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Lisdexamfetamine: Drug information

Lisdexamfetamine: Drug information
(For additional information see "Lisdexamfetamine: Patient drug information" and see "Lisdexamfetamine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Abuse and dependence:

CNS stimulants (amphetamines and methylphenidate-containing products), including lisdexamfetamine, 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.

Brand Names: US
  • Vyvanse
Brand Names: Canada
  • Vyvanse
Pharmacologic Category
  • Central Nervous System Stimulant
Dosing: Adult

Note: Prior to treatment, assess for presence of cardiac disease and assess for risk of abuse.

Attention-deficit/hyperactivity disorder

Attention-deficit/hyperactivity disorder (ADHD): Oral: Initial: 30 mg once daily in the morning; may increase in increments of 10 mg or 20 mg at weekly intervals until optimal response is obtained; maximum: 70 mg/day. Note: Individualize dosage based on patient need and response to therapy. Administer at the lowest effective dose.

Binge eating disorder

Binge eating disorder: Oral: Initial: 30 mg once daily in the morning; may titrate in increments of 20 mg at weekly intervals to target dose of 50 to 70 mg once daily (maximum: 70 mg/day); discontinue use if binge eating does not improve.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling.

GFR 15 to <30 mL/minute/1.73 m2: Maximum dose: 50 mg/day.

GFR <15 mL/minute/1.73 m2: Maximum dose: 30 mg/day.

ESRD requiring hemodialysis: Maximum dose: 30 mg/day; lisdexamfetamine and dextroamphetamine are not dialyzable.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Lisdexamfetamine: Pediatric drug information")

Note: Use lowest effective individualized dose; administer first dose as soon as awake; avoid late evening doses.

Attention-deficit/hyperactivity disorder

Attention-deficit/hyperactivity disorder (ADHD): Children ≥6 years and Adolescents: Capsules, chewable tablets: Oral: Initial: 20 to 30 mg once daily in the morning; may increase in increments of 10 mg/day or 20 mg/day at 3- to 7-day intervals until optimal response is obtained; maximum daily dose: 70 mg/day (AAP 2011; manufacturer labeling)

Binge eating disorder, moderate to severe

Binge eating disorder, moderate to severe: Adolescents ≥18 years: Capsule, chewable tablets: Oral: Initial: 30 mg once daily in the morning; may titrate in increments of 20 mg/day at weekly intervals to target dose of 50 to 70 mg once daily; maximum daily dose: 70 mg/day; discontinue use if binge eating does not improve.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥6 years and Adolescents:

GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling.

GFR 15 to <30 mL/minute/1.73 m2: Maximum daily dose: 50 mg/day.

GFR <15 mL/minute/1.73 m2: Maximum daily dose: 30 mg/day.

ESRD requiring hemodialysis: Maximum daily dose: 30 mg/day; lisdexamfetamine and dextroamphetamine are not dialyzable.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling

Dosing: Older Adult

Refer to adult dosing; initiate dose at the low end of the dosing range.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as dimesylate:

Vyvanse: 10 mg, 20 mg

Vyvanse: 30 mg [contains fd&c yellow #6 (sunset yellow)]

Vyvanse: 40 mg, 50 mg, 60 mg [contains fd&c blue #1 (brilliant blue)]

Vyvanse: 70 mg [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow)]

Tablet Chewable, Oral, as dimesylate:

Vyvanse: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as dimesylate:

Vyvanse: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg [contains fd&c blue #1 (brilliant blue), fd&c yellow #6 (sunset yellow)]

Tablet Chewable, Oral, as dimesylate:

Vyvanse: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Controlled Substance

C-II

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Vyvanse: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38

Administration: Adult

Administer in the morning without regard to meals; avoid afternoon doses because of potential for insomnia. Do not take less than one capsule or chewable tablet per day; a single dose should not be divided.

Capsules: Swallow capsule whole, do not chew. Capsule may be opened and the entire contents mixed with water, yogurt, or orange juice; stir until dispersed completely and consume the entire mixture immediately; do not store mixture. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.

Chewable tablets: Chew thoroughly before swallowing.

Administration: Pediatric

Oral: Administer in the morning without regard to food; avoid afternoon doses to prevent insomnia. Do not take less than 1 chewable tablet or capsule daily; a single dose should not be divided.

