Vyvanse (lisdexamfetamine dimesylate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Lisdexamfetamine dimesylate is a prodrug of dextroamphetamine, a noncatecholamine, sympathomimetic amine with CNS-stimulating activity.
Lisdexamfetamine, a prodrug of dextroamphetamine, is a CNS stimulant. Lisdexamfetamine is inactive until hydrolyzed in vivo to l-lysine and dextroamphetamine, which is responsible for the drug's activity. The exact mechanism of therapeutic action in attention deficit hyperactivity disorder (ADHD) and binge-eating disorder is not known.
Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of the monoamines into the extraneuronal space.
Following single-dose administration of lisdexamfetamine, the pharmacokinetics of dextroamphetamine are linear over the oral dosage range of 30-70 mg in children 6-12 years of age and over the oral dosage range of 50-250 mg in adults. Following single-dose administration of a lisdexamfetamine capsule, peak plasma concentrations of lisdexamfetamine occur in approximately 1 hour; concentrations are low and transient, and become nonquantifiable by 8 hours after administration. Peak plasma concentrations of dextroamphetamine occur in approximately 3.5 hours.
Following administration of the chewable tablets, peak plasma concentrations of lisdexamfetamine occur at about 1 hour and dextroamphetamine at 4.4 hours. Lisdexamfetamine and dextroamphetamine do not accumulate at steady state in adults. Administration of capsules with food (high-fat meal or yogurt) delays time to peak plasma concentrations of dextroamphetamine by about 1 hour; however, administration with a high-fat meal, yogurt, or orange juice does not affect the AUC or magnitude of the peak plasma concentration of dextroamphetamine.
Peak plasma concentrations and AUC of lisdexamfetamine are reduced by about 15% when the chewable tablets are administered versus the capsules; however, exposure to dextroamphetamine is similar between products. Food (high-fat meal) decreases the magnitude of peak plasma concentrations and AUC of dextroamphetamine by about 5-7% and delays the time to peak concentrations by about 1 hour. Lisdexamfetamine is not metabolized by CYP isoenzymes.
Lisdexamfetamine is converted to l-lysine and dextroamphetamine by hydrolytic activity of erythrocytes, which have a high capacity for metabolism of lisdexamfetamine. Lisdexamfetamine is excreted principally in urine. Approximately 96% of a 70-mg radiolabeled oral dose of lisdexamfetamine was recovered in urine; parent drug accounted for about 2% of the recovered radioactivity.
Changes in urinary pH may alter excretion of amphetamines. The elimination half-life of lisdexamfetamine is less than 1 hour in patients >=6 years of age, and is approximately 8.6-9.5 hours in pediatric patients 6-12 years of age and 10-11.3 hours in adults for dextroamphetamine.
USES: Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, stay focused, and stop fidgeting. Lisdexamfetamine may also be used to treat binge eating disorder (BED).
It may help to reduce the number of binge eating days. This medication is a stimulant. It is thought to work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain.
This medication is not recommended for use for weight loss due to the risk of serious side effects.
Generic name: lisdexamfetamine dimesylate
Pronunciation: (lis-DEX-am-FET-a-meen)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Vyvanse:
- Attention-Deficit Hyperactivity Disorder
- Binge Eating Disorder
Also known as: Add With Hyperactivity.
Dosing
Available as lisdexamfetamine dimesylate; dosage expressed in terms of the salt.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to amphetamines or any ingredient in the formulation of lisdexamfetamine dimesylate. Anaphylactic reactions, hypersensitivity, Stevens-Johnson syndrome, angioedema, and urticaria have been reported during postmarketing surveillance of lisdexamfetamine.
*Concurrent or recent (i.e., within 14 days) therapy with a monoamine oxidase (MAO) inhibitor, including linezolid or IV methylene blue, since hypertensive crisis could result.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects occurring in >=5% of children, adolescents, or adults receiving lisdexamfetamine for ADHD and at a frequency at least twice that reported with placebo include anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.
Adverse effects occurring in >=5% of adults receiving lisdexamfetamine for binge-eating disorder and at a frequency at least twice that reported with placebo include dry mouth, insomnia, decreased appetite, increased heart rate, constipation, jittery feeling, and anxiety.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of lisdexamfetamine for the management of ADHD have not been established in children <6 years of age.
Safety and efficacy of lisdexamfetamine for binge-eating disorder have not been established in pediatric patients <18 years of age.
Psychotic (e.g., hallucinations, delusional thinking) or manic symptoms have been reported in children and adolescents receiving stimulants for management of ADHD.
Long-term administration is expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.
The National Pregnancy Registry for ADHD Medications monitors outcomes in women exposed to ADHD medications during pregnancy. Clinicians are encouraged to register women who become pregnant while receiving lisdexamfetamine by calling 866-961-2388 or visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/ .
Data are limited regarding use of lisdexamfetamine dimesylate in pregnant women. Amphetamines may decrease placental perfusion through vasoconstriction, and may stimulate uterine contractions in pregnant women, increasing the risk of premature delivery. Infants born to amphetamine-dependent women have increased risk of prematurity and low birth weight; such infants should be monitored for withdrawal symptoms (e.g., feeding difficulties, irritability, agitation, excessive drowsiness).
In animals, lisdexamfetamine dimesylate had no effects on embryofetal morphology or survival when administered orally to rats and rabbits throughout the period of organogenesis. Prenatal and postnatal studies were not conducted specifically with lisdexamfetamine dimesylate. However, administration of amphetamine to pregnant rats during gestation and lactation resulted in decreased pup survival and body weight that correlated with developmental delays at clinically relevant dosages of amphetamine.
Amphetamine is distributed into human milk based on limited case reports. There are no reports of adverse effects on breast-feeding infants; long-term neurodevelopmental effects from amphetamine exposure are not known. Large dosages of dextroamphetamine may interfere with milk production, especially in women whose lactation is not well established. Because of the potential for serious adverse reactions to lisdexamfetamine in breast-feeding infants (e.g., blood pressure and heart rate increases, growth suppression, peripheral vasculopathy), the manufacturer does not recommend breast-feeding during therapy.
The manufacturer does not provide specific dosage recommendations in geriatric patients; however, dosage in geriatric patients should generally start at the lower end of the dosing range, reflecting the greater incidence of reduced hepatic, renal, or cardiac function, and of concomitant diseases and drug therapies.
Clinical studies of lisdexamfetamine dimesylate did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. While other reported clinical experience has not revealed differences in response between geriatric and younger adults, dosage selection in geriatric patients should generally start at the lower end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in such patients.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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