Vyvanse Chewable Tablets

— THERAPEUTIC CATEGORIES —
  • ADHD
  • Anxiety/OCD
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vyvanse Chewable Tablets Generic Name & Formulations

    Legal Class

    CII

    General Description

    Lisdexamfetamine dimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg; strawberry-flavored.

    Pharmacological Class

    CNS stimulant.

    See Also

    How Supplied

    Caps, Chew tabs—100

    How Supplied

    Vyvanse chewable tablets are supplied in bottles of 100 in the following strengths:

    • 10 mg – white to off-white round shaped tablet debossed with ‘10’ on one side and ‘S489’ on the other

    • 20 mg – white to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S489’ on the other

    • 30 mg – white to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S489’ on the other

    • 40 mg – white to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S489’ on the other

    • 50 mg – white to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S489’ on the other

    • 60 mg – white to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S489’ on the other

    Storage

    Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC and 30ºC (59 to 86ºF).

    Manufacturer

    Takeda Pharmaceutical Company

    Generic Availability

    NO

    Mechanism of Action

    Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.

    Vyvanse Chewable Tablets Indications

    Indications

    Attention deficit hyperactivity disorder.

    Vyvanse Chewable Tablets Dosage and Administration

    Prior to Treatment Evaluations

    • Assess for the presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

    • Assess the risk of abuse. After prescribing, keep prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Vyvanse use.

    Adults and Children

    <6yrs: not established. Do not subdivide a single dose. Caps: swallow whole or may open and mix/dissolve contents in yogurt, water, orange juice; take immediately. Chew tabs: chew thoroughly before swallowing. Individualize. ≥6yrs: initially 30mg once daily in AM. May adjust in increments of 10mg or 20mg at weekly intervals; max 70mg/day. Severe renal impairment (GFR 15–<30mL/min/1.73m2): max 50mg/day; ESRD (GFR <15mL/min/1.73m2): max 30mg/day.

    Renal Impairment

    • Patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2): maximum daily dose should not exceed 50 mg.

    • Patients with end stage renal disease (GFR < 15 mL/min/1.73m2): maximum daily dose is 30 mg.

    Administration

    • Take by mouth in the morning with or without food. Avoid afternoon doses due to the potential for insomnia.

    • Information for Vyvanse capsules:

      • Swallow whole, or

      • Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. May break apart any compacted powder with a spoon. Mix contents until completely dispersed, then consume immediately. Do not store mixed content.

    • Information for Vyvanse chewable tablets:

      • Must chew thoroughly before swallowing.

    • May substitute Vyvanse capsules with Vyvanse chewable tablets on a unit per unit/mg per mg basis.

    • A single dose should not be divided.

    Vyvanse Chewable Tablets Contraindications

    Contraindications

    During or within 14 days of MAOIs.

    Vyvanse Chewable Tablets Boxed Warnings

    Boxed Warning

    Abuse and dependence.

    Boxed Warning

    Abuse and Dependence

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Vyvanse Chewable Tablets Warnings/Precautions

    Warnings/Precautions

    Abuse potential (monitor). Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode prior to initiating. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for serotonin syndrome; discontinue if occurs. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Renal impairment. Monitor growth (in children), BP, HR. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy; monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

    Warnings/Precautions

    Potential for Abuse and Dependence 

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Serious Cardiovascular Reactions 

    • Sudden death, stroke, and myocardial infarction have been reported in adults receiving CNS stimulants. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems receiving CNS stimulants.

    • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems.

    • Evaluate further if exertional chest pain, unexplained syncope, or arrhythmias develop during treatment.

    Blood Pressure and Heart Rate Increases

    • Monitor all patients for potential tachycardia and hypertension.

    Psychiatric Adverse Reactions

    • Exacerbation of pre-existing psychosis: May exacerbate symptoms of behavior disturbance and thought disorders in patients with pre-existing psychotic behavior.

    • Induction of a manic episode in patients with bipolar disorder: May induce a mixed/manic episode in patients with bipolar disorder. Screen for risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

    • New psychotic or manic symptoms: May cause psychotic or manic symptoms in patients without a history of psychotic illness or mania. Consider discontinuing if symptoms occur.

