MEDICATION GUIDE

VYVANSE® (Vi’ - vans)

(lisdexamfetamine dimesylate)
Capsules and Chewable Tablets, CII

What is the most important information I should know What is VYVANSE?

about VYVANSE? VYVANSE is a central nervous system (CNS) stimulant prescription
VYVANSE may cause serious side effects, including: medicine used for the treatment of:
• Abuse and dependence. VYVANSE, other amphetamine • Attention Deficit Hyperactivity Disorder (ADHD) in adults and
containing medicines, and methylphenidate have a high children 6 years of age and older. VYVANSE may help increase
chance for abuse and may cause physical and psychological attention and decrease impulsiveness and hyperactivity in
dependence. Your healthcare provider should check you or people with ADHD.
your child for signs of abuse and dependence before and • Moderate to severe binge eating disorder (BED) in adults.
during treatment with VYVANSE. VYVANSE may help reduce the number of binge eating days in
❍ Tell your healthcare provider if you or your child have ever people with BED.
abused or been dependent on alcohol, prescription VYVANSE is not for use in children under 6 years of age with ADHD.
medicines, or street drugs.
VYVANSE is not for weight loss. It is not known if VYVANSE is
❍ Your healthcare provider can tell you more about the safe and effective for the treatment of obesity.
differences between physical and psychological
It is not known if VYVANSE is safe and effective for use in children
dependence and drug addiction.
with BED.
• Heart-related problems including:
VYVANSE is a federally controlled substance (CII) because it
❍ sudden death, stroke, and heart attack in adults contains lisdexamfetamine dimesylate that can be a target for
❍ sudden death in children who have heart problems or people who abuse prescription medicines or street drugs. Keep
heart defects VYVANSE in a safe place to protect it from theft. Never give your
❍ increased blood pressure and heart rate VYVANSE to anyone else because it may cause death or harm
them. Selling or giving away VYVANSE may harm others and is
Your healthcare provider should check you or your child carefully
against the law.
for heart problems before starting treatment with VYVANSE. Tell
your healthcare provider if you or your child have any heart
problems, heart defects, high blood pressure, or a family history Do not take VYVANSE if you or your child are:
of these problems. • allergic to amphetamine products or any of the ingredients in
Your healthcare provider should check your or your child’s blood VYVANSE. See the end of this Medication Guide for a complete
pressure and heart rate regularly during treatment with VYVANSE. list of ingredients in VYVANSE.
Call your healthcare provider or go to the nearest hospital • taking, or have stopped taking in the last 14 days, a medicine
emergency room right away if you or your child have any signs called a Monoamine Oxidase Inhibitor (MAOI).
of heart problems such as chest pain, shortness of breath, or • being treated with the antibiotic linezolid or intravenous
fainting during treatment with VYVANSE. methylene blue.
• Mental (psychiatric) problems, including:
• new or worse behavior and thought problems Before taking VYVANSE, tell your healthcare provider about
• new or worse bipolar illness all medical conditions, including if you or your child:
• new psychotic symptoms (such as hearing voices, or • have heart problems, heart defects, or high blood pressure
seeing or believing things that are not real) or new manic • have mental problems including psychosis, mania, bipolar
symptoms illness, or depression or have a family history of suicide,
Tell your healthcare provider about any mental problems you bipolar illness, or depression
or your child have or about a family history of suicide, bipolar • have circulation problems in fingers and toes
illness, or depression. • are pregnant or plan to become pregnant. VYVANSE may harm
Call your healthcare provider right away if you or your child the unborn baby.
have any new or worsening mental symptoms or problems ❍ There is a pregnancy registry for females who are exposed to
during treatment with VYVANSE, especially hearing voices, VYVANSE during pregnancy. The purpose of the registry is to
seeing or believing things that are not real, or new manic collect information about the health of females exposed to
symptoms. VYVANSE and their baby. If you or your child becomes
 pregnant during treatment with VYVANSE, talk to your ❍It is normal to see a filmy coating on the inside of your
healthcare provider about registering with the National glass or container after you eat or drink all the VYVANSE
Pregnancy Registry for Psychostimulants at 1-866-961-2388 mixture.
or visit online at https://womensmentalhealth.org/ Taking VYVANSE Chewable Tablets:
clinical-and-research-programs/pregnancyregistry/adhd- • Chew VYVANSE tablets completely before swallowing.
medications/.
If you or your child take too much VYVANSE, call your healthcare
• are breastfeeding or plan to breastfeed. VYVANSE passes into
provider or poison control center at 1-800-222-1222 or go to the
breast milk. You should not breastfeed during treatment with
nearest hospital emergency room right away.
VYVANSE. Talk to your healthcare provider about the best way
to feed the baby during treatment with VYVANSE.
Tell your healthcare provider about all the medicines that you What should I avoid while taking VYVANSE?
or your child take, including prescription and over-the-counter Do not drive, operate machinery, or do other dangerous activities
