August 24, 2016
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Included as part of the PRECAUTIONS section.


Potential For 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 [see Drug Abuse and Dependence].

Serious Cardiovascular Reactions

Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during VYVANSE treatment.

Blood Pressure And Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric Adverse Reactions

Exacerbation of Pre-existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode.

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms, e.g. hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing VYVANSE. In a pooled analysis of multiple short-term, placebocontrolled studies of CNS stimulants, psychotic or manic symptoms occurred in 0.1% of CNS stimulant-treated patients compared to 0% in placebo-treated patients.

Suppression Of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including VYVANSE. In a 4-week, placebo-controlled trial of VYVANSE in patients ages 6 to 12 years old with ADHD, there was a doserelated decrease in weight in the VYVANSE groups compared to weight gain in the placebo group. Additionally, in studies of another stimulant, there was slowing of the increase in height [see ADVERSE REACTIONS].

Peripheral Vasculopathy, Including Raynaud's Phenomenon

Stimulants, including VYVANSE, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Patient Counseling Information

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

Controlled Substance Status/High Potential for Abuse and Dependence

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]. 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 WARNINGS AND 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 WARNINGS AND PRECAUTIONS].

Suppression of Growth

Advise patients that VYVANSE may cause slowing of growth including weight loss [see WARNINGS AND PRECAUTIONS].

Table 8: Summary of Primary Efficacy Results in BED

Study Number Treatment Group Primary Efficacy Measure: Binge Days per Week at Week 12
Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Differencea (95% CI)
Study10 VYVANSE (50 or 70 mg/day)* 4.79
(-1.70, -1.01)
Placebo 4.60
Study11 VYVANSE (50 or 70 mg/day)* 4.66
(-2.04, -1.28)
Placebo 4.82
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.
a Difference (drug minus placebo) in least-squares mean change from baseline.
* Doses statistically significantly superior to placebo.

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 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 WARNINGS AND PRECAUTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, And Impairment Of Fertility


Carcinogenicity studies of lisdexamfetamine dimesylate have not been performed. No evidence of carcinogenicity was found in studies in which d-, l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats.


Lisdexamfetamine dimesylate was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli and S. typhimurium components of the Ames test and in the L5178Y/TK+- mouse lymphoma assay in vitro.

Impairment of Fertility

Amphetamine (d- to l-enantiomer ratio of 3:1) did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day.

Table 7: Summary of Primary Efficacy Results from Short-term Studies of VYVANSE in Children, Adolescents, and Adults with ADHD

Study No.
(Age range)
Primary Endpoint Treatment Group Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Differencea
(95% CI)

(6 -12 years)

(30 mg/day)*
(50 mg/day)*
(70 mg/day)*
45.1(6.8) -26.7
Placebo 42.4
Study 2
(6 -12 years)
(30, 50 or 70 mg/day)*
-- b 0.8
(-1.1, -0.7)
Placebo -- b 1.7
Study 3
(6 -12 years)
(30, 50 or 70 mg/day)*
(-0.9, -0.6)
Placebo 0.7
(13 -17 years)
(30 mg/day)*
(-9.0, -2.0)
(50 mg/day)*
(70 mg/day)*
Placebo 38.5(7.1) -12.8
Study 5
(6-17 years)
(30, 50 or 70 mg/day)*
Placebo 41.0(7.1) -5.7
(18 -55 years)
(30 mg/day)*
40.5(6.2) -16.2
(50 mg/day)*
(70 mg/day)*
41.0(6.0) -18.6
Placebo 39.4
Study 8
(18 -55 years)
(30, 50 or 70 mg/day)*
Placebo 261.4
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.
a Difference (drug minus placebo) in least-squares mean change from baseline.
b Pre-dose SKAMP-DS was not collected.
c Pre-dose SKAMP-DS
(Study 3) or PERMP (Study 8) total score, averaged over both periods.
d LS Mean for SKAMP-DS (Study 2 and 3) or PERMP (Study 8) is post-dose average score over all sessions of the treatment day, rather than change from baseline.
* Doses statistically significantly superior to placebo.

Use In Specific Populations


Pregnancy Category C

Risk Summary

There are no adequate and well-controlled studies with VYVANSE in pregnant women. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines. Long-term neurochemical and behavioral effects have been reported in animal developmental studies using clinically relevant doses of amphetamine (d- or d,l-). Animal reproduction studies performed with lisdexamfetamine dimesylate in rats and rabbits showed no effects on embryofetal morphological development and survival. VYVANSE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations

Amphetamines, such as VYVANSE, cause vasoconstriction and thereby may decrease placental perfusion. Infants born to amphetamine-dependent mothers have an increased risk of premature delivery and low birth weight.

Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.

Human Data

Available data in women using amphetamines during pregnancy do not show a clear increased risk of major congenital malformations. Two case control studies of over a thousand patients in total exposed to amphetamines at different gestational ages did not show an increase in congenital abnormalities.

Animal Data

Lisdexamfetamine dimesylate had no apparent effects on embryofetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 40 and 120 mg/kg/day, respectively. These doses are approximately 4 and 27 times, respectively, the maximum recommended human dose of 70 mg/day given to adolescents, on a mg/m² body surface area basis.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-) at doses similar to those used clinically can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning andmemory deficits, altered locomotor activity, and changes in sexual function.

Nursing Mothers

Amphetamines are excreted into human milk. Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use


Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years [see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY, and Clinical Studies]. Safety and efficacy in pediatric patients below the age of 6 years have not been established.


Safety and effectiveness in patients less than 18 years of age have not been established

Growth Suppression

Growth should bemonitored during treatment with stimulants, including VYVANSE, and children who are not growing or gaining weight as expected may need to have their treatment interrupted [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Juvenile Animal Data

Studies conducted in juvenile rats and dogs at clinically relevant doses showed growth suppression that partially or fully reversed in dogs and female rats but not in male rats after a four-week drug-free recovery period.

A study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of lisdexamfetamine dimesylate from day 7 to day 63 of age. These doses are approximately 0.3, 0.7, and 3 times the maximum recommended human daily dose of 70 mg on a mg/m² basis for a child. Dose-related decreases in food consumption, bodyweight gain, and crown-rump length were seen; after a four-week drug-free recovery period, bodyweights and crown-rump lengths had significantly recovered in females but were still substantially reduced in males. Time to vaginal opening was delayed in females at the highest dose, but there were no drug effects on fertility when the animals were mated beginning on day 85 of age.

In a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning at 10 weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and 12 mg/kg/day, which are approximately 0.5, 1, and 3 times the maximum recommended human daily dose on a mg/m² basis for a child). This effect partially or fully reversed during a four-week drug-free recovery period.

Geriatric Use

Clinical studies of VYVANSE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience and pharmacokinetic data [see CLINICAL PHARMACOLOGY] have not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment

Due to reduced clearance in patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m²), the maximum dose should not exceed 50 mg/day. The maximum recommended dose in ESRD (GFR < 15 mL/min/1.73 m²) patients is 30 mg/day [see CLINICAL PHARMACOLOGY].

Lisdexamfetamine and d-amphetamine are not dialyzable.


No dosage adjustment of VYVANSE is necessary on the basis of gender [see CLINICAL PHARMACOLOGY].

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/20/2016


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