- New five-year data reinforce long-term safety and efficacy
of SPRAVATO® (esketamine) in patients with
inadequate response to two or more oral antidepressants
(treatment-resistant depression)
- 23 abstracts highlight data from Company's robust portfolio
and pipeline, including clinical insights on major depressive
disorder and the significant burden of anhedonia and insomnia
symptoms
- Large real-world analysis highlights the link between
reducing relapse and improving survival in schizophrenia
TITUSVILLE, N.J., Oct. 24,
2024 /PRNewswire/ -- Johnson & Johnson (NYSE:
JNJ) announced today that 23 abstracts featuring new real-world and
clinical trial data from across its neuropsychiatry portfolio and
pipeline will be presented at the annual U.S. Psychiatric and
Mental Health Congress (Psych Congress), taking place October 29 to November 2 in Boston, Massachusetts. Presentations include
new data supporting the safety and efficacy of SPRAVATO®
(esketamine) CIII nasal spray and the Company's innovative
portfolio of long-acting injectables (LAIs) for schizophrenia, as
well as data highlighting the significant burden people living with
major depressive disorder (MDD) and schizophrenia often face.

"For nearly seven decades, J&J has been at the forefront of
driving scientific progress and innovation in neuroscience," said
Bill Martin, Ph.D., Global
Neuroscience Therapeutic Area Head, Johnson & Johnson
Innovative Medicine. "It is our responsibility and privilege to
help advance research and understanding of MDD and schizophrenia so
we can continue to deliver transformational therapies that address
the greatest unmet patient needs."
Key presentations include:
- New five-year, real-world safety data from nearly 35,000 adults
treated with SPRAVATO®, building on more than a decade
of research and reinforcing its well-studied, consistent safety
profile (Poster 151).
- Novel insights into the clinical, humanistic and economic
burden of anhedonia in adults with MDD (Poster 113).
- Results from an analysis of more than 30,000 adults with
schizophrenia highlighting the link between symptom relapse and
risk of death, which can occur 15‐20 years prematurely for adults
living with schizophrenia compared to the general population due to
many different causes.1 (Poster 42).
"Serious mental illness is one of the most complex health
challenges of our time," said Pearl Pugh, President, U.S.
Neuroscience, Johnson & Johnson Innovative Medicine.
"Understanding the patient experience is at the core of our mission
to develop breakthrough solutions that can help improve care and
make a difference in the lives of those living with
challenging-to-treat mental illnesses."
J&J will present the following posters at Psych Congress on
October 31 from 1:30-3:30 p.m. ET and November 1 from 1:30-3:30
p.m. ET in the Exhibit Hall.
Poster
#
|
Title
|
Treatment-Resistant
Depression
|
151
|
Real-World Safety
Profile of Esketamine Nasal Spray: An Analysis of the Risk
Evaluation and Mitigation Strategy Program Approximately 5 Years
After Approval in the United States
|
112
|
Efficacy and Safety of
Esketamine Nasal Spray as Monotherapy in Adults with
Treatment-Resistant Depression: A Randomized, Double-Blind,
Placebo-Controlled Study
|
102
|
Weight and Metabolic
Changes in Patients Treated with Esketamine Nasal Spray Versus
Quetiapine Extended Release: A Post Hoc Subgroup Analysis of the
ESCAPE-TRD Study
|
200
|
Clinical Effectiveness
and Persistence on Esketamine Nasal Spray in Patients with
Treatment-Resistant Depression Overall and Among Transcranial
Magnetic Stimulation-Naïve Subgroup
|
202
|
Response and Remission
on Esketamine Nasal Spray in Patients with Treatment-Resistant
Depression Overall and Among TMS-Naive Subgroup
|
203
|
Comparison of
Real-World Response and Remission Among Patients with
Treatment-Resistant Depression Treated with Esketamine Nasal Spray
or Antipsychotic Augmentation
|
201
|
Real-World Clinical
Effectiveness of Esketamine Nasal Spray Based on the
Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients
with Treatment-Resistant Depression in the United States
|
148
|
Trajectory of Response
and Remission in Induction Nonresponders to Esketamine Nasal Spray:
A Subgroup Analysis of the SUSTAIN-3 Study
|
Major Depressive
Disorder
|
113
|
Higher Anhedonia Is
Associated with Poorer Clinical and Humanistic Outcomes Among U.S.
