lisdexamfetamine (Rx)

Brand and Other Names:Vyvanse
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsules: Schedule II

  • 10mg
  • 20mg
  • 30mg
  • 40mg
  • 50mg
  • 60mg
  • 70mg

chewable tablet: Schedule II

  • 10mg
  • 20mg
  • 30mg
  • 40mg
  • 50mg
  • 60mg

Attention Deficit Hyperactivity Disorder

Starting/switching treatment: 30 mg PO qAM

Dose adjustment: Increase by 10- to 20-mg/day increments approximately qWeek

Not to exceed 70 mg qDay

Binge Eating Disorder

Indicated for moderate-to-severe binge eating disorder (BED) in adults

Starting dose: 30 mg/day PO, THEN

Target dose: Titrate in increments of 20 mg at ~1 week intervals to achieve the recommended target dose of 50-70 mg/day

Not to exceed 70 mg/day

Discontinue if BED does not improve

Dosage Modifications

Renal impairment

  • GFR 15 to <30 mL/min/1.73 m²: Not to exceed 50 mg/day
  • End stage renal disease (GFR <15 mL/min/1.73 m²): Not to exceed 30 mg/day

Coadministration with drugs that alter urinary pH

  • Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine
  • Acidifying agents (eg, ascorbic acid) decrease blood levels, while alkalinizing agents (eg, sodium bicarbonate) increase blood levels
  • Adjust lisdexamfetamine dosage accordingly

Dosing Considerations

Prior to treatment, assess for presence of cardiac disease (eg, a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)

To reduce the abuse of CNS stimulants, assess abuse risk before prescribing; after prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and reevaluate the need for the drug

Limitations of use

  • Not indicated or recommended for weight loss
  • Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events
  • The safety and effectiveness of lisdexamfetamine for the treatment of obesity have not been established

Dosage Forms & Strengths

capsules: Schedule II

  • 10mg
  • 20mg
  • 30mg
  • 40mg
  • 50mg
  • 60mg
  • 70mg

chewable tablet: Schedule II

  • 10mg
  • 20mg
  • 30mg
  • 40mg
  • 50mg
  • 60mg

Attention Deficit Hyperactivity Disorder

<6 years: Safety and efficacy not established

≥6 years: 30 mg PO qAM initially; may increase by 10- to 20-mg/day increments approximately qWeek; not to exceed 70 mg qDay

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Interactions

Interaction Checker

and lisdexamfetamine

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            Adverse Effects

            >10%

            Anorexia (27%)

            Insomnia (27%)

            Xerostomia (26%)

            Headache (12%)

            Upper abdominal pain (12%)

            1-10%

            Irritability (10%)

            Problem of growth and development, weight decreased (pediatric patients, 9% )

            Nausea (7%)

            Diarrhea (7%)

            Seizure (4% )

            Rash (pediatric patients, 3%)

            Hyperhidrosis (3%)

            Increased blood pressure (3%)

            Increased heart rate (2%)

            Dizziness (5%)

            Emotional lability (3%)

            Tremor (2%)

            Tics (2%)

            Vomiting (9%)

            Frequency Not Defined

            Serious

            • Chest pain, sudden death (rare), myocardial infarction, palpitations, ventricular hypertrophy
            • Cerebrovascular accident, Gilles de la Tourette syndrome
            • Stevens-Johnson syndrome, toxic epidermal necrolysis due to drug

            Postmarketing Reports

            Ophthalmic disorders: Blurred vision, mydriasis, diplopia, difficulties with visual accommodation

            Cardiovascular: Palpitations, cardiomyopathy

            General disorders and administration site conditions: Fatigue

            Hepatobiliary disorders: Eosinophilic hepatitis

            Immune and allergy system disorders: Anaphylactic reaction, hypersensitivity, Stevens-Johnson syndrome, angioedema, urticaria

