• Attention deficit hyperactivity disorder (ADHD).
• Moderate to severe binge eating disorder.

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
• History of substance abuse
• Concurrent use or use within 14 days of MAO inhibitors or MAO-like drugs (linezolid or methylene blue)
• Lactation: Lactation.

Use Cautiously in:

• History of pre-existing psychosis, bipolar disorder, aggression, tics, Tourette's syndrome or seizures (may exacerbate condition)
• Severe renal impairment (↓ maximum daily dose)
• OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk
• Pedi: Children <6 yr (safety and effectiveness not established).

CV: Raynaud's phenomenon, SUDDEN DEATH.

Derm: alopecia, rash.

EENT: blurred vision, poor accommodation.

GI: ↓ appetite, abdominal pain, dry mouth, intestinal ischemia, nausea, vomiting.

GU: ↓ libido, priapism.

Metab: ↓ weight.

MS: RHABDOMYOLYSIS.

Neuro: behavioral disturbances, dizziness, hallucinations, insomnia, irritability, mania, paresthesia, psychomotor hyperactivity, thought disorder, tics.

Misc: long-term growth suppression, SEROTONIN SYNDROME.

Drug-Drug:

• Concurrent use with MAO inhibitors or MAO-inhibitor-like drugs, such as linezolid or methylene blue may result in serious, potentially fatal reactions; wait at least 14 days following discontinuation of MAO inhibitor before initiation of amphetamine mixtures.
• Drugs that affect serotonergic neurotransmitter systems, including MAO inhibitors, tricyclic antidepressants, SSRIs, SNRIs, fentanyl, buspirone, tramadol, lithium, and triptans ↑ risk of serotonin syndrome.
• Concurrent use of other sympathomimetic amines may result in additive effects and ↑ risk of adverse reactions.
• Urinary acidifying agents including 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.

(Generic available)

• Capsules: 10 mg; 20 mg; 30 mg; 40 mg; 50 mg; 60 mg; 70 mg;
• Chewable tablets: 10 mg; 20 mg; 30 mg; 40 mg; 50 mg; 60 mg;

Attention Deficit Hyperactivity Disorder

• PO (Adults and Children ≥6 yr): 30 mg once daily; may ↑ by 10–20 mg/day at weekly intervals, up to 70 mg/day.

Binge Eating Disorder

• PO (Adults): 30 mg once daily; may ↑ by 20 mg/day at weekly intervals, up to target dose of 50–70 mg/day.

Vyvanse

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

• Improved attention span in ADHD.
• Reduction in number of binge eating days per wk.

Therapeutic Classification: central nervous system stimulants

Pharmacologic Classification: sympathomimetics

Absorption: Rapidly absorbed and converted to dextroamphetamine, the active drug.

Distribution: Unknown.

Metabolism/Excretion: 42% excreted in urine as amphetamine.

Half-life: less than 1 hr for lisdexamfetamine.

Schedule II (C-II)

• 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. Pedi: 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.
  • Rep: May cause fetal harm. Advise patient to notify health care professional if pregnancy is planned or suspected, and to avoid breastfeeding. May cause premature delivery. Monitor infants born to mothers taking lisdexamfetamine for symptoms of withdrawal (feeding difficulties, irritability, agitation, excessive drowsiness). Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Register patient by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/adhdmedications/.
  • Emphasize the importance of routine follow-up exams to monitor progress.
• Home Care Issues: Advise parents to notify school nurse of medication regimen.

lis-dex-am-FET-a-meen

NDC Code^*

• 59417- Shire LLC
  • 59417-101- Vyvanse
    • 59417-101-10- 100 CAPSULE in 1 BOTTLE (59417-101-10)

• 59417- Shire LLC
  • 59417-102- Vyvanse
    • 59417-102-10- 100 CAPSULE in 1 BOTTLE (59417-102-10)

• 59417- Shire LLC
  • 59417-103- Vyvanse
    • 59417-103-10- 100 CAPSULE in 1 BOTTLE (59417-103-10)

• 59417- Shire LLC
  • 59417-104- Vyvanse
    • 59417-104-10- 100 CAPSULE in 1 BOTTLE (59417-104-10)

• 59417- Shire LLC
  • 59417-105- Vyvanse
    • 59417-105-10- 100 CAPSULE in 1 BOTTLE (59417-105-10)

• 59417- Shire LLC
  • 59417-106- Vyvanse
    • 59417-106-10- 100 CAPSULE in 1 BOTTLE (59417-106-10)

• 59417- Shire LLC
  • 59417-107- Vyvanse
    • 59417-107-10- 100 CAPSULE in 1 BOTTLE (59417-107-10)

• 59417- Shire LLC
  • 59417-115- Vyvanse
    • 59417-115-01- 100 TABLET, CHEWABLE in 1 BOTTLE (59417-115-01)

• 59417- Shire LLC
  • 59417-116- Vyvanse
    • 59417-116-01- 100 TABLET, CHEWABLE in 1 BOTTLE (59417-116-01)

• 59417- Shire LLC
  • 59417-117- Vyvanse
    • 59417-117-01- 100 TABLET, CHEWABLE in 1 BOTTLE (59417-117-01)

• 59417- Shire LLC
  • 59417-118- Vyvanse
    • 59417-118-01- 100 TABLET, CHEWABLE in 1 BOTTLE (59417-118-01)

• 59417- Shire LLC
  • 59417-119- Vyvanse
    • 59417-119-01- 100 TABLET, CHEWABLE in 1 BOTTLE (59417-119-01)

• 59417- Shire LLC
  • 59417-120- Vyvanse
    • 59417-120-01- 100 TABLET, CHEWABLE in 1 BOTTLE (59417-120-01)