INDICATION AND LIMITATION OF USE

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

This site is intended for US healthcare professionals only.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION    This site is intended for US healthcare professionals only.

WARNING: ABUSE AND DEPENDENCE

  • | CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Shire has provided educational resources about ADHD to healthcare professionals and their patients for over a decade.

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Take the guesswork out of your patients' co-pay with our formulary coverage tool

Check patient’s individual health plan coverage and costs as plan status may change without notice.

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*Results data are provided by Fingertip Formulary® as of .

Tier (Tier#) = A formulary category that determines the amount of co-pay required for a drug. The number of tiers varies by plan and can range from 1 to 7.

Prior authorization (PA) = Approval process in which a prescriber must justify the use of a prescribed medication.

Step edit (SE) = Prescription for a medication is filled only after treatment failure on one or more alternatives.

Not covered (NC) = Drugs that are not covered by the plan.

Not available (NA) = Data are not available.

Shire has provided educational resources about ADHD to healthcare professionals and their patients for over a decade.

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    IMPORTANT SAFETY INFORMATION

    WARNING: ABUSE AND DEPENDENCE

    • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
    • Contraindications
      Patients should not take Vyvanse if they are:
      • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
      • taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
    • Warnings and Precautions
      • Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
      • CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
      • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
      • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
      • CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
      • Increased risk of serotonin syndrome when co-administered with serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), but also during overdosage situations. The potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to the active metabolite of Vyvanse (dextroamphetamine). In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6. If serotonin syndrome occurs, discontinue Vyvanse and any concomitant serotonergic agents immediately and initiate supportive treatment.
    • Adverse Reactions
      The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
      • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
      • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
      • Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
    • Pregnancy and Lactation
      Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.

    INDICATION AND LIMITATION OF USE

    Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

    Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

    References

    1. Biederman J, Kishnan S, Zhang Y, McGough JJ, Findling RL. 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(3):450-463.
    2. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
    3. Data on file; LDX006; Shire US Inc.

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