Safety Profile

Important Safety Information About SYMLIN^® (pramlintide acetate) injection

WARNING: SEVERE HYPOGLYCEMIASYMLIN 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.

CONTRAINDICATIONS

• Serious hypersensitivity reaction to SYMLIN or its ingredients
• Hypoglycemia unawareness
• Confirmed gastroparesis

WARNINGS AND PRECAUTIONS

Proper patient selection is critical to the safe and effective use of SYMLIN. Before initiating SYMLIN, review HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight. Only consider SYMLIN for patients who failed to achieve adequate glycemic control despite individualized insulin management, and patients who are receiving ongoing care under the guidance of a healthcare professional skilled in insulin use and are supported by a diabetes educator.

Do NOT consider SYMLIN for patients who have poor compliance with current insulin regimen or with self blood glucose monitoring, HbA1c >9%, recurrent severe hypoglycemia requiring assistance during the past 6 months, presence of hypoglycemia unawareness, confirmed gastroparesis, patients requiring medications that stimulate gastrointestinal motility, or pediatric patients.

Prescribe with caution in patients with visual or dexterity impairment.

Severe Hypoglycemia: Increased risk, particularly for type 1 diabetes. Upon initiation of SYMLIN, reduce mealtime insulin dose by 50% and frequently monitor pre- and post-meal blood glucose. If SYMLIN-associated severe hypoglycemia occurs, it is usually seen within the first 2 to 3 hours following SYMLIN injection. Use caution when administering with medications that may increase susceptibility to hypoglycemia.

Never share a SymlinPen between patients. Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed.

Never mix SYMLIN and insulin. Administer as separate injections. Mixing can alter the pharmacokinetics of both products, which may result in inadequate glucose control or hypoglycemia.

SYMLIN slows gastric emptying which may delay absorption of concomitantly administered oral medications. Administer concomitant oral medications at least 1 hour before or 2 hours after SYMLIN if rapid onset or threshold concentration is critical. SYMLIN is not recommended for patients taking other medications that alter gastrointestinal motility.

Local allergy may occur at injection site and usually resolves within a few days to a few weeks (eg, erythema, edema, pruritus).

ADVERSE REACTIONS

Most common adverse events reported in ≥5% of patients treated with SYMLIN plus insulin and with greater incidence than in patients treated with placebo plus insulin were:

• Type 1 Diabetes: nausea (48% vs 17%), anorexia (17% vs 2%), inflicted injury (14% vs 10%), vomiting (11% vs 7%), arthralgia (7% vs 5%), fatigue (7% vs 4%), allergic reaction (6% vs 5%), dizziness (5% vs 4%)
• Type 2 Diabetes: nausea (28% vs 12%), headache (13% vs 7%), anorexia (9% vs 2%), vomiting (8% vs 4%), abdominal pain (8% vs 7%), fatigue (7% vs 4%), dizziness (6% vs 4%), cough (6% vs 4%), pharyngitis (5% vs 2%)

Incidence for severe hypoglycemic adverse events in placebo-controlled trials with SYMLIN plus insulin vs placebo plus insulin and with greater incidence than in patients treated with placebo plus insulin were:

• Type 1 Diabetes: Patient-ascertained severe hypoglycemia at 0-3 months (16.8% vs 10.8%) and at >3-6 months (11.1% vs 8.7%). Medically assisted severe hypoglycemia at 0-3 months (7.3% vs 3.3%) and at >3-6 months (5.2% vs 4.3%)
• Type 2 Diabetes: Patient-ascertained severe hypoglycemia at 0-3 months (8.2% vs 2.1%) and at >3-6 months (4.7% vs 2.4%). Medically assisted severe hypoglycemia at 0-3 months (1.7% vs 0.7%)

SPECIFIC POPULATIONS

Pregnant and Nursing Women: No adequate and well-controlled studies have been conducted in pregnant women. It is unknown whether SYMLIN is excreted in human milk. SYMLIN should only be used in pregnancy or while nursing if the potential benefit justifies the potential risk.

Indication

SYMLIN is indicated as an adjunctive treatment in adults 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.

Please see full Prescribing Information, including Boxed WARNING regarding severe hypoglycemia, Medication Guide, and Instructions for Use for SYMLIN.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.