DRUG DESCRIPTION
BYETTA (exenatide) is a synthetic peptide that was originally identified in
the lizard Heloderma suspectum. Exenatide differs in chemical structure
and pharmacological action from insulin, sulfonylureas (including D-phenylalanine
derivatives and meglitinides), biguanides, thiazolidinediones, alpha-glucosidase
inhibitors, amylinomimetics and dipeptidyl peptidase-4 inhibitors.
Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formula
C184H282N50O60S and molecular weight
of 4186.6 Daltons. The amino acid sequence for exenatide is shown below.
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu
-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2
BYETTA (exenatide injection) is supplied for SC injection as a sterile, preserved isotonic solution
in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter
(mL) contains 250 micrograms (mcg) synthetic exenatide, 2.2 mg metacresol as
an antimicrobial preservative, mannitol as a tonicity-adjusting agent, and glacial
acetic acid and sodium acetate trihydrate in water for injection as a buffering
solution at pH 4.5. Two prefilled pens are available to deliver unit doses of
5 mcg or 10 mcg. Each prefilled pen will deliver 60 doses to provide for 30
days of twice daily administration (BID).
What are the possible side effects of exenatide (Byetta)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using exenatide and call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst;
- swelling, weight gain, feeling short of breath; or
- severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite,...
Read All Potential Side Effects and See Pictures of Byetta »
What are the precautions when taking exenatide injection (Byetta)?
Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, severe stomach/intestinal disorders (e.g., digestion problems such as gastroparesis, or pancreatitis).
You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages since alcohol...
Read All Potential Precautions of Byetta »
Byetta Consumer (continued)
SIDE EFFECTS: Nausea, vomiting, diarrhea, nervousness or upset stomach may occur as your body adjusts to the medication. Nausea usually lessens as you continue to use exenatide. Other side effects include decreased appetite/food intake or decreased body weight. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rare but serious pancreas problems (pancreatitis) can occur while using exenatide. Get immediate medical attention if you develop severe/persistent stomach/abdominal pain, or persistent severe nausea/vomiting. Do not restart exenatide treatment without first talking with your doctor.
Tell your doctor immediately if this rare but serious side effect occurs: a change in the amount of your urine.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using exenatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, severe stomach/intestinal disorders (e.g., digestion problems such as gastroparesis, or pancreatitis).
You may experience blurred vision, headache, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages since alcohol can affect your blood sugar.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.
During times of severe stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication or how often you test your blood sugar may be required.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully.
It is unknown if this medication passes into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Byetta Patient Information Including Side Effects
Brand Names: Byetta
Generic Name: exenatide (Pronunciation: ex EN a tide)
- What is exenatide (Byetta)?
- What are the possible side effects of exenatide (Byetta)?
- What is the most important information I should know about exenatide (Byetta)?
- What should I discuss with my healthcare provider before using exenatide (Byetta)?
- How should I use exenatide (Byetta)?
- What happens if I miss a dose (Byetta)?
- What happens if I overdose (Byetta)?
- What should I avoid while using exenatide (Byetta)?
- What other drugs will affect exenatide (Byetta)?
- Where can I get more information?
What is exenatide (Byetta)?
Exenatide is an injectable diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin more efficiently.
Exenatide is used to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with exenatide if needed.
Exenatide may also be used for other purposes not listed in this medication guide.
What are the possible side effects of exenatide (Byetta)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using exenatide and call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst;
- swelling, weight gain, feeling short of breath; or
- severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate.
Less serious side effects may include:
- nausea, vomiting, heartburn, diarrhea;
- loss of appetite;
- weight loss; or
- dizziness, headache, or feeling jittery.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them:
- hunger, headache, confusion, irritability;
- drowsiness, weakness, dizziness, tremors;
- sweating, fast heartbeat;
- seizure (convulsions); or
- fainting, coma (severe hypoglycemia can be fatal).
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about exenatide (Byetta)?
Do not use exenatide to treat type 1 (insulin-dependent) diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Before using exenatide, tell your doctor if you use any of these oral diabetes medications: acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (DiaBeta), tolazamide (Tolinase), tolbutamide (Orinase).
You must use this medication within 60 minutes (1 hour) before eating a meal. If you miss a dose, use the medication as soon as you remember, but only if you have not yet eaten a meal. If you have already eaten a meal, wait until your next scheduled dose (1 hour before a meal) to use the medicine. Your exenatide doses should be spaced at least 6 hours apart. Do not use exenatide after eating a meal.
Stop using exenatide and call your doctor at once if you have severe pain in your upper stomach spreading to your back, with nausea, vomiting, and a fast heart rate. These could be symptoms of pancreatitis.
It is important to use exenatide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.
To be sure this medication is helping your condition, you will need to check your blood sugar at home. Your blood will also need to be tested by your doctor on a regular basis. Do not miss any scheduled appointments.
If you are using any type of antibiotic or birth control pill, take these medicines at least 1 hour before you use exenatide.
- Byetta
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