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Click to view full Prescribing Information for:   INVEGA SUSTENNA®  INVEGA
TRINZA®  INVEGA HAFYERA®  Important Safety Information

The Janssen Portfolio of Long-Acting Injectable (LAI) Antipsychotics for Adults
With Schizophrenia


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Starting Adult Patients With Schizophrenia on INVEGA SUSTENNA ® Earlier in the
Treatment Journey

Support for discussing INVEGA SUSTENNA® with appropriate adult patients earlier
in their schizophrenia treatment journey as well as common questions about
identifying those patients and starting and maintaining their treatment.

Supporting Patients Transitioning From Inpatient to Outpatient Setting

An institutional perspective on starting adult patients on INVEGA SUSTENNA®
earlier after a schizophrenia relapse and establishing tolerability, making sure
they are treated with both initiation doses while in the inpatient setting to
avoid a missed dose, and helping patients prepare for ongoing outpatient
treatment on INVEGA SUSTENNA®.

Tips for Successful Dialogue When Offering a Janssen Long-Acting Injectable
Antipsychotic to Adult Patients With Schizophrenia

Considerations for successful dialogue with adult patients when offering INVEGA
SUSTENNA® and how the possibility of just 2 doses a year may have further impact
on this conversation.

Developing a Plan for Longer-Term Treatment Goals With Appropriate Adult
Patients With Schizophrenia

How to transition adult patients who are stable on INVEGA SUSTENNA® to INVEGA
TRINZA® or INVEGA HAFYERA®, including identifying appropriate patients,
discussing longer dosing options, and planning to maintain regular visits.

Achieving Longer-Term Symptom Control With Janssen Long-Acting Treatment Options

A personal perspective on how the introduction of long-acting injectables has
changed the landscape of treating adult patients with schizophrenia.


ABOUT THE THREE KOLS

DR GUS ALVA

Dr Gus Alva is a Distinguished Fellow of the American Psychiatric Association
and board certified by the American Board of Psychiatry and Neurology. He was
the recipient of the Physician’s Recognition Award by the American Medical
Association, and is an international speaker and assistant professor at UC
Riverside Medical School, Department of Neuroscience. Dr Alva has been featured
in numerous media outlets as an expert guest and is published in several
journals, including The Journal of the American Psychiatric Association.

MELISSA VITALE

Melissa Vitale, PMHNP, is a board-certified psychiatric mental health nurse
practitioner at Northwest Community Hospital in Illinois. She provides
psychiatric services for patients with depression, anxiety disorders, bipolar
disorder, and schizophrenia. Ms Vitale provides comprehensive initial
psychiatric assessments as well as subsequent mental health treatment, including
medication management and individual psychotherapy. Besides direct patient care,
Ms Vitale is also a research investigator and speaker.

BROOKE KEMPF

Brooke Kempf, PMHNP-BC, is a psychiatric mental health nurse practitioner who
diagnoses and treats patients with serious mental illnesses at the Hamilton
Center in Indiana. Ms Kempf speaks nationwide and is an adjunct faculty member
and clinical coordinator for IUPUI’s Psychiatric Mental Health Nurse
Practitioner program. She also volunteers her time to precept NP/PA and medical
students, was the recipient of the Hamilton Award for Outstanding Staff Member,
and is past president of the Indiana Chapter of the American Psychiatric Nurses
Association (APNA).

DR GUS ALVA

Dr Gus Alva is a Distinguished Fellow of the American Psychiatric Association
and board certified by the American Board of Psychiatry and Neurology. He was
the recipient of the Physician’s Recognition Award by the American Medical
Association, and is an international speaker and assistant professor at UC
Riverside Medical School, Department of Neuroscience. Dr Alva has been featured
in numerous media outlets as an expert guest and is published in several
journals, including The Journal of the American Psychiatric Association.

MELISSA VITALE

Melissa Vitale, PMHNP, is a board-certified psychiatric mental health nurse
practitioner at Northwest Community Hospital in Illinois. She provides
psychiatric services for patients with depression, anxiety disorders, bipolar
disorder, and schizophrenia. Ms Vitale provides comprehensive initial
psychiatric assessments as well as subsequent mental health treatment, including
medication management and individual psychotherapy. Besides direct patient care,
Ms Vitale is also a research investigator and speaker.

