II. Indications
- Type I and II Diabetes Mellitus
- Adjunct to Insulin therapy
- Third-line measure due to Hypoglycemia risk and cost
III. Contraindications
- Gastroparesis
- Hypoglycemia history (esp. if patient unaware of episodes)
IV. Mechanism
- Pramlintide is a synthetic analogue of human Amylin
- Amylin is secreted with Insulin from the Pancreas
- Amylin lowers post-prandial Blood Sugars
- Delays gastric emptying
- Inhibits Glucagon release
V. Precautions
- Switch to new pen device which replaces the vials and prevents dosing errors
- Warning: Pen concentration is different than vial concentration
- Dosing errors are common with the vials
- Dosing is typically listed in mcg, but is drawn up in Insulin syringes marked with units
- A patient who mistakes their 30 mcg dose for 30 units is accidentally taking 180 mcg
VI. Medications
- Pramlintide (SymlinPen) 1000 mcg/ml pen injector: 1.5 or 2.7 ml
- Pen replaces the older vials that required a 100 unit 0.3 ml syringe
- Store unopened vials in refrigerator
- Once opened, may be kept at room Temperature for up to 28 days
VII. Dosing
- Protocol
- Reduce short and mixed-acting Insulin dose by 50%
- Take with at least 250 calories (>30 g Carbohydrate)
- Inject SQ into Abdomen or thigh
- Type I Diabetes Mellitus
-
Type II Diabetes Mellitus
- Start: 60 mcg (10 U) SQ three times daily immediately before meals
- Target: 60 to 120 mcg (10-20 units) SQ three times daily before meals
- Discontinue or lower dose to 60 mcg if significant Nausea
VIII. Adverse effects
-
Nausea (28%) or Vomiting (8%): Especically Type I DM (related to Delayed Gastric Emptying)
- Contraindicated in Gastroparesis
- Headache (13%)
- Anorexia (9%)
- Abdominal Pain (8%)
- Severe Hypoglycemia (4.7%)
- Occurs 3 hours after Insulin and Pramlintide dose (higher risk in Type 1 Diabetes Mellitus)
- FDA Black box warning (decrease Insulin dose before starting)
IX. Safety
- Pregnancy Category C
- Unknown safety in Lactation
X. Efficacy
- Drops Hemoglobin A1C 0.5 to 0.6% (contrast with Placebo: 0.25% )
- No good longterm outcome data (other agents with better longterm efficacy are preferred)
- Lowers weight 3 lb or 1.4 kg (Placebo: 0.6 kg gained)
XI. Drug Interactions
- Gastrointestinal motility medications
- Avoid with Pramlintide
- Alpha glucosidase Inhibitors
- Avoid with Pramlintide
- Drugs that require rapid onset
- Take rapid onset medications 1 hour prior to, or 2 hours after Pramlintide