IMPORTANT SAFETY INFORMATION – DAYTRANA

• 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 death, 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. Erythema has been commonly reported. 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.

Please see accompanying Full Prescribing Information, including Boxed Warning.

Daytrana Medication Guide

IMPORTANT SAFETY INFORMATION - VYVANSE

• Vyvanse is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 and one controlled trial in adults.
• Vyvanse should not be taken by patients who have:

• advanced arteriosclerosis
• symptomatic cardiovascular disease
• moderate to severe hypertension
• hyperthyroidism
• known hypersensitivity or idiosyncrasy to sympathomimetic amines
• agitated states
• glaucoma
• a history of drug abuse
• 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 death, 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, seizures or EEG abnormalities, bipolar disorder, or depression.  Growth monitoring is advised during prolonged treatment.
• Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
• The most common adverse events reported in clinical studies of Vyvanse were: pediatric – decreased appetite, insomnia, abdominal pain, and irritability; adult – decreased appetite, insomnia, and dry mouth.

Please see accompanying Full Prescribing Information, including Boxed Warning.

Vyvanse Medication Guide

©2008 Shire US Inc., Wayne, Pennsylvania 19087

References

1. nData on file; LDX045; Shire US Inc.
2. Jasinski D, Krishnan S. A double-blind, randomized, placebo- and active-controlled, 6-period crossover study to evaluate the likability, safety, and abuse potential of lisdexamfetamine dimesylate (LDX) in adult stimulant abusers. Presented at: 2006 US Psychiatric & Mental Health Congress; November 18, 2006; New Orleans, LA.
3. Data on file; LDX0TK; Shire US Inc.
4. Biederman J, Krishnan S, Zhang Y, et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29:450-463.
5. Data on file; LDX038; Shire US Inc.
6. Biederman J, Boeliner SW, Childress A, et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007;62:970-976.
7. Findling R, Childress A, Krishnan S, McGough J. Long-term efficacy and safety of lisdexamfetamine in school-age children with attention deficit/hyperactivity disorder. Presented at: 2007 American Psychiatric Association Annual Meeting; May 19-24, 2007; San Diego, CA.
8. Vyvanse [package insert], Wayne, PA: Shire US Inc; 2007.
9. Niebler G, Wilens TE, Weisler R, et al. Evaluation of cardiovascular effects with lisdexamfetamine dimesylate treatment in adults with attention-deficit/hyperactivity disorder. Presented at: Annual Meeting of the American Psychiatric Association; May 3-8, 2008; Washington, DC.