Product – Daytrana

Daytrana^® (methylphenidate transdermal system)

The first patch for ADHD

Daytrana^®, approved for marketing in the U.S. by the FDA in April 2006, is the first and only transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). It is approved for children aged six to twelve years with ADHD. Shire plc, the market leader in ADHD therapy, is the exclusive, global licensee of Daytrana^®, which was developed and is manufactured by Noven.

Important Safety Information
Daytrana^® should not be used in patients with allergy to methylphenidate or patch components; marked anxiety, tension and agitation; glaucoma; tics, diagnosis or a family history of Tourette's syndrome; seizures; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs). Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Growth and hematologic monitoring is advised during prolonged treatment. Patients should avoid applying external heat to the Daytrana^® patch. Skin irritation or contact sensitization may occur.

Daytrana^® should be given cautiously to patients with a history of drug dependence and alcoholism. Chronic abuse can lead to marked tolerance and psychological dependence. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder.

Common adverse events reported by patients who received Daytrana^® in clinical trials were decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, and anorexia, consistent with adverse events commonly associated with the use of methylphenidate.

For full prescribing information and additional product information, go to www.daytrana.com.

For patient, physician and pharmacist inquiries
regarding Daytrana^®, please contact:

Shire US Inc.
725 Chesterbrook Blvd.
Wayne, PA 19087
Ph: 800-828-2088