Lisdexamfetamine Dimesylate

LISDEXAMFETAMINE DIMESYLATE

Manufacturer: Apotex Corp.

Score: 144.0

Quick Summary

Vyvanse is a central nervous system stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older, and for the treatment of moderate to severe binge eating disorder (BED) in adults. The recommended starting dosage is 30 mg once daily in the morning, with dosage adjustments as needed. Important safety information includes the risk of abuse, misuse, and addiction, as well as potential adverse reactions such as insomnia, dry mouth, and decreased appetite. Contraindications include known hypersensitivity to amphetamine products or other ingredients of Vyvanse, and use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs.

Key Clinical Findings and Indications

Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older
Treatment of moderate to severe binge eating disorder (BED) in adults

Important Safety Information

Warning

Vyvanse has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction

Contraindications

Known hypersensitivity to amphetamine products or other ingredients of Vyvanse
Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs

Adverse Reactions

Insomnia
Dry mouth
Decreased appetite
Anorexia
Anxiety
Dizziness
Irritability
Nausea
Upper abdominal pain
Vomiting

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with severe renal impairment or end stage renal disease

ADHD

Adult Dose

30 mg once daily in the morning, with dosage adjustments in increments of 10 mg or 20 mg at approximately weekly intervals

Pediatric Dose

30 mg once daily in the morning, with dosage adjustments in increments of 10 mg or 20 mg at approximately weekly intervals

BED

Adult Dose

30 mg once daily in the morning, with dosage adjustments in increments of 20 mg at approximately weekly intervals

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy
The limited available data from published literature and postmarketing reports on use of Vyvanse in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

It is not known whether Vyvanse is excreted in human milk

Pediatric Use

Safety and effectiveness of Vyvanse have been established in pediatric patients with ADHD ages 6 to 17 years
Safety and effectiveness of Vyvanse have not been established in pediatric patients below the age of 6 years

Geriatric Use

Clinical studies of Vyvanse did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects

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