Adults with Major Depressive Disorder
|
124
|
Seltorexant, Adjunctive
to Antidepressants, in Adults with Major Depressive Disorder with
Insomnia Symptoms: Results of a Double-Blind, Randomized,
Placebo-Controlled Study
|
206
|
Adjunctive Treatment
with Seltorexant Improved Patient-Reported Depressive Symptoms,
Insomnia Symptoms, and Overall Health in Major Depressive Disorder
with Insomnia
|
59
|
Pharmacokinetics and
Safety of Seltorexant, Selective Orexin-2 Receptor Antagonist, in
Healthy Elderly and Young Non-Asian, and Japanese Adult
Participants
|
145
|
Major Depressive
Disorder with Clinically Relevant Insomnia Symptoms: Healthcare
Professional Assessment of Patient Impact and Clinical
Management
|
146
|
Treating Insomnia
Symptoms as Part of Major Depressive Disorder: A Cross-Sectional
Survey on Patient Needs in the U.S.
|
186
|
How Do Patients with
Depression and Their Providers Talk About Anhedonia? An
Ethnographic Analysis of Healthcare Provider Conversations with
Patients in the Clinical Setting
|
16
|
Burden of Prominent
Anhedonia in Major Depressive Disorder Reflected in Polypharmacy,
Healthcare Use, and Humanistic Outcomes
|
64
|
Clinical Burden and
Treatment Satisfaction in a Real-World Survey of Patients Diagnosed
with Major Depressive Disorder (MDD) With Prominent
Anhedonia
|
147
|
Disease Burden
Associated with Prominent Anhedonia in Patients with Major
Depressive Disorder (MDD) from Adelphi Depression Disease Specific
Program
|
32
|
Clinical Burden of
Patients Diagnosed with Major Depressive Disorder with versus
Without Prominent Anhedonia Using a Real-World Dataset in the
United States
|
Schizophrenia
|
42
|
Association of Relapse
with All-Cause Mortality in 32,071 Adults with Stable
Schizophrenia: A Longitudinal Commercial and Medicare Database
Study
|
39
|
Characteristics and
Antipsychotic Treatment Pathways of Patients with Schizophrenia Who
Received Once-Every-6-Months Paliperidone Palmitate Within the
First Two Years of Approval
|
34
|
Real-World Comparative
Effectiveness of Long-Acting Injectable and Oral Antipsychotics
Among U.S. Medicare Beneficiaries with Schizophrenia
|
103
|
Symptomatic and
Functional Remission with Paliperidone Palmitate 3-Month and
6-Month Formulations in Adult Patients with Schizophrenia: A 3-Year
Analysis
|
ABOUT TREATMENT-RESISTANT DEPRESSION
Depression is a
common mental health disorder that impacts an estimated 280 million
people worldwide.2 In the U.S., approximately 21 million
adults have had at least one major depressive episode, and
approximately one-third of medication-treated adults are considered
to have TRD.3,4 People living with MDD are often
considered to have TRD if they have not responded adequately to at
least two different antidepressants of adequate dose and duration
in the current depressive episode.4 TRD has a
significant negative impact on the lives of those affected and has
one of the highest economic burdens of all psychiatric
disorders.4
ABOUT SPRAVATO®
SPRAVATO®
(esketamine) CIII nasal spray is approved by the U.S. Food and Drug
Administration in combination with an oral antidepressant for
adults with TRD and depressive symptoms in adults with major
depressive disorder with acute suicidal ideation or behavior. It is
the first treatment to use a new mechanism of action in decades for
the treatment of TRD. SPRAVATO® is a non-selective,
non-competitive antagonist of the N-methyl-D-aspartate (NMDA)
receptor and is believed to work differently by acting on a pathway
in the brain that affects glutamate. To date, SPRAVATO®
has been approved in 79 countries and administered to more than
100,000 patients worldwide.
