Approved Drug Label (PDF)
5
Warnings and Precautions
5.7 Long-Term Suppression of Growth in Pediatric Patients
Additions and/or
revisions underlined:
QUILLIVANT XR is not approved for use and is not
recommended in pediatric patients below 6 years of age [see Use in Specific
Populations (8.4)].
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…
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of QUILLIVANT XR have
not been established in pediatric patients below the age of 6 years.
In studies evaluating extended-release
methylphenidate products, patients 4 to <6 years of age had higher systemic
methylphenidate exposures than those observed in older pediatric patients at
the same dosage. Pediatric patients 4 to <6 years of age also had a higher
incidence of adverse reactions, including weight loss.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What is QUILLIVANT
XR?
QUILLIVANT
XR is a central nervous system stimulant prescription medicine.
QUILLIVANT XR is a
liquid medicine that
you take by mouth.
It is used for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD). QUILLIVANT XR may
help increase attention and decrease impulsiveness and hyperactivity in people
with ADHD.
QUILLIVANT
XR is not recommended for use in children under 6 years of age with
ADHD.
…
Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE,
MISUSE, AND ADDICTION
QUILLIVANT XR 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 QUILLIVANT XR, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of
administration, such as snorting or injection.
Before prescribing
QUILLIVANT XR, 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 QUILLIVANT XR
treatment, reassess each patient’s risk of abuse, misuse, and addiction and
frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug
Abuse and Dependence (9.2].
5
Warnings and Precautions
5.1 Abuse, Misuse, and Addiction
Additions and/or revisions
underlined:
QUILLIVANT XR has a high potential for abuse and misuse.
The use of QUILLIVANT XR exposes individuals to the risks of abuse
and misuse, which can lead to the development of a substance use disorder,
including addiction. QUILLIVANT XR can be diverted for non-medical use into
illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including QUILLIVANT XR, can
result in overdose and death [see Overdosage (10 )], and this risk
is increased with higher doses or unapproved methods of administration,
such as snorting or injection.
Before
prescribing QUILLIVANT XR, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks and proper disposal of
any unused drug. Advise patients to store QUILLIVANT XR in a safe place,
preferably locked, and instruct patients to not give QUILLIVANT XR to anyone
else. Throughout QUILLIVANT XR treatment, reassess each patient’s risk of
abuse, misuse, and addiction and frequently monitor for signs and symptoms of
abuse, misuse, and addiction.
5.10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome
New
subsection added:
CNS
stimulants, including methylphenidate, have been associated with the onset or
exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has
also been reported [see Adverse Reactions
(6.2)].
Before
initiating QUILLIVANT XR, assess the family history and clinically evaluate
patients for tics or Tourette’s syndrome. Regularly monitor QUILLIVANT XR
-treated patients for the emergence or worsening of tics or Tourette’s
syndrome, and discontinue treatment if clinically appropriate.
5.8 Acute Angle Closure Glaucoma
New
subsection added:
There
have been reports of angle closure glaucoma associated with methylphenidate
treatment.
Although
the mechanism is not clear, QUILLIVANT XR -treated patients considered at risk
for acute angle closure glaucoma (e.g., patients with significant hyperopia)
should be evaluated by an ophthalmologist.
5.9 Increased Intraocular Pressure and Glaucoma
New
subsection added:
There
have been reports of an elevation of intraocular pressure (IOP) associated with
methylphenidate treatment [see Adverse
Reactions (6.2)].
Prescribe
QUILLIVANT XR to patients with open-angle glaucoma or abnormally increased IOP
only if the benefit of treatment is considered to outweigh the risk. Closely
monitor QUILLIVANT XR -treated patients with a history of abnormally increased
IOP or open angle glaucoma.
6
Adverse Reactions
Additions and/or
revisions underlined:
…
Abuse, Misuse, and
Addiction [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence
(9.2, 9.3)]
…
Acute Angle Closure
Glaucoma [see Warnings and Precautions (5.8)]
Increased Intraocular
Pressure and Glaucoma [see Warnings
and Precautions (5.9)]
Motor and Verbal Tics, and
Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10)]
6.2 Postmarketing
Experience
Additions
and/or revisions underlined:
…
Eye Disorders: Diplopia, Increased
intraocular pressure, Mydriasis, Visual impairment
…
Nervous System Disorders: Convulsion,
Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with
serotonergic drugs, Motor and Verbal Tics
…
7
Drug Interactions
Additions
and/or revisions underlined:
…
Halogenated
Anesthetics
Concomitant
use of halogenated anesthetics and QUILLIVANT XR may increase the risk of
sudden blood pressure and heart rate increase during surgery. Monitor blood
pressure and avoid use of QUILLIVANT XR in patients being treated with
anesthetics on the day of surgery.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions
and/or revisions underlined:
…
Abuse,
Misuse, and Addiction
Educate
patients
and their families about the risks of abuse, misuse, and addiction of QUILLIVANT
XR, which can lead to overdose and death, and proper disposal of any unused
drug [see Warnings and Precautions (5.1), Drug Abuse and
Dependence (9.2), Overdosage (10)]. Advise patients
to store QUILLIVANT XR in a safe place, preferably locked, and instruct
patients to not give QUILLIVANT XR to anyone else.
