Vyvanse Patient Counseling Information

Abuse, Misuse and Addiction: Educate patients and their families about the risks of abuse, misuse, and addiction of VYVANSE, which can lead to overdose and death, and proper disposal of any unused drug [see Abuse, Misuse and Addiction and Drug Abuse and Dependence under Precautions; Overdosage]. Advise patients to store VYVANSE in a safe place, preferably locked, and instruct patients to not give VYVANSE to anyone else.
Risks to Patients with Serious Cardiac Disease: Advise patients that there are a potential risks to patients with serious cardiac disease, including sudden death, 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 Risks to Patients with Serious Cardiac Disease under Precautions].
Increased Blood Pressure and Heart Rate: Instruct patients that VYVANSE can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects.
Psychiatric Adverse Reactions: 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].
Long-Term Suppression of Growth in Pediatric Patients: Advise patients that VYVANSE may cause slowing of growth including weight loss [see Long-Term Suppression of Growth in Pediatric Patients under Precautions].
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].
Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Advise patients that motor and verbal tics and worsening of Tourette's Syndrome may occur during treatment with VYVANSE. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette's syndrome occurs [see Motor and Verbal Tics, and Worsening of Tourette's Syndrome under Precautions].
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 Administration Information under Dosage & Administration].