ABOUT MAJOR DEPRESSIVE DISORDER WITH INSOMNIA
SYMPTOMS
MDD is one of the most common psychiatric disorders and leading
causes of disability worldwide,5 with an estimated 280
million people living with the disorder around the
world.2 MDD is often accompanied by sleep disturbances
such as insomnia or hypersomnia, affecting up to 60 percent of
patients with MDD.6 Disturbed sleep and insomnia
symptoms have a significant impact on a patient's quality of life
and exacerbate the risk of depressive relapse and
suicide.7,8
ABOUT SELTOREXANT
Seltorexant, an investigational potential first-in-class therapy,
is a selective antagonist of the human orexin-2 receptor currently
being developed as an adjunctive treatment for adults with MDD with
insomnia symptoms. Seltorexant is believed to selectively
antagonize the orexin-2 receptors, potentially improving mood and
sleep symptoms associated with depression. When orexin-2 receptors
are stimulated for too long or at inappropriate times, their
activation can cause hyperarousal manifestations, including
insomnia and excessive cortisol release, which may contribute to
depression and insomnia.
ABOUT SCHIZOPHRENIA
Schizophrenia is a chronic and
severe brain disorder affecting approximately 20 million people
worldwide and an estimated 2.4 million adults in the
U.S.9-11 The disease is characterized by distortions in
thinking, perception, emotions, language, sense of self, and
behavior.9 It can also lead to neurological impairment
and severe disability.12 Antipsychotic medication is
recognized as an essential component in the treatment of
schizophrenia, and adherence to medication plays a critical role in
controlling symptoms and costly relapses.13
ABOUT J&J'S U.S. LONG-ACTING INJECTABLES
The
J&J U.S. portfolio of long-acting injectable treatments for
adults with schizophrenia provides the most varied range of dosing
options and the longest-lasting schizophrenia treatments with each
dose available. Our portfolio includes INVEGA SUSTENNA®
(1-month paliperidone palmitate), INVEGA TRINZA®
(3-month paliperidone palmitate), and INVEGA HAFYERA®
(6-month paliperidone palmitate), all of which are administered in
a clinical setting by a medical professional.
Long-acting injectables (LAIs) allow for the slow release
of medicine into the bloodstream and have been available and
studied for more than 50 years. Based on clinical guidance, the
National Council for Mental Wellbeing and the American Psychiatric
Association have updated their guidance and practice guidelines to
recommend the use of LAIs for appropriate
patients.14-16
SPRAVATO® IMPORTANT SAFETY
INFORMATION
What is SPRAVATO® (esketamine) CIII nasal
spray?
SPRAVATO® is a prescription medicine, used along with
an antidepressant taken by mouth to treat:
- Adults with treatment-resistant depression (TRD)
- Depressive symptoms in adults with major depressive disorder
(MDD) with suicidal thoughts or actions
SPRAVATO® is not for use as a medicine to prevent or
relieve pain (anesthetic). It is not known if SPRAVATO®
is safe or effective as an anesthetic medicine.
It is not known if SPRAVATO® is safe and effective
for use in preventing suicide or in reducing suicidal thoughts or
actions. SPRAVATO® is not for use in place of
hospitalization if your healthcare provider determines that
hospitalization is needed, even if improvement is experienced after
the first dose of SPRAVATO®.
It is not known if SPRAVATO® is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
What is the most
important information I should know about
SPRAVATO®?
SPRAVATO® can cause serious side effects,
including:
- Sedation and
dissociation. SPRAVATO® may cause sleepiness
(sedation), fainting, dizziness, spinning sensation, anxiety, or
feeling disconnected from yourself, your thoughts, feelings, space
and time (dissociation).
- Tell your
healthcare provider right away if you feel like you cannot stay
awake or if you feel like you are going to pass out.
- Your healthcare
provider must monitor you for serious side effects for at least 2
hours after taking SPRAVATO®. Your healthcare
provider will decide when you are ready to leave the healthcare
setting.
- Respiratory
depression was observed with the use of
SPRAVATO®; additionally, there were rare reports of
respiratory arrest.
- Your healthcare
provider must monitor you for serious side effects for at least 2
hours (including pulse oximetry) after taking
SPRAVATO®. Your healthcare provider will decide when you
are ready to leave the healthcare setting.
- Abuse and
misuse. There is a risk for abuse and physical and
psychological dependence with SPRAVATO® treatment. Your
healthcare provider should check you for signs of abuse and
dependence before and during treatment with
SPRAVATO®.