BROOKE KEMPF

Brooke Kempf, PMHNP-BC, is a psychiatric mental health nurse practitioner who
diagnoses and treats patients with serious mental illnesses at the Hamilton
Center in Indiana. Ms Kempf speaks nationwide and is an adjunct faculty member
and clinical coordinator for IUPUI’s Psychiatric Mental Health Nurse
Practitioner program. She also volunteers her time to precept NP/PA and medical
students, was the recipient of the Hamilton Award for Outstanding Staff Member,
and is past president of the Indiana Chapter of the American Psychiatric Nurses
Association (APNA).

INDICATION

INVEGA HAFYERA™, an every-six-month injection, is an atypical antipsychotic
indicated for the treatment of schizophrenia in adults after they have been
adequately treated with:

 * A once-a-month paliperidone palmitate extended release injectable suspension
   (e.g., INVEGA SUSTENNA®) for at least four months or
 * An every-three-month paliperidone palmitate extended release injectable
   suspension (e.g., INVEGA TRINZA®) for at least one three-month cycle.

INVEGA TRINZA® is an atypical antipsychotic indicated for the treatment of
schizophrenia in patients after they have been adequately treated with INVEGA
SUSTENNA® for at least four months.

INVEGA SUSTENNA® is an atypical antipsychotic indicated for the treatment of
schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS.

See full prescribing information for complete Boxed Warning.

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. INVEGA HAFYERA™, INVEGA TRINZA® and
INVEGA SUSTENNA® are not approved for use in patients with dementia-related
psychosis.

Contraindications: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® are
contraindicated in patients with a known hypersensitivity to either
paliperidone, risperidone, or to any excipients of their formulation

Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g.,
stroke, transient ischemic attacks), including fatalities, were reported at a
higher incidence in elderly patients with dementia-related psychosis taking
risperidone, aripiprazole, and olanzapine compared to placebo. No studies have
been conducted with oral paliperidone, INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® in elderly patients with dementia. These medications are not approved
for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex,
has been reported in association with antipsychotic drugs, including
paliperidone.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental
status including delirium, and autonomic instability (irregular pulse of blood
pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and
acute renal failure.

If NMS is suspected, immediately discontinue INVEGA HAFYERA™, INVEGA TRINZA® or
INVEGA SUSTENNA® and provide symptomatic treatment and monitoring.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc)
interval. Avoid the use of drugs that also increase QTc interval and in patients
with risk factors for prolonged QTc interval. Paliperidone should also be
avoided in patients with congenital long QT syndrome and in patients with a
history of cardiac arrhythmias. Certain circumstances may increase the risk of
the occurrence of torsades de pointes and/or sudden death in association with
the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible,
involuntary, dyskinetic movements, may develop in patients treated with
antipsychotic drugs. Although the prevalence of the syndrome appears to be
highest among the elderly, especially elderly women, it is impossible to predict
which patients will develop the syndrome. Whether antipsychotic drug products
differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing TD and the likelihood that it will become irreversible
appear to increase with the duration of treatment and the cumulative dose. The
syndrome can develop after relatively brief treatment periods, even at low
doses. It may also occur after discontinuation. TD may remit, partially or
completely, if antipsychotic treatment is discontinued. Antipsychotic treatment
itself, however, may suppress (or partially suppress) the signs and symptoms of
the syndrome, possibly masking the underlying process. The effect that
symptomatic suppression has upon the long-term course of the syndrome is
unknown.

If signs and symptoms of TD appear in a patient on INVEGA HAFYERA™, INVEGA
TRINZA® or INVEGA SUSTENNA®, drug discontinuation should be considered. However,
some patients may require treatment with INVEGA HAFYERA™, INVEGA TRINZA® or
INVEGA SUSTENNA® despite the presence of the syndrome. In patients who do
require chronic treatment, use the lowest dose and the shortest duration of
treatment producing a satisfactory clinical response. Periodically reassess the
need for continued treatment.

Metabolic Changes: Atypical antipsychotic drugs have been associated with
metabolic changes that may increase cardiovascular/cerebrovascular risk. These
metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.
While all of the drugs in the class have been shown to produce some metabolic
changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in
some cases extreme and associated with ketoacidosis, hyperosmolar coma or death,
have been reported in patients treated with all atypical antipsychotics (APS).
Patients starting treatment with APS who have or are at risk for diabetes
mellitus should undergo fasting blood glucose testing at the beginning of and
during treatment. Patients who develop symptoms of hyperglycemia during
treatment should also undergo fasting blood glucose testing. All patients
treated with atypical antipsychotics should be monitored for symptoms of
hyperglycemia. Some patients require continuation of antidiabetic treatment
despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations have been observed in patients treated
with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use.
Clinical monitoring of weight is recommended.

