INDICATION

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

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

     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.

  2. Mental (psychiatric) problems including:

     • new or worse behavior and thought problems
     • new or worse bipolar illness

     In Children and Teenagers

     • 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

     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.

  3. 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

     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.

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.