Bydureon Warnings and Precautions
People who are about to undergo diabetes treatment with Bydureon should be aware that this drug may increase the risk for certain complications, such as pancreatitis, decreased kidney function, or thyroid tumors. Other precautions for using Bydureon safely include warnings of potential problems that may occur when this drug is combined with insulin or certain other medications.
What Should I Tell My Healthcare Provider?You should talk with your healthcare provider prior to using Bydureon™ (extended-release exenatide) if you have:
- A history of pancreatitis
- A history or family history of cancer, especially thyroid cancer
- Diabetic gastroparesis
- A severe gastrointestinal condition
- Kidney disease, such as kidney failure (renal failure)
- Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Pregnant or thinking of becoming pregnant
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Specific Precautions and Warnings With Bydureon
Some warnings and precautions to be aware of prior to using this drug include the following:
- Very preliminary data suggests incretin mimetics, such as Bydureon, may increase the risk of precancerous cellular changes (called pancreatic duct metaplasia) in people with type 2 diabetes. Researchers are continuing to study the possibility that incretin mimetics might increase the risk of pancreatic cancer, although at this time there is not enough information to know for sure if there is any increased risk.
- Even though it is taken by injection, Bydureon is not insulin and should not be used to treat type 1 diabetes or diabetic ketoacidosis.
- In laboratory rats, Bydureon was shown to cause thyroid tumors, which were cancerous in some cases. However, it is unknown if the drug causes such tumors in humans. Be sure to let your healthcare provider know right away if you develop any signs or symptoms of a thyroid tumor, such as:
- A lump in the neck
- Difficulty swallowing
- Shortness of breath
- A persistent hoarse voice
- Increased calcitonin blood levels (found using a blood test).
- Bydureon may increase the risk of pancreatitis. You may be at a higher risk for this condition if you have ever had pancreatitis in the past. Let your healthcare provider know immediately if you develop any signs or symptoms of pancreatitis, such as:
- Severe, persistent abdominal (stomach) pain, sometimes radiating to the back.
- When used by itself, Bydureon is not particularly likely to cause dangerously low blood sugar levels (hypoglycemia). However, combining it with insulin, or oral medications that increase insulin production, appears to increase this risk (see Bydureon Drug Interactions for further information).
- Bydureon is not recommended for use in people with severe kidney disease.
- There have been a few reports of decreased kidney function, including kidney failure, in people using Bydureon. However, it is not clear if these cases were caused by or related to the medication.
- Bydureon has not been thoroughly studied in people with severe gastrointestinal problems, including diabetic gastroparesis. If you have a gastrointestinal problem, your healthcare provider will probably need to monitor you more closely, as Bydureon slows down the movement of food through the digestive tract. In general, this medication is not recommended for people with severe gastrointestinal problems.
- Bydureon is a manufactured (synthetic) version of a protein found in the saliva of Gila monster lizards. As such, it may cause allergic reactions. Talk to your healthcare provider if you develop an allergic reaction after using this medication. Also, in some people, the immune system may attack Bydureon, perhaps making it less effective.
- It is unknown whether Bydureon passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Bydureon and Breastfeeding).
- Bydureon is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Bydureon and Pregnancy).