Approved Drug Label (PDF)
5
Warnings and Precautions
5.6 Metabolic Changes
(additions
underlined)
…
Pediatric
Patients (6 to 17 years)
In
a 104-week, open-label study in pediatric patients with schizophrenia, bipolar
depression, or autistic disorder, 7 % of patients with a normal baseline
fasting glucose experienced a shift to high at endpoint while taking
lurasidone.
![]()
…
Pediatric
Patients (6 to 17 years)
In
a 104-week, open-label study of pediatric patients with schizophrenia, bipolar
depression, or autistic disorder, shifts in baseline fasting cholesterol from
normal to high at
27% (HDL cholesterol) of patients taking lurasidone. Of patients with normal
baseline fasting triglycerides, 12% experienced shifts to high.
…
![]()
Pediatric
Patients (6 to 17 years)
In
a long-term, open-label study that enrolled pediatric patients with
schizophrenia, bipolar depression, or autistic disorder from three short-term,
placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. The
mean increase in weight from open-label baseline to Week 104 was 5.85 kg. To
adjust for normal growth, z-scores were derived (measured in standard
deviations [SD]), which normalize for the natural growth of children and
adolescents by comparisons to age- and sex-matched population standards. A
z-score change <0.5 SD is considered not clinically significant. In this
trial, the mean change in z-score from open-label baseline to Week 104 was
-0.06 SD for body weight and -0.13 SD for body mass index (BMI), indicating
minimal deviation from the normal curve for weight gain.
5.7 Hyperprolactinemia
(additions
underlined)
![]()
…
Pediatric
Patients (6 to 17 years)
In
a 104-week, open-label study of pediatric patients with schizophrenia, bipolar
depression, or autistic disorder, the median changes from baseline to endpoint
in serum prolactin levels were
-0.20
ng/mL (all patients), -0.30 ng/mL (females), and -0.05 ng/mL (males). The
proportions of patients with a markedly high prolactin level (greater than or
equal to 5 times the upper limit of normal)
at any time during open-label treatment were 2% (all patients), 3%
(females), and 1% (males).
Adverse
events among females in this trial that are potentially prolactin-related
include galactorrhea (0.6%). Among male patients in this study, decreased
libido was reported in one patient (0.2%) and there were no reports of
impotence, gynecomastia, or galactorrhea.
6
Adverse Reactions
6.1 Clinical Trials Experience
(additions
underlined)
…
breast
enlargement, breast pain, galactorrhea, erectile dysfunction, priapism
…
Pediatric
Patients (6 to 17 years)
In
a 104-week, open-label study in pediatric patients with schizophrenia, bipolar
depression, or autistic disorder, the mean change from baseline to Week 104 in
serum creatinine was +0.07 mg/dL. In patients with a normal serum creatinine at
baseline, 6% experienced a shift to high at endpoint.
8
Use in Specific Populations
8.4 Pediatric Use
(additions
underlined)
…
In
a long-term, open-label study that enrolled pediatric patients (age 6 to 17
years) with schizophrenia, bipolar depression, or autistic disorder from three
short-term, placebo-controlled trials, 54% (378/701) received lurasidone for
104 weeks. There was one adverse event in this trial that was considered
possibly drug-related and has not been reported in adults receiving lurasidone:
a 10 year old male experienced a prolonged, painful erection, consistent with
priapism, that led to treatment discontinuation.
In
this trial, the mean increase in height from open-label baseline to Week 104
was 4.94 cm. To adjust for normal growth, z-scores were derived (measured in
standard deviations [SD]), which normalize for the natural growth of children
and adolescents by comparisons to age- and sex- matched population standards. A
z-score change <0.5 SD is considered not clinically significant. In this
trial, the mean change in height z-score from open-label baseline to
Week 104 was +0.05 SD, indicating minimal deviation from the normal growth
curve.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.11 Seizures
(additions underlined)
![]()
…
Bipolar Depression Monotherapy
In the
adult and pediatric 6-week, flexible-dose, placebo-controlled
monotherapy bipolar depression studies, no patients experienced
seizures/convulsions.
…
5.12 Potential for Cognitive and Motor Impairment
(additions underlined)
…
Bipolar Depression
Adults
Monotherapy
…
![]()
Pediatric Patients (10 to 17
years)
In
the 6-week, placebo-controlled bipolar depression study in pediatric patients
10 to 17 years, somnolence was reported by 11.4% (20/175) of patients treated
with LATUDA 20 to 80 mg/day compared to 5.8% (10/172) of placebo treated
patients.
