Lisdexamfetamine (Lexi-Drugs)

ALERT: US Boxed Warning
  Abuse and dependence:
Pronunciation

(lis dex am FET a meen)

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 (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: 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.

Dosing: Geriatric

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

Dosing: Renal 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

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

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: 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.

Dosing: Renal 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

Use: Labeled Indications

Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder (ADHD).

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

Clinical Practice Guidelines

American Academy of Child and Adolescent Psychiatry, “Attention-Deficit/Hyperactivity Disorder,” 2007

American Academy of Pediatrics, “Attention-Deficit/Hyperactivity Disorder,” 2011

Canadian ADHD Resource Alliance (CADDRA): Canadian ADHD Practice Guidelines, Third Edition, 2011

Canadian Agency for Drugs and Technologies in Health (CADTH): Guidelines and Recommendations for ADHD in Children and Adolescents, October 2011

National Collaborating Centre for Mental Health, “Attention Deficit Hyperactivity Disorder, NICE Guidelines,” 2009

Administration: Oral

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.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anxiety, diarrhea, constipation, nausea, vomiting, dry mouth, feeling jittery, lack of appetite, weight loss, insomnia, or abdominal pain. Have patient report immediately to prescriber signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), severe headache, tachycardia, abnormal heartbeat, decreased libido, sexual dysfunction, agitation, tremors, discoloration of hands or feet, burning or numbness of hands or feet, dark urine, muscle pain, muscle weakness, urinary retention, change in amount of urine passed, sores on fingers or toes, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, shortness of breath, severe dizziness, passing out, vision changes, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), hallucinations, or behavioral changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
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: http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s044lbl.pdf#page=37

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:

• Cardiovascular events: Stimulant use has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems (sudden death in children and adolescents; sudden death, stroke, and MI in adults). Consistent with other studies, a large retrospective cohort study involving 1,200,438 children, adolescents, and young adults (aged 2 to 24 years) prescribed methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine found no evidence that current use of an ADHD medication increased risk for sudden cardiac death, acute MI, or stroke (Cooper 2011). Stimulants should be avoided in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, Marfan syndrome, or other serious cardiac problems. Some products are contraindicated in patients with moderate or severe hypertension. Prior to initiating stimulant, assess medical history and family history of sudden death or ventricular arrhythmia; conduct a physical exam to assess for cardiac disease; patients should receive further evaluation if findings suggest cardiac disease, such as ECG and echocardiogram. Promptly conduct cardiac evaluation in patients who develop exertional chest pain, unexplained syncope, or any other symptoms of cardiac disease during stimulant treatment.

• 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).

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, Stevens-Johnson syndrome, angioedema, and urticaria have been observed.

• 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: CNS stimulants may increase heart rate and blood pressure; the observed mean increase in heart rate was 3 to 6 bpm and blood pressure was 2 to 4 mm Hg. Use with caution in patients with hypertension, heart failure, recent MI, ventricular arrhythmia, and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate. Some products are contraindicated in patients with moderate to severe hypertension or hyperthyroidism.

• Psychiatric disorders: Use with caution in patients with preexisting psychosis or bipolar disorder (may induce mixed/manic episode). May exacerbate symptoms of behavior and thought disorder in psychotic patients; new onset psychosis or mania may occur in children or adolescents with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing mania prior to treatment; consider discontinuation if such symptoms (eg, delusional thinking, hallucinations, or mania) occur. May be associated with aggressive behavior or hostility (causal relationship not established); monitor for development or worsening of these behaviors.

• 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).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) may occur when lisdexamfetamine is used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John’s wort, tryptophan), agents that impair metabolism of serotonin (eg, monoamine oxidase inhibitors) or CYP2D6 inhibitors that impair metabolism of lisdexamfetamine. Concomitant use with monoamine oxidase inhibitors is contraindicated. If concomitant use of lisdexamfetamine with serotonergic drugs or CYP2D6 inhibitors is indicated, initiate lisdexamfetamine at a low dose and monitor patient closely for signs and symptoms of SS. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

Special populations:

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

• Pediatric: Appetite suppression may occur; particularly in children. Use of stimulants has been associated with weight loss and slowing of growth rate; monitor growth rate and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Has high potential for abuse and dependence; assess for abuse potential prior to use and monitor for signs of abuse and dependence while on therapy. 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

CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities; one study reported methylphenidate increased risk for arrhythmia and MI in youth without congenital heart disease (Shin 2016) and a retrospective case-control study reported an association with stimulants and sudden unexplained death in youth (Gould 2009). However, as noted in reviews (Martinez-Raga 2013; Westover 2012) several large studies have not found an association between prescription stimulants and cardiovascular events; though most retrospective studies were large (n=55,383 to 2,131,953), some had statistical power or methodological limitations (Westover 2012). A large retrospective cohort study involving 1,200,438 children and young adults (aged 2 to 24 years) prescribed ADHD medication (methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine) found no evidence that ADHD medication was associated with an increased risk of serious cardiovascular events (ie, acute MI, sudden cardiac death, stroke) in current (adjusted hazard ratio: 0.75; 95% CI: 0.31 to 1.85) or former (adjusted hazard ratio: 1.03; 95% CI: 0.57 to 1.89) users compared with nonusers, nor in current compared with former users. Results were similar with multiple alternative analyses to assess for bias or study assumptions. While point estimates of relative risks for ADHD drugs did not demonstrate increased risk, the upper limit of the 95% CI suggested a doubling of the risk could not be ruled out, although absolute magnitude of increased risk would be low. Data on any individual medication, other than methylphenidate, were too sparse for separate regression analyses (Cooper 2011). Prior to treatment with medications for 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).

Long-term effects in pediatric patients have not been determined. Use of stimulants in children has been associated with growth suppression; in pediatric clinical trials after 4 weeks of therapy, higher lisdexamfetamine doses were associated with greater weight loss; adolescents may experience larger weight loss than children; monitor growth; treatment interruption may be needed. Evaluation of the effect of stimulants on growth in ADHD diagnosed children <12 years receiving treatment for at least 3 years with stimulants has shown decreased height and weight changes over time compared to age matched control; height: 4.7 to 5.5 cm/year compared to 6.3 cm/year and 2.1 to 3.3 kg/year compared to 4.4 kg/year (Poulton 2016). In pediatric patients 8 to 17 years actively treated with stimulants, significant reductions in total femoral, femoral neck, and lumbar bone mineral density (BMD) were observed compared to matched unmedicated cohorts; also reported were significantly more subjects in the stimulant-treated group with BMD measurements in the osteopenic range compared to matched cohorts (38.3% to 21.6%) (Howard 2017). A longitudinal cohort-controlled trial reported no different in peak height velocity and final adult height in subjects with ADHD and/or treated with stimulants (Harstad 2014).

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).

Breast-Feeding 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.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Central nervous system: Insomnia (13% to 27%)

Gastrointestinal: Xerostomia (adults: 26% to 36%; children and adolescents: 4% to 5%), upper abdominal pain (children: 12%; adults: 2%)

1% to 10%:

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

Central nervous system: Irritability (children: 10%), anxiety (adults: 5% to 6%), jitteriness (adults: 4% to 6%), dizziness (children: 5%), agitation (adults: 3%), emotional lability (children: 3%), restlessness (adults: 2% to 3%), drowsiness (children: 2%), increased energy (adults: 2%), nightmares (adults: 2%), paresthesia (adults: 2%), tics (children: 2%)

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

Endocrine & metabolic: Weight loss (children and adolescents: 9%; adults: 3% to 4%), decreased libido (adults: <2%)

Gastrointestinal: Vomiting (children: 9%; adults: 2%), diarrhea (adults: 7%), nausea (6% to 7%), constipation (adults: 6%), anorexia (2% to 5%), gastroenteritis (adults: 2%)

Genitourinary: Erectile dysfunction (adults: 3%)

Neuromuscular & skeletal: Tremor (2%)

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

Miscellaneous: Fever (children: 2%)

Frequency not defined:

Central nervous system: Outbursts of anger, paranoia, talkativeness

<1%, postmarketing, and/or case reports: Accommodation disturbance, aggressive behavior, alopecia, anaphylaxis, angioedema, blurred vision, bruxism, cardiomyopathy, chest pain, decreased linear skeletal growth rate, depression, dermatillomania, diplopia, dysgeusia, dyskinesia, excoriation, frequent erections, hallucination, headache, hepatitis (eosinophilic), hypersensitivity, mania, mydriasis, peripheral vascular insufficiency, prolonged erection, psychotic reaction, Raynaud phenomenon, seizure, Stevens-Johnson syndrome, urticaria

Metabolism/Transport Effects

None known.