    Suppression of Growth 

    • In pediatric patients, closely monitor growth (weight and height).

    • May need to interrupt treatment in patients who are not growing or gaining height or weight as expected.

    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.

    • These signs and symptoms generally improve after reduction in dose or discontinuation.

    • Observe carefully for digital changes during treatment. Evaluate further (eg, rheumatology referral) for certain patients.

    Serotonin Syndrome

    • Serotonin syndrome may occur when used concomitantly with other drugs such as MAOIs, SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. Concomitant use with MAOIs is contraindicated.

    • Increased risk of serotonin syndrome when co-administered with CYP2D6 inhibitors. 

    • Consider using an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6.

    • Discontinue Vyvanse and any concomitant drugs immediately if serotonin syndrome occurs, and initiate supportive symptomatic treatment. 

    • If concomitant use with other serotonergic drugs or CYP2D6 inhibitors are unavoidable, initiate Vyvanse at lower doses and monitor patients during drug initiation or titration.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    Risk Summary

    • Available data on the use of Vyvanse in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Infants born to mothers dependent on amphetamines have been observed with adverse pregnancy outcomes, including premature delivery and low birth weight.

    • The estimated background risk of major birth defects and miscarriage is unknown.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause vasoconstriction and 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 amphetamine-dependent mothers for symptoms of withdrawal.

    Nursing Mother Considerations

    Risk Summary

    • No reports of adverse effects on the breastfed infant. Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown.

    • Advise patients that breastfeeding is not recommended during Vyvanse treatment due to the risk for serious adverse reactions (eg, serious cardiovascular reactions, BP and HR increase, suppression of growth, and peripheral vasculopathy).

    Pediatric Considerations

    • ADHD: Safety and efficacy of Vyvanse has not been established in patients less than 6 years of age.

    • Binge eating disorder: Safety and efficacy of Vyvanse has not been established in patients less than 18 years of age.

    • Growth suppression: Monitor growth during treatment and may need to interrupt treatment in pediatric patients who are not growing or gaining weight as expected.

    Geriatric Considerations

    • In general, start elderly patients at the low end of the dosing range due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Renal Impairment Considerations

    • Patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2): maximum daily dose should not exceed 50 mg.

    • Patients with end stage renal disease (GFR < 15 mL/min/1.73m2): maximum daily dose is 30 mg.

    Vyvanse Chewable Tablets Pharmacokinetics

    Absorption

    • After a single dose administration of 60 mg Vyvanse chewable tablet in healthy subjects under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 4.4 hours post dose, respectively. The exposure (Cmax and AUCinf) of dextroamphetamine is similar between Vyvanse chewable tablet and Vyvanse capsule.

    • Administration of 60 mg Vyvanse chewable tablet with food (a high-fat meal) decreases the exposure (Cmax and AUCinf) of dextroamphetamine by about 5% to 7%, and prolongs mean Tmax by approximately 1 hour (from 3.9 hours at fasted state to 4.9 hours). 

    Metabolism

    • Lisdexamfetamine is converted to dextroamphetamine and l-lysine primarily in blood due to the hydrolytic activity of red blood cells after oral administration of lisdexamfetamine dimesylate.

    • Lisdexamfetamine is not metabolized by cytochrome P450 enzymes.

    Elimination

    • Renal (96%), fecal (0.3%). 

    • Half-life: <1 hour (lisdexamfetamine).

    • Plasma elimination half-life of dextroamphetamine: 8.6–9.5 hours for pediatric patients 6 to 12 years of age, and 10–11.3 hours in healthy adults.

    Vyvanse Chewable Tablets Interactions

    Interactions

    See Contraindications. Hypertensive crisis with MAOIs (including linezolid, IV methylene blue). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, busprione, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by urinary alkalinizers (eg, sodium bicarbonate, acetazolamide); avoid. Antagonized by acidifiers (eg, ascorbic acid). May potentiate TCAs or sympathomimetics; adjust dose or use alternatives.

    Vyvanse Chewable Tablets Adverse Reactions

    Adverse Reactions

    Anorexia, anxiety, decreased appetite/weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, vomiting, constipation, jitters; hypertension, tachycardia.

