Dosing and uses of Symlin (pramlintide)
Adult dosage forms and strengths
injectable solution
- 0.6mg/mL
pen-injector
- 15mcg/dose
- 30mcg/dose
- 45mcg/dose
- 60mcg/dose
- 120mcg/dose
Type 1 Diabetes
Initial: 15 mcg SC immediately prior to major meals
Increase by 15 mcg q3Days (if not significant nausea occur)
Reduce postprandial short-acting insulin dose by 50%
Maintenance: 30-60 mcg SC
Type 2 Diabetes
Initial: 60 mcg SC immediately prior to major meals
After 3-7 days increase to 120 mcg prior to meals (if not significant nausea occurs)
Reduce postprandial short-acting insulin dose by 50%
Maintenance: 60-120 mcg SC
Renal Impairment
No adjustments necessary
Monitor
Blood glucose AC, PC & Hs
Pediatric dosage forms and strengths
Safety and efficacy not established
Symlin (pramlintide) adverse (side) effects
>10%
Nausea
Headache
Vomiting
Anorexia
Severe hypoglycemia
Inflicted injury
1-10%
Dizziness
Fatigue
Abdominal pain
Pharyngitis
Cough
Arthralgia
Allergic reaction
Postmarketing Reports
Injection site reactions
Pancreatitis
Warnings
Black box warnings
Pramlintide 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 pramlintide use occurs, it is seen within 3 hours following injection
If severe hypoglycemia occurs while operating a motor vehicle or 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
Contraindications
Hypersensitivity
Gastroparesis
Hypoglycemia unawareness
Cautions
Risk of severe insulin-induced hypoglycemia; pramlintide alone does not cause hypoglycemia; however, since it is indicated to be coadministered with mealtime insulin therapy, and in this setting there is an increased risk of severe hypoglycemia
Do not mix with insulin - administer the two separately
Slows gastric emptying, which may delay the absorption of concomitantly administered oral medications; administer the concomitant oral medication at least 1 hr prior or 2 hr after pramlintide
Slows gastric emptying; not recommended if taking other medications that alter gastrointestinal motility
Never share pen between patients even if needle is changed
Erythema, edema, or pruritus at site of injection reported; may be related to other factors, such as irritants in a skin cleansing agent or improper injection technique
Proper patient selection
- Proper patient selection is essential to safe and effective use
- For use only in patients with type 1 or type 2 diabetes using mealtime insulin who fulfill the following criteria:
- -failed to achieve adequate glycemic control despite individualized insulin management
- -receiving ongoing care under the guidance of a healthcare professional skilled in the use of insulin and supported by the services of diabetes educator
- Not for use in patients with ANY of the following criteria:
- -poor compliance with current insulin regimen
- -poor compliance with prescribed self blood glucose monitoring
- -have a 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
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Symlin (pramlintide)
Mechanism of action
Synthetic analog of the polypeptide pancreatic hormone amylin, which slows gastric emptying, supresses glucagon, and regulate appetite
Pharmacokinetics
Half-Life: 48 min
Bioavailability: 30-40%
Metabolism: kidneys
Excretion: Primarily urine
Duration: 3 hr
Protein binding: 60%
