Lisdexamfetamine (Vyvanse) is a derivative of amphetamine. It is used in conjunction with psychological and behavioral therapies for the treatment of ADHD and binge eating disorder.

Indications of Lisdexamfetamine (Vyvanse):

• Attention-deficit/hyperactivity disorder:

  • The treatment of attention deficit/hyperactivity disorder is indicated (ADHD).

• Binge eating disorder:

  • Adults with moderate to severe binge eating disorders are treated with it.

Lisdexamfetamine (Vyvanse)  dose in adults:

Note: Assessment for the presence of cardiac disease risk of abuse is necessary before starting therapy.

Lisdexamfetamine (Vyvanse) dose in the treatment of Attention-deficit/hyperactivity disorder (ADHD):

• Initial: 30 mg taken orally once day in the morning; dosage may be increased in 10 mg or 20 mg steps per week until the desired result is attained
• The maximum daily dose is 70 mg.
• Note:
  • The dosage ought to be determined by the patient's needs and therapeutic response.
  • Use the smallest effective dose possible.

Lisdexamfetamine (Vyvanse) dose in the treatment of Binge eating disorder:

• Initial: 30 mg per oral once daily in the morning;
• The dose may be titrated in increments of 20 mg at weekly intervals to the target dose of 50 to 70 mg once daily.
• The maximum dose: 70 mg/day.
• In the case of no improvement, therapy should be stopped.

Lisdexamfetamine (Vyvanse) dose in children:

Note:

• It is best to administer the lowest effective, individual dose.
• Early morning doses are preferred; late-night ones should be avoided.

Lisdexamfetamine (Vyvanse) dose in the treatment of Attention-deficit/hyperactivity disorder (ADHD):

• Children ≥6 years and Adolescents:

  • Capsules, chewable tablets:
    • Initial: 20 to 30 mg per oral once daily in the morning;
    • Until the best response is attained, the dose may be raised by 10 mg/day or 20 mg/day at 3- to 7-day intervals.
    • The maximum daily dose: 70 mg/day.

Lisdexamfetamine (Vyvanse) dose in the treatment of moderate to severe Binge eating disorder:

• Adolescents ≥18 years:

  • Capsule, chewable tablets:
    • Initial: 30 mg per oral once daily in the morning;
    • To reach the goal dose of 50 to 70 mg once daily, the dose may be increased by 20 mg/day at weekly intervals.
    • The maximum daily dose: 70 mg/day.
    • If there is no improvement, therapy should be stopped.

Lisdexamfetamine (Vyvanse) Pregnancy Risk Category: C

• Lisdexamfetamine can be converted to dextroamphetamine.
• Most human data are based on illicit methamphetamine/amphetamine exposure, and not therapeutic maternal use.
• Amphetamine abuse can increase the risk of low birth weight and premature birth.
• Infants can experience withdrawal symptoms.
• Therapy can cause behavioral problems in children.

Use of lisdexamfetamine during breastfeeding

• Most human data are based on illicit methamphetamine/amphetamine exposure, and not therapeutic maternal use.
• Breast milk contains Amphetamines.
• Amphetamines can cause a decrease in milk production.
• Breastfeeding infants can cause increased crying, agitation, or irritability.
• The company advises against breastfeeding due to the likelihood of negative effects on nursing infants.

Lisdexamfetamine (Vyvanse) Dose adjustment in renal disease:

• GFR ≥30 mL/minute/1.73 m²:
  • The manufacturer's labelling does not mention dosage modifications.
• 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.

Lisdexamfetamine (Vyvanse) Dose adjustment in liver disease:

There are no dosage adjustments on manufacturer's labeling.