    Vyvanse Chewable Tablets Clinical Trials

    Clinical Trials

    Pediatric Patients Ages 6 to 12 Years with ADHD – Studies 1, 2, and 3

    Study 1

    • The double-blind, randomized, placebo-controlled, parallel-group study included 290 pediatric patients 6 to 12 years with ADHD. Patients were randomly assigned to receive final doses of 30 mg, 50 mg, or 70 mg of Vyvanse or placebo once daily in the morning for 4 weeks total. All patients were initiated on 30 mg during the 1st week, and titrated.

    • The primary efficacy outcome was change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating Scale (ADHD-RS).

    • All doses of Vyvanse were found to be superior to placebo in the primary efficacy outcome. The highest dose of 70 mg/day was numerically superior to both lower doses.

    Study 2

    • The double-blind, placebo-controlled, randomized, crossover design, analog classroom study included 52 pediatric patients 6 to 12 years of age with ADHD. Following a 3­ week open-label dose optimization with Adderall XR, patients were randomly assigned to continue their optimized dose of Adderall XR (10 mg, 20 mg, or 30 mg), Vyvanse (30 mg, 50 mg, or 70 mg), or placebo once daily in the morning for 1 week each treatment.

    • Efficacy assessments were conducted at 1, 2, 3, 4.5, 6, 8, 10, and 12 hours post-dose using the Swanson, Kotkin, Agler, M.Flynn, and Pelham Deportment scores (SKAMP-DS).

    • There was a significant difference in patient behavior based upon the average of investigator ratings on the SKAMP-DS observed between patients who received Vyvanse vs patients who received placebo.

    • Vyvanse achieved statistical significance in drug effect from hours 2 to 12 post-dose.

    Study 3

    • The second double-blind, placebo-controlled, randomized, crossover design, analog classroom study included 129 pediatric patients 6 to 12 years of age with ADHD. Following a 4-week open-label dose optimization with Vyvanse (30 mg, 50 mg, 70 mg), patients were randomly assigned to continue their optimized dose of Vyvanse or placebo once daily in the morning for 1 week each treatment.

    • There was a significant difference in patient behavior based on the average of investigator ratings on the SKAMP-Deportment scores across all 7 assessments conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose observed between patients who received Vyvanse vs patients who received placebo.

     

    Pediatric Patients Ages 13 to 17 Years with ADHD 

    Study 4

    • The double-blind, randomized, placebo-controlled, parallel-group study included 314 pediatric patients 13 to 17 years of age with ADHD. Patients were randomly assigned 1:1:1:1 to receive either Vyvanse 30 mg, 50 mg, 70 mg, or placebo once daily for 4 weeks. All patients in the Vyvanse arm were initiated on 30 mg for the 1st week.

    • The primary efficacy outcome was change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating Scale (ADHD-RS).

    • All Vyvanse dose groups were found to be superior to placebo in the primary efficacy outcome.

     

    Pediatric Patients Ages 6 to 17 Years: Short-Term Treatment in ADHD

    Study 5

    • The double-blind, randomized, placebo- and active-controlled parallel-group, dose-optimization study included 336 pediatric patients 6 to 17 years of age with ADHD. Patients were randomly assigned 1:1:1 to receive either Vyvanse (30 mg, 50 mg, or 70 mg per day), an active control, or placebo for 8 weeks. During the Dose Optimization Period, subjects were titrated until an optimal dose, based on tolerability and investigator’s judgment, was reached.

    • Patients treated with Vyvanse achieved significantly greater efficacy compared with placebo (placebo-adjusted mean reduction in ADHD-RS-IV total score of 18.6).

    • Vyvanse also achieved greater improvement on the Clinical Global Impression-Improvement (CGI-I) rating scale compared to subjects on placebo.

     

    Pediatric Patients Ages 6 to 17 Years: Maintenance Treatment in ADHD 

    Study 6

    • The double-blind, placebo-controlled, randomized withdrawal study included 276 pediatric patients 6 to 17 years of age with ADHD. Patients received open-label Vyvanse for at least 26 weeks prior to being assessed for entry into the randomized withdrawal period. Treatment response was determined based on CGI-S <3 and Total Score on the ADHD-RS ≤22.

