Vyvanse


Also found in: Dictionary.

lisdexamfetamine dimesylate

Vyvanse

Pharmacologic class: Amphetamine prodrug

Therapeutic class: CNS stimulant

Controlled substance schedule II

Pregnancy risk category C

FDA Box Warning

• Drug has high abuse potential. Prolonged use may lead to drug dependence. Stay alert for possibility of persons obtaining it for nontherapeutic use or distribution. Drug should be prescribed or dispensed sparingly.

• Drug misuse may cause sudden death and serious cardiovascular adverse events.

Action

Rapidly absorbed and converted to dextroamphetamine, which is responsible for CNS activity. Therapeutic action in attention deficit hyperactivity disorder (ADHD) is unknown.

Availability

Capsules: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg

Indications and dosages

ADHD

Adults and Children ages 6 to 12: Individualize dosage based on therapeutic needs and response. For child starting treatment for first time or switching from another drug, recommended dosage is 30 mg P.O. once daily in morning. If daily dosage will be increased above 30 mg, adjust in increments of 10 to 20 mg/day at approximately weekly intervals. Maximum recommended dosage is 70 mg/day.

Contraindications

• Hypersensitivity or idiosyncratic reaction to sympathomimetic amines
• Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, agitated state
• History of drug abuse
• During or within 14 days of MAO inhibitor therapy

Precautions

Use cautiously in:
• concurrent use of other sympathomimetics
• tics, Tourette syndrome, hypertension or other cardiovascular conditions, preexisting psychosis (such as bipolar disorder)
• electroencephalogram (EEG) abnormalities or seizures
• pregnant and breastfeeding patients
• adults
• children younger than age 6 or older than age 12 (safety and efficacy not established).

Administration

• Administer with or without food.
• Give in morning to avoid insomnia.
• Give capsules whole, or open and dissolve entire contents in glass of water. When using solution method, don't divide single-capsule dose; make sure patient consumes solution immediately.

Don't give within 14 days of MAO inhibitors.

Adverse reactions

CNS: dizziness, headache, somnolence, insomnia, irritability, labile affect, manic symptoms, dysphoria, euphoria, aggression, restlessness, tics, dyskinesia, psychomotor hyperactivity, psychotic episodes, depression, tremor, seizure, stroke

CV: palpitations, tachycardia, hypertension, ventricular hypertrophy, myocardial infarction, cardiomyopathy, sudden death

EENT: visual disturbances

GI: abdominal pain, nausea, vomiting, diarrhea, constipation, dry mouth, unpleasant taste

GU: libido changes, erectile dysfunction

Skin: rash, toxic epidermal necrolysis, urticaria, Stevens-Johnson syndrome

Other: decreased appetite, weight loss, growth suppression, fever, amphetamine tolerance and dependency, hypersensitivity reactions including angioedema and anaphylaxis

Interactions

Drug-drug.Adrenergic blockers: inhibited adrenergic blocker action

Antihistamines: decreased sedative effect of antihistamine

Antihypertensives: antagonism of anti-hypertensive effect

Chlorpromazine: inhibited stimulant effect

Desipramine, protriptyline (and possibly other tricyclic antidepressants): enhanced antidepressant activity, causing sustained rise in d-amphetamine concentration in brain

Ethosuximide: delayed intestinal absorption of this drug

Haloperidol: inhibited central stimulant effects

Lithium carbonate: inhibited anorectic and stimulatory effects of lisdexamfetamine

MAO inhibitors: slowed lisdexamfetamine metabolism, possibly leading to hypertensive crises

Meperidine: potentiated analgesic effect of meperidine

Methenamine therapy: increased amphetamine urinary excretion, causing reduced lisdexamfetamine blood level and efficacy

Norepinephrine: enhanced norepinephrine adrenergic effect

Phenobarbital, phenytoin: possible delayed intestinal absorption of these drugs, possible synergistic anticonvulsant action

Propoxyphene: increased risk of potentiated CNS stimulation (leading to life-threatening seizures in propoxyphene overdosage)

Drug-diagnostic tests.Plasma corticosteroids: increased levels

Urinary steroids: interference with results

Drug-herbs. Veratrum alkaloids, such as Veratrum album (white hellebore), V. eschsholtzii (American hellebore), and V. luteum (false unicorn): inhibited hypotensive effect of these herbs

Patient monitoring

• Before initiating therapy, evaluate patient and family for history of cardiovascular abnormalities, tics or Tourette syndrome (or exacerbation of these), EEG abnormalities, and seizures. Drug may lower seizure threshold.
• During early treatment phase, stay alert for worsening of aggressive behavior or hostility.
• Monitor blood pressure and pulse.
• Know that when possible, drug therapy should be interrupted occasionally to determine if behavioral symptoms recur to extent that necessitates continued therapy.
• Monitor patient for appropriate growth and weight gain.
• Watch for signs and symptoms of drug tolerance, dependence, and abuse.