Capsule: Swallow capsule whole, do not chew. Capsule may be opened and the entire contents dissolved in glass of water, yogurt, or orange juice; stir until dispersed completely and consume the resulting mixture immediately; do not store the mixture. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.

Chewable tablets: Chew thoroughly before swallowing.

Use: Labeled Indications

Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients ≥6 years of age.

Binge eating disorder: Treatment of moderate to severe binge eating disorder in adults.

Medication Safety Issues
Sound-alike/look-alike issues:

Vyvanse may be confused with Glucovance, Visanne, ViVAXIM, Vytorin, Vivactil

Adverse Reactions (Significant): Considerations
Cardiovascular events

Cardiovascular events including myocardial infarctions (MI), stroke, sudden cardiac death (SCD), increased heart rate, and increased blood pressure have been reported with the use of CNS stimulants in adult and pediatric patients (Ref); syncope and severe cardiac arrythmia have been described with lisdexamfetamine use in children and adolescents (Ref). CNS stimulants have also been associated with SCD in children and adolescents with preexisting structural cardiac abnormalities. Available data in patients without congenital heart disease are conflicting (Ref). A large retrospective cohort study showed an overall low incidence and risk of serious cardiovascular events in children and young adults (Ref); similarly, retrospective claims databases have not shown an increase in serious cardiovascular events (MI, sudden death, stroke) with stimulant use in young and middle-aged adults (Ref). A study evaluating the cardiac effects of long-term treatment with lisdexamfetamine in adults did not find any clinically significant changes in cardiac structure or function (Ref).

Mechanism : Dose-related; amphetamines increase the mean heart rate and systolic blood pressure by mediating noradrenergic and dopaminergic transmission (Ref). This increase in heart rate and blood pressure can ultimately lead to cardiovascular events such as arrhythmias and/or MI.

Onset: Varied; MI and SCD usually occur within hours (especially in cases of overdose), but arrhythmias usually occur with long term use (Ref)

Risk factors:

• Higher doses (Ref)

• Prior structural cardiac abnormalities (Ref)

• Family history of SCD or other cardiovascular diseases (eg, MI, cardiac arrhythmias) (Ref)

• Concomitant use of QTc-prolonging medications may increase the risk of arrhythmias

• Strenuous exercise and dehydration (Ref)

Growth suppression

Growth retardation, including weight loss and decreased rate of growth, has been reported in pediatric patients. Statistically significant decreases in weight, height, and BMI in children and adolescents (age range: 6 to 13 years) have been observed in short- and long-term studies (Ref). Similarly, statistically significant reductions in total femoral, femoral neck, and lumbar bone mineral density (BMD) were observed in pediatric patients (age range: 8 to 17 years) actively treated with stimulants (including, but not limited to lisdexamfetamine) when compared to matched unmedicated controls; also reported were significantly more subjects in the stimulant-treated group with BMD measurements in the osteopenic range compared to matched controls (38.3% vs 21.6%) (Ref). The effect of lisdexamfetamine on weight in adults is variable and the long-term effects of treatment on growth into adulthood have yet to be determined (Ref).

Mechanism: Dose- and time-related; possibly due to effects on CNS growth factors and hepatic growth factors and direct cartilage effects. Weight loss may result from appetite suppression, reduced food intake, increased activity, and metabolic shifts (Ref).

Onset: Growth suppression in children: Varied; appears to occur within 4 weeks of initiating treatment (median 29 days; range: 1 to 677 days) (Ref).

Risk factors:

• Higher doses (Ref)

• Duration of treatment/cumulative exposure (Ref)

• Baseline height and/or weight above CDC norms upon initiation (Ref)

• Children and adolescents (Ref)

• No prior history of stimulant use (Ref)

Psychiatric/behavioral effects

New-onset psychosis or mania and exacerbation of psychotic or manic symptoms (eg, delusional thinking, hallucination) may occur with neurostimulant use in all ages (Ref). Aggressive behavior, hostility, and suicidal ideation have also been reported with lisdexamfetamine use in children and adolescents, however a causal relationship has not been established (Ref). A study of commercial insurance claims data from 221,846 patients (age: 13 to 25 years) prescribed amphetamines or methylphenidate reported a higher risk of psychosis with amphetamine products compared to methylphenidate (Ref). Studies in adults have suggested that the resolution of an amphetamine-associated psychotic episode may be incomplete without treatment and may take up to 6 months even if abstinence occurs (Ref).