Drug Interactions 

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

Alkalinizing Agents: May decrease the excretion of Amphetamines. 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

Antihistamines: Amphetamines may diminish the sedative effect of Antihistamines. Risk C: Monitor therapy

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

Antipsychotic Agents: May diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy

Ascorbic Acid: May decrease the serum concentration of Amphetamines. 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. Exceptions: Cannabidiol. Risk C: Monitor therapy

Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Exceptions: Brinzolamide; Dorzolamide. 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. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Amphetamines. 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

Ethosuximide: Amphetamines may diminish the therapeutic effect of Ethosuximide. Amphetamines may decrease the serum concentration of Ethosuximide. 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 anticonvulsants. 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 anticonvulsants. 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 anticonvulsants. Risk D: Consider therapy modification

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modification

Lithium: May diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy

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. Exceptions: Linezolid; Tedizolid. 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

PHENobarbital: Amphetamines may decrease the serum concentration of PHENobarbital. Risk C: Monitor therapy

Phenytoin: Amphetamines may decrease the serum concentration of Phenytoin. 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 stimulatory effect of Amphetamines. Tricyclic Antidepressants may also potentiate the cardiovascular effects of Amphetamines. 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.

Test Interactions

Amphetamines may elevate plasma corticosteroid levels; may interfere with urinary steroid determinations.

Monitoring Parameters

Cardiac evaluation should be completed on any patient who develops exertional chest pain, unexplained syncope, and any symptom of cardiac disease during treatment with stimulants. Thoroughly evaluate for cardiovascular risk and the presence of (and family history of) cardiac disease, cardiac arrhythmias, or Marfan syndrome prior to initiating treatment. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation (Vetter 2008). Monitor growth (height and weight) in children; CNS activity in all patients; signs of peripheral vasculopathy (eg, digital changes); behavioral changes. Assess for risk of abuse prior to prescribing and signs of misuse, abuse, or addiction throughout treatment.

Advanced Practitioners Physical Assessment/Monitoring

Perform careful cardiovascular assessment prior to initiating therapy. Monitor weight, blood pressure, and vital signs at beginning of therapy and periodically throughout. Taper dose when discontinuing.

Nursing Physical Assessment/Monitoring

Perform careful cardiovascular assessment prior to initiating therapy. Monitor weight, blood pressure, and vital signs at beginning of therapy and periodically throughout. Children should also have height measured often while taking this medication.

Controlled Substance

C-II

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, 30 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #6 (sunset yellow)]

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

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

Tablet Chewable, Oral, as dimesylate:

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

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 BRILLIANT BLUE FCF (FD&C BLUE #1), FD&C YELLOW #6 (SUNSET YELLOW)]

Anatomic Therapeutic Chemical (ATC) Classification
  • N06BA12
Generic Available (US)

No

Pricing: US

Capsules (Vyvanse Oral)

10 mg (per each): $11.80

20 mg (per each): $11.80

30 mg (per each): $11.80

40 mg (per each): $11.80

50 mg (per each): $11.80

60 mg (per each): $11.80

70 mg (per each): $11.80

Chewable (Vyvanse Oral)

10 mg (per each): $11.80

20 mg (per each): $11.80

30 mg (per each): $11.80

40 mg (per each): $11.80

50 mg (per each): $11.80

60 mg (per each): $11.80

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.

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.

Pharmacodynamics/Kinetics

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; does not undergo CYP mediated metabolism

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)

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: 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.

Local Anesthetic/Vasoconstrictor Precautions

Use vasoconstrictor with caution in patients taking lisdexamfetamine. Amphetamines enhance the sympathomimetic response of epinephrine or mepivacaine and levonordefrin (Carbocaine® 2% with Neo-Cobefrin®) leading to potential hypertension and cardiotoxicity.

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Lisdexamfetamine causes tachycardia, increases in blood pressure, and palpitations. Consider monitoring blood pressure prior to using local anesthetic with a vasoconstrictor. Symptoms associated with bruxism have been observed in some patients.