medicines, vitamins, and herbal supplements. until you know how VYVANSE affects you.
VYVANSE can affect the way other medicines work and other
medicines may affect how VYVANSE works. Taking VYVANSE with
other medicines can cause serious side effects. Sometimes the What are possible side effects of VYVANSE?
doses of other medicines will need to be changed while taking VYVANSE may cause serious side effects, including:
VYVANSE. • See “What is the most important information I should know
Especially tell your healthcare provider if you or your child take: about VYVANSE?”
• selective serotonin • serotonin norepinephrine • Slowing of growth (height and weight) in children. Children
reuptake inhibitors (SSRIs) reuptake inhibitors (SNRIs) should have their height and weight checked often during
• medicines used to treat migraine • tricyclic antidepressants treatment with VYVANSE. VYVANSE treatment may be stopped
headaches called triptans if your child is not growing or gaining weight.
• lithium • fentanyl • Circulation problems in fingers and toes (Peripheral
vasculopathy, including Raynaud’s phenomenon). Signs and
• tramadol • tryptophan
symptoms may include:
• buspirone • St. John’s Wort
❍ Fingers or toes may feel numb, cool, painful
Keep a list of all medicines to show your healthcare provider and
❍ Fingers or toes may change color from pale, to blue, to red
pharmacist when you get a new medicine. Your healthcare provider
will decide if VYVANSE can be taken with other medicines. Tell your healthcare provider if you or your child have
numbness, pain, skin color change, or sensitivity to
Do not start any new medicine during treatment with VYVANSE
temperature in your fingers or toes.
without talking to your healthcare provider first.
Call your healthcare provider right away if you or your child
have any signs of unexplained wounds appearing on fingers or
How should VYVANSE be taken? toes during treatment with VYVANSE.
• Take VYVANSE exactly as prescribed by your healthcare provider. • Serotonin Syndrome. A potentially life-threatening problem
• Your healthcare provider may change the dose if needed. called serotonin syndrome may happen when VYVANSE is
taken with certain other medicines. Stop taking VYVANSE and
• Take VYVANSE 1 time each day in the morning with or without
call your healthcare provider or go to the nearest hospital
food.
emergency room right away if you or your child develop any of
• Your healthcare provider may sometimes stop VYVANSE
the following signs and symptoms of serotonin syndrome:
treatment for a while to check ADHD or BED symptoms.
❍ agitation ❍ fast heartbeat
• VYVANSE comes in capsules or chewable tablets.
❍ flushing ❍ seizures
Taking VYVANSE Capsules:
❍ coma ❍ sweating
• VYVANSE capsules may be swallowed whole.
• If VYVANSE capsules cannot be swallowed whole, the ❍ loss of coordination ❍ confusion
capsule may be opened, and the entire contents sprinkled ❍ dizziness ❍ tremors, stiff muscles, or
onto yogurt, or poured into water or orange juice. muscle twitching
❍ Using a spoon, break apart any powder that is stuck ❍ seeing or hearing things that ❍ changes in blood
together. Stir the VYVANSE powder and yogurt, water, or are not real (hallucination) pressure
orange juice until they are completely mixed together. ❍ high body temperature ❍ nausea, vomiting,
❍ Swallow all the yogurt, water, or orange juice mixture (hyperthermia) diarrhea
right away. Do not store the yogurt, water, or orange
juice mixture.
The most common side effects of VYVANSE in children 6 to one or more of the following: FD&C Red #3, FD&C Yellow #6,
17 years old and adults with ADHD include: FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.
• loss of appetite (anorexia) • anxiety Chewable Tablet Inactive Ingredients: colloidal silicon dioxide,
• decreased appetite • weight loss croscarmellose sodium, guar gum, magnesium stearate, mannitol,
• diarrhea • dizziness microcrystalline cellulose, sucralose, artificial strawberry flavor.
• dry mouth • irritability
• trouble sleeping • nausea
Distributed by: Takeda Pharmaceuticals America, Inc.,
• stomach pain • vomiting Lexington, MA 02421.
The most common side effects of VYVANSE in adults with BED VYVANSE® and the VYVANSE Logo® are registered trademarks of
include: Takeda Pharmaceuticals U.S.A., Inc.
• dry mouth • trouble sleeping ©2021 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
• decreased appetite • increased heart rate For more information, go to www.vyvanse.com or call
• constipation • feeling jittery 1-877-TAKEDA-7 (1-877-825-3327).
• anxiety This Medication Guide has been approved by the U.S. Food and
These are not all the possible side effects of VYVANSE. Drug Administration.
Call your doctor for medical advice about side effects. You may Revised: 10/2021
report side effects to FDA at 1-800-FDA-1088.
SPI-0340

How should I store VYVANSE?

• 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.

General information about the safe and effective use of

VYVANSE.
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use VYVANSE for a
condition for which it was not prescribed. Do not give VYVANSE to
other people, even if they have the same symptoms that you have.
It may harm them, and it is against the law. You can ask your
pharmacist or healthcare provider for information about VYVANSE
that is written for health professionals.

What are the ingredients in VYVANSE?

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