Approved Drug Label (PDF)
4
Contraindications
Additions and/or
revisions underlined:
MYDAYIS is contraindicated in patients with:
- Known hypersensitivity to amphetamine, or other components of MYDAYIS. Hypersensitivity reactions such as
angioedema and anaphylactic reactions have been reported in patients treated
with other amphetamine products [see
Adverse Reactions (6.2)].
Concomitant treatment
with monoamine oxidase
inhibitors (MAOIs), and also within 14 days of
stopping MAOIs (including MAOIs such as linezolid or intravenous methylene
blue), because of an increased risk of hypertensive crisis [see Drug Interactions (7.1)].
7
Drug Interactions
7.2
Laboratory Tests
Subsection
title revised
Additions and/or revisions
underlined:
Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase
is greatest in the evening. Amphetamines may interfere with urinary
steroid determinations.
Allow for an adequate washout
period between administration of MYDAYIS and radioactive diagnostic agents used for dopamine transporter (DAT) visualization. MYDAYIS
can interfere with the
test results of a radioactive diagnostic agent (ioflupane I-123) that is used
for DAT visualization by binding and internalization of the DAT, which may
result in lower DAT in the striatum. This may lead to false-positive diagnostic
results.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions
underlined:
…
Who should
not take MYDAYIS?
Do not take MYDAYIS
if you or your child are:
allergic
to amphetamine or any of the ingredients in MYDAYIS. See the end of the Medication
Guide for a complete list of ingredients in MYDAYIS.
taking,
or have stopped taking within the past 14 days, a medicine called a monoamine
oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous
methylene blue.
…
Before taking MYDAYIS, tell your healthcare provider about all medical conditions, including if you or your child:
…
…
Your healthcare provider may tell
you to stop taking MYDAYIS for a short time before you get certain imaging tests because MYDAYIS may impact the results of some
tests.
…
How should I take MYDAYIS?
…
…
…
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Concomitant Medications
Advise patients to notify
their physicians if they are taking, or plan to take, any prescription or over-the-counter
drugs because there is a potential for interactions [see Drug Interactions (7.1)].
Advise patient or caregiver of steps to take with MYDAYIS when a laboratory imaging procedure is ordered [see Drug Interactions (7.2)].
…
Approved Drug Label (PDF)
Boxed Warning
Additions and/or
revisions underlined:
WARNING: ABUSE,
MISUSE, AND ADDICTION
MYDAYIS 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 MYDAYIS, 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
MYDAYIS, 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 MYDAYIS 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
5.1Abuse, Misuse,
and Addiction
Additions and/or
revisions underlined:
MYDAYIS has a high
potential for abuse and misuse. The use of MYDAYIS exposes
individuals to the risks of abuse and misuse, which can lead to the
development of a substance use disorder, including addiction. MYDAYIS 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 MYDAYIS, 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 MYDAYIS, 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 MYDAYIS in a safe place, preferably locked, and instruct patients to not
give MYDAYIS to anyone else. Throughout MYDAYIS 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 amphetamine, 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 MYDAYIS, assess the family
history and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor MYDAYIS-treated patients for the emergence or worsening of
tics or Tourette’s syndrome, and discontinue treatment if clinically
appropriate.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following adverse reactions are discussed in
greater 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)]
…
Motor and Verbal Tics, and
Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10)]
6.2 Adverse Reactions Associated with the Use of
Amphetamines
Additions
and/or revisions underlined:
…
Central Nervous
System: Psychotic
episodes at recommended doses, overstimulation, restlessness, euphoria,
dyskinesia, dysphoria, headache, tics, fatigue, aggression, anger, logorrhea,
dermatillomania, and paresthesia (including formication), motor and verbal
tics.
…
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
MYDAYIS, 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 MYDAYIS in a safe place, preferably locked, and
instruct patients to not give MYDAYIS to anyone else.
…
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 MYDAYIS.
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
Pediatric Use
Additions and/or
revisions underlined:
Safety and effectiveness of MYDAYIS in pediatric
patients with ADHD ages 13 to 17 years have been established in two placebo-controlled
clinical studies.
Safety
and effectiveness of MYDAYIS
have not been established in pediatric
patients ages 12 years and
younger.
MYDAYIS
has been studied for the treatment of ADHD in
pediatric patients 6 to 12 years in two placebo
controlled safety and efficacy
trials. In the first trial, pediatric patients 6 to 12 years
experienced higher rates of adverse reactions in some cases compared to patients
13 years
and older, including higher rates of
insomnia (30% versus 8%) and appetite decreased (43% versus 22%). In addition,
amphetamine systemic exposures (both d- and l-) in pediatric patients 6 to 12 years following a single dose
were higher than those
observed in adults at the same dose
(72-79% higher Cmax and approximately 83% higher AUC).
A second trial evaluated
a lower dose than those approved
for pediatric patients
13 to 17 years; efficacy
was not demonstrated for the
lower dose. Therefore, a safe and effective dose cannot be
established in pediatric patients 12 years
and younger.
Pregnancy
Newly added information:
Pregnancy Exposure
Registry
There is a
pregnancy exposure registry
that monitors pregnancy
outcomes in women
exposed to MYDAYIS during pregnancy. Healthcare providers are encouraged to register patients
by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online
at
https://womensmentalhealth.org/research/pregnancyregistry/.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Newly added
information:
Pregnancy
Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MYDAYIS
during pregnancy.
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