5.14 Activation of Mania/Hypomania
(addition underlined)
![]()
Antidepressant treatment can
increase the risk of developing a manic or hypomanic episode, particularly in
patients with bipolar disorder. Monitor patients for the emergence of such episodes.
In the adult
bipolar depression monotherapy and adjunctive therapy (with lithium or
valproate) studies, less than 1% of subjects in the LATUDA and placebo groups
developed manic or hypomanic episodes.
5.4 Neuroleptic Malignant Syndrome
(additions underlined)
A
potentially fatal symptom complex sometimes referred to as Neuroleptic
Malignant Syndrome (NMS) has been reported in association with administration
of antipsychotic drugs, including LATUDA. Clinical manifestations of NMS are
hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic
instability. Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure.
If NMS is suspected,
immediately discontinue LATUDA and provide intensive symptomatic treatment and
monitoring.
5.5 Tardive Dyskinesia
Additions underlined)
![]()
…
The risk of
developing tardive dyskinesia and the likelihood that it will become
irreversible are believed to increase as the duration of treatment and the
total cumulative dose of antipsychotic drugs administered to the patient
increase. However, the syndrome can develop, although much less commonly, after
relatively brief treatment periods at low doses or may even arise after
discontinuation of treatment.
…
5.6 Metabolic Changes
…
Bipolar
Depression
Adults
Monotherapy
…
Pediatric Patients (10 to
17 years)
In studies of pediatric
patients 10 to 17 years and adults with bipolar depression, changes in fasting
glucose were similar. In the 6-week, placebo-controlled study of pediatric
patients with bipolar depression, mean change in fasting glucose was +1.6 mg/dL
for LATUDA 20 to 80 mg/day (n=145) and -0.5 mg/dL for placebo (n=145).
…
Bipolar Depression
Adults
Monotherapy
…
Pediatric Patients (10 to
17 years)
In the 6-week,
placebo-controlled bipolar depression study with pediatric patients 10 to 17
years, mean change in fasting cholesterol was -6.3 mg/dL for LATUDA 20 to 80
mg/day (n=144) and -
1.4 mg/dL for placebo
(n=145), and mean change in fasting triglyceride was -7.6 mg/dL for LATUDA 20
to 80 mg/day (n=144) and +5.9 mg/dL for placebo (n=145).
5.7 Hyperprolactinemia
(additions
underlined)
…
Adjunctive Therapy with Lithium or Valproate
…
Pediatric Patients (10 to
17 years)
In the 6-week, placebo-controlled
bipolar depression study with pediatric patients 10 to 17 years, the median
change from baseline to endpoint in prolactin levels for LATUDA-treated
patients was +1.10 ng/mL and was +0.50 ng/mL for placebo-treated patients. For
LATUDA-treated patients, the median change from baseline to endpoint for males
was +0.85 ng/mL and for females was +2.50 ng/mL. Median changes for prolactin
are shown in Table 18.
![]()
![]()
(please refer to label to view Table 8)
The proportion of
patients with prolactin elevations
greater than or equal to 5x ULN was 0% for LATUDA-treated patients and
0.6% for placebo-treated patients. The proportion of female patients with
prolactin elevations greater than or
equal to 5x ULN was 0% for LATUDA-treated patients and 1.3% for placebo-treated
female patients. No male patients in the placebo or LATUDA treatment groups had
prolactin elevations greater than or
equal to 5x ULN.
5.9 Orthostatic Hypotension and Syncope
(additions underlined)
…
Bipolar Depression
Adults
Monotherapy
…
![]()
Pediatric Patients (10 to 17
years)
In
the 6-week, placebo-controlled bipolar depression study in pediatric patients
10 to 17 years, there were no reported adverse events of orthostatic
hypotension or syncope.
Orthostatic
hypotension, as assessed by vital signs, occurred with a frequency of 1.1% with
LATUDA 20 to 80 mg/day, compared to 0.6% with placebo.
6
Adverse Reactions
6.1 Clinical Trials Experience
(extensive additions, please refer to label)
6.2 Postmarketing Experience
(additions underlined)
…
Hypersensitivity
Reactions: Urticaria, throat swelling, tongue swelling, dyspnea, and rash.