Orthostatic Hypotension and Syncope: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® may induce orthostatic hypotension in some patients due to its
alpha-adrenergic blocking activity. INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® should be used with caution in patients with known cardiovascular
disease, cerebrovascular disease or conditions that would predispose patients to
hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive
medications). Monitoring should be considered in patients for whom this may be
of concern.

Falls: Somnolence, postural hypotension, motor and sensory instability have been
reported with the use of antipsychotics, including INVEGA HAFYERA™, INVEGA
TRINZA® and INVEGA SUSTENNA®, which may lead to falls and, consequently,
fractures or other fall-related injuries. For patients, particularly the
elderly, with diseases, conditions, or medications that could exacerbate these
effects, assess the risk of falls when initiating antipsychotic treatment and
recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia and Agranulocytosis have been reported with
antipsychotics, including INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®.
In patients with a history of clinically significant low white blood cell count
(WBC)/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia,
perform a complete blood count frequently during the first few months of
therapy. Consider discontinuing INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® at the first sign of a clinically significant decline in WBC in the
absence of other causative factors. Monitor patients with clinically significant
neutropenia for fever or other symptoms or signs of infection and treat promptly
if such symptoms or signs occur. Discontinue INVEGA HAFYERA™, INVEGA TRINZA® and
INVEGA SUSTENNA® in patients with severe neutropenia (absolute neutrophil count
<1000/mm3) and follow their WBC until recovery.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors,
INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® elevate prolactin levels,
and the elevation persists during chronic administration. Paliperidone has a
prolactin-elevating effect similar to risperidone, which is associated with
higher levels of prolactin elevation than other antipsychotic agents.

Potential for Cognitive and Motor Impairment: Somnolence, sedation, and
dizziness were reported as adverse reactions in subjects treated with INVEGA
HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®. INVEGA HAFYERA™, INVEGA TRINZA®
and INVEGA SUSTENNA® have the potential to impair judgment, thinking, or motor
skills. Patients should be cautioned about performing activities that require
mental alertness such as operating hazardous machinery, including motor
vehicles, until they are reasonably certain that INVEGA HAFYERA™, INVEGA TRINZA®
and INVEGA SUSTENNA® do not adversely affect them.

Seizures: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® should be used
cautiously in patients with a history of seizures or with conditions that
potentially lower seizure threshold. Conditions that lower seizure threshold may
be more prevalent in patients 65 years or older.

Administration: For intramuscular injection only by a healthcare professional
using only the needles provided in the INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® kits. Care should be taken to avoid inadvertent injection into a blood
vessel.

Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a
strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John’s
Wort) during a dosing interval for INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA®. If administering a strong inducer is necessary, consider managing the
patient using paliperidone extended-release tablets.

Pregnancy/Nursing: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may
cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester
exposure. Advise patients to notify their healthcare professional if they become
pregnant or intend to become pregnant during treatment with INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA®. Patients should be advised that there is a
pregnancy registry that monitors outcomes in women exposed to INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA® during pregnancy. INVEGA HAFYERA™, INVEGA
TRINZA® and INVEGA SUSTENNA® can pass into human breast milk. The benefits of
breastfeeding should be considered along with the mother’s clinical need for
INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® and any potential adverse
effect on the breastfed infant from INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® or the mother’s underlying condition.

Commonly Observed Adverse Reactions for INVEGA HAFYERA™: The most common adverse
reactions (incidence at least 5% in the double-blind phase) in the INVEGA
HAFYERA™ clinical trial were upper respiratory tract infection, injection site
reaction, weight increased, headache and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA TRINZA®: The most common adverse
reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were
injection site reaction, weight increased, headache, upper respiratory tract
infection, akathisia and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA SUSTENNA®: The most common
adverse reactions in clinical trials in patients with schizophrenia (incidence ≥
5% and occurring at least twice as often as placebo) were injection site
reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal
disorder.

