HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VYVANSE safely and effectively. See full prescribing information for
VYVANSE.
VYVANSE
®
(lisdexamfetamine dimesylate) capsules, for oral use, CII
VYVANSE ® (lisdexamfetamine dimesylate) chewable tablets, for oral
use, CII
Initial U.S. Approval: 2007
WARNING: ABUSE AND DEPENDENCE
See full prescribing information for complete boxed warning.
CNS stimulants (amphetamines and methylphenidate-containing
products), including VYVANSE, have a high potential for abuse
and dependence (5.1, 9.2, 9.3)
Assess the risk of abuse prior to prescribing and monitor for signs
of abuse and dependence while on therapy (5.1, 9.2)
---------------------------RECENT MAJOR CHANGES---------------------------
Indications and Usage (1) 10/2016
Dosage and Administration (2.1) 10
Dosage and Administration (2.2) 01/2017
Dosage and Administration (2.3) 10
Dosage and Administration (2.4) 10
Contraindications (4) 01/2017
Warnings and Precautions (5.4) 10
Warnings and Precautions (5.7) 01
----------------------------INDICATIONS AND USAGE---------------------------
VYVANSE
is a central nervous system (CNS) stimulant indicated for the
treatment of (1):
Attention Deficit Hyperactivity Disorder (ADHD)
Moderate to Severe Binge Eating Disorder (BED) in adults
Limitation of Use: VYVANSE is not indicated for weight loss. Use of other
sympathomimetic drugs for weight loss has been associated with serious
cardiovascular adverse events. The safety and effectiveness of VYVANSE for
the treatment of obesity have not been established.
------------------------DOSAGE AND ADMINISTRATION----------------------
Indication Initial Dose Titration
Schedule
Recommended
Dose
ADHD
and Pediatric
patients) (2.2)
30 mg
every
morning
10 mg or
20 mg
weekly
30 mg to 70 mg
per day
Dose
70 mg
per day
BED (Adult
patients) (2.3)
30 mg
every
morning
20 mg
weekly
50 mg to 70 mg
per day
70 mg
per day
Prior to treatment, assess for presence of cardiac disease (2.4)
Severe renal impairment: Maximum dose is 50 mg/day (2.5)
End stage renal disease (ESRD): Maximum dose is 30 mg/day (2.5)
-----------------------DOSAGE FORMS AND STRENGTHS-------------------
Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg (3)
Chewable tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg (3)
-------------------------------CONTRAINDICATIONS------------------------------
Known hypersensitivity to amphetamine products or other ingredients in
VYVANSE (4)
Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the
last MAO inhibitor dose (4, 7.2)
------------------------WARNINGS AND PRECAUTIONS-----------------------
Serious Cardiovascular Reactions: Sudden death has been reported in
association with CNS stimulant treatment at recommended doses in
pediatric patients with structural cardiac abnormalities or other
problems. In adults, sudden death, stroke, and myocardial infarction have
been reported. Avoid use in patients with known structural cardiac
abnormalities, cardiomyopathy, serious heart arrhythmia, or coronary artery
disease (5.2)
Blood Pressure and Heart Rate Increases: Monitor blood pressure and
pulse. Consider benefits and risks before use in patients for whom blood
pressure increases may be problematic (5.3)
Psychiatric Adverse Reactions: May cause psychotic or manic symptoms
in patients with no prior history, or exacerbation of symptoms in patients
with pre-
existing psychosis. Evaluate for bipolar disorder prior to stimulant
use (5.4)
Suppression of Growth: Monitor height and weight in pediatric patients
during treatment (5.5)
Peripheral Vasculopathy, including Raynaud’s phenomenon: Stimulants
are associated with peripheral vasculopathy, including Raynaud’s
phenomenon. Careful observation for digital changes is necessary during
treatment with stimulants (5.6)
Serotonin Syndrome: Increased risk when co-administered with
serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during
overdosage situations. If it occurs, discontinue VYVANSE and initiate
supportive treatment (4, 5.7, 10).
------------------------------ADVERSE REACTIONS-------------------------------
Most common adverse reactions
placebo) in children, adolescents, and/or adults with ADHD were anorexia,
anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth,
irritability, insomnia, nausea, upper abdominal pain, and vomiting (6.1)
Most common adverse reactions (incidence
5% and at a rate at least twice
placebo) in adults with BED were dry mouth, insomnia, decreased appetite,
increased heart rate, constipation, feeling jittery, and anxiety (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc.
at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
-------------------------------DRUG INTERACTIONS------------------------------
Acidifying and Alkalinizing Agents:
Agents that alter urinary pH can alter
blood levels of amphetamine. Acidifying agents decrease amphetamine blood
levels, while alkalinizing agents increase amphetamine blood levels. Adjust
VYVANSE dosage accordingly (2.6, 7.1)
------------------------USE IN SPECIFIC POPULATIONS-----------------------
Pregnancy: May cause fetal harm (8.1)
Lactation: Breastfeeding not recommended (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 01/2017
Reference ID: 4048056