Effects on Bleeding

No information available to require special precautions

Index Terms

Lisdexamfetamine Dimesylate; Lisdexamphetamine; NRP104

FDA Approval Date
February 23, 2007
References

American Academy of Pediatrics, “ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents,” Pediatrics, 2011,128(5):1007-22.[PubMed 22003063]

American College of Obstetricians and Gynecologists (ACOG) Committee Opinion: No. 479, “Methamphetamine Abuse in Women of Reproductive Age,” Obstet Gynecol, 2011, 117(3):751-5.[PubMed 21343793]

Canadian Attention Deficit Hyperactivity Disorder Resource Alliance (CADDRA): “Canadian ADHD Practice Guidelines,” Third Edition, Toronto, ON: CADDRA, 2011. Available at http://caddra.ca/cms4/pdfs/caddraGuidelines2011.pdf. Last accessed on July 12, 2013.

Chiang WK, “Amphetamines,” Goldfrank’s Toxicologic Emergencies, 8th edition, Flomenbaum NE, Goldfrank LR, Hoffman RS, et al, eds, New York: The McGraw-Hill Companies, Inc, 2006, 1119.

Cooper WO, Habel LA, Sox CM, et al, “ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults,” N Engl J Med, 2011, 365(20):1896-904.[PubMed 22043968]

Cortese S, Holtmann M, Banaschewski T, et al; European ADHD Guidelines Group. Practitioner review: current best practice in the management of adverse events during treatment with ADHD medications in children and adolescents. J Child Psychol Psychiatry. 2013;54(3):227-246. doi: 10.1111/jcpp.12036.[PubMed 23294014]

Fratto G, Manzon L. Use of psychotropic drugs and associated dental diseases. Int J Psychiatry Med. 2014;48(3):185-197.[PubMed 25492713]

Golub M, Costa L, Crofton K, et al, “NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Amphetamine and Methamphetamine,” Birth Defects Res B Dev Reprod Toxicol, 2005, 74(6):471-584.[PubMed 16167346]

Gould MS, Walsh BT, Munfakh JL, et al, “Sudden Death and Use of Stimulant Medications in Youths,” Am J Psychiatry, 2009, 166(9):992-1001.[PubMed 19528194]

Habel LA, Cooper WO, Sox CM, et al, “ADHD Medications and Risk of Serious Cardiovascular Events in Young and Middle-Aged Adults,” 2011, JAMA, 306(24):2673-83.[PubMed 22161946]

Harstad EB, Weaver AL, Katusic SK, et al. ADHD, stimulant treatment, and growth: a longitudinal study. Pediatrics. 2014;134(4):e935-944.[PubMed 25180281 ]

Howard JT, Walick KS, Rivera JC. Preliminary evidence of an association between ADHD medications and diminished bone health in children and adolescents. J Pediatr Orthop. 2017;37(5):348-354.[PubMed 26398435 ]

Jain R, Jain S, Montano CB. Addressing diagnosis and treatment gaps in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2017;19(5). pii: 17nr02153. doi: 10.4088/PCC.17nr02153.[PubMed 28906602]

LaGasse LL, Derauf C, Smith LM, et al, “Prenatal Methamphetamine Exposure and Childhood Behavior Problems at 3 and 5 Years of Age,” Pediatrics, 2012, 129(4):681-8.[PubMed 22430455]

Martinez-Raga J, Knecht C, Szerman N, Martinez MI. Risk of serious cardiovascular problems with medications for attention-deficit hyperactivity disorder. CNS Drugs. 2013;27(1):15-30.[PubMed 23160939]

Murphy TK, Lewin AB, Storch EA, Stock S; American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice parameter for the assessment and treatment of children and adolescents with tic disorders. J Am Acad Child Adolesc Psychiatry. 2013;52(12):1341-1359.[PubMed 24290467]

National Institute for Health and Clinical Excellence (NICE), National Collaborating Centre for Mental Health , “Attention Deficit Hyperactivity Disorder, The NICE Guideline on Diagnosis and Management of ADHD in Children, Young People and Adults,” National Clinical Practice Guideline Number 72, 2008:1-664. Available at www.nice.org.uk/cg072

Nissen SE, “ADHD and Cardiovascular Risk,” N Engl J Med, 2006, 354:1445-8.[PubMed 16549404]

