Vyvanse® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Vyvanse in the treatment of ADHD was established on the basis of three short-term controlled trials in children ages 6 to 12 years, one short-term controlled trial in adolescents ages 13 to 17 years, one short-term trial in children and adolescents ages 6-17 years, one maintenance trial in children and adolescents ages 617 years, two short-term controlled trials in adults, and one maintenance trial in adults [see Clinical Studies].

General Instructions for Use

Take Vyvanse 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:

• Take Vyvanse capsules whole, or
• Open capsules and empty and mix the entire contents in a glass of water. If the contents include any compacted powder, a spoon may be used to break apart the powder in the water. The content should be stirred until completely dispersed. Consume the full glass of water 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 once the water is consumed. Do not take anything less than one capsule per day, and a single capsule should not be divided.

Dosing Information

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. Patients may be maintained on their optimal dose [see Clinical Studies].

Important Information Prior to Dosing

Prior to treating children, adolescents, and adults with CNS stimulants, 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].

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, Drug Abuse and Dependence].

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].

Dosage Forms And Strengths

Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)

Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)

Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)

Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)

Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)

Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)

Vyvanse capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), bottles of 100, NDC 59417102-10

Vyvanse capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg), bottles of 100, NDC 59417103-10

Vyvanse capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg), bottles of 100, NDC 59417-104-10

Vyvanse capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), bottles of 100, NDC 59417105-10

Vyvanse capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), bottles of 100, NDC 59417-106-10

Vyvanse capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg), bottles of 100, NDC 59417107-10

Storage and Handling

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

Store at 25° C (77° F). Excursions permitted to 15-30° C (59-86° 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.

Manufactured for: Shire US Inc., Wayne, PA 19087. Made in USA. For more information call 1-800-828-2088. Revised: April 2013

Last reviewed on RxList: 5/9/2013
This monograph has been modified to include the generic and brand name in many instances.