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Better Health, Brighter Future

Vyvanse Capsules as a Titration Dose


New titration strength, along with the ability to mix Vyvanse capsule contents in water, orange juice, or yogurt, provides increased flexibility to help meet the dosing and administration needs of patients ages 6 and above with ADHD.

Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, today announced that Vyvanse (lisdexamfetamine dimesylate) is now available in a 10 milligram (mg) strength capsule. This new titration dose, which was approved by the U.S. Food and Drug Administration (FDA) on October 30, 2014, is the seventh Vyvanse dosage strength available in addition to the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsule strengths.

In July 2014, Shire received approval for two additional administration options for Vyvanse capsules. In addition to swallowing whole or mixing the capsule contents with water, the contents can be mixed with yogurt or orange juice for patients who have trouble swallowing capsules. Patients must follow the full instructions outlined in the Medication Guide for taking Vyvanse including how to mix in water, yogurt, or orange juice.

“We are pleased to offer more flexible dosing and administration options for patients,” said Perry Sternberg, Head of Shire’s Neuroscience Business Unit. “The 10 mg titration option, in addition to our previous approval allowing Vyvanse capsule contents to be mixed in orange juice or yogurt, underscores our commitment to helping to meet the needs of patients with ADHD.”

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.

About VYVANSE (lisdexamfetamine dimesylate)

Vyvanse is a prescription medicine currently only approved in the United States, Canada, Australia, several European countries (trade name: Elvanse®/Tyvense®) and Brazil (trade name: Venvanse™) for ADHD. Vyvanse should only be used in accordance with locally approved prescribing information.

INDICATION

Vyvanse is a prescription medicine for the treatment of ADHD in patients 6 years and above.

Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

IMPORTANT SAFETY INFORMATION

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.

  • Do not take Vyvanse if you or your child:
    • is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
    • is sensitive to, allergic to, or had a reaction to other stimulant medicines
  • Some people have had the following problems when taking stimulant medicines, such as Vyvanse:
    1. Heart-related problems including:
      • sudden death in people who have heart problems or heart defects
      • sudden death, stroke and heart attack in adults
      • increased blood pressure and heart rate
    2. Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. The doctor should check your or your child’s blood pressure and heart rate regularly during treatment.
      Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.

    3. Mental (psychiatric) problems including:
      • new or worse behavior and thought problems
      • new or worse bipolar illness
      • new psychotic symptoms such as:
        • seeing things or hearing voices that are not real
        • believing things that are not true
        • being suspicious
      • new manic symptoms
    4. In Children and Teenagers Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had, or about a family history of suicide, bipolar illness, or depression.
      Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking Vyvanse.

    5. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
      • Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red
    6. Call your doctor right away if you have or your child has any of these signs or symptoms or develops unexplained wounds on fingers or toes while taking Vyvanse.
  • Tell the doctor if you or your child is pregnant, breast-feeding, or plans to become pregnant or breast-feed.
  • Vyvanse may cause serious side effects, including:
    • slowing of growth (height and weight) in children. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
  • The most common side effects reported in studies of Vyvanse were:
    • anxiety
    • decreased appetite
    • diarrhea
    • dizziness
    • dry mouth
    • irritability
    • loss of appetite
    • nausea
    • trouble sleeping
    • upper stomach pain
    • vomiting
    • weight loss

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

About ADHD

Attention-Deficit/Hyperactivity Disorder is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.

ADHD is one of the most common childhood psychiatric disorders. An estimated 11 percent (6.4 million) of US school-aged children have been diagnosed with ADHD in their lifetime, based on the 2011/12 National Survey of Children’s Health, in which parents were asked if a health care practitioner had ever told them their child had ADD or ADHD. Although many people tend to think of ADHD as a childhood problem, 60% to 85% of children with ADHD may continue to meet the criteria for the disorder during their teenage years. Nearly 50% of children with ADHD may continue to meet the criteria for the disorder in adulthood, based on parent report. The disorder is estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication. When this percentage is extrapolated to the full US population aged 18 and over, approximately 10 million adults are estimated to have ADHD. Drug treatment may not be appropriate for all patients with ADHD.

The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5®) or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD.

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification, and/or medication.

For further information please contact:

Investor Relations

Sarah Elton-Farr
seltonfarr@shire.com
+44 1256 894157

Media

Gwen Fisher
gfisher@shire.com
+1 484 595 9836

NOTES TO EDITORS

About Shire

Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.

We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

Click here for the PDF version of this press release.

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