Lisdexamfetamine

What is Lisdexamfetamine dimesylate?

• Lisdexamfetamine dimesylate (Vyvanse) is a central nervous system (CNS) stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), Moderate to severe binge eating disorder (BED).

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What are the uses of this medicine?

This medicine is used for the treatment of:

• Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. Vyvanse may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
• Moderate to severe binge eating disorder (BED) in adults. Vyvanse may help reduce the number of binge eating days in people with BED.

Limitations of Use:

• 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 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.

How does this medicine work?

• Lisdexamfetamine is a prodrug of dextroamphetamine.
• Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity.
• The exact mode of therapeutic action in ADHD and BED is not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• allergic to amphetamine products or any of the ingredients in Vyvanse. See the end of this Medication Guide for a complete list of ingredients in Vyvanse.
• taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI).
• being treated with the antibiotic linezolid or intravenous methylene blue.

What drug interactions can this medicine cause?

• Do not administer Vyvanse during or within 14 days following the administration of MAOI.
• The concomitant use of Vyvanse and serotonergic drugs increases the risk of serotonin syndrome.
• The concomitant use of Vyvanse and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of Vyvanse compared to the use of the drug alone and increase the risk of serotonin syndrome.
• Co-administration of Vyvanse and urinary alkalinizing agents should be avoided.
• Urinary acidifying agents can lower blood levels and efficacy of amphetamines.

Is this medicine FDA approved?

• Initial U.S. Approval: 2007

How should this medicine be used?

• Prior to treating patients 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).

Recommended dosage: Treatment of ADHD

• The recommended starting dosage in adults and pediatric patients 6 years and older is 30 mg once daily in the morning. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum recommended dosage of 70 mg once daily.

Treatment of Moderate to Severe BED in Adults

• The recommended starting dosage in adults is 30 mg once daily to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70 mg once daily. The maximum recommended dosage is 70 mg once daily.

Patients with Renal Impairment

• In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m2), the maximum dosage should not exceed 50 mg once daily. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m2), the maximum recommended dosage is 30 mg once daily.

Administration:

• Take Vyvanse exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose if needed.
• Take Vyvanse 1 time each day in the morning with or without food.
• Your healthcare provider may sometimes stop Vyvanse treatment for a while to check ADHD or BED symptoms.
• Vyvanse comes in capsules or chewable tablets.
• Taking Vyvanse Capsules:
• Vyvanse capsules may be swallowed whole.
• If Vyvanse capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto yogurt, or poured into water or orange juice.
• Using a spoon, break apart any powder that is stuck together. Stir the Vyvanse powder and yogurt, water, or orange juice until they are completely mixed together.
• Swallow all the yogurt, water, or orange juice mixture right away. Do not store the yogurt, water, or orange juice mixture.
• It is normal to see a filmy coating on the inside of your glass or container after you eat or drink all the Vyvanse mixture.
• Taking Vyvanse Chewable Tablets:
• Chew Vyvanse tablets completely before swallowing.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg
• Chewable tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

This medicine is available in fallowing brand namesː

• Vyvanse

What side effects can this medication cause?

The most common side effects of Vyvanse in children 6 to 17 years old and adults with ADHD include:

• loss of appetite (anorexia)
• decreased appetite
• diarrhea
• dry mouth
• trouble sleeping
• stomach pain
• anxiety
• weight loss
• dizziness
• irritability
• nausea
• vomiting

The most common side effects of Vyvanse in adults with BED include:

• dry mouth
• decreased appetite
• constipation
• anxiety
• trouble sleeping
• increased heart rate
• feeling jittery

Vyvanse may cause serious side effects, including:

• Abuse and dependence
• Heart-related problems
• Mental (psychiatric) problems
• Slowing of growth (height and weight) in children
• Circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud's phenomenon)
• Serotonin syndrome

What special precautions should I follow?

• Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart 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.
• CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.
• 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.
• CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor height and weight in pediatric patients during treatment.
• Stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with stimulants.
• Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort. If it occurs, discontinue Vyvanse and initiate supportive treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may 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.

Management of overdosage:

• Lisdexamfetamine and d-amphetamine are not dialyzable.
• 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.

Can this medicine be used in pregnancy?

• The limited available data from published literature and postmarketing reports on use of Vyvanse in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhd-medications/.

Can this medicine be used in children?

ADHD:

• Safety and effectiveness of Vyvanse have been established in pediatric patients with ADHD ages 6 to 17 years.
• Safety and effectiveness of Vyvanse have not been established in pediatric patients below the age of 6 years.

BED:

• Safety and effectiveness of Vyvanse have not been established in patients less than 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lisdexamfetamine dimesylate
• 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.

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

Who manufactures and distributes this medicine?

• Distributed by: Takeda Pharmaceuticals America, Inc., Lexington, MA 02421. Vyvanse® and the Vyvanse Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A

What should I know about storage and disposal of this medication?

• Store Vyvanse in a safe place (like a locked cabinet) and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect Vyvanse from light.
• Dispose of remaining, unused, or expired Vyvanse by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Vyvanse with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) Vyvanse in the household trash.
• Keep Vyvanse and all medicines out of the reach of children.

Commonly asked questions

Here are some of the most frequently asked questions.

What should you not do while on Vyvanse?

• Do break the capsule or chewable tablet into smaller dosages
• Do not drink alcohol while taking Vyvanse
• Take exactly as directed by your doctor
• Do not take more than recommended

Does Vyvanse change your personality?

• Yes, to some degree.
• Vyvanse can have a temporary effect on personality sometimes causing changes in a person's thoughts or behavior.
• Vyvanse can sometimes cause irritability, anger, or mood changes, particularly in children.

Does Vyvanse start working immediately?

• Vyvanse is a prodrug, which means it needs to be taken orally and metabolized and hence can take approximately one to two hours to take effect
• It lasts approximately 14 hours.

=Can you drink caffeine on Vyvanse?

• Yes, in moderation. No interactions were found between caffeine and Vyvanse.

What foods should you avoid when taking Vyvanse?

• Vitamin C (ascorbic acid) — found in dietary supplements, citrus fruits, and certain vegetables like broccoli and cauliflower which can make the medicine less effective than expected.

Is anger a side effect of Vyvanse?

Anger wasn't reported as a side effect

Does Vyvanse help with anxiety?

While it is not an axiety medication, it may help reduce anxiety

Does Vyvanse make you lose weight?

While Vyvanse is not a weight loss medication, because it is an amphetamine that can increase cellular metabolism, it can indirectly lead to slight weight loss.

Can you help answer these questions?

• Does Vyvanse make you poop?
• When is Vyvanse at its peak?
• Do stimulants make you poop?
• Can you take Vyvanse and CBD?
• Is 70 mg of Vyvanse too much?
• Can you skip a day of Vyvanse?
• Can I take Vyvanse twice a day?
• Does Vyvanse increase serotonin?
• Does Vyvanse cause liver damage?
• How late is too late for Vyvanse?
• Can you stop Vyvanse cold turkey?
• Does lack of sleep affect Vyvanse?
• Why is Adderall not working anymore?
• Does caffeine make Vyvanse last longer?
• Is it OK to drink while taking Vyvanse?
• How do you know if Vyvanse is too strong?
• How do you know if Vyvanse isn't working?
• What does it mean if Vyvanse makes you tired?
• Can you drink alcohol after Vyvanse wears off?
• What are the long term side effects of Vyvanse?
• What happens if you accidentally take two Vyvanse?
• Does ADHD medication change your personality in adults?
• What happens if you take ADHD medication and you don't have ADHD?

• Dailymed label info on Lisdexamfetamine
• FDA Lisdexamfetamine

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