Perrin JM, Friedman RA, Knilans TK; Black Box Working Group; Section on Cardiology and Cardiac Surgery. Cardiovascular monitoring and stimulant drugs for attention-deficit/hyperactivity disorder. Pediatrics. 2008;122(2):451-453.[PubMed 18676566]

Pliszka S and AACAP Work Group on Quality Issues, “Practice Parameter for the Assessment and Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder,” J Am Acad Child Adolesc Psychiatry, 2007, 46(7):894-921.[PubMed 17581453]

Poulton AS, Bui Q, Melzer E, Evans R. Stimulant medication effects on growth and bone age in children with attention-deficit/hyperactivity disorder: a prospective cohort study. Int Clin Psychopharmacol. 2016;31(2):93-99.[PubMed 26544899 ]

Shin JY, Roughead EE, Park BJ, Pratt NL. Cardiovascular safety of methylphenidate among children and young people with attention-deficit/hyperactivity disorder (ADHD): nationwide self controlled case series study. BMJ. 2016;353:i2550.[PubMed 27245699]

Vetter VL, Elia J, Erickson CH, et al; American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee; American Heart Association Council on Cardiovascular Nursing. Cardiovascular monitoring of children and adolescents with heart disease receiving medications for attention deficit/hyperactivity disorder [corrected]: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee and the Council on Cardiovascular Nursing. Circulation. 2008;117(18):2407-2423.[PubMed 18427125]

Vyvanse (lisdexamfetamine) [prescribing information]. Lexington, MA: Shire; January 2018.

Vyvanse (lisdexamfetamine) [product monograph]. Saint-Laurent, Quebec, Canada: Shire Canada Inc; June 2015.

Westfall TC, Westfall DP, “Adrenergic Agonists and Antagonists,” Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 11th ed, Brunton LL, ed, New York, NY: McGraw-Hill, 2006, 257-8.

Westover AN, Halm EA. Do prescription stimulants increase the risk of adverse cardiovascular events?: A systematic review. BMC Cardiovasc Disord. 2012;12:41.[PubMed 22682429]

Wiggs KK, Chang Z, Quinn PD, et al. Attention-deficit/hyperactivity disorder medication and seizures. Neurology. 2018;90(13):e1104-e1110. doi: 10.1212/WNL.0000000000005213.[PubMed 29476037]

Brand Names: International

Elvanse (AT, CH, CZ, DE, DK, ES, FI, GB, NO, PT, SE); Samexid (CL); Tyvense (IE); Venvanse (BR); Vyvanse (AU, BB, IL)

Lisdexamfetamine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(lis dex am FET a meen)

Brand Names: US

Vyvanse

Brand Names: Canada

Vyvanse

Warning
  • This drug has a risk of abuse and misuse. This drug may also be habit-forming if taken for a long time. Do not take longer than you have been told by your doctor. Use this drug only as you were told by your doctor. Tell your doctor if you have ever abused or been addicted to any drugs or alcohol. Misuse of this drug may cause heart-related side effects or even sudden death. If you have any questions, talk with your doctor.
What is this drug used for?
  • It is used to treat attention deficit problems with hyperactivity.
  • It is used to treat binge eating disorder.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to lisdexamfetamine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette’s syndrome or tics.
  • If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If you have ever had any of these health problems: Drug abuse or stroke.
  • If you are taking acetazolamide.
  • If you are taking sodium bicarbonate.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are breast-feeding. Do not breast-feed while you take this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • This drug is not approved for weight loss or to treat obesity. Talk with the doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.
  • This drug may be habit-forming with long-term use.
  • If you have been taking this drug for many weeks, talk with your doctor before stopping. You may want to slowly stop this drug.
  • You may have some heart tests before starting this drug. Talk with your doctor.
  • This drug may cause high blood pressure.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this drug. Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Not able to get or keep an erection.
  • Lowered interest in sex.
  • Restlessness.
  • Shakiness.
  • Change in color of hands or feet from pale to blue or red.
  • Numbness, pain, tingling, or cold feeling of the hands or feet.
  • Any sores or wounds on the fingers or toes.
  • Dark urine.
  • Not able to pass urine or change in how much urine is passed.
  • Muscle pain or weakness.
  • Heart attacks, strokes, and sudden deaths have happened in adults taking this drug. Sudden deaths have also happened in children with some heart problems or heart defects. Call your doctor right away if you have a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; trouble speaking or thinking; change in balance; drooping on 1 side of the face; change in eyesight; chest pain or pressure; shortness of breath; or severe dizziness or passing out.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Anxiety.
  • Constipation.
  • Diarrhea.
  • Upset stomach or throwing up.
  • Dry mouth.
  • Feeling jittery.
  • Not hungry.
  • Weight loss.
  • Not able to sleep.
  • Dizziness.
  • Belly pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take this drug at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Take this drug early in the day to prevent sleep problems.
  • Take with or without food.
  • Capsules:
  • Swallow capsule whole. Do not chew, break, or crush.
  • You may open the capsule and mix the powder with water, orange juice, or yogurt. If needed, a spoon may be used to break apart powder that is stuck together. Mix well.
  • If mixed, swallow the mixed drug right away. Do not store for use at a later time.
  • Chewable tablet:
  • Chew well before swallowing.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Lisdexamfetamine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(lis dex am FET a meen)

