Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE,
MISUSE, AND ADDICTION
Focalin 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, 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, 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 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:
Focalin has a high
potential for abuse and misuse. The use of Focalin exposes
individuals to the risks of abuse and misuse, which can lead to the
development of a substance use disorder, including addiction. Focalin 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, 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, 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 in a safe place, preferably locked, and
instruct patients to not give Focalin to anyone else. Throughout Focalin
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, 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-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-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:
…
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
…
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,
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 in a
safe place, preferably locked, and instruct patients to not give
Focalin to anyone else.
…
Increased
Intraocular Pressure (IOP) and Glaucoma
Advise
patients that IOP and glaucoma may occur during treatment with Focalin [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. 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
and any potential adverse effects
on the breastfed infant from FOCALIN 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
have been established in pediatric patients ages 6 to 17 years in two adequate
and well-controlled clinical
trials.
The safety and effectiveness of Focalin
in pediatric patients less than 6 years
have not been established. The long-term efficacy
of Focalin in pediatric
patients has not been established.
Long Term Suppression of Growth
Growth should be monitored
during treatment with stimulants, including Focalin. 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 to 14), 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 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 no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 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,
during pregnancy.
Approved Drug Label (PDF)
Boxed Warning
(newly
createdby PLR conversion as below)
WARNING: ABUSE
AND DEPENDENCE
CNS stimulants,
including Focalin, 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
(the following subsections created by PLR conversion, please refer to
label for more information)
5.1 Potential for Abuse and Dependence
5.2 Serious Cardiovascular Reactions
5.3 Blood Pressure and Heart Rate
Increases
5.4 Psychiatric Adverse Reactions
5.5 Priapism
5.6 Peripheral Vasculopathy, Including
Raynaud’s Phenomenon
5.7 Long-Term Suppression of Growth
6
Adverse Reactions
6.1 Clinical
Trials Experience
(new
subsection added, please refer to label)
6.2
Postmarketing Experience
(new
subsection added, please refer to label)
7
Drug Interactions
7.1 Clinically Important Interactions with Focalin
(new
subsection added, additions underlined)
Table
2 presents clinically important drug interactions with Focalin.
Table
2: Clinically Important Drug Interactions with Focalin
(please
refer to label to view Table 2)
8
Use in Specific Populations
8.4 Pediatric Use
(additions
underlined)
The
safety and effectiveness of Focalin have been established in pediatric patients
ages 6 to 17 years in two adequate and well-controlled clinical trials.
…
Long
Term Suppression of Growth
Growth
should be monitored during treatment with stimulants, including Focalin.
Pediatric patients who are not growing or gaining weight as expected may need
to have their treatment interrupted.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(minor additions and revisions, please refer to label)
PATIENT COUNSELING INFORMATION
(new
section added per PLR conversion)
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