Please click here to read the full Prescribing Information, including Boxed
WARNING, for INVEGA HAFYERA™, click here to read the full Prescribing
Information, including Boxed WARNING, for INVEGA TRINZA® and click here to read
the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA®.

cp-256260v1

INDICATION

INVEGA HAFYERA™, an every-six-month injection, is an atypical antipsychotic
indicated for the treatment of schizophrenia in adults after they have been
adequately treated with:

 * A once-a-month paliperidone palmitate extended release injectable suspension
   (e.g., INVEGA SUSTENNA®) for at least four months or
 * An every-three-month paliperidone palmitate extended release injectable
   suspension (e.g., INVEGA TRINZA®) for at least one three-month cycle.

INVEGA TRINZA® is an atypical antipsychotic indicated for the treatment of
schizophrenia in patients after they have been adequately treated with INVEGA
SUSTENNA® for at least four months.

INVEGA SUSTENNA® is an atypical antipsychotic indicated for the treatment of
schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS.

See full prescribing information for complete Boxed Warning.

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. INVEGA HAFYERA™, INVEGA TRINZA® and
INVEGA SUSTENNA® are not approved for use in patients with dementia-related
psychosis.

Contraindications: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® are
contraindicated in patients with a known hypersensitivity to either
paliperidone, risperidone, or to any excipients of their formulation

Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g.,
stroke, transient ischemic attacks), including fatalities, were reported at a
higher incidence in elderly patients with dementia-related psychosis taking
risperidone, aripiprazole, and olanzapine compared to placebo. No studies have
been conducted with oral paliperidone, INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® in elderly patients with dementia. These medications are not approved
for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex,
has been reported in association with antipsychotic drugs, including
paliperidone.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental
status including delirium, and autonomic instability (irregular pulse of blood
pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and
acute renal failure.

If NMS is suspected, immediately discontinue INVEGA HAFYERA™, INVEGA TRINZA® or
INVEGA SUSTENNA® and provide symptomatic treatment and monitoring.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc)
interval. Avoid the use of drugs that also increase QTc interval and in patients
with risk factors for prolonged QTc interval. Paliperidone should also be
avoided in patients with congenital long QT syndrome and in patients with a
history of cardiac arrhythmias. Certain circumstances may increase the risk of
the occurrence of torsades de pointes and/or sudden death in association with
the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible,
involuntary, dyskinetic movements, may develop in patients treated with
antipsychotic drugs. Although the prevalence of the syndrome appears to be
highest among the elderly, especially elderly women, it is impossible to predict
which patients will develop the syndrome. Whether antipsychotic drug products
differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing TD and the likelihood that it will become irreversible
appear to increase with the duration of treatment and the cumulative dose. The
syndrome can develop after relatively brief treatment periods, even at low
doses. It may also occur after discontinuation. TD may remit, partially or
completely, if antipsychotic treatment is discontinued. Antipsychotic treatment
itself, however, may suppress (or partially suppress) the signs and symptoms of
the syndrome, possibly masking the underlying process. The effect that
symptomatic suppression has upon the long-term course of the syndrome is
unknown.

If signs and symptoms of TD appear in a patient on INVEGA HAFYERA™, INVEGA
TRINZA® or INVEGA SUSTENNA®, drug discontinuation should be considered. However,
some patients may require treatment with INVEGA HAFYERA™, INVEGA TRINZA® or
INVEGA SUSTENNA® despite the presence of the syndrome. In patients who do
require chronic treatment, use the lowest dose and the shortest duration of
treatment producing a satisfactory clinical response. Periodically reassess the
need for continued treatment.

Metabolic Changes: Atypical antipsychotic drugs have been associated with
metabolic changes that may increase cardiovascular/cerebrovascular risk. These
metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.
While all of the drugs in the class have been shown to produce some metabolic
changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in
some cases extreme and associated with ketoacidosis, hyperosmolar coma or death,
have been reported in patients treated with all atypical antipsychotics (APS).
Patients starting treatment with APS who have or are at risk for diabetes
mellitus should undergo fasting blood glucose testing at the beginning of and
during treatment. Patients who develop symptoms of hyperglycemia during
treatment should also undergo fasting blood glucose testing. All patients
treated with atypical antipsychotics should be monitored for symptoms of
hyperglycemia. Some patients require continuation of antidiabetic treatment
despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations have been observed in patients treated
with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use.
Clinical monitoring of weight is recommended.

