatide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Exenatide slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Exenatide may affect the way some medicines work and some other medicines may affect the way exenatide works.

Especially tell your doctor if you take:

• insulin, or any other anti-diabetes medicines
• birth control pills that are taken by mouth (oral contraceptives). Exenatide may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy. Take your birth control pills at least one hour before your injection of exenatide. If you must take your birth control pills with food, take it with a meal or snack where you do not also take exenatide.
• an antibiotic. Take antibiotic medicines at least one hour before taking exenatide. If you must take your antibiotic with food, take it with a meal or snack where you do not also take exenatide.
• warfarin sodium (Coumadin, Jantoven)
• a blood pressure medicine
• a water pill (diuretic)
• a pain medicine
• lovastatin (Altoprev, Mevacor, Advicor)

This is not a complete list of exenatide drug interactions. Ask your doctor or pharmacist for more information.

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.

Before receiving exenatide, tell your doctor about all of your medical conditions including if you:

• have or have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels
• have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food
• have or have had kidney problems, or have had a kidney transplant
• are allergic to any ingredients in this medication
• have medullary thyroid cancer
• have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• have any other medical conditions

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Exenatide slows stomach emptying and can affect medicines that need to pass through the stomach quickly. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Exenatide falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Pregnancy Registry: Talk to your doctor about enrolling in the pregnancy registry for women who take this medication during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

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.

Twice Daily Exenatide

Exenatide comes in a prefilled pen. 

Your healthcare provider must teach you how to inject exenatide before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist.

• Inject your dose of exenatide under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm as instructed by your healthcare provider. Do not inject into a vein or muscle.
• Exenatide is injected two times each day, at any time within the 60 minutes (1 hour) before your morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). Do not take exenatide after your meal.
• If you miss a dose, 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 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.

Once Weekly Exenatide (Bydureon and Bydureon BCise)

You may have been prescribed either Bydureon or Bydureon BCise. These both contain the same medication but Bydureon BCise comes as a premixed and prefilled autoinjector (automatic injecting pen). 

Both of these pens are long-acting subcutaneous injections and are given once every seven days (weekly) any time during the day, with or without meals.

• The brand, Bydureon, comes as a dry powder to be mixed with a liquid. Exenatide must be injected right after you mix it.
• You can administer the injection in your stomach area (abdomen), your thigh, or the back of your upper arm. Each week you can use the same area of your body. But be sure to choose a different injection site in that area.
• If you miss a dose of exenatide, it should be taken as soon as you remember, provided the next regularly scheduled dose is due at least three days later. If the next dose is due one or two days later, skip the missed dose and instead resume the medication with the next regularly scheduled dose. 
• The brand, Bydureon BCise, comes as a premixed and prefilled autoinjector (automatic injecting pen). 

General Information

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 because you may need to adjust your current treatment plan for your diabetes.

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.

Never share your exenatide with another person. You may give an infection to them, or get an infection from them, and exenatide may harm them.

Use exenatide exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The exenatide dose your doctor recommends will be based on the following:

• other medications you are taking
• how you respond to this medication

Twice Daily Dosage

• The recommended starting exenatide dose is 5 mcg twice daily, before the two main meals of the day, approximately 6 hours or more apart. 
• Depending on your response to the medication, your doctor may decide to increase your dose of exenatide to 10 mcg twice daily after 1 month of therapy.

Once Weekly Dosage

• The recommended dose of exenatide is 2 mg injected once every seven days (weekly). The dose can be administered at any time of day, with or without meals.

If you use too much exenatide, call your doctor or local Poison Control Center 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.

Exenatide (Byetta)

• Prior to first use, this medication must be stored refrigerated at 36°F to 46°F (2°C to 8°C).
• After the first use, it can be kept at a temperature not to exceed 77°F (25°C).
• Do not freeze. Do not use if it has been frozen.
• Protect from light.
• The pen should be discarded 30 days after first use, even if some drug remains in the pen.
• Use a puncture-resistant container to discard the needles. Do not reuse or share needles.
• This medication should not be used past the expiration date.

Once Weekly Exenatide (Bydureon and Bydureon BCise)

• This medication should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C), up to the expiration date. 
• Do not use this medication past the expiration date. The expiration date can be found on the carton, on the cover of the single-dose tray, or on the pen label.
• Do not freeze medication. Do not use if it has been frozen. Protect from light.

Room Temperature

• Bydureon BCise can be kept at room temperature not to exceed 86°F (30°C) [see USP Controlled Room Temperature] for no more than a total of 4 weeks, if needed.
• Bydureon can be kept at room temperature not to exceed 77°F (25°C) [see USP Controlled Room Temperature] for no more than a total of 4 weeks, if needed.

Bydureon 

• Use the diluent only if it is clear and free of particulate matter.
• After suspension, the mixture should be white to off-white and cloudy.
• Bydureon must be administered immediately after the powder is suspended in the diluent.

Use a puncture-resistant container to discard medication with the needle still attached. Do not reuse or share needles or syringes.

Keep out of the reach of children.

WARNING: RISK OF THYROID C-CELL TUMORS

Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether exenatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. Exenatide is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with exenatide. Patients should be counseled regarding the risk and symptoms of thyroid tumors.