These highlights do not include all the information needed to use SYMLIN safely and effectively. See full prescribing information for SYMLIN.
SYMLIN ® (pramlintide acetate) injection for subcutaneous use
Initial U.S. Approval: 2005
WARNING: SEVERE HYPOGLYCEMIA
See full prescribing information for complete boxed warning.
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SYMLIN use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes.
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Hypoglycemia risk may be reduced by appropriate patient selection, careful patient instruction, and insulin dose reduction (5.1, 5.2).
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 8/2014
INDICATIONS AND USAGE
SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy. (1)
DOSAGE AND ADMINISTRATION
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Upon initiation of SYMLIN, reduce mealtime insulin dose by 50%. Monitor glucoses frequently and individualize subsequent insulin dose adjustments (2.1).
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Type 1 Diabetes: Start at 15 mcg subcutaneously before major meals. Increase in 15 mcg increments to a maximum premeal dose of 30 or 60 mcg; if not tolerated, reduce to 30 mcg, as tolerated (2.2).
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Type 2 Diabetes: Start at 60 mcg subcutaneously before major meals then increase to 120 mcg before meals, as tolerated (2.2).
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Wait at least 3 days between dose titrations to minimize nausea (2.1).
DOSAGE FORMS AND STRENGTHS
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1.5 mL SymlinPen ® 60 disposable multidose pen-injector, (1000 mcg/mL) for 15, 30, 45, and 60 mcg doses (3).
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2.7 mL SymlinPen ® 120 disposable multidose pen-injector, (1000 mcg/mL) for 60 and 120 mcg doses (3).
CONTRAINDICATIONS
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Prior serious hypersensitivity reaction to SYMLIN or its ingredients (4)
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Hypoglycemia unawareness (4)
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Confirmed gastroparesis (4)
WARNINGS AND PRECAUTIONS
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Severe hypoglycemia: Increased risk particularly for type 1 diabetes. Upon initiation of SYMLIN, reduce mealtime insulin dose by 50% and frequently monitor blood glucoses (5.2).
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Never share a SymlinPen between patients, even if the needle is changed (5.3).
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Do not mix SYMLIN and insulin: Mixing can alter the pharmacokinetics of both products. Administer as separate injections (5.4, 7.1).
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Slows gastric emptying: Administer concomitant oral medications at least 1 hour before or 2 hours after SYMLIN if rapid onset or threshold concentration is critical (5.6, 7.2).
ADVERSE REACTIONS
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Most common adverse reactions (incidence ≥5% and higher incidence than placebo): nausea, vomiting, anorexia, headache (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2014