Orthostatic Hypotension and Syncope: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® may induce orthostatic hypotension in some patients due to its
alpha-adrenergic blocking activity. INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® should be used with caution in patients with known cardiovascular
disease, cerebrovascular disease or conditions that would predispose patients to
hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive
medications). Monitoring should be considered in patients for whom this may be
of concern.

Falls: Somnolence, postural hypotension, motor and sensory instability have been
reported with the use of antipsychotics, including INVEGA HAFYERA™, INVEGA
TRINZA® and INVEGA SUSTENNA®, which may lead to falls and, consequently,
fractures or other fall-related injuries. For patients, particularly the
elderly, with diseases, conditions, or medications that could exacerbate these
effects, assess the risk of falls when initiating antipsychotic treatment and
recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia and Agranulocytosis have been reported with
antipsychotics, including INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®.
In patients with a history of clinically significant low white blood cell count
(WBC)/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia,
perform a complete blood count frequently during the first few months of
therapy. Consider discontinuing INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® at the first sign of a clinically significant decline in WBC in the
absence of other causative factors. Monitor patients with clinically significant
neutropenia for fever or other symptoms or signs of infection and treat promptly
if such symptoms or signs occur. Discontinue INVEGA HAFYERA™, INVEGA TRINZA® and
INVEGA SUSTENNA® in patients with severe neutropenia (absolute neutrophil count
<1000/mm3) and follow their WBC until recovery.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors,
INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® elevate prolactin levels,
and the elevation persists during chronic administration. Paliperidone has a
prolactin-elevating effect similar to risperidone, which is associated with
higher levels of prolactin elevation than other antipsychotic agents.

Potential for Cognitive and Motor Impairment: Somnolence, sedation, and
dizziness were reported as adverse reactions in subjects treated with INVEGA
HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®. INVEGA HAFYERA™, INVEGA TRINZA®
and INVEGA SUSTENNA® have the potential to impair judgment, thinking, or motor
skills. Patients should be cautioned about performing activities that require
mental alertness such as operating hazardous machinery, including motor
vehicles, until they are reasonably certain that INVEGA HAFYERA™, INVEGA TRINZA®
and INVEGA SUSTENNA® do not adversely affect them.

Seizures: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® should be used
cautiously in patients with a history of seizures or with conditions that
potentially lower seizure threshold. Conditions that lower seizure threshold may
be more prevalent in patients 65 years or older.

Administration: For intramuscular injection only by a healthcare professional
using only the needles provided in the INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® kits. Care should be taken to avoid inadvertent injection into a blood
vessel.

Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a
strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John’s
Wort) during a dosing interval for INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA®. If administering a strong inducer is necessary, consider managing the
patient using paliperidone extended-release tablets.

Pregnancy/Nursing: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may
cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester
exposure. Advise patients to notify their healthcare professional if they become
pregnant or intend to become pregnant during treatment with INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA®. Patients should be advised that there is a
pregnancy registry that monitors outcomes in women exposed to INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA® during pregnancy. INVEGA HAFYERA™, INVEGA
TRINZA® and INVEGA SUSTENNA® can pass into human breast milk. The benefits of
breastfeeding should be considered along with the mother’s clinical need for
INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® and any potential adverse
effect on the breastfed infant from INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® or the mother’s underlying condition.

Commonly Observed Adverse Reactions for INVEGA HAFYERA™: The most common adverse
reactions (incidence at least 5% in the double-blind phase) in the INVEGA
HAFYERA™ clinical trial were upper respiratory tract infection, injection site
reaction, weight increased, headache and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA TRINZA®: The most common adverse
reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were
injection site reaction, weight increased, headache, upper respiratory tract
infection, akathisia and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA SUSTENNA®: The most common
adverse reactions in clinical trials in patients with schizophrenia (incidence ≥
5% and occurring at least twice as often as placebo) were injection site
reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal
disorder.

Please click here to read the full Prescribing Information, including Boxed
WARNING, for INVEGA HAFYERA™, click here to read the full Prescribing
Information, including Boxed WARNING, for INVEGA TRINZA® and click here to read
the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA®.

cp-256260v1

INDICATION

INVEGA HAFYERA™, an every-six-month injection, is an atypical antipsychotic
indicated for the treatment of schizophrenia in adults after they have been
adequately treated with:

 * A once-a-month paliperidone palmitate extended release injectable suspension
   (e.g., INVEGA SUSTENNA®) for at least four months or
 * An every-three-month paliperidone palmitate extended release injectable
   suspension (e.g., INVEGA TRINZA®) for at least one three-month cycle.

