Vyvanse Patient Counseling Information

High Potential for Abuse and Dependence: Advise patients that VYVANSE can be abused and lead to dependence and not to give VYVANSE to anyone else [see Drug Abuse and Dependence under Precautions]. 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 Risks: 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 Serious Cardiovascular Reactions under Precautions].
Hypertension and Tachycardia: Instruct patients that VYVANSE can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects.
Psychiatric Risks: 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 Psychiatric Adverse Reactions under Precautions].
Suppression of Growth: Advise patients that VYVANSE may cause slowing of growth including weight loss [see Suppression of Growth under Precautions].
Impairment in Ability to Operate Machinery or Vehicles: 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 Clinical Trials Experience and Post-marketing Experience under Adverse Reactions].
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud's Phenomenon]: 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 Peripheral Vasculopathy, including Raynaud's Phenomenon under Precautions].
Serotonin Syndrome: 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; Serotonin Syndrome under Precautions; Drugs Having Clinically Important Interactions with Amphetamines under Interactions]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.
Concomitant Medications: 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 Drugs Having Clinically Important Interactions with Amphetamines under Interactions].
Pregnancy: 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 Pregnancy under Use in Pregnancy & Lactation].
Lactation: Advise women not to breastfeed if they are taking VYVANSE [see Lactation under Use in Pregnancy & Lactation].
Administration Instructions: Advise patients to take the capsules whole or empty and mix the entire contents with yogurt, water, or orange juice. Advise patients to consume the mixture immediately and not to store for future use [see General Instructions for Use under Dosage & Administration].