Metabolism and Nutrition Disorders: Hyponatremia
8
Use in Specific Populations
8.4 Pediatric Use
(additions underlined)
…
The safety
and effectiveness of LATUDA has not been established in pediatric patients less
than 13 years of age with schizophrenia.
Bipolar Depression
The
safety and effectiveness of LATUDA 20 to 80 mg/day for the treatment of bipolar
depression in pediatric patients (10 to 17 years) was established in a 6-week,
placebo-controlled clinical study in 347 pediatric patients.
The safety
and effectiveness of LATUDA has not been established in pediatric patients less
than 10 years of age with bipolar depression.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions and
revisions, please refer to label)
PATIENT COUNSELING INFORMATION
(additions underlined)
…
Pregnancy
Advise patients that LATUDA may cause
extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to
notify their healthcare provider with a known or suspected pregnancy. Advise patients that there is a
pregnancy exposure registry that monitors pregnancy outcomes in women exposed
to LATUDA during pregnancy
Approved Drug Label (PDF)
Boxed Warning
(Additions and/or revisions are underlined)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA?RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
Suicidal Thoughts and Behaviors
…LATUDA is not approved for use in pediatric patients
with depression.
5
Warnings and Precautions
5.10 Seizures
(Additions and/or revisions are underlined)
Schizophrenia
In adult short-term, placebo-controlled schizophrenia
studies, seizures/convulsions occurred in 0.1% (2/1508) of patients treated
with LATUDA compared to 0.1% (1/708) placebo-treated patients.
Bipolar Depression
Monotherapy
In the adult short-term, flexible-dose,
placebo-controlled monotherapy bipolar depression study, no patient experienced
seizures/convulsions.
Adjunctive Therapy
with Lithium or Valproate
In the adult short-term, flexible-dose,
placebo-controlled adjunctive therapy bipolar depression studies, no patient
experienced seizures/convulsions.
5.11 Potential for Cognitive and Motor Impairment
(Additions and/or revisions are underlined)
Schizophrenia
Adolescents
In the short-term, placebo-controlled adolescent
schizophrenia study, somnolence was reported by 14.5% (31/214) of patients
treated with LATUDA (15.5% LATUDA 40 mg and 13.5% LATUDA 80 mg,/day) compared
to 7.1% (8/112) of placebo patients.
Bipolar Depression
Monotherapy
In the adult short-term, flexible-dosed,
placebo-controlled monotherapy bipolar depression study, somnolence was
reported by 7.3% (12/164) and 13.8% (23/167) with LATUDA 20 to 60 mg and 80 to120 mg, respectively compared to 6.5% (11/168) of
placebo patients.
Adjunctive Therapy
with Lithium or Valproate
In the adult short-term, flexible-dosed,
placebo-controlled adjunctive therapy bipolar depression studies, somnolence
was reported by 11.4% (41/360) of patients treated with LATUDA 20-120 mg
compared to 5.1% (17/334) of placebo patients.
5.2. Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
(Additions and/or revisions are underlined)
In pooled analyses of placebo-controlled trials of
antidepressant drugs (SSRIs and other antidepressant classes)
that included approximately
77,000 adult patients,
and over 4,400 pediatric patients, the incidence of
suicidal thoughts and behaviors in pediatric and young adult patients
was greater in antidepressant-treated patients than in placebo-treated
patients.
LATUDA is not approved for use in pediatric patients with
depression.
5.6 Metabolic Changes
(Additions and/or revisions are underlined)
Schizophrenia
Adults
Table 3: Change in Fasting Glucose in Adult
Schizophrenia Studies
Adolescents
In studies of adolescents and adults with schizophrenia,
changes in fasting glucose were similar. In the short-term, placebo-controlled
study of adolescents, fasting serum glucose mean values were -+1.3 for placebo
(n=95), +0.1 for 40mg (n=90), and +1.8 for 80mg (n=92).
Bipolar Depression
Monotherapy
Data from the adult short-term,
flexible-dose,
placebo-controlled
monotherapy bipolar depression
study are presented in Table 4.
Table 4: Change in Fasting Glucose in the Adult
Monotherapy Bipolar Depression Study
Adjunctive Therapy
with Lithium or Valproate
Data from the adult short-term, flexible-dosed,
placebo-controlled adjunctive therapy bipolar depression studies are presented
in Table 5.