            Nervous system disorders: Somnolence, seizure, dyskinesia, tics, bruxism

            Psychiatric disorders: Psychotic episodes, mania, hallucination, depression, aggression, dysphoria, euphoria, logorrhea, dermatillomania

            Genitourinary: Libido changes, frequent/prolonged erections

            Gastrointestinal: Constipation, dysgeusia

            Musculoskeletal: Rhabdomyolysis

            Serotonin syndrome (when coadministered with serotonergic drugs)

            Dermatologic: Alopecia

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            Warnings

            Black Box Warnings

            Dextroamphetamine has a high potential for abuse; particular attention should be paid to the possibility of patients obtaining dextroamphetamine for nontherapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly

            Administration of dextroamphetamine for prolonged periods of time may lead to drug dependence and must be avoided

            Contraindications

            Hypersensitivity

            Patient taking MAOIs or within 14 days of stopping MAOIs (including linezolid or IV methylene blue) owing to increased risk of hypertensive crisis

            Cautions

            Use with caution in hyperthyroidism, glaucoma, mild to severe hypertension, advanced arteriosclerosis, symptomatic CVD, agitated states, history of psychosis or drug abuse

            May cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis; evaluate for bipolar disorder prior to stimulant use

            Misuse of dextroamphetamine may cause sudden death and serious cardiovascular adverse events

            Monitor blood pressure and pulse; consider benefits and risks before use in patients for whom blood pressure increases may be problematic

            Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems; in adults, sudden death, stroke, and myocardial infarction have been reported; avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, or coronary artery disease

            Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation

            Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients; screen for risk factors for developing a manic episode before initiating

            Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility

            Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected

            Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures

            Use with caution in patients who use other sympathomimetic drugs Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications

            Interrupt drug administration occasionally to assess if recurrence of behavioral symptoms sufficient to require continued treatment

            Associated with peripheral vasculopathy, including Raynaud phenomenon

            Difficulties with accommodation and blurring of vision have been reported with stimulant treatment

            Use of stimulants may suppress appetite, especially in children, which may cause weight loss and slows the rate of growth

            Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections

            Serotonin syndrome

            • Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems (eg, MAOIs, SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, St John’s Wort)
            • Coadministration with MAOI drugs is contraindicated (see Contraindications)
            • Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by CYP2D6 and display minor CYP2D6 inhibition
            • Discontinue therapy with any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment; concomitant use with other serotonergic drugs or CYP2D6 inhibitors should be used only if potential benefit justifies the potential risk
            • If clinically warranted, consider initiating therapy with lower doses, monitoring patients for emergence of serotonin syndrome during drug initiation or titration, and informing patients of increased risk for serotonin syndrome
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Amphetamines are excreted in breast milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Prodrug of dextroamphetamine

            Sympathomimetic amine that promotes release of dopamine and norepinephrine from their storage sites in the presynaptic nerve terminals; may also block reuptake of catecholamines by competitive inhibition

            Absorption

            Rapid absorption

            Peak plasma time: 1 hr (lisdexamfetamine); 3.5 hr (dextroamphetamine)

            Distribution

            Vd: 3.5-4.6 L/kg; distributes into CNS

            Elimination

            Half-life elimination: 10-13 hr (dextroamphetamine); < 1hr (lisdexamphetamine)

            Excretion: Urine (96%), feces (minimal)

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            Administration

            Oral Administration

            Take in AM with or without food

            Avoid afternoon doses (potential for insomnia)

            Vyvanse capsules can be substituted with Vyvanse chewable tablets on a mg per mg basis (eg, 30 mg capsules for 30 mg chewable tablet)

            Do not take anything <1 capsule or chewable tablet daily; a single dose should not be divided

            Chewable tablets must be chewed thoroughly before swallowing

            Swallow capsule whole

            Unable to swallow capsule

            • May open capsule and mix entire contents in yogurt, water, or orange juice
            • If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder
            • The contents should be mixed until completely dispersed and consumed immediately (do not store)
            • 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
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.