- Tell your
healthcare provider if you have ever abused or been dependent on
alcohol, prescription medicines, or street drugs.
- Your healthcare
provider can tell you more about the differences between physical
and psychological dependence and drug addiction.
- SPRAVATO® Risk Evaluation
and Mitigation Strategy (REMS). Because of the risks for
sedation, dissociation, respiratory depression, and abuse and
misuse, SPRAVATO® is only available through a restricted
program called the SPRAVATO® Risk Evaluation and
Mitigation Strategy (REMS) Program. SPRAVATO® can only
be administered at healthcare settings certified in the
SPRAVATO® REMS Program. Patients treated in outpatient
healthcare settings (e.g., medical offices and clinics) must be
enrolled in the program.
- Increased risk
of suicidal thoughts and actions. Antidepressant medicines may
increase suicidal thoughts and actions in some people 24 years of
age and younger, especially within the first few months of
treatment or when the dose is changed. SPRAVATO®
is not for use in children.
- Depression and
other serious mental illnesses are the most important causes of
suicidal thoughts and actions. Some people may have a higher risk
of having suicidal thoughts or actions. These include people who
have (or have a family history of) depression or a history of
suicidal thoughts or actions.
- How can I watch
for and try to prevent suicidal thoughts and actions in myself or a
family member?
- Pay close attention
to any changes, especially sudden changes, in mood, behavior,
thoughts, or feelings, or if you develop suicidal thoughts or
actions.
- Tell your
healthcare provider right away if you have any new or sudden
changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up
visits with your healthcare provider as scheduled. Call your
healthcare provider between visits as needed, especially if you
have concerns about symptoms.
- Tell your
healthcare provider right away if you or your family member have
any of the following symptoms, especially if they are new, worse,
or worry you:
- suicide
attempts
- thoughts about
suicide or dying
- worsening
depression
- other unusual
changes in behavior or mood
|
Do not take SPRAVATO® if you:
- have blood vessel (aneurysmal vascular) disease (including in
the brain, chest, abdominal aorta, arms and legs)
- have an abnormal connection between your veins and arteries
(arteriovenous malformation)
- have a history of bleeding in the brain
- are allergic to esketamine, ketamine, or any of the other
ingredients in SPRAVATO®.
If you are not sure if you have any of the above conditions,
talk to your healthcare provider before taking
SPRAVATO®.
Before you take SPRAVATO®, tell your healthcare
provider about all of your medical conditions, including if
you:
- have heart or brain problems, including:
- high blood pressure (hypertension)
- slow or fast heartbeats that cause shortness of breath, chest
pain, lightheadedness, or fainting
- history of heart attack
- history of stroke
- heart valve disease or heart failure
- history of brain injury or any condition where there is
increased pressure in the brain
- have liver problems
- have ever had a condition called "psychosis" (see, feel, or
hear things that are not there, or believe in things that are not
true).
- are pregnant or plan to become pregnant. SPRAVATO®
may harm your baby. You should not take SPRAVATO® if you
are pregnant.
- Tell your healthcare provider right away if you become pregnant
during treatment with SPRAVATO®.
- If you are able to become pregnant, talk to your healthcare
provider about methods to prevent pregnancy during treatment with
SPRAVATO®.
- There is a pregnancy registry for women who are exposed to
SPRAVATO® during pregnancy. The purpose of the registry
is to collect information about the health of women exposed to
SPRAVATO® and their baby. If you become pregnant during
treatment with SPRAVATO®, talk to your healthcare
provider about registering with the National Pregnancy Registry for
Antidepressants at 1-844-405-6185 or online at
https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. You should not
breastfeed during treatment with SPRAVATO®.
Tell your healthcare provider about all the medicines that
you take, including prescription and over-the-counter
medicines, vitamins and herbal supplements. Taking
SPRAVATO® with certain medicine may cause side
effects.
Especially tell your healthcare provider if you take
central nervous system (CNS) depressants, psychostimulants, or
monoamine oxidase inhibitors (MAOIs) medicine. Keep a list of them
to show to your healthcare provider and pharmacist when you get a
new medicine.
