This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US health care 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

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence1

Advise patients that Vyvanse is a controlled substance and it can be abused and lead to dependence and not to give Vyvanse to anyone else [see Drug Abuse and Dependence (9.1, 9.2, and 9.3)]. Advise patients to store Vyvanse in a safe place, preferably locked, to prevent abuse. Advise patients to dispose of remaining, unused, or expired Vyvanse by a medicine take-back program.

Serious Cardiovascular Risks1

Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with Vyvanse use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Hypertension and Tachycardia1

Instruct patients that Vyvanse can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects.

Psychiatric Risks1

Advise patients that Vyvanse at recommended doses may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Impairment in Ability to Operate Machinery or Vehicles1

Advise patients that Vyvanse may impair their ability to engage in potentially dangerous activities such as operating machinery or vehicles. Instruct patients to find out how Vyvanse will affect them before engaging in potentially dangerous activities [see Adverse Reactions (6.1, 6.2)].

Circulation Problems in Fingers and Toes (Peripheral Vasculopathy, including Raynaud's Phenomenon)1

Instruct patients beginning treatment with Vyvanse about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Vyvanse. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Serotonin Syndrome1

Caution patients about the risk of serotonin syndrome with concomitant use of VYVANSE and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4), Warnings and Precautions (5.7) and Drug Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Concomitant Medications1

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].

Pregnancy1

Advise patients of the potential fetal effects from the use of Vyvanse during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Vyvanse. [see Use in Specific Populations (8.1)].

Lactation1

Advise women not to breastfeed if they are taking Vyvanse. [see Use in Specific Populations (8.1)].

These highlights do not include all the information needed to use Vyvanse appropriately. See Full Prescribing Information.

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, 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 of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, feeling jittery, constipation, and anxiety.
  • Pregnancy and Lactation
    Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
  • Other Considerations
    • Safety and effectiveness in patients <18 years with B.E.D. have not been established.

INDICATION AND LIMITATION OF USE

Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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.

Reference

  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
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