RE: Nausea and TTHTo Futher support...
Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection
--A New First-in-Class Treatment for Patients with Type 2 Diabetes--
SAN DIEGO, Calif. and INDIANAPOLIS, Ind., April 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
Safety and Tolerability Information
In the three 30-week controlled trials, adverse events associated with BYETTA were generally mild to moderate in intensity. The most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy in most patients who initially experienced nausea, the frequency and severity decreased over time.
Patients receiving BYETTA in combination with a sulfonylurea have an increased risk of hypoglycemia; to reduce this risk, reduction in the dose of the sulfonylurea should be considered. In the 30-week controlled clinical trials, hypoglycemia appeared to be dependent on the doses of both BYETTA and a sulfonylurea. Most episodes of hypoglycemia were mild to moderate in intensity and all were resolved with oral administration of carbohydrate. No increased risk of hypoglycemia was observed in the 30-week controlled studies with BYETTA when used in combination with metformin compared to placebo.
Patients should also be advised that treatment with BYETTA may result in a reduction in appetite, food intake, and/or body weight and that there is no need to modify the dosing regimen due to such effects.
BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, nor is BYETTA a substitute for insulin in insulin-requiring patients. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.
For full Prescribing Information, visit www.BYETTA.com .