INTUNIV FAQ (guanfacine) Answers to some

Information about a nonstimulant treatment option
for children and adolescents ages 6 to 17 with ADHD
INTUNIV FAQ
(guanfacine)
Answers to some
of the most frequently
asked questions
Ask your
child’s doctor
about a
Starter Kit
today!
INTUNIV is a prescription medicine
used to treat Attention Deficit
Hyperactivity Disorder (ADHD) in
patients 6 to 17, either alone or in
combination with ADHD stimulant
medications.
INTUNIV may cause serious side
effects including low blood pressure,
low heart rate, fainting, and sleepiness.
1
Q
About ADHD
ADHD is one of the most common childhood psychiatric
disorders in the United States. Symptoms of ADHD may
vary from child to child and must be present in two or more
settings—such as at home and at school—continue for at
least 6 months, and start before the age of 7.
Symptoms may include inattention,
hyperactivity, and impulsivity. The
doctor will try to rule out other
possible causes for your
child’s symptoms.
What is INTUNIV (guanfacine)?
INTUNIV is a prescription medicine used to treat
Attention-Deficit/Hyperactivity Disorder (ADHD)
in patients 6 to 17, either alone or in combination
with ADHD stimulant medications. INTUNIV is not a
controlled substance. INTUNIV was shown to work
in clinical studies lasting up to 8 weeks.
Q
Is INTUNIV right for everyone?
No. Patients should not take INTUNIV if they are
allergic to guanfacine or other ingredients in
INTUNIV, or other products containing guanfacine.
Tell the doctor about all medicines, vitamins, and
herbal supplements your child is taking.
A treatment plan for your
child’s ADHD may include
medication, behavior
management, individual or
family counseling, skills
training, or other therapies.
Q
What are some of the side effects
of INTUNIV?
INTUNIV may cause serious side effects including
low blood pressure, low heart rate, fainting,
and sleepiness.
The most common side effects of INTUNIV are
sleepiness, tiredness, trouble sleeping, low blood
pressure, nausea, stomach pain, and dizziness.
2
Please see Full Prescribing Information,
including Patient Information.
3
Q
Is INTUNIV (guanfacine) a stimulant?
Q
INTUNIV is not a stimulant and is not a
controlled substance. INTUNIV has no known
potential for abuse or dependence.
Q
You should know that your child should not drive
or use machinery like lawn mowers or power tools
until you know how INTUNIV affects your child.
INTUNIV can slow thinking and motor skills. While
taking INTUNIV, your child should not drink alcohol
or take other medicines that can cause sleepiness
or dizziness because these symptoms may get
worse.
Can INTUNIV be added to a stimulant?
For some children, adding once-daily nonstimulant
INTUNIV to their stimulant has been shown to
provide more ADHD symptom improvement.
Q
Can INTUNIV help improve my child’s
ADHD symptoms?
Whether used alone or added to a stimulant, INTUNIV
may help improve your child’s ADHD symptoms.
INTUNIV was studied in clinical trials to treat ADHD.
In some studies, it was used alone. In another, it was
added to a stimulant.
One 9-week study included 455 children who were
on a stable stimulant dose for at least 4 weeks
and had some improvement, but still had ADHD
symptoms. These children then took either INTUNIV
or a sugar pill with their stimulant. Doctors saw
about 30% improvement in ADHD symptoms when
INTUNIV was added to a stimulant compared with a
sugar pill added to a stimulant.
Q
What should I tell the doctor before my
child takes INTUNIV?
What should be avoided while taking
INTUNIV (guanfacine)?
Patients should drink plenty of water and not get
overheated while taking INTUNIV.
Q
How is INTUNIV given?
Your child should take INTUNIV exactly as
prescribed by the doctor. INTUNIV comes in 4
doses—1 mg, 2 mg, 3 mg, and 4 mg—and is taken
once a day. The doctor should start your child with
1 mg and adjust the dose to find the one that’s
right for your child. The right dose depends on your
child’s weight and response to INTUNIV. It may
take a few weeks to see improvement in your child’s
ADHD symptoms. Do not change your child’s dose
unless directed by the doctor.
INTUNIV should be swallowed whole with liquid,
without crushing, chewing, or breaking the tablet.
INTUNIV should not be taken with a high-fat
meal. Tell the doctor if your child cannot swallow
INTUNIV whole. The doctor will regularly check
your child’s blood pressure and heart rate.
Before deciding if INTUNIV is an option for your child,
the doctor needs to know if your child has low blood
pressure, low heart rate, heart problems, has fainted,
has liver or kidney problems, or has any other
medical condition. Also tell the doctor if your child
is pregnant or breast-feeding or plans to become
pregnant or breast-feed.
4
Please see Full Prescribing Information,
including Patient Information.
5
Q
What other medications should I tell my
child’s doctor about before my child takes
INTUNIV (guanfacine)?
Tell your child’s doctor about all of the medicines
your child takes, including prescription and
nonprescription medicines, vitamins, and herbal
supplements.
Save on INTUNIV (guanfacine)
Get caregiver support, materials, and a
great money-saving offer
Ask the doctor today about the INTUNIV Starter Kit—a free
resource that includes
INTUNIV may affect the way other medicines work,
and other medicines may affect how INTUNIV works.
• Information about INTUNIV
Especially tell your child’s doctor if your child takes
• A trial sample offer
• ketoconazole
• A savings card that limits the cost of each
prescription to just $15*
• medicines that can affect enzyme metabolism
• high blood pressure medicine
• sedatives
• benzodiazepines
• barbiturates
• antipsychotics
Know the medicines your child takes. Keep a list
of them and show it to your child’s doctor and
pharmacist when your child is prescribed a new
medicine.
Q
Can my child’s physician call in
a refill for INTUNIV?
INTUNIV is not a controlled substance. Your child’s
physician can call in refills to the pharmacy
if appropriate.
6
*The offer covers the amount above
$15 up to a maximum of $115 per
prescription, for up to 12 prescriptions.
Restrictions may apply.
Ask your
child’s doctor
about a
Starter Kit
today!
If you don’t receive a Starter Kit,
visit www.intuniv.com to get your
savings coupon.
Please see Full Prescribing Information,
including Patient Information.
7
SUPPORT PROGRAM
TM
Instant Support Every Day
Join today for free support and tools
A little help can go a long way. That’s why we created
the inTUNE Support ProgramTM — a support resource that
provides free tools, materials, and more to help you every
step of the way. After registering, you’ll receive
• The Progress Tracker
• The Refill Reminder Tool
Shire Cares is a program that helps parents who need
help paying for their child’s INTUNIV prescription. If your
child doesn’t have prescription insurance or if you are
having trouble affording your child’s prescription, Shire
Cares may be able to help.
Visit shirecares.com to learn more.
•A
Doctor Discussion Guide
• More information about
INTUNIV and ADHD
Visit intuniv.com
today to learn
more about
INTUNIV
(guanfacine)
8
Please see Full Prescribing Information,
including Patient Information.
9
For more
information visit
intuniv.com
Please see Full Prescribing Information,
including Patient Information.
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
INTUNIV® is a registered trademark
of Shire LLC.
1-800-828-2088 www.intuniv.com
©2013 Shire US Inc., Wayne, PA 19087
INT-05208 06/13