Label Changes for:
Byetta (exenatide) injection
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) November 2009, November 2010, and October 2011
WARNINGS AND PRECAUTIONS
Use with Medications Known to Cause Hypoglycemia
- When Byetta is used in combination with insulin, the dose of insulin should be evaluated. In patients at increased risk of hypoglycemia consider reducing the dose of insulin [see Adverse Reactions (6.1)]. The concurrent use.....
Clinical Trial Experience
- Add-on to insulin glargine with or without metformin and/or thiazolidinedione.....For the 30-week placebo-controlled.....
- Table 5 added
- The most frequently reported adverse reactions leading to withdrawal for Byetta-treated patients were.....
PATIENT COUNSELLING INFORMATION
Risk of Hypoglycemia
- When Byetta is used in combination with insulin, evaluate.....
- These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Byetta.
- The use of Byetta with short acting insulin is not recommended.
- The use of Byetta with rapid acting insulin is not recommended.
- Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher .....
- The most common side effects with Byetta include: constipation, weakness
Also see: Instructions for Use
- Do not mix Byetta and insulin in the same syringe or vial even if you take them at the same time.
- Skin and Subcutaneous Tissue Disorders: alopecia
WARNINGS and PRECAUTIONS
- Based on postmarketing data Byetta has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation of Byetta, and after dose increases, observe patients carefully for signs and symptoms of ancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting). If pancreatitis is suspected, Byetta should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Byetta should not be restarted. Consider ntidiabetic therapies other than Byetta in patients with a history of pancreatitis.
- Byetta should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease and should be used with caution in patients with renal transplantation [see Use in Specific Populations (8.6)]. In patients with end-stage renal disease receiving dialysis, single doses of Byetta 5 mcg were not well-tolerated due to gastrointestinal side effects. Because Byetta may induce nausea and vomiting with transient hypovolemia, treatment may worsen renal function. Caution should be applied when initiating or escalating doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).
- There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Byetta or any other antidiabetic drug.