Approved Drug Label (PDF)
5
Warnings and Precautions
5.7 Long-Term Suppression of Growth in Pediatric Patients
Additions and/or revisions underlined:
QuilliChew ER is not
approved for use and is not recommended in pediatric patients below 6 years of
age [see Use in
Specific Populations (8.4)].
…
8
Use in Specific Populations
8.4. Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of QuilliChew ER 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 QuilliChew
ER?
QuilliChew
ER is a central nervous system stimulant prescription medicine. QuilliChew ER
is an extended-release chewable tablet. It
is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). QuilliChew
ER may help increase attention and decrease impulsiveness and hyperactivity in
people with ADHD. QuilliChew ER 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
QuilliChew ER 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 QuilliChew ER, 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
QuilliChew ER, 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 QuilliChew ER
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) and Drug Abuse and
Dependence (9.2)].
5
Warnings and Precautions
5.1 Abuse, Misuse, and Addiction
Additions
and/or revisions underlined:
QuilliChew
ER has a high potential for abuse and misuse. The use of QuilliChew ER exposes
individuals to the risks of abuse and misuse, which can lead to the development
of a substance use disorder, including addiction. QuilliChew ER 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 QuilliChew ER, can result in overdose and, and this risk is increased with higher
doses or unapproved methods of administration, such as snorting or injection.
Before
prescribing QuilliChew ER, 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 QuilliChew ER in a safe place, preferably locked, and
instruct patients to not give QuilliChew ER to anyone else. Throughout
QuilliChew ER 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 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 QuilliChew ER to patients with
open-angle glaucoma or abnormally increased IOP only if the benefit of
treatment is considered to outweigh the risk. Closely monitor QuilliChew ER
-treated patients with a history of abnormally increased IOP or open angle
glaucoma.
5.11 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 QuilliChew ER, assess the family history and clinically evaluate
patients for tics or Tourette’s syndrome. Regularly monitor QuilliChew
ER-treated patients for the emergence or worsening of tics or Tourette’s
syndrome, and discontinue treatment if clinically appropriate.
5.9 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, QuilliChew ER -treated patients considered at risk
for acute angle closure glaucoma (e.g., patients with significant hyperopia)
should be evaluated by an ophthalmologist.
6
Adverse Reactions
Additions and/or
revisions underlined:
…
…
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 QuilliChew ER may increase the risk of
sudden blood pressure and heart rate increase during surgery. Avoid use of
QuilliChew ER 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 QuilliChew
ER, 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 QuilliChew ER in a safe
place, preferably locked, and instruct patients to not give QuilliChew ER to
anyone else.
…
Increased Intraocular Pressure (IOP) and Glaucoma
Advise patients that IOP and glaucoma may occur
during treatment with QuilliChew ER [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 QuilliChew ER.
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 females exposed to QuilliChew ER
during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise nursing mother to monitor infants exposed to
QuilliChew ER through breastmilk for agitation, poor feeding, and reduced
weight gain [see Use in Specific Populations (8.2)].
MEDICATION GUIDE
Medication
Guide has undergone extensive changes; please refer to label.
Approved Drug Label (PDF)
4
Contraindications
Revised, as below:
4.1
Hypersensitivity to Methylphenidate or other Components of QuilliChew ER
QuilliChew
ER is contraindicated in patients known to be hypersensitive to
methylphenidate, or other components of QuilliChew ER. Hypersensitivity
reactions such as angioedema and anaphylactic reactions have been reported in
patients treated with other methylphenidate products.
4.2
Monoamine Oxidase Inhibitors
QuilliChew
ER is contraindicated during concomitant treatment with monoamine oxidase
inhibitors (MAOIs), and also within 14 days following discontinuation of
treatment with a monoamine oxidase inhibitor (MAOI), because of the risk of
hypertensive crisis.
5
Warnings and Precautions
5.2 Serious Cardiovascular Reactions
Additions
and/or revisions underlined:
Stroke
and myocardial infarction have occurred in adults treated with CNS stimulants
at recommended doses. Sudden death has doccurred in children and adolescents with
structural cardiac abnormalities and other serious cardiac problems, and in
adults taking CNS stimulants at recommended doses for ADHD. Avoid use in
patients with known structural cardiac …
5.6 Peripheral Vasculopathy, including Raynaud’s Phenomenon
CNS stimulants, including QuilliChew ER, used to treat ADHD …
6
Adverse Reactions
Additions and/or revisions underlined:
The
following are discussed in more detail in other sections of the labeling:
- Known
hypersensitivity to methylphenidate products or other ingredients
of QuilliChew ER.
- Hypertensive Crisis When Used Concomitantly with
Monoamine Oxidase Inhibitors.
- Drug Dependence
- Serious Cardiovascular Reactions
- …
6.1 Clinical Trials Experience
Because
clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of a drug cannot be directly compared to
rates in the clinical trials of another drug and may not reflect the rates
observed in clinical practice.
Clinical Trials Experience with
Other Methylphenidate Products in Children, Adolescents, and Adults with
ADHD
Commonly
reported (greater than or equal to 2% of the methylphenidate group …
Clinical Trials Experience with
QuilliChew ER in Children with ADHD
There
is limited experience with QuilliChew ER in controlled trials …
8
Use in Specific Populations
8.4 Pediatric Use
Additions
and/or revisions underlined:
The safety and effectiveness of QuilliChew ER have been established in pediatric patients ages 6 to
17 years. Use of QuilliChew ER
in these age … from other methylphenidate-containing
products. The long-term efficacy of methylphenidate in pediatric patients has not been established. Safety and
efficacy in pediatric patients below the age of 6 years have not been established.
Long
Term Suppression of Growth
Growth
should be monitored during treatment with CNS stimulants, including QuilliChew
ER. Children who are not growing or gaining weight …
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Healthcare provider replaces doctor
in all instances in this section.
Additions and/or revisions
underlined:
How should QuilliChew ER be taken?
- Read the step-by-step instructions for using QuilliChew
ER extended-release chewable tablets at the end of this Medication Guide.
- Take QuilliChew ER 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.
- If a dose is missed, you or your child should talk to
your health care provider about dosing.
What should I avoid while taking
QuilliChew ER?
- QuilliChew ER should not be taken with MAOI medicines.
Do not start taking QuilliChew ER if you stopped taking an MAOI in the
last 14 days.
- Do not drink alcohol while taking QuilliChew ER. This
may cause a faster release of your methylphenidate dose.
What are possible side effects of
QuilliChew ER?
QuilliChew ER may cause serious side
effects, including:
Other
serious side effects include:
- painful and prolonged erections (priapism) have
occurred with methylphenidate. If you or your child develop priapism seek
medical help right away. Because priapism
can cause long lasting damage, it should be checked by a
health care provider right away.
Get Email Alerts |
Guide