    • Patients who maintained treatment response for 2 weeks at the end of the open label treatment were eligible to be randomized to ongoing treatment with the same dose of Vyvanse or switched to placebo during the double-blind phase.

    • 15.8% of patients treated with Vyvanse had treatment failures compared with 67.5% of patients treated with placebo at the end of the randomized withdrawal period. Treatment failure was defined as at least a 50% increase (worsening) in the ADHD-RS Total Score and at least a 2-point increase in the CGI-S score compared with scores at entry into the double-blind randomized withdrawal phase.

     

    Adults: Short-Term Treatment in ADHD – Studies 7 and 8

    Study 7

    • The double-blind, randomized, placebo-controlled, parallel-group study included 420 adults 18 to 55 years of age with ADHD. Patients were randomly assigned to receive final doses of Vyvanse 30 mg, 50 mg, or 70 mg or placebo for 4 weeks. In the Vyvanse arm, all patients were initiated on 30 mg for the 1st week.

    • The primary efficacy outcome was change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating Scale (ADHD-RS).

    • All dose groups of Vyvanse achieved superiority to placebo in the primary efficacy outcome.

    Study 8

    • The multi-center, randomized, double-blind, placebo-controlled, cross-over, modified analog classroom study included 142 adults 18 to 55 years of age with ADHD. After a 4-week open-label, dose optimization phase, patients were randomly assigned to 1 of 2 treatment sequences:

      • 1) Vyvanse (optimized dose) followed by placebo, each for 1 week, or

      • 2) Placebo followed by Vyvanse, each for 1 week.

    • Efficacy was assessed using the Permanent Product Measure of Performance (PERMP), a skill-adjusted math test that measures attention in ADHD.

    • Vyvanse achieved a statistically significant improvement in attention across all post-dose time points as measured by average PERMP total scores compared with placebo. PERMP assessments were obtained pre-dose (-0.5 hours) and at 2, 4, 8, 10, 12, and 14 hours post-dose.

     

    Adults: Maintenance Treatment in ADHD 

    Study 9

    • The double-blind, placebo-controlled, randomized withdrawal design study included 123 adults 18 to 55 years of age with ADHD. Eligible patients must have had a minimum of 6 months of Vyvanse treatment and demonstrated treatment response, as defined by CGI-S ≤3 and Total Score on the ADHD-RS <22.

    • Patients that maintained treatment response at Week 3 of the open label treatment phase (N=116) were eligible to be randomized to ongoing treatment with the same dose of Vyvanse (N=56) or switched to placebo (N=60) during the double-blind phase. Patients were observed for relapse (treatment failure) during the 6-week double-blind phase.

    • Efficacy endpoint was the proportion of patients with treatment failure during the double-blind phase. Treatment failure was defined as at least a 50% increase (worsening) in the ADHD-RS Total Score and at least a 2-point increase in the CGI-S score compared with scores at entry into the double-blind phase.

    • 9% of patients treated with Vyvanse had treatment failures compared with 75% of patients treated with placebo at the end of the double-blind phase. 

    Vyvanse Chewable Tablets Note

    Not Applicable

    Vyvanse Chewable Tablets Patient Counseling

    Patient Counseling

    Controlled Substance Status/High Potential for Abuse and Dependence 

    • Advise patients of the risk for abuse and dependence. Store Vyvanse in a safe place, preferably locked, to prevent abuse.

    Serious Cardiovascular Risks

    • Advise patients of the risk for serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension. Contact healthcare provider immediately if patients develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

    Hypertension and Tachycardia

    • May cause elevated blood pressure and pulse rate. Monitor for these effects.

    Psychiatric Risks

    • May cause psychotic or manic symptoms even in patients without a prior history of psychotic symptoms or mania.

    Suppression of Growth

    • May cause slowing of growth including weight loss.

    Impairment in Ability to Operate Machinery or Vehicles

    • May impair patient’s ability to operate machinery or vehicles.

    Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] 

    • Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms.

    Serotonin Syndrome

    • Advise patients about the risk for serotonin syndrome with concomitant use of Vyvanse and other serotonergic drugs including SSRIs, SNRIs, triptans, TCAs, 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.