How will I take SPRAVATO®?
- You will take SPRAVATO nasal spray yourself, under the
supervision of a healthcare provider in a healthcare setting. Your
healthcare provider will show you how to use the
SPRAVATO® nasal spray device.
- Your healthcare provider will tell you how much
SPRAVATO® you will take and when you will take it.
- Follow your SPRAVATO® treatment schedule exactly as
your healthcare provider tells you to.
- During and after each use of the SPRAVATO® nasal
spray device, you will be checked by a healthcare provider who will
decide when you are ready to leave the healthcare setting.
- You will need to plan for a caregiver or family member to drive
you home after taking SPRAVATO®.
- If you miss a SPRAVATO® treatment, your healthcare
provider may change your dose and treatment schedule.
- Some people taking SPRAVATO® get nausea and
vomiting. You should not eat for at least 2 hours before taking
SPRAVATO® and not drink liquids at least 30 minutes
before taking SPRAVATO®.
- If you take a nasal corticosteroid or nasal decongestant
medicine take these medicines at least 1 hour before taking
SPRAVATO®.
What should I avoid while taking SPRAVATO?
Do not drive, operate machinery, or do anything
where you need to be completely alert after taking
SPRAVATO®. Do not take part in these activities
until the next day following a restful sleep. See "What is the
most important information I should know about
SPRAVATO®?"
What are the possible side effects of
SPRAVATO®?
SPRAVATO® may cause serious side effects
including:
See "What is the most important information I should know
about SPRAVATO?"
Increased blood pressure. SPRAVATO® can
cause a temporary increase in your blood pressure that may last for
about 4 hours after taking a dose. Your healthcare provider will
check your blood pressure before taking SPRAVATO® and
for at least 2 hours after you take SPRAVATO®. Tell your
healthcare provider right away if you get chest pain, shortness of
breath, sudden severe headache, change in vision, or seizures after
taking SPRAVATO®.
Problems with thinking clearly. Tell your healthcare
provider if you have problems thinking or remembering.
Bladder problems. Tell your healthcare provider if
you develop trouble urinating, such as a frequent or urgent need to
urinate, pain when urinating, or urinating frequently at night.
The most common side effects of SPRAVATO when used along with
an antidepressant taken by mouth include:
•
feeling disconnected from yourself, your
thoughts, feelings and things
around you
•
dizziness
•
nausea
•
feeling sleepy
•
spinning sensation
|
•
decreased feeling of sensitivity (numbness)
•
feeling anxious
•
lack of energy
•
increased blood pressure
•
vomiting
•
feeling drunk
•
feeling very happy or excited
|
If these common side effects occur, they usually happen right
after taking SPRAVATO and go away the same day.
These are not all the possible side effects of
SPRAVATO®.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1‑800‑FDA‑1088.
Please see full Prescribing
Information, including Boxed WARNINGS, and
Medication Guide for
SPRAVATO® and discuss any questions you may
have with your healthcare provider.
cp-170363v3
INVEGA® IMPORTANT SAFETY INFORMATION
INDICATIONS
INVEGA HAFYERA® (6-month paliperidone palmitate)
is a prescription medicine given by injection every 6 months by a
healthcare professional and used to treat schizophrenia. INVEGA
HAFYERA® is used in adults who have been treated with
either:
- INVEGA SUSTENNA® (paliperidone palmitate) a
1-time-each-month paliperidone palmitate extended-release
injectable suspension for at least 4 months
- INVEGA TRINZA® (paliperidone palmitate) a
1-time-every-3-months paliperidone palmitate extended-release
injectable suspension for at least 3 months
INVEGA TRINZA® is a prescription medicine given by
injection every 3 months by a healthcare professional and used to
treat schizophrenia. INVEGA TRINZA® is used in people
who have been adequately treated with INVEGA SUSTENNA®
for at least 4 months.
INVEGA SUSTENNA® is a prescription medicine
given by injection by a healthcare professional.
INVEGA SUSTENNA® is used to treat schizophrenia in
adults.
