VYVANSE Capsule / Tablet chewable Ref.[11110] Active ingredients: Lisdexamfetamine

2.1 Pre-treatment Screening

Prior to treating children, adolescents, and adults with CNS stimulants, including VYVANSE, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for VYVANSE use [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

2.2 General Instructions for Use

Take VYVANSE by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. VYVANSE may be administered in one of the following ways:

Information for VYVANSE capsules:

• Swallow VYVANSE capsules whole, or
• Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.

Information for VYVANSE chewable tablets:

• VYVANSE chewable tablets must be chewed thoroughly before swallowing.

VYVANSE capsules can be substituted with VYVANSE chewable tablets on a unit per unit/mg per mg basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical Pharmacology (12.3)].

Do not take anything less than one capsule or chewable tablet per day. A single dose should not be divided.

2.3 Dosage for Treatment of ADHD

The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum dose of 70 mg/day [see Clinical Studies (14.1)].

2.4 Dosage for Treatment of Moderate to Severe BED in Adults

The recommended starting dose is 30 mg/day to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 to 70 mg/day. The maximum dose is 70 mg/day [see Clinical Studies (14.2)]. Discontinue VYVANSE if binge eating does not improve.

2.5 Dosage in Patients with Renal Impairment

In patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m²), the maximum dose should not exceed 50 mg/day. In patients with end stage renal disease (ESRD, GFR <15 mL/min/1.73 m²), the maximum recommended dose is 30 mg/day [see Use in Specific Populations (8.6)].

2.6 Dosage Modifications due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly [see Drug Interactions (7.1)].

Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has been reported with amphetamine use, including VYVANSE. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Lisdexamfetamine and d-amphetamine are not dialyzable.

Dispense in a tight, light-resistant container as defined in the USP.

Store at room temperature, 20ºC to 25º C (68ºF to 77º F). Excursions permitted between 15ºC and 30º C (59 to 86º F) [see USP Controlled Room Temperature].

Disposal:

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program.