INVEGA TRINZA® is an atypical antipsychotic indicated for the treatment of
schizophrenia in patients after they have been adequately treated with INVEGA
SUSTENNA® for at least four months.

INVEGA SUSTENNA® is an atypical antipsychotic indicated for the treatment of
schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS.

See full prescribing information for complete Boxed Warning.

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. INVEGA HAFYERA™, INVEGA TRINZA® and
INVEGA SUSTENNA® are not approved for use in patients with dementia-related
psychosis.

Contraindications: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® are
contraindicated in patients with a known hypersensitivity to either
paliperidone, risperidone, or to any excipients of their formulation

Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g.,
stroke, transient ischemic attacks), including fatalities, were reported at a
higher incidence in elderly patients with dementia-related psychosis taking
risperidone, aripiprazole, and olanzapine compared to placebo. No studies have
been conducted with oral paliperidone, INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® in elderly patients with dementia. These medications are not approved
for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex,
has been reported in association with antipsychotic drugs, including
paliperidone.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental
status including delirium, and autonomic instability (irregular pulse of blood
pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and
acute renal failure.

If NMS is suspected, immediately discontinue INVEGA HAFYERA™, INVEGA TRINZA® or
INVEGA SUSTENNA® and provide symptomatic treatment and monitoring.

QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc)
interval. Avoid the use of drugs that also increase QTc interval and in patients
with risk factors for prolonged QTc interval. Paliperidone should also be
avoided in patients with congenital long QT syndrome and in patients with a
history of cardiac arrhythmias. Certain circumstances may increase the risk of
the occurrence of torsades de pointes and/or sudden death in association with
the use of drugs that prolong the QTc interval.

Tardive Dyskinesia (TD): TD, a syndrome consisting of potentially irreversible,
involuntary, dyskinetic movements, may develop in patients treated with
antipsychotic drugs. Although the prevalence of the syndrome appears to be
highest among the elderly, especially elderly women, it is impossible to predict
which patients will develop the syndrome. Whether antipsychotic drug products
differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing TD and the likelihood that it will become irreversible
appear to increase with the duration of treatment and the cumulative dose. The
syndrome can develop after relatively brief treatment periods, even at low
doses. It may also occur after discontinuation. TD may remit, partially or
completely, if antipsychotic treatment is discontinued. Antipsychotic treatment
itself, however, may suppress (or partially suppress) the signs and symptoms of
the syndrome, possibly masking the underlying process. The effect that
symptomatic suppression has upon the long-term course of the syndrome is
unknown.

If signs and symptoms of TD appear in a patient on INVEGA HAFYERA™, INVEGA
TRINZA® or INVEGA SUSTENNA®, drug discontinuation should be considered. However,
some patients may require treatment with INVEGA HAFYERA™, INVEGA TRINZA® or
INVEGA SUSTENNA® despite the presence of the syndrome. In patients who do
require chronic treatment, use the lowest dose and the shortest duration of
treatment producing a satisfactory clinical response. Periodically reassess the
need for continued treatment.

Metabolic Changes: Atypical antipsychotic drugs have been associated with
metabolic changes that may increase cardiovascular/cerebrovascular risk. These
metabolic changes include hyperglycemia, dyslipidemia, and body weight gain.
While all of the drugs in the class have been shown to produce some metabolic
changes, each drug has its own specific risk profile.

Hyperglycemia and Diabetes Mellitus: Hyperglycemia and diabetes mellitus, in
some cases extreme and associated with ketoacidosis, hyperosmolar coma or death,
have been reported in patients treated with all atypical antipsychotics (APS).
Patients starting treatment with APS who have or are at risk for diabetes
mellitus should undergo fasting blood glucose testing at the beginning of and
during treatment. Patients who develop symptoms of hyperglycemia during
treatment should also undergo fasting blood glucose testing. All patients
treated with atypical antipsychotics should be monitored for symptoms of
hyperglycemia. Some patients require continuation of antidiabetic treatment
despite discontinuation of the suspect drug.

Dyslipidemia: Undesirable alterations have been observed in patients treated
with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use.
Clinical monitoring of weight is recommended.

