Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE, MISUSE, AND ADDICTION
Focalin 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 Focalin 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 Focalin 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 Focalin
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:
Focalin XR has a high
potential for abuse and misuse. The use of Focalin XR exposes individuals
to the risks of abuse and misuse, which can lead to the development of a
substance use disorder, including addiction. Focalin 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 Focalin 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 Focalin 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 Focalin XR in a safe
place, preferably locked, and instruct patients to not give Focalin XR to
anyone else. Throughout Focalin 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 Focalin XR, assess the family history and clinically evaluate
patients for tics or Tourette’s syndrome. Regularly monitor Focalin -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,
Focalin 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 Focalin to patients with
open-angle glaucoma or abnormally increased IOP only if the benefit of treatment
is considered to outweigh the risk. Closely monitor Focalin XR-treated patients
with a history of abnormally increased IOP or open angle glaucoma.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following are discussed in more detail in other
sections of the labeling:
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:
…
Adverse Reactions Reported with All Ritalin and
Focalin Formulations
The following adverse reactions associated with the
use of all Ritalin and Focalin formulations were identified in clinical trials,
spontaneous reports, and literature. Because these reactions were reported
voluntarily from a population of uncertain size, it is not always possible to
estimate their frequency reliably or to establish a causal relationship to drug
exposure.
…
Psychiatric
Disorders: insomnia,
anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile
hallucinations), depressed mood, depression
…
Musculoskeletal
and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis,
trismus
…
Nervous System
Disorders: migraine,
motor and verbal tics
Eye Disorders: diplopia, increased
intraocular pressure, mydriasis
…
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 Focalin
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 Focalin XR in
a safe place, preferably locked, and instruct patients to not give
Focalin XR to anyone else.
…
Increased Intraocular Pressure (IOP) and Glaucoma
Advise patients that IOP and glaucoma may occur
during treatment with Focalin 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 Focalin 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)].
…
MEDICATION GUIDE
Medication Guide has undergone extensive changes;
please refer to label.
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Extensive
changes: please refer to labeling)
8.2 Lactation
(Pregnancy and Lactation Labeling
Rule (PLLR) Conversion; Additions
and/or revisions underlined)
Risk Summary
Dexmethylphenidate is the d-threo
enantiomer of racemic
methylphenidate. Limited
published literature, based on milk sampling
from seven mothers reports that methylphenidate is present
in human milk, which resulted
in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports
of adverse effects
on the breastfed infant and no effects
on milk production. Long-term neurodevelopmental effects on infants
from stimulant exposure are unknown.
The developmental and health
benefits of breastfeeding should be considered along with the mother’s clinical
need for FOCALIN
XR and any potential adverse
effects on the breastfed infant
from FOCALIN XR or from the underlying maternal condition.
Clinical Considerations
Monitor breastfeeding infants for adverse
reactions, such as agitation, insomnia, anorexia, and reduced weight
gain.
8.4 Pediatric Use
(Additions and/or revisions underlined)
The safety and effectiveness of Focalin
XR in pediatric patients
less than 6 years have not been established.
The safety and effectiveness of Focalin
XR for the treatment
of ADHD have been established in pediatric patients
ages 6 to 17 years in two adequate and well-controlled clinical
trials. The long-term efficacy of Focalin XR in pediatric
patients has not been established.
Long Term Suppression of Growth
Growth should be monitored
during treatment with stimulants, including Focalin XR. Pediatric
patients who are not growing or gaining
weight as expected
may need to have their
treatment interrupted.
Juvenile Animal
Toxicity Data
Rats treated with racemic methylphenidate early in the postnatal
period through
sexual maturation demonstrated a decrease in spontaneous locomotor activity
in adulthood. A deficit in acquisition of a specific
learning task was observed in females
only. The doses at which these findings
were observed are at least 6 times the MRHD of 60 mg/day given to children on a mg/m2 basis.
In a study conducted
in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day
for 9 weeks, starting early
in the postnatal period (postnatal Day 7) and continuing through sexual
maturity (postnatal Week 10). When these animals
were tested as adults
(postnatal Weeks 13 to14), decreased
spontaneous locomotor
activity was observed in males and females previously treated with 50 mg/kg/day
(approximately 4
times the MRHD of 60 mg/day of racemic methylphenidate given to children on a mg/m2 basis]
or greater, and a deficit
in the acquisition of a specific learning task was seen in females
exposed to the highest
dose (8 times the MRHD given
to children on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions
and/or revisions underlined)
Pregnancy Registry
Advise patients that there is a pregnancy
exposure registry that monitors
pregnancy outcomes in patients
exposed to ADHD medications, including FOCALIN XR, during pregnancy.
Approved Drug Label (PDF)
Boxed Warning
(updated)
CNS stimulants,
including Focalin XR, other methylphenidate-containing products, and
amphetamines, have a high potential for abuse and dependence. Assess the risk
of abuse prior to prescribing, and monitor for signs of abuse and dependence
while on therapy.
5
Warnings and Precautions
5.1 Potential for Abuse and Dependence
(new subsection added)
CNS stimulants, including Focalin XR, other
methylphenidate-containing products, and amphetamines, have a high potential
for abuse and dependence. Assess the risk of abuse prior to prescribing, and
monitor for signs of abuse and dependence while on therapy.
(additions and revisions to the following subsections, please refer to
label for more information)
5.2 Serious Cardiovascular Reactions
5.3 Blood Pressure and Heart Rate
Increases
5.4 Psychiatric Adverse Reactions
5.7 Long-Term Suppression of Growth
6
Adverse Reactions
6.1 Clinical
Trials Experience
(additions
and revisions, please refer to label for more information)
6.2
Postmarketing Experience
(additions
and revisions, please refer to label for more information)
7
Drug Interactions
7.1 Clinically Important Interactions with Focalin XR
(new
subsection created, please refer to label)
8
Use in Specific Populations
8.4 Pediatric Use
(subsection
revised, additions underlined)
The
safety and effectiveness of Focalin XR in pediatric patients less than 6 years
have not been established.
The
safety and effectiveness of Focalin XR for the treatment of ADHD have
been established in pediatric patients ages 6 to 17 years in two adequate
and well-controlled clinical trials. The long-term efficacy of Focalin XR in
pediatric patients has not been established.
Long
Term Suppression of Growth
Growth
should be monitored during treatment with stimulants, including Focalin XR.
Pediatric patients who are not growing or gaining weight as expected may need
to have their treatment interrupted.
Juvenile
Animal Toxicity Data
In
a study conducted in young rats, racemic methylphenidate was administered
orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the
postnatal period (postnatal Day 7) and continuing through sexual maturity
(postnatal Week 10). When these animals were tested as adults (postnatal Weeks
13 to14), decreased spontaneous locomotor activity was observed in males and
females previously treated with 50 mg/kg/day [approximately 6 times the maximum
recommended human dose (MRHD) of 60 mg of racemic methylphenidate on a
mg/m2 basis] or greater, and a deficit in the acquisition of a specific
learning task was seen in females exposed to the highest dose (12 times the
MRHD of 60 mg of racemic on a mg/m2 basis). The no effect level for
juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD
of 60 mg of racemic methylphenidate on a mg/m2 basis). The clinical
significance of the long-term behavioral effects observed in rats is unknown.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(additions
and revisions, please refer to label)
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