Table 5: Change in Fasting Glucose in the Adult Adjunctive
Therapy Bipolar Depression Studies
Dyslipidemia
Schizophrenia
Adults
Pooled data from short-term, placebo-controlled
schizophrenia studies are presented in Table 6: Change in Fasting Lipids in Adult Schizophrenia
Studies
Table 6: Change in Fasting Lipids in Adult Schizophrenia
Studies
Adolescents
In the adolescent
short-term, placebo-controlled study, fasting serum cholesterol mean values
were -9.6 for placebo (n=95), -4.4 for 40mg (n=89), and +1.6 for 80mg (n=92),
and fasting serum triglyceride mean values were +0.1 for placebo (n=95), -0.6
for 40mg (n=89), and +8.5 for 80mg (n=92).
Bipolar Depression
Monotherapy
Data from the adult short-term,
flexible-dosed,
placebo-controlled,
monotherapy bipolar depression
study are presented in Table 7.
Table 7: Change in Fasting Lipids in the Adult Monotherapy
Bipolar Depression Study
Adjunctive Therapy
with Lithium or Valproate
Data from the adult short-term, flexible-dosed,
placebo-controlled, adjunctive therapy bipolar depression studies are presented
in Table 8
Table 8: Change in Fasting Lipids in the Adult Adjunctive
Therapy Bipolar Depression Studies
Weight Gain
Schizophrenia
Adults
Table 9: Mean Change in Weight (kg) from Baseline in Adult
Schizophrenia Studies
Adolescents
Data from the short-term, placebo-controlled adolescent
schizophrenia study are presented in Table 10. The mean weight gain was +0.5 kg
for LATUDA-treated patients compared to +0.2 kg for placebo-treated patients.
The proportion of patients with a greater than or equal to 7% increase in body
weight (at Endpoint) was 3.3% for LATUDA-treated patients versus 4.5% for
placebo-treated patients.
Table 10: Mean Change in Weight (kg) from Baseline in the
Adolescent Schizophrenia Study (Table
revised; please refer to label)
Bipolar Depression
Monotherapy
Data from the adult short-term, flexible-dosed,
placebo-controlled monotherapy bipolar depression study are presented in Table 11.
Table 11: Mean Change in Weight (kg) from Baseline
in the Adult Monotherapy Bipolar Depression
Study
Adjunctive Therapy
with Lithium or Valproate
Data from the adult short-term, flexible-dosed,
placebo-controlled adjunctive therapy bipolar depression studies are presented
in Table 12.
Table 12: Mean Change in Weight (kg) from Baseline
in the Adult Adjunctive Therapy Bipolar Depression Studies
5.7 Hyperprolactinemia
(Additions and/or revisions are underlined)
Schizophrenia
Adults
…Median changes for prolactin by dose are shown in Table 13.
Table 13: Median Change in Prolactin (ng/mL) from
Baseline in Adult Schizophrenia Studies
Adolescents
In the short-term, placebo-controlled adolescent
schizophrenia study, the median change from baseline to endpoint in prolactin
levels for LATUDA-treated patients was +1.1 ng/mL and was +0.1 ng/mL for
placebo-treated patients. For LATUDA-treated patients, the median change from
baseline to endpoint for males was +1.0 ng/mL and for females was +2.6 ng/mL.
Median changes for prolactin by dose are shown in Table 14.
Table 14: Median Change in Prolactin (ng/mL) from
Baseline in the Adolescent Schizophrenia Study
(New table added;
please refer to label)
The proportion of patients with prolactin elevations ?5x
ULN was 0.5% for LATUDA-treated patients versus
1.0% for placebo-treated patients.
The proportion of
female patients with prolactin elevations 5x ULN was 1.3% for
LATUDA-treated patients versus 0% for placebo- treated female patients. The
proportion of male patients with prolactin elevations 5x ULN was 0% versus 1.6%
for placebo-treated male patients.
Bipolar Depression
Monotherapy
The median change from
baseline to endpoint in prolactin levels, in the adult short-term, flexible-dosed,
placebo-controlled monotherapy bipolar depression study…
The median change from baseline to endpoint for males was +1.5 ng/mL and
for females was +3.1 ng/mL. Median changes for prolactin by dose range are
shown in Table 15.
Table 15: Median Change in Prolactin (ng/mL) from
Baseline in the Adult Monotherapy Bipolar Depression Study
Adjunctive Therapy
with Lithium or Valproate
The median change from baseline to endpoint in
prolactin levels, in the adult
short-term, flexible-dosed, placebo-controlled adjunctive therapy
bipolar depression studies was +2.8 ng/mL with LATUDA 20 to 120 mg/day compared
to 0.0 ng/mL with placebo-treated patients.
