Vyvanse, lisdexamfetamine dimesylate, is a stimulant medication for the treatment of Attention-Deficit/Hyperactivity Disorder, or ADHD for patients aged 6 and above.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Vyvanse is indicated for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 and older. Pediatric patients with ADHD younger than 6 years of age experienced more long term weight loss than patients 6 years and older. Vyvanse is not indicated or recommended 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.
CNS stimulants, including Vyvanse, other amphetamine containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Vyvanse has the following contraindications:
Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens Johnson Syndrome, angioedema, and urticaria have occurred.
Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Vyvanse, or lisdexamfetamine dimesylate, is an inactive, water-soluble prodrug of dextroamphetamine, in which d-amphetamine is bonded to l-lysine, a naturally occurring amino acid.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
2. Han HK, Amidon GL. Targeted prodrug design to optimize drug delivery. AAPS PharmSci. 2000;2(1):
In general, prodrugs are pharmacologically inert chemical derivatives that are converted in vivo into active drug molecules.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
2. Han HK, Amidon GL. Targeted prodrug design to optimize drug delivery. AAPS PharmSci. 2000;2(1):
The clinical relevance of the prodrug formulation of lisdexamfetamine has not been established.
The mode of therapeutic action in ADHD is not known.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
After oral administration, lisdexamfetamine is rapidly absorbed from the GI tract.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
2. Krishnan S, Pennick M, Stark JG. Metabolism, distribution and elimination of lisdexamfetamine dimesylate. Clin Drug Invest. 2008;28(12):745 755.
Lisdexamfetamine is converted to dextroamphetamine and l-lysine primarily in blood due to the hydrolytic activity of red blood cells.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Dextroamphetamine is a noncatecholamine sympathomimetic amine with central nervous system stimulant activity.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Amphetamines block the reuptake of the catecholamines norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
The parent drug, lisdexamfetamine, does not bind to the sites responsible for the reuptake of norepinephrine and dopamine in vitro.
The clinical significance of in vitro data is unknown.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
The clinical relevance of the prodrug formulation of lisdexamfetamine has not been established.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
In summary, lisdexamfetamine, a prodrug of dextroamphetamine, is rapidly absorbed from the gastrointestinal tract into the circulatory system where it undergoes a conversion to dextroamphetamine primarily in the blood and then passes to the central nervous system.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
2. Krishnan S, Pennick M, Stark JG. Metabolism, distribution and elimination of lisdexamfetamine dimesylate. Clin Drug Invest. 2008;28(12):745 755.
The mode of therapeutic action in ADHD is not known.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Exacerbation of Pre-existing Psychosis: Vyvanse may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). Treatment may need to be interrupted in patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Swallowing oral medications can be difficult for some patients.
1. Schiele JT, Quinzler R, Klimm HD, et al. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013;69(4):937 948.
Only Vyvanse offers 5 administration options for patients with ADHD to tailor administration to meet the individual needs of appropriate patients.1
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Chewable
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Mixable
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
And swallowable
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
2. Data on file; SPD489 166; Takeda Pharmaceuticals U.S.A., Inc.
Vyvanse is available in six chewable tablet strengths.
Chewable Vyvanse tablets must be chewed thoroughly before swallowing.
Take the entire chewable tablet daily—do not divide the dose.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Vyvanse capsule contents can be mixed with water, orange juice or yogurt.
To administer:
- Open capsule and mix contents until completely dispersed
- Stir to break apart any compacted powder
- Consume immediately (do not store)
- Take full contents of capsule (do not divide the dose)
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Capsules may be swallowed whole and should be taken daily. Do not divide the dose.
Vyvanse is available in seven capsule strengths. The recommended starting dosage in adults and pediatric patients 6 years and older is 30 mg once daily in the morning.
Avoid afternoon doses due to the potential for insomnia.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
2. Data on file; SPD489 166; Takeda Pharmaceuticals U.S.A., Inc.
The dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals. The maximum recommended dosage is 70 mg once daily.
Capsules and chewable tablets may be taken with or without food and are interchangeable on a unit per unit or mg per mg basis—for example, a 30 mg capsule for a 30 mg chewable tablet.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
In patients with severe renal impairment the maximum dosage should not exceed 50 mg once daily. In patients with end stage renal disease, the maximum recommended dosage is 30 mg once daily.
Prior to treatment, assess for cardiac disease; after prescribing, keep prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for Vyvanse use.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
1. Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
For more information please visit www.vyvansepro.com.