Common Side Effects of Lisdexamfetamine (Vyvanse):

• Central nervous system:

  • Insomnia

• Gastrointestinal:

  • Decreased appetite
  • Xerostomia
  • Upper abdominal pain

Uncommon side effects of Lisdexamfetamine (Vyvanse):

• Cardiovascular:

  • Increased Heart Rate
  • Increased Blood Pressure
  • Palpitations

• Central Nervous System:

  • Irritability
  • Anxiety
  • Jitteriness
  • Dizziness
  • Agitation
  • Emotional Lability
  • Restlessness
  • Drowsiness
  • Increased Energy
  • Nightmares
  • Paresthesia
  • Tic Disorder

• Dermatologic:

  • Hyperhidrosis
  • Skin Rash
  • Pruritus

• Endocrine & Metabolic:

  • Weight Loss
  • Decreased Libido

• Gastrointestinal:

  • Vomiting
  • Diarrhea
  • Nausea
  • Constipation
  • Anorexia
  • Gastroenteritis

• Genitourinary:

  • Erectile Dysfunction
  • Urinary Tract Infection

• Neuromuscular & Skeletal:

  • Tremor

• Respiratory:

  • Dyspnea
  • Oropharyngeal Pain

• Miscellaneous:

  • Fever

Rare Side effects of Lisdexamfetamine (Vyvanse):

• Central nervous system:

  • Drug abuse
  • Drug dependence
  • Talkativeness

Contraindications to Lisdexamfetamine (Vyvanse):

• sensitivity to any ingredient in the formulation or to amphetamines
• within 14 days of the last MAO inhibition dose or during combination therapy.

Canadian labeling: Additional contraindications not in US labeling

• Hypersensitivity to sympathomimetic drugs or known hypersensitivity
• Moderate to severe hypertension
• Hyperthyroidism
• Advanced arteriosclerosis
• Cardiovascular disease symptoms
• States in agitation
• Glaucoma
• Histories of drug abuse

Warnings and precautions

• Cardiovascular events

  • Amphetamine abuse has led to fatal cardiovascular events, including sudden death in patients suffering from preexisting structural heart abnormalities or other serious problems.
  • One large retrospective cohort study that included 1,200,438 children and adolescents (aged 2-24 years) who were prescribed methylphenidate or dexmethylphenidate, amphetamine salts or atomoxetine, found no evidence of increased stroke, sudden cardiac death, acute MI or stroke risk from current ADHD medication use.
  • Patients with known structural heart abnormalities, cardiomyopathy or serious heart rhythm abnormalities, such as Marfan syndrome, coronary artery disease, Marfan Syndrome, and other conditions, should not be prescribed amphetamines.
  • Patients with severe hypertension or moderate hypertension may find some products contraindicated.
  • Before starting treatment, it is important to have a complete medical history as well as a family history of sudden death and/or ventricular arrhythmia.
  • ECG and echocardiogram are recommended for any signs of heart disease.
  • Complete cardiac evaluation is required for patients who complain of exertional chest pain, unexplained syncope or other symptoms related to cardiac disease.

• CNS effects

  • Activities that call for mental attentiveness can be more difficult to do when using amphetamines.
  • It is important to warn patients about driving or operating machinery.

• Hypersensitivity

  • Anaphylaxis, Stevens Johnson syndrome, angioedema and urticaria are all known hypersensitivity reactions to stimulant drugs.

• Peripheral vasculopathy

  • Amphetamine therapy can treat peripheral vasculopathy.
  • Peripheral Vasculopathy can happen at any age, in any dose and at any time.
  • You can treat the condition by adjusting the dose or stopping therapy.
  • Digital ulceration and/or soft tissue destruction can be rare side effects of stimulants.
  • Monitoring for digital changes during therapy is necessary. Further evaluation (eg, in rheumatology), may also be required.

• Visual disturbance

  • Anmphetamine therapy can blur your vision and make it difficult to adjust.

• Cardiovascular diseases

  • The use of stimulants can raise blood pressure and pulse rate.
  • The heart rate grew by 3 to 6 beats per minute, and blood pressure rose by 2 to 4 millimeters Hg.
  • Amphetamines should not be taken by patients suffering from hypertension, heart disease, heart failure, recent MI, or other cardiovascular conditions.
  • Patients with hypertension, moderate to severe hypertension, or hyperthyroidism should not use certain products.

