Lisdexamfetamine Dimesylate (3 brand names, 3 dosage forms, 1 route)
Available dosage forms: CAPSULE, TABLET, CHEWABLE, SOLUTION.
Routes of administration: ORAL.
Brand Names
- ARYNTA
- LISDEXAMFETAMINE DIMESYLATE
- VYVANSE
Boxed Warning
Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing lisdexamfetamine dimesylate capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout lisdexamfetamine dimesylate capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].
Indications and Usage
Lisdexamfetamine Dimesylate Capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].
Contraindications
Lisdexamfetamine dimesylate capsules are contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions (6.2)]. Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1)].
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules [see Contraindications (4)] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1)] Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5)] Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions (5.6)] Serotonin Syndrome [see Warnings and Precautions (5.7)] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.8)]
Mechanism of Action
Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.