Reviewed pramlintide acetate (Symlin)

Approved for: self administration

Indications for Prior Authorization

  • Pramlintide is approved for adjunctive therapy in patients with type 1 or type 2 diabetes who have failed to achieve glucose control despite optimal therapy with insulin.

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee.

  • Treatment of ketoacidosis
  • Appetite suppression or treatment of obesity
  • Use contraindicated in patients with gastroparesis

All of the following must be met:

  • Diagnosis of Type 1 or Type 2 diabetes
  • Failure, as defined as an HbA1c > 7%; on optimal doses of insulin.
    • Optimal insulin dosing is defined as, three months of 3 or more daily injections of mealtime insulin; (e.g. Humalog, Humulin R; injections or use of an insulin pump) , combined with a long acting insulin medication.
  • Used as an adjunctive treatment to current insulin therapy.

Dosing

Pramlintide Therapy in Patients Using Insulin for Type 2 Diabetes

  • Pramlintide should be started at a dose of 60 mcg SC immediately before main meals, and increased to a dose of 120 mcg as tolerated. Prescribing information recommends that patients be instructed to reduce preprandial, rapid-acting, or short-acting insulin dosages, including fixed-mix insulins (70/30) by 50%, to monitor blood glucose frequently, and to increase the pramlintide dose to 120 mcg when no clinically significant nausea has occurred for 3 to 7 days. If significant nausea persists, the dose should be decreased to 60 mcg.
  • Once the target dose of pramlintide has been reached and nausea has subsided, insulin doses should be adjusted to optimize glycemic control

Pramlintide Therapy in Patients With Type 1 Diabetes

  • Pramlintide should be started at a dose of 15 mcg SC immediately before main meals, and titrated at 15-mcg increments to a maintenance dose of 30 mcg to 60 mcg as tolerated. The same instructions given in the preceding paragraph regarding the need to reduce the insulin dosage for patients with type 2 diabetes should be followed. Specifically, patients should be instructed to reduce preprandial, rapid-acting, or short-acting insulin dosages, including fixed-mix insulins (70/30), by 50% and to monitor blood glucose frequently. The dose of pramlintide should be increased to the next increment (30 mcg, 45 mcg, or 60 mcg) when no clinically significant nausea has occurred for 3 days. If significant nausea persists at the 45- or 60-mcg dose level, the dose should be decreased to 30 mcg. If this dose is not tolerated, discontinuing the drug should be considered. Once the target dose of pramlintide is achieved and nausea has subsided, insulin doses should be adjusted to optimize glycemic control

Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: March 2010 Reviewed: December 2013