Patient teaching

• Inform patient or caregiver that drug can be taken with or without food. Advise them that it should be taken in morning to help avoid insomnia.
• Instruct patient to take capsule whole, or to open it and dissolve entire contents in glass of water, and consume solution immediately.
• Advise patient or caregiver to watch for and report seizures, worsening of aggressive behavior, tics, or inappropriate growth or weight gain.
• Instruct patient to avoid using herbs unless prescriber approves.
• Caution patient to avoid hazardous activities until drug's effects on concentration, coordination, and vision are known.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

lisdexamfetamine

(lis-dex-am-fet-a-meen) ,

Vyvanse

(trade name)

Classification

Therapeutic: central nervous system stimulants
Pharmacologic: sympathomimetics
Pregnancy Category: C

Indications

Management of attention deficit hyperactivity disorder (ADHD) (in adults and children).

Action

Blocks reuptake and increases release of norepinephrine and dopamine resulting in increased levels in extaneuronal space.

Therapeutic effects

Improved attention span in ADHD.

Pharmacokinetics

Absorption: Rapidly absorbed and converted to dextroamphetamine, the active drug.
Distribution: Unknown.
Metabolism and Excretion: 42% excreted in urine as amphetamine.
Half-life: less than 1 hr for lisdexamfetamine.

Time/action profile

ROUTEONSETPEAKDURATION
POrapid1 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to lisdexamfetamine or other sympathomimetic amines; Advanced arteriosclerosis; Symptomatic cardiovascular disease including known structural cardiac abnormalities (may ↑ the risk of sudden death); Moderate to severe hypertension; Glaucoma; Agitation; Lactation: Lactation; History of substance abuse; During or within 14 days of MAO inhibitor therapy.
Use Cautiously in: History of pre-existing psychosis, bipolar disorder, aggression, tics, Tourette's syndrome or seizures (may exacerbate condition); Obstetric: Use only if maternal benefit outweighs fetal risk; Pediatric: Children <6 yr (safety and effectiveness not established).

Adverse Reactions/Side Effects

Central nervous system

  • behavioral disturbances
  • dizziness
  • hallucinations
  • insomnia
  • irritability
  • mania
  • psychomotor hyperactivity
  • thought disorder
  • tics

Cardiovascular

  • sudden death (life-threatening)
  • Raynaud's phenomenon

Ear, Eye, Nose, Throat

  • blurred vision
  • poor accommodation

Gastrointestinal

  • abdominal pain
  • ↓ appetite
  • dry mouth
  • nausea
  • vomiting

Dermatologic

  • rash

Metabolic

  • ↓ weight

Neurologic

  • paresthesia

Miscellaneous

  • long-term growth suppression

Interactions

Drug-Drug interaction

Serious adverse reactions including hyperpyrexia and hypertension may occur with monamine oxidase inhibitors ; avoid use within 14 days.Concurrent use of other sympathomimetic amines may result in additive effects and ↑ risk of adverse reactions.Urinary acidifying agents including ammonium chloride and sodium acid phosphate ↑ excretion and ↓ blood levels and may result in ↓ effectiveness.May ↓ effectiveness of adrenergic blockers.↑ risk of adverse cardiovascular reactions with tricyclic antidepressants.May ↓ sedating effects of antihistamines.May ↓ effectiveness of antihypertensives..Effects may be ↓ by haloperidol, lithium, or chlorpromazine.May ↓ absorption of phenobarbital or phenytoin.

Route/Dosage

Oral (Adults and Children 6–17 yr) 30 mg daily; may ↑ by 10–20 mg/day at weekly intervals, up to 70 mg/day.

Availability

Capsules: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg Cost: 20 mg $531.93 / 90, 30 mg $566.90 / 90, 40 mg $509.91 / 90, 50 mg $514.34 / 90, 60 mg $529.67 / 90, 70 mg $500.01 / 90

Nursing implications

Nursing assessment

  • Assess child's attention span, impulse control, and interactions with others. Therapy may be interrupted at intervals to determine whether symptoms are sufficient to continue therapy.
  • Monitor BP, pulse, and respiration before administering and periodically during therapy. Obtain a history (including assessment of family history of sudden death or ventricular arrhythmia), physical exam to assess for cardiac disease, and further evaluation (ECG and echocardiogram), if indicated. If exertional chest pain, unexplained syncope, or other cardiac symptoms occur, evaluate promptly.
    • Monitor growth, both height and weight, in children on long-term therapy.
    • Monitor closely for behavior change.
    • Lisdexamfetamine has the potential for dependence and abuse. Prolonged abuse may result in tolerance.
  • Lab Test Considerations: May cause ↑ plasma corticosteroid levels interfering with urinary steroid determinations.

