1. Dosage
Adults
Pramlintide (Symlin®), a synthetic analog of human amylin, is FDA-approved for use as adjunct therapy in patients with type 1 or type 2 diabetes using mealtime insulin who are not adequately controlled with optimal insulin therapy. Amylin is a neuroendocrine hormone secreted concurrently with insulin in response to food intake to decrease hepatic glucose output and slow gastric emptying, which results in reduced carbohydrate absorption and lower postprandial glucose levels. Similarly, pramlintide works by delaying gastric emptying, decreasing postprandial increases in glucagon levels, and causing satiety, which promotes decreased caloric intake and potential weight loss.1-3 Pramlintide is available as a 1.5 ml disposable, multidose 60-pen injector or a 2.7 ml disposable, multidose 120-pen injector containing pramlintide 1000 mcg/ml. The 60-pen injector provides doses of 15 mcg, 30 mcg, 45 mcg, or 60 mcg while the 120-pen injector provides pramlintide doses of 60 mcg or 120 mcg1,3. Recommended pramlintide dosages are summarized in Table 1.
| Treatment Indication | Dosage Form/Strength | Initial Dose | Dosage Titration | Maximum Recommended Dosage |
|---|---|---|---|---|
| type 1 diabetes mellitus | SymlinPen® 60 solution pen-injector (1000 mcg/mL, 1.5 mL) | 15 mcg subcutaneously immediately prior to each major meal | 15 mcg increments | 60 mcg subcutaneously immediately prior to each major meal |
| type 2 diabetes mellitus (insulin-using) | SymlinPen® 120 solution pen-injector (1000 mcg/mL, 2.7 mL) | 60 mcg subcutaneously immediately prior to each major meal | 60 mcg increments | 120 mcg subcutaneously immediately prior to each major meal |
In patients with type 1 diabetes, dosage titrations should be initiated when clinically significant nausea has been absent for at least 3 days. If nausea persists with the 45 mcg or 60 mcg dose, the dosage may be reduced to 30 mcg. If patients do not tolerate the 30 mcg dose, discontinuing therapy may be necessary. In insulin-using patients with type 2 diabetes, dosage titrations may be initiated when significant nausea is absent for at least 3 days. If the 120 mcg dose is not tolerated, the dosage may be decreased to 60 mcg. For patients with type 1 or type 2 diabetes receiving pre-prandial rapid or short-acting insulin therapy, including fixed-mixed insulin, dose should be decreased by 50% when adjunctive pramlintide therapy is initiated to minimize hypoglycemic episodes. Insulin doses may be titrated upward as needed when a maintenance pramlintide dose is established1,3. Patient profiles containing pramlintide prescription quantities of greater than 2 x 60-pen injectors or 1 x 120-pen injector per 30 days for patients with type 1 diabetes will be reviewed. Likewise, patient profiles containing pramlintide prescription quantities of greater than 2 x 120-pen injectors per 30 days for patients with type 2 diabetes will be reviewed.
Pramlintide should not be administered to patients who1,3:
- have been diagnosed with gastroparesis
- have recurrent episodes of hypoglycemia requiring intervention in the last 6 months and/or hypoglycemia unawareness
- have an HbA1c greater than 9%
- require therapy with medications that stimulate gastrointestinal motility
- are poorly compliant with insulin regimens and/or self-monitoring of blood glucose serum concentrations
Pediatrics
Safety and efficacy of pramlintide injections in pediatric patients have not been established. However, a few small, short-term studies have evaluated pramlintide use in adolescents with type 1 diabetes and demonstrated significant reductions in postprandial hyperglycemia. Further long-term studies are necessary to solidify results4-7.