Orthostatic Hypotension and Syncope: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® may induce orthostatic hypotension in some patients due to its
alpha-adrenergic blocking activity. INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® should be used with caution in patients with known cardiovascular
disease, cerebrovascular disease or conditions that would predispose patients to
hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive
medications). Monitoring should be considered in patients for whom this may be
of concern.

Falls: Somnolence, postural hypotension, motor and sensory instability have been
reported with the use of antipsychotics, including INVEGA HAFYERA™, INVEGA
TRINZA® and INVEGA SUSTENNA®, which may lead to falls and, consequently,
fractures or other fall-related injuries. For patients, particularly the
elderly, with diseases, conditions, or medications that could exacerbate these
effects, assess the risk of falls when initiating antipsychotic treatment and
recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia and Agranulocytosis have been reported with
antipsychotics, including INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®.
In patients with a history of clinically significant low white blood cell count
(WBC)/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia,
perform a complete blood count frequently during the first few months of
therapy. Consider discontinuing INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA
SUSTENNA® at the first sign of a clinically significant decline in WBC in the
absence of other causative factors. Monitor patients with clinically significant
neutropenia for fever or other symptoms or signs of infection and treat promptly
if such symptoms or signs occur. Discontinue INVEGA HAFYERA™, INVEGA TRINZA® and
INVEGA SUSTENNA® in patients with severe neutropenia (absolute neutrophil count
<1000/mm3) and follow their WBC until recovery.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors,
INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® elevate prolactin levels,
and the elevation persists during chronic administration. Paliperidone has a
prolactin-elevating effect similar to risperidone, which is associated with
higher levels of prolactin elevation than other antipsychotic agents.

Potential for Cognitive and Motor Impairment: Somnolence, sedation, and
dizziness were reported as adverse reactions in subjects treated with INVEGA
HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®. INVEGA HAFYERA™, INVEGA TRINZA®
and INVEGA SUSTENNA® have the potential to impair judgment, thinking, or motor
skills. Patients should be cautioned about performing activities that require
mental alertness such as operating hazardous machinery, including motor
vehicles, until they are reasonably certain that INVEGA HAFYERA™, INVEGA TRINZA®
and INVEGA SUSTENNA® do not adversely affect them.

Seizures: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® should be used
cautiously in patients with a history of seizures or with conditions that
potentially lower seizure threshold. Conditions that lower seizure threshold may
be more prevalent in patients 65 years or older.

Administration: For intramuscular injection only by a healthcare professional
using only the needles provided in the INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® kits. Care should be taken to avoid inadvertent injection into a blood
vessel.

Drug Interactions: Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a
strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John’s
Wort) during a dosing interval for INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA®. If administering a strong inducer is necessary, consider managing the
patient using paliperidone extended-release tablets.

Pregnancy/Nursing: INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may
cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester
exposure. Advise patients to notify their healthcare professional if they become
pregnant or intend to become pregnant during treatment with INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA®. Patients should be advised that there is a
pregnancy registry that monitors outcomes in women exposed to INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA® during pregnancy. INVEGA HAFYERA™, INVEGA
TRINZA® and INVEGA SUSTENNA® can pass into human breast milk. The benefits of
breastfeeding should be considered along with the mother’s clinical need for
INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® and any potential adverse
effect on the breastfed infant from INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA
SUSTENNA® or the mother’s underlying condition.

Commonly Observed Adverse Reactions for INVEGA HAFYERA™: The most common adverse
reactions (incidence at least 5% in the double-blind phase) in the INVEGA
HAFYERA™ clinical trial were upper respiratory tract infection, injection site
reaction, weight increased, headache and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA TRINZA®: The most common adverse
reactions (incidence ≥ 5% and occurring at least twice as often as placebo) were
injection site reaction, weight increased, headache, upper respiratory tract
infection, akathisia and parkinsonism.

Commonly Observed Adverse Reactions for INVEGA SUSTENNA®: The most common
adverse reactions in clinical trials in patients with schizophrenia (incidence ≥
5% and occurring at least twice as often as placebo) were injection site
reactions, somnolence/sedation, dizziness, akathisia and extrapyramidal
disorder.

Please click here to read the full Prescribing Information, including Boxed
WARNING, for INVEGA HAFYERA™, click here to read the full Prescribing
Information, including Boxed WARNING, for INVEGA TRINZA® and click here to read
the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA®.

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