Mechanism: Psychosis: Amphetamine stimulates the release of dopamine from presynaptic nerve endings and prevents its reuptake. This leads to an increased concentration of dopamine in the neuronal synapse, leading to glutamate dysregulation. Increased dopamine and glutamate dysregulation have been associated with the development of psychotic symptoms (Ref).

Onset: Delayed and varied; a study of commercial insurance claims data from 221,846 patients (age: 13 to 25 years) prescribed amphetamines or methylphenidate reported a mean time of 128 days (IQR: 48 to 333 days) from the time medication was dispensed to the first psychotic episode (Ref). In cases of overdose/intoxication the onset of symptoms is usually acute and within hours.

Risk factors:

• Preexisting mood or psychotic disorders (Ref)

• Prior history of substance use/abuse (Ref)

• Family history of mood and psychotic disorders (eg, major depression, bipolar disorder, and schizophrenia) (Ref)

• Young age (children, adolescents, and young adults) (Ref)

• Concomitant use of corticosteroids (Ref)

Serotonin syndrome

Serotonin syndrome may occur when amphetamines are used in combination with drugs that affect the serotonergic neurotransmitter system in all ages. Early symptoms of serotonin syndrome include tachycardia, shivering, diarrhea, diaphoresis, muscle cramps, agitation, and increased body temperature; these symptoms are usually followed by hypertension, hyperthermia, hyperreflexia, delirium, tremors, and rigidity (Ref). Prompt treatment is needed to minimize risk of adverse outcome including death (Ref). The incidence of serotonin syndrome from stimulants use is unknown, likely due to under reporting (Ref).

Mechanism: Amphetamines increase serotonin release and inhibit reuptake, which can lead to dangerously high extracellular concentration of serotonin especially when used in combination with other drugs that also increase serotonin concentrations (eg, CYP2D6 inhibitors, serotonin reuptake inhibitors, serotonin-norepinephrine uptake inhibitors) (Ref).

Onset: Rapid; symptoms usually begin within 24 hours of ingestion of the causative agent(s) (Ref).

Risk factors:

• Genetic polymorphism: Poor CYP2D6 metabolizers (Ref)

• Concurrent use of CYP2D6 inhibitors (Ref); consult drug interactions database for more information.

• Concurrent use of serotonergic agents (Ref); consult drug interactions database for more information.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatrics.

>10%:

Gastrointestinal: Decreased appetite (children and adolescents: 34% to 39%; adults 8% to 27%), upper abdominal pain (children: 12%; adults: 2%), xerostomia (children and adolescents: 4% to 5%; adults: 26% to 36%)

Nervous system: Insomnia (13% to 27%)

1% to 10%:

Cardiovascular: Increased blood pressure (adults: 3%) (table 1), increased heart rate (adults: 2% to 7%) (table 2), palpitations (adolescents and adults: 2%)

Lisdexamfetamine: Adverse Reaction: Increased Blood Pressure

Drug (Lisdexamfetamine)

Placebo

Population

Indication

Number of Patients (Lisdexamfetamine)

Number of Patients (Placebo)

3%

0%

Adults

Attention deficit hyperactivity disorder

358

62

Lisdexamfetamine: Adverse Reaction: Increased Heart Rate

Drug (Lisdexamfetamine)

Placebo

Population

Indication

Number of Patients (Lisdexamfetamine)

Number of Patients (Placebo)

2%

0%

Adults

Attention deficit hyperactivity disorder

358

62

7%

1%

Adults

Binge eating disorder

373

372

Dermatologic: Hyperhidrosis (adults: 3% to 4%), pruritus (adults: 2%), skin rash (children: 3%)

Endocrine & metabolic: Decreased libido (adults: 1%), weight loss (children and adolescents: 9%; adults: 3% to 4%)

Gastrointestinal: Anorexia (2% to 5%), constipation (adults: 6%), diarrhea (adults: 4% to 7%), gastroenteritis (adults: 2%), nausea (6% to 7%), vomiting (children: 9%; adults: 2%)

