Indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk.

SYMLIN is contraindicated in patients with any of the following:

• hypoglycemia unawareness
• confirmed gastroparesis

SYMLIN therapy should only be considered in patients with type 1 diabetes or patients with type 2 diabetes using mealtime insulin 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)

Patients meeting any of the following criteria should NOT be considered for SYMLIN therapy:

• 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

SYMLIN therapy should be discontinued if there is:

• recurrent unexplained hypoglycemia that requires medical assistance
• persistent clinically significant nausea
• noncompliance with self-monitoring of blood glucose concentrations
• noncompliance with insulin dose adjustments
• noncompliance with scheduled healthcare provider contacts or recommended clinic visits

SYMLIN should be prescribed with caution to persons with visual or dexterity impairment.

Mixing SYMLIN and insulin can alter the pharmacokinetics of both products which may result in inadequate glucose control or hypoglycemia. Therefore, SYMLIN and insulin must always be administered as separate injections and should never be mixed.

Due to its effects on gastric emptying, SYMLIN should not be considered for patients taking medications that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine) or medications that slow the intestinal absorption of nutrients (e.g., alpha-glucosidase inhibitors).

The following are examples of medications that may increase the susceptibility to hypoglycemia when administered with SYMLIN: oral anti-diabetic products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogs, and sulfonamide antibiotics. SYMLIN and these drugs should be co-administered with caution.

No adequate and well-controlled studies have been conducted in pregnant women. Studies in perfused human placenta indicate that SYMLIN has low potential to cross the maternal/fetal placental barrier. Animal studies: congenital abnormalities (neural tube defect, cleft palate, exencephaly).

It is unknown whether SYMLIN is excreted in human milk. Many drugs, including peptides, are excreted in human milk.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Weight loss. GoToSource 

• Use as monotherapy. GoToSource 

• Alzheimer’s disease. GoToSource

Hypoglycemia (low blood sugar). GoToSource 

Delayed gastric emptying. GoToSource 

Nausea, vomiting and anorexia. GoToSource

No major injury lawsuits reported.