SYMLIN® (pramlintide acetate) injection was approved by the U.S. Food and
Drug Administration on March 16, 2005. SYMLIN is given at mealtime and is indicated
- Type 2 diabetes, as an adjunct treatment in patients who use mealtime
insulin therapy and have failed to achieve desired glucose control
despite optimal insulin therapy, with or without a concurrent sulfonylurea
agent and/or metformin.
- Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
SYMLIN is an antihyperglycemic drug for use in patients with diabetes
treated with insulin. SYMLIN is a synthetic analog of human amylin, a
naturally occurring hormone that is made in the beta cells of the pancreas,
the same cells that make insulin. In patients with type 2 diabetes who
use insulin, and in patients with type 1 diabetes, those cells in the
pancreas are either damaged or destroyed, resulting in reduced secretion
of both insulin and amylin after meals. The use of SYMLIN contributes
to glucose control after meals.
Clinical studies demonstrate that SYMLIN, a self-administered injection
given prior to meals, helps patients achieve lower blood glucose (sugar)
after meals, leading to less fluctuation during the day, and better long-term
glucose control (A1C) compared to patients taking insulin alone. On average,
patients in these studies used less mealtime insulin and also had a reduction
in body weight compared to patients taking insulin alone. SYMLIN was studied
in over 5300 individuals in the clinical program that led to approval.
Important safety information
SYMLIN is not intended for all patients with diabetes. SYMLIN is used
with insulin and has been associated with an increased risk of insulin-induced
severe hypoglycemia, particularly in patients with type 1 diabetes. When
severe hypoglycemia associated with SYMLIN use occurs, it is seen within
3 hours following a SYMLIN injection. If severe hypoglycemia occurs while
operating a motor vehicle, heavy machinery, or while engaging in other
high-risk activities, serious injuries may occur. Appropriate patient
selection, careful patient instruction, and insulin dose adjustments are
critical elements for reducing this risk. This information is highlighted
in a boxed warning in the SYMLIN prescribing information for health professionals
and in a Medication Guide for patients, which will be distributed by pharmacists.
Other adverse events commonly associated with SYMLIN when co-administered
with insulin were mostly gastrointestinal in nature, including nausea,
which was the most frequently reported. The incidence of nausea was higher
at the beginning of SYMLIN treatment and decreased with time in most patients.
The incidence and severity of nausea are reduced when SYMLIN is gradually
titrated to the recommended doses.
Healthcare professionals and people with diabetes may obtain more information,
including the complete prescribing information and the medication guide,
About the hormone amylin
The hormone amylin is made in and secreted from the same cells in the
pancreas that make and secrete insulin. These pancreatic cells are called
beta cells. Amylin and insulin work together with another hormone, glucagon,
to maintain normal glucose concentrations. Insulin and amylin concentrations
normally increase while glucagon levels decrease after meals. Amylin helps
suppress glucagon secretion.
Diabetes affects an estimated 194 million adults worldwide and more
than 18 million people in the United States. Approximately 4.5 million
of these people in the United States are using insulin to treat their
diabetes, one million people with type 1 diabetes and 3.5 million with
type 2 diabetes. This population currently has limited therapeutic options.
Patients with type 1 diabetes have complete beta cell deficiency and generally
must use insulin to sustain life. Patients with type 2 diabetes who have
progressed to insulin therapy have typically exhausted other therapeutic
options for improved blood glucose control due to advanced beta cell dysfunction.
||Amylin Pharmaceuticals Announces FDA Approval of SYMLIN(R) for Insulin-Using Type 2 and Type 1 Diabetes
||Additional diabetes links
||Juvenile Diabetes Research Foundation
||American Diabetes Association
||European Association for the Study of Diabetes
||International Diabetes Federation