Genitourinary: Erectile dysfunction (adults: 3%), urinary tract infection (adults: 2%)

Nervous system: Agitation (adults: 3%), anxiety (adults: 5% to 6%), dizziness (children: 5%), drowsiness (children: 2%), emotional lability (children: 3%), increased energy (adults: 2%), irritability (children: 10%), jitteriness (adults: 4% to 6%), nightmares (adults: 2%), paresthesia (adults: 2%), restlessness (adults: 2% to 3%), tic disorder (children: 2%)

Neuromuscular & skeletal: Tremor (adolescents and adults: 2%)

Respiratory: Dyspnea (adults: 2%), oropharyngeal pain (adults: 2%)

Miscellaneous: Fever (children: 2%)

Frequency not defined: Nervous system: Drug abuse, drug dependence, talkativeness

Postmarketing:

Cardiovascular: Cardiac arrhythmia (Coghill 2017), cardiomyopathy, chest pain, peripheral vascular insufficiency, Raynaud's disease (Gnanavel 2018), syncope (Coghill 2017)

Dermatologic: Alopecia (Brahm 2009), dermatillomania, Stevens-Johnson syndrome, urticaria

Endocrine & metabolic: Change in libido, growth retardation (Coghill 2014)

Gastrointestinal: Bruxism, dysgeusia, mesenteric ischemia

Genitourinary: Frequent erections (Majeed 2017), prolonged erections (Majeed 2017)

Hepatic: Hepatitis (eosinophilic) (Hood 2010)

Hypersensitivity: Anaphylaxis, angioedema

Nervous system: Aggressive behavior (Coghill 2017), depression (Coghill 2017, Pozzi 2019), euphoria (Pozzi 2019), headache (Coghill 2017), hostility (Coghill 2017), mania (Coghill 2017), outbursts of anger (Coghill 2017), paranoid ideation (including obsessive thoughts) (Pozzi 2019), psychomotor agitation (Coghill 2014), seizure, suicidal ideation (Coghill 2017)

Neuromuscular & skeletal: Dyskinesia, rhabdomyolysis

Ophthalmic: Accommodation disturbance, angle-closure glaucoma (acute, bilateral) (Davanian 2021), blurred vision, diplopia, mydriasis

Miscellaneous: Crying (Pozzi 2019)

Contraindications

Hypersensitivity to amphetamine products or any component of the formulation; concurrent use of MAO inhibitor, or within 14 days of the last MAO inhibitor dose.

Canadian labeling: Additional contraindications (not in US labeling): Known hypersensitivity or idiosyncrasy to sympathomimetic amines; advanced arteriosclerosis; symptomatic cardiovascular disease; moderate-to-severe hypertension; hyperthyroidism; glaucoma; agitated states; history of drug abuse

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: Amphetamines may impair the ability to engage in potentially hazardous activities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs/symptoms are usually mild and intermittent, and generally improve with dose reduction or discontinuation. Peripheral vasculopathy effects have been observed at different times, at therapeutic doses, and in all age groups. Digital ulceration and/or soft tissue breakdown have been observed rarely; monitor for digital changes during therapy and seek further evaluation (eg, rheumatology) if necessary.

• Visual disturbance: Difficulty in accommodation and blurred vision has been reported with the use of stimulants.

Disease-related concerns:

• Cardiovascular disorders: Use with caution in patients with hypertension, ventricular arrhythmia, and other cardiovascular conditions that might be exacerbated by increases in BP or heart rate.

• Bipolar disorder: May precipitate a mixed or manic episode in patients with bipolar illness.

• Seizure disorder: Limited information exists regarding stimulant use in seizure disorder. Whereas patients with ADHD are at an increased risk for seizure activity compared to the general population, a retrospective study using drug claims data showed that the use of stimulant medications was associated with a lower risk (Cortese 2013; Wiggs 2018). Manufacturers of some stimulants recommend discontinuing therapy if seizures occur.

• Tourette syndrome/tics: Use with caution in patients with Tourette syndrome or other tic disorders. Stimulants may exacerbate tics (motor and phonic) and Tourette syndrome; however, evidence demonstrating increased tics is limited. Evaluate for tics and Tourette syndrome prior to therapy initiation (AACAP [Murphy 2013]; Pliszka 2007).