The median change from baseline to endpoint for males was +2.4 ng/mL and
for females was +3.2 ng/mL. Median changes for prolactin across the dose range
are shown in Table 16.
Table 16: Median Change in Prolactin (ng/mL) from
Baseline in the Adult Adjunctive Therapy Bipolar Depression
Studies
5.9 Orthostatic Hypotension and Syncope
(Additions and/or revisions are underlined)
Schizophrenia
Adolescents
The incidence of
orthostatic hypotension reported
as adverse events
from the short-term, placebo-controlled adolescent
schizophrenia study was
0.5% (1/214) in
LATUDA-treated patients and 0% (0/112) in placebo-treated patients. No
syncope event was reported.
Orthostatic hypotension, as assessed by vital signs,
occurred with a frequency of 0% with LATUDA 40 mg and 2.9% with LATUDA 80 mg,
compared to 1.8% with placebo.
Bipolar Depression
Monotherapy
In the adult short-term, flexible-dose,
placebo-controlled monotherapy bipolar depression study, there were no reported
adverse events of orthostatic hypotension and syncope.
Adjunctive Therapy
with Lithium or Valproate
In the adult short-term, flexible-dose,
placebo-controlled adjunctive therapy bipolar depression therapy studies, there
were no reported adverse events of orthostatic hypotension and syncope.
6
Adverse Reactions
6.1 Clinical Trials Experience
(Extensive revisions; please refer to label)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR)
Conversion; Additions and/or revisions are underlined)
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to LATUDA during pregnancy. For more
information, contact the National Pregnancy Registry for Atypical
Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-
researchprograms/pregnancyregistry/.
Risk Summary
…There are no studies of LATUDA use in pregnant women.
The limited available data are not sufficient to inform a drug-associated risk
of birth defects or miscarriage. In animal reproduction studies, no teratogenic
effects were seen in pregnant rats and rabbits given lurasidone during the
period of organogenesis at doses approximately 1.5- and 6-times, the maximum
recommended human dose (MRHD) of 160
mg/day, respectively based on mg/m2 body surface area.
The estimated background risk of major birth defects and
miscarriage for the indicated population(s) is unknown. All pregnancies have a
background risk of birth defect, loss or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and
miscarriage in clinically recognized pregnancies is 2-4% and 15-20%,
respectively.
Clinical Considerations
Fetal/Neonatal
Adverse Reactions
Extrapyramidal and/or withdrawal symptoms, including
agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and
feeding disorder have been reported in neonates who were exposed to
antipsychotic drugs during the third trimester of pregnancy. These symptoms
have varied in severity. Some neonates recovered within hours or days without
specific treatment; others required prolonged hospitalization. Monitor neonates
for extrapyramidal and/or withdrawal symptoms and manage symptoms
appropriately.
Data
Animal Data
Pregnant rats were treated with oral lurasidone at
doses of 3, 10, and 25 mg/kg/day during the period of organogenesis. These
doses are 0.2, 0.6, and 1.5 times the MRHD of 160 mg/day based on mg/m2
body surface area. No teratogenic or embryo-fetal effects were observed
up to 1.5 times the MHRD of 160 mg/day, based on mg/m2.
Pregnant rabbits were treated with oral
lurasidone at doses of 2, 10, and 50 mg/kg/day during the period of
organogenesis. These doses are 0.2, 1.2 and 6 times the
MRHD of 160 mg/day based on mg/m2 No
teratogenic or embryo-fetal effects were observed up to 6 times the MHRD
of 160 mg/day based on mg/m2.
Pregnant rats were treated with oral lurasidone at doses
of 0.4, 2, and 10 mg/kg/day during the periods of organogenesis and lactation.
These doses are 0.02, 0.1 and 0.6 times the MRHD of 160 mg/day based on mg/m2.
No pre- and postnatal developmental effects were observed up to 0.6 times the
MRHD of 160 mg/day, based on mg/m2.
8.2 Lactation
(Pregnancy and Lactation Labeling Rule (PLLR)
Conversion; Additions and/or revisions are underlined)
Risk Summary
Lactation studies have not been conducted to assess the
presence of lurasidone in human milk, the effects on the breastfed infant, or
the effects on milk production. Lurasidone is present in rat milk. The
development and health benefits of breastfeeding should be considered along
with the mother’s clinical need for LATUDA and any potential adverse effects on
the breastfed infant from LATUDA or from the underlying maternal condition.
