Pronunciation:

lis-dex-am-FET-a-meen dye-MES-i-late

Brand Names:

• Vyvanse

Dosage Forms:

• Capsule
• Tablet, Chewable

Warnings:

Abuse, Misuse, and AddictionLisdexamfetamine dimesylate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.Before prescribing lisdexamfetamine dimesylate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout lisdexamfetamine dimesylate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Lisdexamfetamine

Uses of This Medicine:

Lisdexamfetamine dimesylate is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. This medicine is also used to treat moderate to severe binge eating disorder (BED). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Lisdexamfetamine dimesylate increases attention and decreases restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lisdexamfetamine dimesylate to treat ADHD in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of lisdexamfetamine dimesylate to treat binge eating disorder in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lisdexamfetamine dimesylate in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving lisdexamfetamine dimesylate.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acetazolamide
• Alfentanil
• Almotriptan
• Aluminum
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anileridine
• Benzhydrocodone
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Calcium Carbonate
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cimetidine
• Cinacalcet
• Citalopram
• Clobazam
• Clomipramine
• Cobicistat
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dexlansoprazole
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Esomeprazole
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Gepirone
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Iobenguane I 131
• Ketobemidone
• Lansoprazole
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Magaldrate
• Magnesium Carbonate
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Omeprazole
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Pantoprazole
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Rabeprazole
• Remifentanil
• Ritonavir
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse and dependence, history of—Use with caution. Dependence may be more likely to develop.

• Allergy to amphetamine-containing products (eg, Adderall®, Desoxyn®, Dexedrine®, Dextrostat®) or
• Coronary artery disease or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy), severe or
• Heart failure or
• Heart rhythm problems (eg, ventricular arrhythmia), severe or
• Stroke, history of—Should not be used in patients with these conditions unless your doctor tells you otherwise.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (eg, Raynaud disease) or
• Depression, or a family history of or
• Heart rhythm problems (eg, fast heartbeat), mild or
• Hypertension (high blood pressure) or
• Mania, history of or
• Motor tics (repeated muscle movements) or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Tourette's syndrome, or family history of—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you or your child feel that the medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Take this medicine with or without food.

It is best to take this medicine in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep.

The capsule should be swallowed whole, and not crushed, divided, or chewed. If you or your child are not able to swallow the capsule whole, carefully open the capsule and pour the medicine into a glass of water, yogurt, or orange juice. Stir this mixture well and swallow it right away. The drug mixture can not be stored for future use.

Chewable tablets must be chewed thoroughly before swallowing.

You may substitute Vyvanse® capsules with Vyvanse® chewable tablets with the same dosage strength. Do not take anything less than 1 capsule or chewable tablet per day.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules and chewable tablets):
  • For attention deficit hyperactivity disorder (ADHD):
    • Adults and children 6 years of age and older—At first, 30 milligrams (mg) once a day in the morning. If needed, your doctor may slowly increase the dose until symptoms improve or a maximum dose of 70 mg per day is reached.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor. .
  • For moderate to severe binge eating disorder (BED):
    • Adults—At first, 30 milligrams (mg) once a day in the morning. If needed, your doctor may slowly increase the dose until symptoms improve or a maximum dose of 70 mg per day is reached.
    • Children—Use and dose must be determined by your doctor. .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not throw away any remaining, unused, or expired medicine in the trash as it may cause harm to other people or animals. Ask your doctor or pharmacist about a medicine take-back program in your community.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits and make sure that your dose is right and that the medicine is helping you. Your doctor will need to check your or your child's blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine.

You should not use this medicine if you or your child is using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

Tell your doctor about all the medicines you or your child take or plan to take, including prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies (eg, St. John's wort), or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.

This medicine may cause blurred vision or make you drowsy or dizzy. If any of these occur, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

Lisdexamfetamine dimesylate may cause serious heart or blood vessel problems, such as heart attack or stroke. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, fast, pounding, or uneven heartbeat, trouble breathing, or fainting while taking this medicine.

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

This medicine may cause a condition called Raynaud phenomenon. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)

Incidence not known

Agitation

blistering, peeling, or loosening of the skin

chest discomfort or pain

chills

confusion

cough

diarrhea

difficulty with breathing

difficulty with swallowing

discouragement

dizziness

faintness

fast, irregular, pounding, or racing heartbeat or pulse

feeling sad or empty

fever

hives or welts, itching, or skin rash

irritability

joint or muscle pain

lack of appetite

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of interest or pleasure

overreactive reflexes

poor coordination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

shivering

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sweating

swelling of the feet or lower legs

talking or acting with excitement you cannot control

tightness in the chest

trembling or shaking

trouble concentrating

trouble sleeping

twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach cramps

blurred vision

change in consciousness

confusion

dark-colored urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast breathing

loss of consciousness

muscle cramps or spasms

muscle pain or stiffness

nervousness

overactive reflexes

panic states

physical attempt to injure yourself

pounding in the ears

restlessness

seeing, hearing, or feeling things that are not there

seizures

shakiness in the legs, arms, hands, or feet

sweating

trembling or shaking of the hands or feet

violent actions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

headache

nausea

upper abdominal or stomach pain

vomiting

weight decreased

Less common

Crying

depersonalization

dry mouth

dysphoria

euphoria

paranoia

quick to react or overreact emotionally

rapidly changing moods

sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.