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:

  • People use a certain method to help with attention and hyperactivity issues called ADHD.

• Binge eating disorder:

  • It is used to treat grown-ups who have significant binge-eating problems.

Lisdexamfetamine (Vyvanse)  dose in adults:

Before beginning treatment, it's important to assess whether there is a risk of heart disease or abuse.

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

• Start with 30 mg by mouth in the morning, and you can increase the dose by 10 mg or 20 mg each week until you reach the desired effect.

• The highest daily amount should not exceed 70 mg.

• Note:
  • Decide on the dosage based on the patient's requirements and how they respond to treatment. Aim for the smallest effective dose.

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

• Start with 30 mg orally once a day in the morning.

• Adjust the dose by increasing in 20 mg increments weekly until reaching the target dose of 50 to 70 mg once daily.

• The maximum daily dose is 70 mg.

• If there's no improvement, consider discontinuing the therapy.

Lisdexamfetamine (Vyvanse) dose in children:

Note:

• Give the smallest effective dose, tailored to the individual.
• Administer doses in the early morning; avoid giving them late at night.

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

• Children ≥6 years and Adolescents:

  • For capsules and chewable tablets:
  • Start with 20 to 30 mg orally once daily in the morning.
  • Increase the dose by 10 mg/day or 20 mg/day at 3- to 7-day intervals until the best response is achieved.
  • The maximum daily dose is 70 mg.

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

• Adolescents ≥18 years:

  • For capsules and chewable tablets:

  • Start with 30 mg orally once daily in the morning.

  • Increase the dose by 20 mg/day at weekly intervals until reaching the target dose of 50 to 70 mg once daily.

  • The maximum daily dose is 70 mg.

  • If there's no improvement, consider discontinuing the therapy.

Lisdexamfetamine (Vyvanse) Pregnancy Risk Category: C

• Lisdexamfetamine can change into dextroamphetamine in the body.

• Most information about humans comes from illegal use of methamphetamine/amphetamine, not prescribed by doctors to pregnant women.

• Misusing amphetamines during pregnancy can raise the chances of having a baby with low birth weight and being born too early.

• Newborns might show signs of withdrawal.

• Treatment might lead to behavioral issues in children.

Use of lisdexamfetamine during breastfeeding

• The available information on humans mainly comes from illegal use of methamphetamine/amphetamine, not from when these substances are prescribed to pregnant women.

• Amphetamines are found in breast milk, and they can reduce milk production.

• Breastfeeding babies might become more fussy, restless, or irritable.

• The company recommends against breastfeeding due to the potential harmful effects on nursing infants.

Lisdexamfetamine (Vyvanse) Dose adjustment in renal disease:

• When the Glomerular Filtration Rate (GFR) is 30 mL/minute/1.73 m² or higher, there is no mention of dosage adjustments according to the manufacturer's labeling.

• For GFR between 15 to <30 mL/minute/1.73 m², the maximum daily dose is 50 mg.

• For GFR less than 15 mL/minute/1.73 m², the maximum daily dose is 30 mg.

• In cases of End-Stage Renal Disease (ESRD) requiring hemodialysis, the maximum daily dose is 30 mg.

• It's important to note that lisdexamfetamine and dextroamphetamine cannot be removed by dialysis.

Lisdexamfetamine (Vyvanse) Dose adjustment in liver disease:

The manufacturer's labeling does not recommend any dosage adjustments.

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):

• If you've experienced a reaction to any component in the formula or amphetamines within two weeks of your last MAO inhibitor dose, or while using combination therapy, caution is advised.

Canadian labeling: Additional contraindications not in US labeling

• Avoid if you have a heightened sensitivity to sympathomimetic drugs or a documented allergy, as well as if you suffer from moderate to severe hypertension, hyperthyroidism, advanced arteriosclerosis, cardiovascular symptoms, states of agitation, glaucoma, or a history of substance abuse.

Warnings and precautions

• Cardiovascular events

  • Amphetamine abuse has resulted in fatal cardiovascular events, particularly sudden death in individuals with preexisting heart abnormalities.

  • However, a large retrospective study involving over a million children and adolescents prescribed various ADHD medications found no increased risk of stroke, sudden cardiac death, or acute myocardial infarction associated with current medication use.

  • Nevertheless, individuals with known structural heart issues, cardiomyopathy, significant heart rhythm abnormalities (such as Marfan syndrome), coronary artery disease, or other relevant conditions should not be prescribed amphetamines.

  • Some products may be contraindicated in patients with severe or moderate hypertension.

  • Prior to initiating treatment, a comprehensive medical history, including a family history of sudden death or ventricular arrhythmia, is essential.

  • Electrocardiography (ECG) and echocardiography are advisable to detect any signs of heart disease.

  • Patients experiencing exertional chest pain, unexplained fainting, or other cardiac-related symptoms require a complete cardiac evaluation.

• CNS effects

  • Using amphetamines may make tasks requiring mental attentiveness more challenging.
  • Patients should be cautioned about driving or operating machinery while on these medications due to this effect.
  • Additionally, individuals with hypersensitivity to amphetamines should be particularly aware of potential adverse reactions.

• Hypersensitivity

  • Anaphylaxis, Stevens-Johnson syndrome, angioedema, and urticaria are all recognized hypersensitivity reactions associated with stimulant medications.

• Peripheral vasculopathy

  • Amphetamine therapy can be effective in treating peripheral vasculopathy.