8.4 Pediatric Use
(Additions and/or revisions are underlined)
Schizophrenia
The safety and effectiveness of LATUDA 40-mg/day and
80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years)
was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients.
Depression
The safety and effectiveness of LATUDA have not been
established with depression.
Irritability
Associated with Autistic Disorder
The effectiveness of LATUDA in pediatric patients for the
treatment of irritability associated with autistic disorder has not been
established.
Efficacy was not demonstrated in a 6-week study evaluating LATUDA 20 mg/day and 60 mg/day for
the treatment of pediatric patients 6 to 17 years of age with irritability
associated with autistic disorder diagnosed by Diagnostic and Statistical
Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria. The
primary objective of the study as
measured by improvement from Baseline in the irritability subscale of the
Aberrant Behavior Checklist (ABC) at Endpoint (Week 6) was not met. A total of
149 patients were randomized to LATUDA or placebo. Vomiting occurred at a
higher rate than reported in other LATUDA studies (4/49 or 8% for 20mg, 14/51
or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6
to 12 (13 out of 18 patients on LATUDA with vomiting).
Juvenile animal studies
Adverse effects were seen on growth, physical and
neurobehavioral development at doses as low as 0.2 times the MRHD based on
mg/m2.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Pregnancy
Advise patients that LATUDA may cause extrapyramidal
and/or withdrawal symptoms in a neonate. Advise patients to notify their
healthcare provider with a known or suspected pregnancy.
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What is the most important information I should know
about LATUDA? LATUDA may cause serious side effects, including:
Increased
risk of death in elderly people who are confused, have memory loss and
have lost touch with reality (dementia-related psychosis). Medicines
like LATUDA can increase the risk of death in elderly people who are confused,
have memory loss and have lost touch with reality (dementia-related
psychosis). LATUDA should not be used to treat people with
dementia-related psychosis.
Increased
risk of suicidal thoughts or actions (antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions).
Depression and other serious mental illnesses
are the most important causes of suicidal thoughts and actions. Some people may
have a particularly high risk of having suicidal thoughts or actions. These
include people who have (or have a family history of) depression, bipolar
illness (also called manic-depressive illness), or a history of suicidal
thoughts or actions.
What is LATUDA?
LATUDA is a prescription medicine used to treat:
schizophrenia in people 13 years of age or
older
depressive episodes associated with bipolar I
disorder, alone or with lithium or valproate in adults
It is not known if LATUDA is safe and
effective in people under 13 years of age.
Do not take LATUDA if you are:
taking certain other medicines called CYP3A4
inhibitors or inducers including ketoconazole, clarithromycin, ritonavir,
voriconazole, mibefradil, rifampin, avasimibe, St. John’s wort, phenytoin, or
carbamazepine. Ask your healthcare provider if you are not sure if you are
taking any of these medicines.
Before taking LATUDA, tell your healthcare provider about
all of your medical conditions, including if you:
are pregnant or plan to become pregnant.
It is not known if LATUDA will harm your unborn baby. Using LATUDA in
the last trimester of pregnancy may cause muscle movement problems, medicine
withdrawal symptoms, or both in your newborn.
If you become pregnant while taking LATUDA,
talk to your healthcare provider about registering with the National Pregnancy
Registry for Atypical Antipsychotics at 1-866-961-2388 or visit
http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.
are breastfeeding or plan to breastfeed. It
is not known if LATUDA passes into your breast milk.
Especially tell your healthcare provider if you take or plan
to take medicines for:
Know the medicines you take. Keep a list of your
medicines to show your healthcare provider and pharmacist when you
get a new medicine.
What should I avoid while taking LATUDA?
The most common side effects of LATUDA in adults
include:
The most common side effects of LATUDA in adolescents
(13 to 17 years old) include:
How should I store LATUDA?
Approved Drug Label (PDF)
Boxed Warning
(Additions and/or revisions are underlined)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA?RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
Suicidal Thoughts and Behaviors
…LATUDA is not approved for use in pediatric patients
with depression.
5
Warnings and Precautions
5.10 Seizures
(Additions and/or revisions are underlined)
Schizophrenia
In adult short-term, placebo-controlled schizophrenia
studies, seizures/convulsions occurred in 0.1% (2/1508) of patients treated
with LATUDA compared to 0.1% (1/708) placebo-treated patients.