Potential Nursing Diagnoses

Disturbed thought process (Side Effects)

Implementation

  • Oral: Administer in the morning without regard to meals. Afternoon doses should be avoided due to potential for insomnia. Capsules may be swallowed whole or opened and the entire contents dissolved in a glass of water. If solution method is used, consume immediately; do not store for future use. Do not divide capsules or take less than one capsule per day.

Patient/Family Teaching

  • Instruct patient to take medication as directed. Advise patient and parents to read Medication Guide prior to initiation of therapy and with each renewal of Rx refill. If more than prescribed amount is taken notify health care professional immediately. Instruct patient not to alter dose without consulting health care professional.
    • Inform patient that sharing this medication may be dangerous.
    • Advise patient to check weight 2–3 times weekly and report weight loss to health care professional. Pediatric: If reduced appetite and weight loss are a problem, advise parents to provide high calorie meals when drug levels are low (at breakfast and or bedtime).
    • Inform patients starting therapy of risk of peripheral vasculopathy. Instruct patients to notify health care professional of any new numbness; pain; skin color change from pale, to blue, to red; or coolness or sensitivity to temperature in fingers or toes, and call if unexplained wounds appear on fingers or toes. May require rheumatology consultation.
    • Advise parents to notify health care professional immediately if child has signs of heart problems (chest pain, shortness of breath, fainting) or if new or worsening mental symptoms or problems, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious occur.
    • May cause dizziness or blurred vision. Caution patient to avoid driving or activities requiring alertness until response to medication is known.
    • Advise patient to notify health care professional if nervousness, restlessness, insomnia, dizziness, anorexia, or dry mouth becomes severe.
    • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
    • Inform patient that health care professional may order periodic holidays from the drug to assess progress and to decrease dependence.
    • Advise patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.
    • Caution patients to inform health care professional if they have ever abused or been dependent on alcohol or drugs, or if they are now abusing or dependent on alcohol or drugs.
    • Emphasize the importance of routine follow-up exams to monitor progress.
  • Home Care Issues: Advise parents to notify school nurse of medication regimen.

Evaluation/Desired Outcomes

  • Improved attention span, decreased impulsiveness and hyperactivity in ADHD.

Vyvanse

a trademark for lisdexamfetamine.
References in periodicals archive ?
Medications in this category include Adderall XR, Concerta, Ritalin LA and Vyvanse.
Drug manufacturer Shire created "binge-eating disorder" to promote several amphetamine drugs, including Adderall (mixed amphetamine salts) and Vyvanse (lisdexanfetamine mesylate).
In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on an a placebo.
Lisdexamfetamine, the central nervous system stimulant marketed as Vyvanse, has been approved for treating binge-eating disorder in adults and is the first drug approved for this indication, the Food and Drug Administration has announced.
Adderrall XR, Vyvanse and Daytrona are FDA-approved for treatment of attention deficit hyperactivity disorder, and Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis.
Adderrall KR, Vyvanse and Daytrona are FDA approved for treatment of attention deficit hyperactivity disorder, and Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis.
In addition, the settlement also resolves allegations that between February 2007 and September 2010 the company's sales representatives allegedly made false and misleading statements regarding the efficacy and abuse liability of its other ADHD medicine Vyvanse to state Midicaid formulary committees and doctors.
Shire is the real McCoy, a prize in British pharma, for its Dublin domicile, its 25 per cent earnings growth, its core ADHD drug blockbuster Vyvanse and its own highly-successful takeover of blood disease specialist Viropharma Demographics make health care a winner in US, Europe, Japan and even China as genetic medicine, cancer research, hepatitis C mean revolutionary drug pipeline and merger mania at huge takeover premia.
Vyvanse, an amphetamine used to treat childhood attention deficit hyperactivity disorder (ADHD), holds the eighth position on the list of most prescribed meds.
Keffer's prescription history, that he had been prescribed both Cymbalta and Vyvanse, and that he was filling both medications simultaneously.
Last week trials showed a type of amphetamine called Vyvanse could help treating Binge Eating Disorder.
7 million people have prescriptions for ADHD drugs including Novartis' Ritalin, known generically as methylphenidate, Johnson & Johnson's Concerta, Shire's Adderall and Vyvanse and Eli Lilly's Strattera.