  • This condition can occur regardless of age, dosage, or timing of medication.

  • Adjusting the dose or discontinuing therapy can help manage the condition.

  • Rare side effects of stimulant medications may include digital ulceration and/or soft tissue destruction.

  • It's important to monitor for any digital changes during therapy and consider further evaluation, such as consulting a rheumatologist, if necessary.

• Visual disturbance

  • Amphetamine therapy may cause blurred vision and difficulty with focus and adjustment.

• Cardiovascular diseases

  • The use of stimulants can lead to an increase in both blood pressure and pulse rate.

  • Heart rate typically rises by 3 to 6 beats per minute, and blood pressure may increase by 2 to 4 millimeters of mercury.

  • Individuals with hypertension, heart disease, heart failure, recent myocardial infarction (MI), or other cardiovascular conditions should avoid taking amphetamines.

  • Certain products should also be avoided by patients with hypertension, moderate to severe hypertension, or hyperthyroidism.

• Psychiatric disorders

  • Patients with bipolar disorder or psychosis should approach stimulant therapy with caution, as it may precipitate mixed or manic episodes.

  • Those with psychotic conditions may experience exacerbations of thought disorder and behavioral symptoms.

  • Children and adolescents using amphetamine drugs may be at risk of developing new-onset psychosis or mania.

  • Therefore, it's crucial to screen for bipolar disorder and risk factors for developing mania before initiating treatment.

  • If delusional thinking, hallucinations, or manic symptoms occur, therapy should be discontinued.

  • While stimulant therapy may help alleviate aggression and hostility, causal relationships have not been definitively established.

  • Hence, it's important to monitor for the development or worsening of these behaviors during treatment.

• Seizure disorder

  • Limited information exists regarding the use of stimulants in seizure disorders.

  • Individuals with ADHD have a higher risk of seizure activity compared to the general population.

  • However, a retrospective analysis using drug claims data indicated that patients using stimulant medication had a lower risk of seizures.

  • In cases where seizures are reported as a side effect by some manufacturers, therapy should be discontinued.

• Tourette syndrome/tics

  • Patients with Tourette syndrome and other tic disorders should approach stimulant therapy with caution, as it may potentially cause or exacerbate symptoms of Tourette syndrome, including both motor and phonic tics.

  • However, the evidence supporting this association is limited.

  • Before initiating stimulant therapy, it's important to evaluate patients for Tourette syndrome and tics to assess the potential risks and benefits of treatment.

Lisdexamfetamine: Drug Interaction

Monitoring parameters:

• Monitoring children's growth in terms of height and weight is important during stimulant therapy

• . Before initiating treatment, it's essential to check blood pressure.

• All patients experience central nervous system (CNS) activity, and behavior changes may occur.

• For patients experiencing chest pain, unexplained fainting, or any other symptoms suggestive of cardiac disease while on stimulant treatment, cardiac evaluation is necessary.

• It's crucial to evaluate cardiovascular risk factors, family history, and existing cardiac conditions before starting treatment.

• Signs of peripheral vasculopathy, such as digital changes, should be monitored.

• Assessing for the risk of abuse and being vigilant for signs of misuse, addiction, or other related problems throughout the treatment process is also important prior to prescribing stimulant medication.

How to administer Lisdexamfetamine?

• Take the medication orally in the morning, regardless of meals.

• Avoid afternoon doses to prevent insomnia.

• Ensure you take at least one chewable tablet or capsule per day, and do not take a single dose twice.

  For capsules:

• Swallow the capsules whole without chewing.
• Alternatively, you can open the capsule and mix the contents with water, yogurt, or orange juice.
• Consume the mixture immediately.
• Once the active ingredient disperses, it dissolves completely.
• However, the film containing inactive ingredients may remain in the container or glass after consumption.

• For tablets with chewable:

• Before swallowing, thoroughly chew the tablets.

Mechanism of action of Lisdexamfetamine (Vyvanse):

• The exact mechanism of action of lisdexamfetamine in ADHD or binge eating disorders is not fully understood.

• Lisdexamfetamine dimesylate, a prodrug, is converted into the active component dextroamphetamine, a non-catecholamine and sympathomimetic amine.

• Non-catecholamine sympathomimetic amines like amphetamines are responsible for releasing catecholamines from storage sites at the presynaptic nervous terminals.

• Competitive inhibition, which can block the reuptake of catecholamines, may be a less important mechanism.

  Here are some pharmacokinetic details:

• 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:
    • Lisdexamfetamine: T max ~1 hour in both children (6 to 12 years) and adults
    • Dextroamphetamine: T max ~3.5 hours in children (6 to 12 years), ~3.8 hours in adults (fasting), ~4.7 hours in adults (after a high-fat meal)
  • Chewable tablet:
    • Lisdexamfetamine: T max ~1 hour in both children (6 to 12 years) and adults
    • Dextroamphetamine: T max ~3.9 to 4.4 hours in children and ~4.9 hours in adults (fasting), ~4.9 hours in adults (after a high-fat meal)
• Excretion: Primarily through urine (96%, with 42% as amphetamine-related compounds, 2% as lisdexamfetamine, and 25% hippuric acid); minimal excretion occurs in feces.

International Brands of Lisdexamfetamine:

• Vyvanse
• Elvanse
• Samexid
• Tyvense
• Venvanse

Lisdexamfetamine Brands in Pakistan:

No Brands Available in Pakistan.