…
Increased
Intraocular Pressure (IOP) and Glaucoma
Advise
patients that IOP and glaucoma may occur during treatment with QUILLIVANT XR [see Warnings and Precautions (5.9)].
Motor
and Verbal Tics, and Worsening of Tourette’s Syndrome
Advise
patients that motor and verbal tics and worsening of Tourette’s Syndrome may
occur during treatment with QUILLIVANT XR. Instruct patients to notify their
healthcare provider if emergence of new tics or worsening of tics or Tourette’s
syndrome occurs [see Warnings and
Precautions (5.10)].
Pregnancy
Registry
Advise
patients that there is a pregnancy exposure registry that monitors pregnancy
outcomes in women exposed to QUILLIVANT XR during pregnancy [see Use in Specific Populations (8.1)].
…
MEDICATION GUIDE
Medication
Guide has undergone extensive changes; please refer to label.
Approved Drug Label (PDF)
7
Drug Interactions
Additions
underlined
…
Antihypertensive
Drugs
QUILLIVANT
XR may decrease the effectiveness of drugs used to treat hypertension. Monitor
blood pressure and adjust the dosage of the hypertensive drug as needed [see Warnings and Precautions (5.3)].
Risperidone
Combined
use of methylphenidate with risperidone when there is a change, whether an
increase or decrease, in dosage of either or both medications, may increase the
risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.
8
Use in Specific Populations
8.1 Pregnancy
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions underlined
…
QUILLIVANT
XR may not be right for you or your child. Before starting QUILLIVANT XR tell your
or your child’s health care provider about all health conditions (or a family
history of) including:
…
The purpose of
the registry is to collect information about the health of females exposed to QUILLIVANT XR and their baby. If you or your child becomes pregnant
during treatment with QUILLIVANT XR, talk to your healthcare provider
about registering with the National Pregnancy Registry for
Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical- and-research-programs/pregnancyregistry/othermedications/.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.7 Long-Term Suppression of Growth
(Additions and/or revisions are underlined)
Closely monitor growth (weight and height) in
pediatric patients treated with CNS stimulants, including QUILLIVANT XR…
6
Adverse Reactions
6 ADVERSE REACTIONS
(Additions and/or revisions are underlined)
The following are discussed in more detail in other
sections of the labeling:
Known hypersensitivity to methylphenidate
products or other ingredients of QUILLIVANT XR
Hypertensive Crisis When Used Concomitantly
with Monoamine Oxidase Inhibitors
Drug Dependence
Serious Cardiovascular Reactions
Blood Pressure and Heart Rate Increases
Psychiatric Adverse Reactions
Priapism
Peripheral Vasculopathy, including Raynaud’s
phenomenon
Long-Term Suppression of Growth
7
Drug Interactions
7.1 Clinically Important Drug Interactions
(Revised subsection title)
8
Use in Specific Populations
8.4 Pediatric Use
(Additions and/or revisions are underlined)
…Use of QUILLIVANT XR in pediatric patients 6 to 12 years of
age is supported by one adequate and well-controlled study…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Instructions for Using the Enclosed Oral Dosing Dispenser
Provide the following instructions on administration to the patient
or caregiver:
The pharmacist should provide this medicine
in its original packaging (bottle within carton) with the bottle adapter fully
inserted and the accompanying oral dosing dispenser. Use only with the oral
dosing dispenser provided with this product.
Check and make sure that the QUILLIVANT XR
bottle contains liquid medicine. If QUILLIVANT XR is in powder form, do not use
it. Return it to your pharmacist.
VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for
at least 10 seconds before each dose, to ensure that the proper dose is administered.
Alcohol Effect
Patients should be advised to avoid alcohol while taking
QUILLIVANT XR Oral Suspension. Consumption of alcohol while taking QUILLIVANT XR may result in a more rapid release
of the dose of methylphenidate.
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What is the most important information I should know about QUILLIVANT XR?
Tell your health care provider if you or your child have
(or have a family history of) ever abused or been dependent on alcohol,
prescription medicines or street drugs.
How should QUILLIVANT XR be taken?
Read
the step-by-step instructions for using QUILLIVANT XR extended-release
suspension at the end of this Medication Guide.
Take QUILLIVANT
XR exactly as prescribed. Your health care provider may adjust the dose,
if needed, until it is right for you or your child. During dose
adjustment, you or your child may still have ADHD symptoms.
Check
and make sure that the QUILLIVANT XR bottle contains liquid medicine. If
QUILLIVANT XR is in powder form, do not use it. Return it to your pharmacist.
Check and make sure that the bottle adapter
was fully inserted into the bottle by the pharmacist. If the bottle adapter is
not fully inserted, insert the adapter into the bottle.
If a dose is missed, you or your child should
talk to your health care provider about dosing.
What should I avoid while taking QUILLIVANT XR?
QUILLIVANT XR should not be taken with MAOI
medicines. Do not start taking QUILLIVANT XR if you stopped taking an MAOI in
the last 14 days.
Do not drink alcohol while taking QUILLIVANT
XR. This may cause a faster release of your methylphenidate dose.
What are the possible side effects of QUILLIVANT XR? QUILLIVANT XR may cause serious side
effects, including:
Other serious side effects include:
For more information, go to www.quillivantxr.com or call
1-800-438-1985.
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