Brand Names: US

Vyvanse

Brand Names: Canada

Vyvanse

Warning
  • This drug has a risk of abuse and misuse. This drug may also be habit-forming if taken for a long time. Do not give to your child longer than you have been told by the doctor. Give this drug only as you were told by the doctor. Tell the doctor if your child has ever abused or been addicted to any drugs or alcohol. Misuse of this drug may cause heart-related side effects or even sudden death. If you have any questions, talk with your child’s doctor.
What is this drug used for?
  • It is used to treat attention deficit problems with hyperactivity.
  • It is used to treat binge eating disorder.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child or a family member has any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette’s syndrome or tics.
  • If your child has any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If your child has ever had any of these health problems: Drug abuse or stroke.
  • If your child is taking any of these drugs: Acetazolamide or sodium bicarbonate
  • If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If your child is taking any of these drugs: Linezolid or methylene blue.
  • If your child is breast-feeding a baby:
  • Be sure your child does not breast-feed a baby while taking this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug is not approved for weight loss or to treat obesity. Talk with the doctor.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
  • This drug may be habit-forming with long-term use.
  • If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
  • Your child may have some heart tests before starting this drug. Talk with your child’s doctor.
  • This drug may cause high blood pressure.
  • Have your child’s blood pressure and heart rate checked often. Talk with your child’s doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Talk with the health care provider before giving OTC products that may increase blood pressure. These include cough or cold remedies, diet pills, stimulants, ibuprofen or like products, and certain natural products or supplements.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Restlessness.
  • Shakiness.
  • Change in color of hands or feet from pale to blue or red.
  • Numbness, pain, tingling, or cold feeling of the hands or feet.
  • Any sores or wounds on the fingers or toes.
  • Dark urine.
  • Not able to pass urine or change in how much urine is passed.
  • Muscle pain or weakness.
  • Sudden deaths have happened with this drug in children with some heart problems or heart defects. Stroke, heart attack, and sudden death have also happened in adults taking this drug. Call your child’s doctor right away if your child has a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; trouble speaking or thinking; change in balance; drooping on 1 side of the face; change in eyesight; chest pain or pressure; shortness of breath; or severe dizziness or passing out.
  • New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this drug. Tell the doctor if your child or a family member has any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call the doctor right away if your child has hallucinations; change in the way your child acts; or signs of mood changes like low mood (depression), thoughts of killing him/herself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call the doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • If your child is or may be sexually active:
  • Not able to get or keep an erection.
  • Lowered interest in sex.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Belly pain.
  • Upset stomach or throwing up.
  • Not hungry.
  • Weight loss.
  • Not able to sleep.
  • Anxiety.
  • Diarrhea.
  • Dry mouth.
  • Dizziness.
  • Constipation.
  • Feeling jittery.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug at the same time of day.
  • To gain the most benefit, do not miss giving your child doses.
  • Give early in the day to help prevent sleep problems.
  • Give this drug with or without food.
  • Capsules:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • You may open the capsule and mix the powder with water, orange juice, or yogurt. If needed, a spoon may be used to break apart powder that is stuck together. Mix well.
  • If mixed, swallow the mixed drug right away. Do not store for use at a later time.
  • Chewable tablet:
  • Have your child chew well before swallowing.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.