SYMLIN® (PRAMLINTIDE ACETATE) INJECTION
SYMLIN is the first and only analogue of the human hormone amylin—a partner to insulin—and a first-in-class diabetes therapy offering improved glucose control with potential for weight loss.
About SYMLIN
Glucose control depends on two hormones, insulin and amylin, both produced in the beta cells of the pancreas. In patients with type 1 diabetes and often with type 2, beta cells have been damaged or destroyed, resulting in insulin and amylin deficiencies. As a synthetic version of amylin, SYMLIN functions similarly to the naturally occurring hormone, working in partnership with insulin to improve glucose control.
Clinical studies showed that SYMLIN injection before a meal helps patients lower their blood glucose afterward, leading to less fluctuation during the day and better long-term glucose control (A1C) compared to patients taking insulin alone. On average, study participants treated with SYMLIN used less mealtime insulin than those using insulin alone—and also experienced weight loss.
In a 6-month, open-label clinical trial, insulin-using patients with type 2 (n = 166) or type 1 (n = 265) diabetes lost, on average, 6 Ib. SYMLIN is not indicated for the management of obesity.
Important Safety Information for SYMLIN® (pramlintide acetate) injection
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.
Indications and Usage
SYMLIN is given at mealtimes and is indicated for:- Type 2 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, 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.
Contraindications
Hypersensitivity to SYMLIN or any of its components, including metacresol; confirmed diagnosis of gastroparesis; hypoglycemia unawareness.
Warnings
Patient Selection. Proper patient selection is critical to safe and effective use of SYMLIN.SYMLIN therapy should only be considered in patients with insulin-using type 2 or type 1 diabetes who fulfill the following criteria:
- have failed to achieve adequate glycemic control despite individualized insulin management;
- are receiving ongoing care under the guidance of a healthcare professional skilled in the use of insulin and supported by the services of diabetes educator(s).
- poor compliance with current insulin regimen;
- poor compliance with prescribed self-blood glucose monitoring;
- have an HbA1c >9%;
- recurrent severe hypoglycemia requiring assistance during the past 6 months;
- presence of hypoglycemia unawareness;
- confirmed diagnosis of gastroparesis;
- require the use of drugs that stimulate gastrointestinal motility;
- pediatric patients.
Hypoglycemia. SYMLIN alone does not cause hypoglycemia. However, SYMLIN is indicated to be co-administered with insulin therapy and in this setting SYMLIN increases the risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. Therefore, when introducing SYMLIN therapy, appropriate precautions need to be taken to avoid increasing the risk for insulin-induced severe hypoglycemia. These precautions include frequent pre- and post-meal glucose monitoring combined with an initial 50% reduction in pre-meal doses of short-acting insulin.
Adverse Events
The most common adverse event was nausea, which decreased with time in most patients. For adverse events regarding severe hypoglycemia, see WARNINGS.
Healthcare professionals and people with diabetes may obtain more information, including the complete prescribing information and the Medication Guide, at www.SYMLIN.com.
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.