    Pregnancy

    • Advise patients about the potential fetal effects. Notify healthcare provider if patients becomes pregnant or intends to become pregnant.

    Lactation

    • Do not breastfeed during treatment.

    Cost Savings Program

    Vyvanse Savings Card

    Vyvanse Chewable Tablets Generic Name & Formulations

    Legal Class

    CII

    General Description

    Lisdexamfetamine dimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg; strawberry-flavored.

    Pharmacological Class

    CNS stimulant.

    See Also

    How Supplied

    Caps, Chew tabs—100

    How Supplied

    Vyvanse capsules are supplied in bottles of 100 in the following strengths:

    • 10 mg – pink body/pink cap (imprinted with S489 and 10 mg)

    • 20 mg – ivory body/ivory cap (imprinted with S489 and 20 mg)

    • 30 mg – white body/orange cap (imprinted with S489 and 30 mg)

    • 40 mg – white body/blue green cap (imprinted with S489 and 40 mg)

    • 50 mg – white body/blue cap (imprinted with S489 and 50 mg)

    • 60 mg – aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)

    • 70 mg – blue body/orange cap (imprinted with S489 and 70 mg)

    Storage

    Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC and 30ºC (59 to 86ºF).

    Manufacturer

    Takeda Pharmaceutical Company

    Generic Availability

    NO

    Mechanism of Action

    Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.

    Vyvanse Chewable Tablets Indications

    Indications

    Moderate to severe binge eating disorder (BED).

    Limitations of Use

    Not indicated for weight loss. Safety and effectiveness not established for treatment of obesity.

    Vyvanse Chewable Tablets Dosage and Administration

    Prior to Treatment Evaluations

    • Assess for the presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam).

    • Assess the risk of abuse. After prescribing, keep prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Vyvanse use.

    Adult

    Do not subdivide a single dose. Caps: swallow whole or may open and mix/dissolve contents in yogurt, water, orange juice; take immediately. Chew tabs: chew thoroughly before swallowing. Individualize. ≥18yrs: initially 30mg once daily in the AM. May adjust in increments of 20mg at weekly intervals to target dose of 50–70mg/day; max 70mg/day. Discontinue if binge eating does not improve. Severe renal impairment (GFR 15–<30mL/min/1.73m2): max 50mg/day; ESRD (GFR <15mL/min/1.73m2): max 30mg/day.

    Children

    <18yrs: not established.

    Renal Impairment

    • Patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2): maximum daily dose should not exceed 50 mg.

    • Patients with end stage renal disease (GFR < 15 mL/min/1.73m2): maximum daily dose is 30 mg.

    Administration

    • Take by mouth in the morning with or without food. Avoid afternoon doses due to the potential for insomnia.

    • Information for Vyvanse capsules:

      • Swallow whole, or

      • Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. May break apart any compacted powder with a spoon. Mix contents until completely dispersed, then consume immediately. Do not store mixed content.

    • Information for Vyvanse chewable tablets:

      • Must chew thoroughly before swallowing.

    • May substitute Vyvanse capsules with Vyvanse chewable tablets on a unit per unit/mg per mg basis.

    • A single dose should not be divided.

    Vyvanse Chewable Tablets Contraindications

    Contraindications

    During or within 14 days of MAOIs.

    Vyvanse Chewable Tablets Boxed Warnings

    Boxed Warning

    Abuse and dependence.

    Boxed Warning

    Abuse and Dependence

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Vyvanse Chewable Tablets Warnings/Precautions

    Warnings/Precautions

    Abuse potential (monitor). Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode prior to initiating. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for serotonin syndrome; discontinue if occurs. Peripheral vasculopathy, including Raynaud's phenomenon; monitor for digital changes. Renal impairment. Monitor growth (in children), BP, HR. Write ℞ for smallest practical amount. Reevaluate periodically. Pregnancy; monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

    Warnings/Precautions

    Potential for Abuse and Dependence 

    • High potential for abuse and dependence.

    • Assess the risk of abuse prior to prescribing and monitor during therapy.

    Serious Cardiovascular Reactions 

    • Sudden death, stroke, and myocardial infarction have been reported in adults receiving CNS stimulants. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems receiving CNS stimulants.

    • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems.

    • Evaluate further if exertional chest pain, unexplained syncope, or arrhythmias develop during treatment.

    Blood Pressure and Heart Rate Increases

    • Monitor all patients for potential tachycardia and hypertension.

    Psychiatric Adverse Reactions

    • Exacerbation of pre-existing psychosis: May exacerbate symptoms of behavior disturbance and thought disorders in patients with pre-existing psychotic behavior.

    • Induction of a manic episode in patients with bipolar disorder: May induce a mixed/manic episode in patients with bipolar disorder. Screen for risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

    • New psychotic or manic symptoms: May cause psychotic or manic symptoms in patients without a history of psychotic illness or mania. Consider discontinuing if symptoms occur.

    Suppression of Growth 

    • In pediatric patients, closely monitor growth (weight and height).

    • May need to interrupt treatment in patients who are not growing or gaining height or weight as expected.

    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.

    • These signs and symptoms generally improve after reduction in dose or discontinuation.

    • Observe carefully for digital changes during treatment. Evaluate further (eg, rheumatology referral) for certain patients.

    Serotonin Syndrome

    • Serotonin syndrome may occur when used concomitantly with other drugs such as MAOIs, SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. Concomitant use with MAOIs is contraindicated.

    • Increased risk of serotonin syndrome when co-administered with CYP2D6 inhibitors. 

    • Consider using an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6.

    • Discontinue Vyvanse and any concomitant drugs immediately if serotonin syndrome occurs, and initiate supportive symptomatic treatment. 

    • If concomitant use with other serotonergic drugs or CYP2D6 inhibitors are unavoidable, initiate Vyvanse at lower doses and monitor patients during drug initiation or titration.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    Risk Summary

    • Available data on the use of Vyvanse in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Infants born to mothers dependent on amphetamines have been observed with adverse pregnancy outcomes, including premature delivery and low birth weight.

    • The estimated background risk of major birth defects and miscarriage is unknown.

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: May cause vasoconstriction and 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 amphetamine-dependent mothers for symptoms of withdrawal.

    Nursing Mother Considerations

    Risk Summary

    • No reports of adverse effects on the breastfed infant. Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown.

    • Advise patients that breastfeeding is not recommended during Vyvanse treatment due to the risk for serious adverse reactions (eg, serious cardiovascular reactions, BP and HR increase, suppression of growth, and peripheral vasculopathy).

    Pediatric Considerations

    • ADHD: Safety and efficacy of Vyvanse has not been established in patients less than 6 years of age.

    • Binge eating disorder: Safety and efficacy of Vyvanse has not been established in patients less than 18 years of age.

    • Growth suppression: Monitor growth during treatment and may need to interrupt treatment in pediatric patients who are not growing or gaining weight as expected.

    Geriatric Considerations

    • In general, start elderly patients at the low end of the dosing range due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Renal Impairment Considerations

    • Patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2): maximum daily dose should not exceed 50 mg.

    • Patients with end stage renal disease (GFR < 15 mL/min/1.73m2): maximum daily dose is 30 mg.

    Vyvanse Chewable Tablets Pharmacokinetics

    Absorption

    • After single-dose oral administration of Vyvanse capsule (30 mg, 50 mg, or 70 mg) in patients 6 to 12 years of age with ADHD under fasting conditions, the time to peak drug concentration (Tmax) of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 3.5 hours post dose, respectively.

    • After single-dose oral administration of Vyvanse 70 mg capsule, food prolonged Tmax by approximately 1 hour (from 3.8 hours at fasted state to 4.7 hours after a high fat meal or to 4.2 hours with yogurt). Food or orange juice did not affect the observed AUC and Cmax.

    Metabolism

    • Lisdexamfetamine is converted to dextroamphetamine and l-lysine primarily in blood due to the hydrolytic activity of red blood cells after oral administration of lisdexamfetamine dimesylate.

    • Lisdexamfetamine is not metabolized by cytochrome P450 enzymes.

    Elimination

    • Renal (96%), fecal (0.3%). 

    • Half-life: <1 hour (lisdexamfetamine).

    • Plasma elimination half-life of dextroamphetamine: 8.6–9.5 hours for pediatric patients 6 to 12 years of age, and 10–11.3 hours in healthy adults.