Bipolar Depression
Monotherapy
In the adult short-term, flexible-dose,
placebo-controlled monotherapy bipolar depression study, no patient experienced
seizures/convulsions.
Adjunctive Therapy
with Lithium or Valproate
In the adult short-term, flexible-dose,
placebo-controlled adjunctive therapy bipolar depression studies, no patient
experienced seizures/convulsions.
5.11 Potential for Cognitive and Motor Impairment
(Additions and/or revisions are underlined)
Schizophrenia
Adolescents
In the short-term, placebo-controlled adolescent
schizophrenia study, somnolence was reported by 14.5% (31/214) of patients
treated with LATUDA (15.5% LATUDA 40 mg and 13.5% LATUDA 80 mg,/day) compared
to 7.1% (8/112) of placebo patients.
Bipolar Depression
Monotherapy
In the adult short-term, flexible-dosed,
placebo-controlled monotherapy bipolar depression study, somnolence was
reported by 7.3% (12/164) and 13.8% (23/167) with LATUDA 20 to 60 mg and
80 to120 mg, respectively compared to 6.5% (11/168) of
placebo patients.
Adjunctive Therapy
with Lithium or Valproate
In the adult short-term, flexible-dosed,
placebo-controlled adjunctive therapy bipolar depression studies, somnolence
was reported by 11.4% (41/360) of patients treated with LATUDA 20-120 mg
compared to 5.1% (17/334) of placebo patients.
5.2. Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
(Additions and/or revisions are underlined)
In pooled analyses of placebo-controlled trials of
antidepressant drugs (SSRIs and other antidepressant classes)
that included approximately
77,000 adult patients,
and over 4,400 pediatric patients, the incidence of
suicidal thoughts and behaviors in pediatric and young adult patients
was greater in antidepressant-treated patients than in placebo-treated
patients.
LATUDA is not approved for use in pediatric patients with
depression.
5.6 Metabolic Changes
(Additions and/or revisions are underlined)
Schizophrenia
Adults
Table 3: Change in Fasting Glucose in Adult
Schizophrenia Studies
Adolescents
In studies of adolescents and adults with schizophrenia,
changes in fasting glucose were similar. In the short-term, placebo-controlled
study of adolescents, fasting serum glucose mean values were -+1.3 for placebo
(n=95), +0.1 for 40mg (n=90), and +1.8 for 80mg (n=92).
Bipolar Depression
Monotherapy
Data from the adult short-term,
flexible-dose,
placebo-controlled
monotherapy bipolar depression
study are presented in Table 4.
Table 4: Change in Fasting Glucose in the Adult
Monotherapy Bipolar Depression Study
Adjunctive Therapy
with Lithium or Valproate
Data from the adult short-term, flexible-dosed,
placebo-controlled adjunctive therapy bipolar depression studies are presented
in Table 5.
Table 5: Change in Fasting Glucose in the Adult Adjunctive
Therapy Bipolar Depression Studies
Dyslipidemia
Schizophrenia
Adults
Pooled data from short-term, placebo-controlled
schizophrenia studies are presented in Table 6: Change in Fasting Lipids in Adult Schizophrenia
Studies
Table 6: Change in Fasting Lipids in Adult Schizophrenia
Studies
Adolescents
In the adolescent
short-term, placebo-controlled study, fasting serum cholesterol mean values
were -9.6 for placebo (n=95), -4.4 for 40mg (n=89), and +1.6 for 80mg (n=92),
and fasting serum triglyceride mean values were +0.1 for placebo (n=95), -0.6
for 40mg (n=89), and +8.5 for 80mg (n=92).
Bipolar Depression
Monotherapy
Data from the adult
short-term, flexible-dosed, placebo-controlled, monotherapy
bipolar depression study are presented in Table 7.
Table 7: Change in Fasting Lipids in the Adult Monotherapy
Bipolar Depression Study
Adjunctive Therapy
with Lithium or Valproate
Data from the adult short-term, flexible-dosed,
placebo-controlled, adjunctive therapy bipolar depression studies are presented
in Table 8
Table 8: Change in Fasting Lipids in the Adult Adjunctive
Therapy Bipolar Depression Studies
Weight Gain
Schizophrenia
Adults
Table 9: Mean Change in Weight (kg) from Baseline in Adult
Schizophrenia Studies
Adolescents
Data from the short-term, placebo-controlled adolescent
schizophrenia study are presented in Table 10. The mean weight gain was +0.5 kg
for LATUDA-treated patients compared to +0.2 kg for placebo-treated patients.
