INDICATION AND LIMITATION OF USE

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above. 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.

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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.

This site is intended for US healthcare professionals only.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above. 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.

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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.

IMPORTANT SAFETY INFORMATION    This site is intended for US healthcare professionals only.

WARNING: ABUSE AND DEPENDENCE

  • | CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Frequently Asked Questions for Healthcare Professionals

What is Vyvanse?

Vyvanse is indicated for the treatment of¹:

  • Attention Deficit Hyperactivity Disorder (ADHD) in patients ages 6 years and above

LIMITATION OF USE:
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.¹

What strengths are available?

Vyvanse comes in capsule strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, and in chewable tablets in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.

Recommended starting dose: 30 mg once daily in the morning. Avoid afternoon doses due to the potential for insomnia.1 May be taken with or without food.1 Dose may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.1 Vyvanse 10 mg is the lowest strength available for patients who may need flexible titration1

  • Maximum dose: 70 mg per day1
  • Capsules and chewable tablets are interchangeable on a unit per unit/mg per mg basis (eg, 30 mg capsule for 30 mg chewable tablet)1

DOSING SAFETY INFORMATION

  • Severe renal impairment: Maximum dose should not exceed 50 mg/day; end stage renal disease (ESRD): Maximum recommended dose of 30 mg/day
  • 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

Learn More About Dosing and Administration

How is Vyvanse stored?

Store Vyvanse at room temperature between 68°F and 77°F (20°C to 25°C). Vyvanse should be stored in a safe place, like a locked cabinet, and protected from light. Patients should not throw away any unused Vyvanse in their household trash, as it may harm other people or animals. Advise patients about a medicine take-back program in their community.¹

How is Vyvanse administered?

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 entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredient may remain in the glass or container once the mixture is consumed. Do not take anything less than one capsule per day, and a single capsule should not be divided.

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

Is there potential for abuse and dependence?

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

What are some questions I should ask my patients diagnosed with ADHD before prescribing Vyvanse?

Note: This is not an exhaustive list of questions to ask your patients to whom you are prescribing Vyvanse. It is important that you review the full Prescribing Information and Medication Guide before prescribing Vyvanse.

Before prescribing Vyvanse, ask your patients if they have or have a family history of¹:

  • Heart problems, heart defects, high blood pressure
  • Mental problems including psychosis, mania, bipolar illness, or depression
  • Circulation problems in fingers and toes

Your patients should not take Vyvanse if¹:

  • they are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
  • they are sensitive to, allergic to, or had a reaction to other stimulant medicines

If your patients have any kidney problems, you may need to lower your patient’s dose of Vyvanse.

Advise patients of the potential fetal effects from the use of Vyvanse during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Vyvanse. Advise women not to breastfeed if they are taking Vyvanse

Continually and frequently monitor patients to whom you have prescribed Vyvanse to evaluate progress and potential side effects and adverse reactions.

What are some possible adverse reactions?

The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults were¹:

  • Decreased appetite
  • Insomnia
  • Dry mouth
  • Diarrhea
  • Nausea
  • Anxiety
  • Anorexia

These are not all the possible side effects of Vyvanse. You may report side effects for your patients or encourage them to report to FDA at 1-800-FDA-1088.¹

See Adverse Reactions in Clinical Trials of Adults with ADHD

What should be avoided while taking Vyvanse?

  • Your patients should avoid operating machinery, driving a vehicle, or other dangerous activities until they know how Vyvanse affects them.¹
  • Advise your patients to avoid afternoon doses due to the potential for insomnia.¹

What if my patients have trouble swallowing pills?

Vyvanse provides flexible administration options. Chewable tablets can be chewed, the capsules swallowed whole, or the capsules opened and the contents mixed with water, orange juice, or yogurt.1 To mix, instruct your patients to open capsules and mix contents until completely dispersed, making sure to stir apart any compacted powder. You should consume the mixture immediately (do not store), taking the full contents of the capsule (do not divide).1

Chewable Tablets:

Vyvanse chewable tablets must be completely chewed 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).
  • Do not take anything less than one capsule or chewable tablet per day. A single dose should not be divided.

How do I find access and affordability information for Vyvanse?

VyvansePro.com offers a formulary coverage tool to look up coverage and co-pay information for your patients. You can also register eligible patients to save on their prescription with the Vyvanse savings offer here.

What are the ingredients in Vyvanse?

Active Ingredient: lisdexamfetamine dimesylate1

Capsule Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.1

Chewable Tablet Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.1

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking 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.
  • Warnings and Precautions
    • 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. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can 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.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
    • 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. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
    • Increased risk of serotonin syndrome when co-administered with serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), but also during overdosage situations. The potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to the active metabolite of Vyvanse (dextroamphetamine). In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6. If serotonin syndrome occurs, discontinue Vyvanse and any concomitant serotonergic agents immediately and initiate supportive treatment.
  • Adverse Reactions
    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.
  • Pregnancy and Lactation
    Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.

INDICATION AND LIMITATION OF USE

Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above. 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.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

Reference

  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking 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.
  • Warnings and Precautions
    • 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. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can 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.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children during treatment with Vyvanse for ADHD. Treatment may need to be interrupted in children not growing as expected.
    • 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. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
    • Increased risk of serotonin syndrome when co-administered with serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), but also during overdosage situations. The potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to the active metabolite of Vyvanse (dextroamphetamine). In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6. If serotonin syndrome occurs, discontinue Vyvanse and any concomitant serotonergic agents immediately and initiate supportive treatment.
  • Adverse Reactions
    The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in ADHD 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.

    The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, feeling jittery, constipation, and anxiety.

  • Pregnancy and Lactation
    Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
  • Other Considerations
    • Safety and effectiveness in patients <18 years with B.E.D. have not been established.

INDICATION AND LIMITATION OF USE

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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 has not been established.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

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