IMPORTANT SAFETY INFORMATION
What is the most
important information I should know about INVEGA
HAFYERA®,
INVEGA TRINZA® and INVEGA
SUSTENNA®?
|
|
INVEGA
HAFYERA®, INVEGA
TRINZA® and INVEGA
SUSTENNA® may cause
serious side effects, including:
|
|
- Increased risk of death in elderly people
with dementia-related psychosis.
INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® increase the risk of death in
elderly people who have lost touch with reality (psychosis) due to
confusion and memory loss (dementia). INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® are not for the treatment of
people with dementia-related psychosis.
|
Do not receive INVEGA
HAFYERA®, INVEGA
TRINZA® or INVEGA SUSTENNA® if
you are allergic to paliperidone, paliperidone palmitate,
risperidone, or any of the ingredients in INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA®. See the end of the Patient Information
leaflet in the full Prescribing Information for a complete list of
INVEGA HAFYERA®, INVEGA TRINZA®
and INVEGA SUSTENNA® ingredients.
Before you receive INVEGA
HAFYERA®, INVEGA
TRINZA® or INVEGA SUSTENNA®,
tell your healthcare professional about all your medical
conditions, including if you:
- have had Neuroleptic Malignant Syndrome (NMS)
- have or have had heart problems, including a heart attack,
heart failure, abnormal heart rhythm, or long QT syndrome
- have or have had low levels of potassium or magnesium in your
blood
- have or have had uncontrolled movements of your tongue, face,
mouth, or jaw (tardive dyskinesia)
- have or have had kidney or liver problems
- have diabetes or have a family history of diabetes
- have Parkinson's disease or a type of dementia called Lewy Body
Dementia
- have had a low white blood cell count
- have had problems with dizziness or fainting or are being
treated for high blood pressure
- have or have had seizures or epilepsy
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if
INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA® will harm your unborn baby
- If you become pregnant while taking INVEGA HAFYERA®,
INVEGA TRINZA® or INVEGA SUSTENNA®, talk
to your healthcare professional about registering with the National
Pregnancy Registry for Atypical Antipsychotics. You can register by
calling 1-866-961-2388 or visit
http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry.
- Infants born to women who are treated with INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA® may experience symptoms such as tremors,
irritability, excessive sleepiness, eye twitching, muscle spasms,
decreased appetite, difficulty breathing, or abnormal movement of
arms and legs. Let your healthcare professional know if these
symptoms occur.
- are breastfeeding or plan to breastfeed. INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA® can pass into your breast milk. Talk to your
healthcare professional about the best way to feed your baby if you
receive INVEGA HAFYERA®, INVEGA TRINZA®
or INVEGA SUSTENNA®.
Tell your healthcare professional about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. INVEGA HAFYERA®,
INVEGA TRINZA® and INVEGA
SUSTENNA® may affect the way other medicines work,
and other medicines may affect how INVEGA HAFYERA®,
INVEGA TRINZA® and INVEGA SUSTENNA®
works.
Your healthcare provider can tell you if it is safe to receive
INVEGA HAFYERA®, INVEGA TRINZA®
or INVEGA SUSTENNA® with your other medicines.
Do not start or stop any medicines during treatment with INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA® without talking to your healthcare provider
first. Know the medicines you take. Keep a list of them to show to
your healthcare professional or pharmacist when you get a new
medicine.
Patients (particularly the elderly) taking antipsychotics with
certain health conditions or those on long-term therapy should be
evaluated by their healthcare professional for the potential risk
of falls.
How will I receive INVEGA HAFYERA®, INVEGA
TRINZA® or INVEGA SUSTENNA®?
- Follow your treatment schedule exactly as your healthcare
provider tells you to.
- Your healthcare provider will tell you how much you will
receive and when you will receive it.
What should I avoid while receiving INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA®?
- INVEGA HAFYERA®, INVEGA TRINZA® and
INVEGA SUSTENNA® may affect your ability to make
decisions, think clearly, or react quickly. Do not drive, operate
heavy machinery, or do other dangerous activities until you know
how INVEGA HAFYERA®, INVEGA TRINZA®
or INVEGA SUSTENNA® affects you.
- Avoid getting overheated or dehydrated.
INVEGA HAFYERA®, INVEGA
TRINZA® and INVEGA SUSTENNA® may cause
serious side effects, including:
- See "What is the most important information I should know
about INVEGA HAFYERA®, INVEGA
TRINZA® and INVEGA
SUSTENNA®?"