    Vyvanse Chewable Tablets Interactions

    Interactions

    See Contraindications. Hypertensive crisis with MAOIs (including linezolid, IV methylene blue). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, busprione, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by urinary alkalinizers (eg, sodium bicarbonate, acetazolamide); avoid. Antagonized by acidifiers (eg, ascorbic acid). May potentiate TCAs or sympathomimetics; adjust dose or use alternatives.

    Vyvanse Chewable Tablets Adverse Reactions

    Adverse Reactions

    Anorexia, anxiety, decreased appetite/weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, vomiting, constipation, jitters; hypertension, tachycardia.

    Vyvanse Chewable Tablets Clinical Trials

    Clinical Trials

    Binge Eating Disorder (BED) – Studies 10, 11, 12, 13

    Study 10

    • The randomized, double-blind, parallel-group, placebo-controlled, forced-dose titration phase 2 study compared the efficacy of Vyvanse 30 mg, 50 mg, and 70 mg per day to placebo in reducing the number of binge days per week in adults with at least moderate to severe BED for 11 weeks.

    • Vyvanse 30 mg/day did not achieve statistical significance on the primary endpoint compared with placebo.

    • Vyvanse 50 mg and 70 mg/day doses met the primary endpoint achieving superiority compared with placebo.

    Study 11 and 12

    • The two 12-week randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies evaluated the efficacy of Vyvanse for the treatment of BED in adults 18 to 55 years of age with moderate to severe BED. A binge day was defined as a day with at least 1 binge episode, as determined from the patient’s daily binge diary.

    • The studies included a 4-week dose-optimization period and an 8-week dose-maintenance period. The primary efficacy outcome was defined as the change from baseline at week 12 in the number of binge days per week.

    • Vyvanse achieved a statistically significantly greater reduction from baseline in mean number of binge days per week at week 12 compared with placebo. 

    • A greater proportion of patients treated with Vyvanse had improvements on the CGI-I rating scale, 4-week binge cessation, and a greater reduction in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score.

    Study 13

    • The double-blind, placebo controlled, randomized withdrawal design study evaluated the maintenance of efficacy based on time to relapse for Vyvanse compared with placebo in 267 adults 18 to 55 years of age with moderate to severe BED.

    • Patients were eligible if they responded to the preceding 12-week open-label treatment phase. Patients enrolled were randomly assigned to continue Vyvanse or placebo for up to 26 weeks of observation for relapse.

    • Relapse during the double-blind phase was defined as having 2 or more binge days each week for two consecutive weeks (14 days) prior to any visit and having an increase in CGI-S score of 2 or more points compared to the randomized-withdrawal baseline.  

    • Vyvanse demonstrated to be superior to placebo as measured by time to relapse.

    Vyvanse Chewable Tablets Note

    Not Applicable

    Vyvanse Chewable Tablets Patient Counseling

    Patient Counseling

    Controlled Substance Status/High Potential for Abuse and Dependence 

    • Advise patients of the risk for abuse and dependence. Store Vyvanse in a safe place, preferably locked, to prevent abuse.

    Serious Cardiovascular Risks

    • Advise patients of the risk for serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension. Contact healthcare provider immediately if patients develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

    Hypertension and Tachycardia

    • May cause elevated blood pressure and pulse rate. Monitor for these effects.

    Psychiatric Risks

    • May cause psychotic or manic symptoms even in patients without a prior history of psychotic symptoms or mania.

    Suppression of Growth

    • May cause slowing of growth including weight loss.

    Impairment in Ability to Operate Machinery or Vehicles

    • May impair patient’s ability to operate machinery or vehicles.

    Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] 

    • Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms.

    Serotonin Syndrome

    • Advise patients about the risk for serotonin syndrome with concomitant use of Vyvanse and other serotonergic drugs including SSRIs, SNRIs, triptans, TCAs, 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.

    Pregnancy

    • Advise patients about the potential fetal effects. Notify healthcare provider if patients becomes pregnant or intends to become pregnant.

    Lactation

    • Do not breastfeed during treatment.

    Cost Savings Program

    Vyvanse Savings Card

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