VYVANSE

What it is

VYVANSE contains lisdexamfetamine dimesilate. Lisdexamfetamine is a pharmacologically inactive prodrug of dexamphetamine, which is a central nervous system stimulant. After oral administration, lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and hydrolysed primarily in whole blood to dexamphetamine, which is responsible for the drug's activity. VYVANSE capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg or 70 mg of lisdexamfetamine dimesilate as the active ingredient. VYVANSE was developed as a capsule for once-a-day oral administration.

Approved indications

— Treatment of Attention Deficit Hyperactivity Disorder (ADHD). — Treatment of moderate to severe binge eating disorder (BED) in adults when non-pharmacological treatment is unsuccessful or unavailable.

Dosing overview

VYVANSE should be taken in the morning with or without food; avoid afternoon doses because of the potential for insomnia. Due to reduced clearance in patients with severe renal insufficiency (GFR 15 to < 30 mL/min/1.73m²) the maximum dose should not exceed 50 mg/day, and further dosage reduction should be considered in patients undergoing dialysis.

Key safety warnings

VYVANSE has a potential for abuse, misuse, dependence, or diversion for non-therapeutic uses. Physicians should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. VYVANSE should be prescribed cautiously to patients with a history of substance abuse or dependence. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. Serious cardiovascular events have been reported with the use of sympathomimetic drugs, including VYVANSE, in the ADHD population. Given the higher cardiovascular risk associated with obesity, the BED population may be at a higher risk. Prescribers should consider this potential risk when treating BED. Sudden death has been reported in children and adolescents taking CNS stimulants at usual doses, including those with structural cardiac abnormalities or other serious heart problems. Stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs. Administration of stimulants may exacerbate symptoms of behaviour disturbance and thought disorder in patients with pre-existing psychotic disorder. Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. VYVANSE was associated with dose-related reductions in weight in children, adolescents and adults in short-term studies. Although a causal relationship has not been established, suppression of growth (i.e. weight and/or height) has been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.

Contraindications

VYVANSE is contraindicated in patients with advanced arteriosclerosis; symptomatic cardiovascular disease including cardiac arrhythmia, ischaemic heart disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncratic reaction to sympathomimetic amines or any of the excipients; glaucoma; agitated states such as severe anxiety, tension and agitation; during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result); phaeochromocytoma; tics, Tourette's syndrome; patients who currently exhibit severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency; and patients with known drug dependence or alcohol abuse.

PBS listing

PBS listing information is not provided in the available source documents.

Regulatory history

The TGA approved Vyvanse for registration on 15 July 2013, with initial ARTG registration on 22 July 2013, for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults. Additional strengths (40 mg and 60 mg capsules) were first listed on the ARTG on 17 November 2017, and 20 mg capsules on 22 November 2017. In July 2019, the PBAC recommended approval for Authority Required listings for three new strengths for ADHD.