Special populations:

• Older adult: Use caution in this age group due to CNS stimulant adverse effects.

Other warnings/precautions:

• Abuse/misuse/diversion: Use with caution in patients with a history of ethanol or drug abuse. Prescriptions should be written for the smallest quantity consistent with good patient care to minimize possibility of overdose.

• ADHD treatment: Appropriate use: Recommended to be used as part of a comprehensive treatment program for attention deficit disorders.

• Weight loss: Appropriate use: Not indicated or recommended for weight loss; safety and efficacy not established for treatment of obesity.

• Discontinuation of therapy: Abrupt discontinuation following high doses or for prolonged periods may result in symptoms for withdrawal (eg, depression, extreme fatigue).

Warnings: Additional Pediatric Considerations

Prior to treatment with medications for attention-deficit/hyperactivity disorder (ADHD), the American Heart Association and the American Academy of Pediatrics recommend that all children and adolescents diagnosed with ADHD have a thorough cardiovascular assessment, including patient and family health histories, determination of all medications used (prescribed and over-the-counter), and a physical examination focused on cardiovascular disease risk factors. An ECG is not mandatory but is reasonable to consider prior to stimulant medication therapy. Prompt evaluation and appropriate referral and testing, if warranted, should occur if any cardiac symptoms present (Vetter 2008).

Metabolism/Transport Effects

Substrate of CYP2D6 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Risk X: Avoid combination

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Alkalinizing Agents: May decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects. Risk D: Consider therapy modification

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy

Ammonium Chloride: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Risk C: Monitor therapy

Antacids: May decrease the excretion of Amphetamines. Risk C: Monitor therapy

Antihypertensive Agents: Amphetamines may diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antipsychotic Agents: May enhance the adverse/toxic effect of Amphetamines. Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy

Antipsychotic Agents: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a moderate CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities (including serotonin syndrome) if used with a strong CYP2D6 inhibitor. Initiate amphetamine therapy at lower doses, monitor frequently, and adjust doses as needed. Discontinue amphetamines if serotoinin syndrome occurs. Risk C: Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Risk C: Monitor therapy

Gastrointestinal Acidifying Agents: May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Iobenguane Radiopharmaceutical Products: Amphetamines may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination

Iobenguane Radiopharmaceutical Products: CNS Stimulants may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination

Ioflupane I 123: Amphetamines may diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Methenamine: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Amphetamines. While linezolid and tedizolid may interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Risk X: Avoid combination

Multivitamins/Fluoride (with ADE): May decrease the serum concentration of Amphetamines. More specifically, the ascorbic acid (vitamin C) in many multivitamins may decrease amphetamine concentrations. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Amphetamines. Specifically, vitamin C may impair absorption of amphetamines. Risk C: Monitor therapy

Opioid Agonists: Amphetamines may enhance the analgesic effect of Opioid Agonists. Risk C: Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Quinolones: Amphetamines may enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Amphetamines may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase the serum concentration of Amphetamines. Management: Monitor for amphetamine toxicities, including serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability). Initiate amphetamines at lower doses, monitor frequently, and adjust dose as needed. Risk C: Monitor therapy

Serotonergic Agents (High Risk): Amphetamines may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability). Initiate amphetamines at lower doses, monitor frequently, and adjust doses as needed. Risk C: Monitor therapy

Sodium Phosphates: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sodium Phosphates. Specifically, the risk of seizure or loss of consciousness may be increased in patients with significant sodium phosphate-induced fluid or electrolyte abnormalities. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Solriamfetol: CNS Stimulants may enhance the hypertensive effect of Solriamfetol. CNS Stimulants may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Amphetamines. Tricyclic Antidepressants may potentiate the cardiovascular effects of Amphetamines. Amphetamines may enhance the serotonergic effect of Tricyclic Antidepressants. This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) and increased cardiovascular effects when these agents are combined. Risk C: Monitor therapy

Urinary Acidifying Agents: May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Food Interactions

High-fat meal prolongs Tmax by ~1 hour. Management: Administer without regard to meals.