- stroke in elderly people (cerebrovascular problems) that can
lead to death
- Neuroleptic Malignant Syndrome (NMS). NMS is a rare but
very serious problem that can happen in people who receive INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA®. NMS can cause death and must be treated in a
hospital. Call your healthcare professional right away if you
become severely ill and have any of these symptoms: high fever;
severe muscle stiffness; confusion; loss of consciousness; changes
in your breathing, heartbeat, and blood pressure.
- problems with your heartbeat. These heart problems can
cause death. Call your healthcare professional right away if you
have any of these symptoms: passing out or feeling like you will
pass out, dizziness, or feeling as if your heart is pounding or
missing beats.
- uncontrolled movements of your tongue, face, mouth, or jaw
(tardive dyskinesia)
- metabolic changes. Metabolic changes may include high
blood sugar (hyperglycemia), diabetes mellitus and changes in the
fat levels in your blood (dyslipidemia), and weight gain.
- low blood pressure and fainting
- changes in your blood cell counts
- high level of prolactin in your blood
(hyperprolactinemia). INVEGA HAFYERA®, INVEGA
TRINZA® or INVEGA SUSTENNA® may cause a rise
in the blood levels of a hormone called prolactin
(hyperprolactinemia) that may cause side effects including missed
menstrual periods, leakage of milk from the breasts, development of
breasts in men, or problems with erection.
- problems thinking clearly and moving your body
- seizures
- difficulty swallowing that can cause food or liquid to get
into your lungs
- prolonged or painful erection lasting more than 4 hours.
Call your healthcare professional or go to your nearest emergency
room right away if you have an erection that lasts more than 4
hours.
- problems with control of your body temperature, especially
when you exercise a lot or spend time doing things that make you
warm. It is important for you to drink water to avoid
dehydration.
The most common side effects of INVEGA HAFYERA®
include: injection site reactions, weight gain, headache, upper
respiratory tract infections, feeling restlessness or difficulty
sitting still, slow movements, tremors, stiffness and shuffling
walk.
The most common side effects of INVEGA TRINZA®
include: injection site reactions, weight gain, headache, upper
respiratory tract infections, feeling restlessness or difficulty
sitting still, slow movements, tremors, stiffness and shuffling
walk.
The most common side effects of INVEGA SUSTENNA®
include: injection site reactions; sleepiness or drowsiness;
dizziness; feeling of inner restlessness or needing to be
constantly moving; abnormal muscle movements, including tremor
(shaking), shuffling, uncontrolled involuntary movements, and
abnormal movements of your eyes.
Tell your healthcare professional if you have any side effect
that bothers you or does not go away. These are not all the
possible side effects of INVEGA HAFYERA®, INVEGA
TRINZA® or INVEGA SUSTENNA®. For more
information, ask your healthcare professional or pharmacist.
Call your healthcare professional for medical advice about
side effects. You may report side effects of
prescription drugs to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of
INVEGA HAFYERA®, INVEGA
TRINZA® or INVEGA
SUSTENNA®
Medicines are sometimes prescribed for purposes other than those
listed in a Patient Information leaflet. Do not use INVEGA
HAFYERA®, INVEGA TRINZA® or INVEGA
SUSTENNA® for a condition for which it was not
prescribed. You can ask your pharmacist or healthcare professional
for information about INVEGA HAFYERA®, INVEGA
TRINZA® or INVEGA SUSTENNA® that is written
for healthcare professionals.
For more information, go to www.invegahafyera.com,
www.invegatrinza.com or www.invegasustenna.com or call
1-800-526-7736.
Please click to read the full Prescribing Information,
including Boxed WARNING, for INVEGA
HAFYERA®, INVEGA
TRINZA® and INVEGA
SUSTENNA® and discuss any questions you have
with your healthcare professional.
cp-256259v4
ABOUT JOHNSON & JOHNSON
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Cautions Concerning Forward-Looking Statements
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the Private Securities Litigation Reform Act of 1995 regarding
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of nipocalimab. The reader is cautioned not to rely on these
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inherent in product research and development, including the
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December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
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result of new information or future events or developments.
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