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Shire to Present Scientific Data Across Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting May 5-9
Date:5/4/2012

y mouth, nausea, diarrhea, anxiety and anorexia.

Please see Full Prescribing Information for Vyvanse (lisdexamfetamine dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and Diversion.

ABOUT INTUNIV (guanfacine) EXTENDED RELEASE TABLETS

INDICATION

INTUNIV (guanfacine) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 9 weeks has not been systematically evaluated. The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.

INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

IMPORTANT SAFETY INFORMATION

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine (eg, TENEX®) should not take INTUNIV.

Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, heart block, bradycardia, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Advise patients to avoid becoming dehydrated or overheated.

Somnolence and sedation were commonly reported adverse reactions in clinical studies (38% for INTUNIV
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SOURCE Shire plc
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3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
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10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
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