• Psychiatric disorders

  • Patients with bipolar disorder or psychosis should exercise caution (may cause mixed/manic episodes).
  • Psychotic patients may experience an exacerbation in their symptoms of thought disorder and behavior.
  • Children and adolescents can develop new-onset psychosis, or mania from taking amphetamine drugs.
  • Screening for bipolar disorder and risk factors to developing mania in patients before treatment is required.
  • Therapy should be stopped if you experience delusional thinking, hallucinations or mania.
  • Stimulant therapy can help with aggression and hostility (causal relationships not established).
  • Therefore, it is important to monitor for the development or worsening these behaviors.

• Seizure disorder

  • Limited information is available on stimulant use in seizure disorder.
  • Patients with ADHD have a higher risk of seizure activity than the general population.
  • However, a retrospective analysis using data from drug claims showed that patients who used stimulant medication had a lower risk.
  • If seizures are reported by some manufacturers, therapy should be stopped.

• Tourette syndrome/tics

  • Patients with Tourette syndrome and other tic disorders should be cautious.
  • Stimulant therapy can cause Tourette syndrome and exacerbation (motor and phonic) of tics. However, there is not much evidence to support this.
  • Evaluation for Tourette syndrome and tics is required before beginning therapy.

Lisdexamfetamine: Drug Interaction

Monitoring parameters:

• Children's growth (height, weight) should be monitored
• Before you start therapy, be sure to check your blood pressure.
• All patients have CNS activity
• Behavior changes
• Cardiac evaluation for patients suffering from chest pain, unexplained syncope or any other symptoms of cardiac disease while on stimulant treatment.
• It is important to evaluate your cardiovascular risk, family history, and cardiac disease before you start treatment.
• Signs of peripheral vasculopathy (eg digital changes)
• Before prescribing, assess for abuse risk and look out for signs of misuse, addiction, or other problems throughout the treatment process.

How to administer Lisdexamfetamine?

• It should be taken orally in morning, without regard for meals.
• Avoid afternoon doses as they can cause insomnia.
• You should take no less than one chewable or capsule per day. A single dose should not be taken twice.
• Capsules
  • You should swallow the capsules whole, without chewing.
  • You can open the capsule and mix the contents with water, yogurt or orange juice. Consume the mixture immediately.
  • Once the active ingredient is dispersed, it dissolves completely.
  • However, the film containing inactive ingredients can remain in the container or glass after the mixture has been consumed.
• Tablets with Chewable:
  • Before swallowing, be sure to chew the tablets thoroughly.

Mechanism of action of Lisdexamfetamine (Vyvanse):

• It is unknown what the exact mechanism of lisdexamfetamine's action in ADHD or binge eating disorders.
• Lisdexamfetamine Dimesylate, a prodrug, is converted into the active component dextroamphetamine. (A non-catecholamine and sympathomimetic drug amine).
• Non-catecholamine sympathomimetic amines, amphetamines, are responsible for releasing catecholamines from storage sites at the presynaptic nervous terminals.
• Competitive inhibition, which can block the reuptake or catecholamines, may be a less important mechanism.

Duration of action:

• 8 to 14 hours.

Absorption:

• Rapid.

Metabolism:

• It is metabolized in the blood by the hydrolytic activity of red blood cells to dextroamphetamine and l-lysine;
• It does not undergo CYP mediated metabolism.

Half-life elimination:

• Lisdexamfetamine: <1 hour
• Dextroamphetamine: 10 to 13 hours

Time to peak: Capsule: T max: 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)

International Brands of Lisdexamfetamine:

• Vyvanse
• Elvanse
• Samexid
• Tyvense
• Venvanse

Lisdexamfetamine Brands in Pakistan:

No Brands Available in Pakistan.