Pregnancy Considerations

Lisdexamfetamine is converted to dextroamphetamine. The majority of human data is based on illicit amphetamine/methamphetamine exposure and not from therapeutic maternal use (Golub 2005). Use of amphetamines during pregnancy may lead to an increased risk of premature birth and low birth weight; newborns may experience symptoms of withdrawal. Behavioral problems may also occur later in childhood (LaGasse 2012).

Breastfeeding Considerations

The majority of human data is based on illicit amphetamine/methamphetamine exposure and not from therapeutic maternal use (Golub 2005). Amphetamines are excreted into breast milk and use may decrease milk production. Increased irritability, agitation, and crying have been reported in nursing infants (ACOG 2011). Due to the potential for adverse reactions in a nursing infant, breast-feeding is not recommended by the manufacturer.

Monitoring Parameters

Cardiac evaluation (including medical or family history of sudden death or ventricular arrhythmia; ECG as indicated) should be completed at baseline and on any patient who develops exertional chest pain, unexplained syncope, and any symptom of cardiac disease during treatment with stimulants. Monitor blood pressure and heart rate (baseline, following dose increases and periodically during treatment); growth rate (height and weight) and appetite in children; weight in adults; signs of peripheral vasculopathy (eg, digital changes); sleep and behavioral changes. Assess for risk of abuse prior to prescribing and signs of misuse, abuse, or addiction throughout treatment (NICE 2018). Screen for bipolar disorder and risk factors for developing a manic episode prior to treatment; monitor for psychotic or manic symptoms (eg, delusional thinking, hallucinations, mania) or suicide-related behavior; monitor for development or worsening of aggressive behavior or hostility.

Mechanism of Action

The exact mechanism of lisdexamfetamine in ADHD and binge eating disorder is not known. Lisdexamfetamine dimesylate is a prodrug that is converted to the active component dextroamphetamine (a noncatecholamine, sympathomimetic amine). Amphetamines are noncatecholamine, sympathomimetic amines that cause release of catecholamines (primarily dopamine and norepinephrine) from their storage sites in the presynaptic nerve terminals. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition.

Pharmacokinetics

Duration of action: 8 to 14 hours (Jain 2017).

Absorption: Rapid.

Metabolism: Metabolized in the blood by hydrolytic activity of red blood cells to dextroamphetamine and l-lysine; lisdexamfetamine does not undergo CYP mediated metabolism; however, dextroamphetamine is metabolized to some degree by CYP2D6.

Half-life elimination: Lisdexamfetamine: <1 hour; Dextroamphetamine: 10 to 13 hours.

Time to peak:

Capsule: Tmax: Lisdexamfetamine: Children 6 to 12 years: 1 hour (fasting); Adults: ~1 hour; Dextroamphetamine: Children 6 to 12 years: 3.5 hours (fasting); Adults: 3.8 hours (fasting), 4.7 hours (after a high-fat meal).

Chewable tablet: Tmax: Lisdexamfetamine: 1 hour (fasting); Dextroamphetamine: 3.9 to 4.4 hours (fasting); 4.9 hours (after a high-fat meal).

Excretion: Urine (96%, 42% as amphetamine-related compounds, 2% as lisdexamfetamine, 25% hippuric acid); feces (minimal).

Pharmacokinetics: Additional Considerations

Altered kidney function: Mean dextroamphetamine clearance was reduced from 0.7 L/hour/kg to 0.4 L/hour/kg with severe renal impairment (GFR 15 to <30 mL/minute/1.73 m2) and to 0.3 L/hour/kg with ESRD.

Pricing: US

Capsules (Vyvanse Oral)

10 mg (per each): $14.07

20 mg (per each): $14.07

30 mg (per each): $14.07

40 mg (per each): $14.07

50 mg (per each): $14.07

60 mg (per each): $14.07

70 mg (per each): $14.07

Chewable (Vyvanse Oral)

10 mg (per each): $14.07

20 mg (per each): $14.07

30 mg (per each): $14.07

40 mg (per each): $14.07

50 mg (per each): $14.07

60 mg (per each): $14.07

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aduvanz (DK, NO);
  • Elvanse (AT, CH, DE, DK, ES, FI, GB, NO, PL, SE);
  • Samexid (CL);
  • Tyvense (IE);
  • Venvanse (BR);
  • Vyvanse (AU, BB, CR, DO, GT, HN, IL, NI, PA, SV)


For country code abbreviations (show table)
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