INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (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 and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (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 and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Patient Counseling Information

Patients, their families, and caregivers should be informed about the benefits and risks associated with treatment with Vyvanse and should be counseled on the appropriate use of Vyvanse.

A patient Medication Guide is available for Vyvanse. Patients, their families, and their caregivers should be instructed to read the Medication Guide and their healthcare provider should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide with their healthcare provider to obtain answers to any questions they may have. The complete text of the Medication Guide is included in the Package Insert.

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. 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.

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.

Suppression of Growth1

Advise patients that Vyvanse may cause slowing of growth including weight loss.

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.

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 (eg, rheumatology referral) may be appropriate for certain patients.

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). 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.

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.

Lactation1

Advise women not to breastfeed if they are taking Vyvanse.

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

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