The proportion of patients with a greater than or equal to 7% increase in body
weight (at Endpoint) was 3.3% for LATUDA-treated patients versus 4.5% for
placebo-treated patients.
Table 10: Mean Change in Weight (kg) from Baseline in the
Adolescent Schizophrenia Study (Table
revised; please refer to label)
Bipolar Depression
Monotherapy
Data from the adult short-term, flexible-dosed,
placebo-controlled monotherapy bipolar depression study are presented in Table 11.
Table 11: Mean Change in Weight (kg) from Baseline
in the Adult Monotherapy Bipolar Depression
Study
Adjunctive Therapy
with Lithium or Valproate
Data from the adult short-term, flexible-dosed,
placebo-controlled adjunctive therapy bipolar depression studies are presented
in Table 12.
Table 12: Mean Change in Weight (kg) from Baseline
in the Adult Adjunctive Therapy Bipolar Depression Studies
5.7 Hyperprolactinemia
(Additions and/or revisions are underlined)
Schizophrenia
Adults
…Median changes for prolactin by dose are shown in Table 13.
Table 13: Median Change in Prolactin (ng/mL) from
Baseline in Adult Schizophrenia Studies
Adolescents
In the short-term, placebo-controlled adolescent
schizophrenia study, the median change from baseline to endpoint in prolactin
levels for LATUDA-treated patients was +1.1 ng/mL and was +0.1 ng/mL for
placebo-treated patients. For LATUDA-treated patients, the median change from
baseline to endpoint for males was +1.0 ng/mL and for females was +2.6 ng/mL.
Median changes for prolactin by dose are shown in Table 14.
Table 14: Median Change in Prolactin (ng/mL) from
Baseline in the Adolescent Schizophrenia Study
(New table added;
please refer to label)
The proportion of patients with prolactin elevations ?5x
ULN was 0.5% for LATUDA-treated patients versus
1.0% for placebo-treated patients.
The proportion of
female patients with prolactin elevations 5x ULN was 1.3% for
LATUDA-treated patients versus 0% for placebo- treated female patients. The
proportion of male patients with prolactin elevations 5x ULN was 0% versus 1.6%
for placebo-treated male patients.
Bipolar Depression
Monotherapy
The median change from
baseline to endpoint in prolactin levels, in the adult short-term, flexible-dosed,
placebo-controlled monotherapy bipolar depression study…
The median change from baseline to endpoint for males was +1.5 ng/mL and
for females was +3.1 ng/mL. Median changes for prolactin by dose range are
shown in Table 15.
Table 15: Median Change in Prolactin (ng/mL) from
Baseline in the Adult Monotherapy Bipolar Depression Study
Adjunctive Therapy
with Lithium or Valproate
The median change from baseline to endpoint in
prolactin levels, in the adult
short-term, flexible-dosed, placebo-controlled adjunctive therapy
bipolar depression studies was +2.8 ng/mL with LATUDA 20 to 120 mg/day compared
to 0.0 ng/mL with placebo-treated patients.
The median change from baseline to endpoint for males was +2.4 ng/mL and
for females was +3.2 ng/mL. Median changes for prolactin across the dose range
are shown in Table 16.
Table 16: Median Change in Prolactin (ng/mL) from
Baseline in the Adult Adjunctive Therapy Bipolar Depression
Studies
5.9 Orthostatic Hypotension and Syncope
(Additions and/or revisions are underlined)
Schizophrenia
Adolescents
The incidence of
orthostatic hypotension reported
as adverse events
from the short-term, placebo-controlled adolescent
schizophrenia study was
0.5% (1/214) in
LATUDA-treated patients and 0% (0/112) in placebo-treated patients. No
syncope event was reported.
Orthostatic hypotension, as assessed by vital signs,
occurred with a frequency of 0% with LATUDA 40 mg and 2.9% with LATUDA 80 mg,
compared to 1.8% with placebo.
Bipolar Depression
Monotherapy
In the adult short-term, flexible-dose,
placebo-controlled monotherapy bipolar depression study, there were no reported
adverse events of orthostatic hypotension and syncope.
Adjunctive Therapy
with Lithium or Valproate
In the adult short-term, flexible-dose,
placebo-controlled adjunctive therapy bipolar depression therapy studies, there
were no reported adverse events of orthostatic hypotension and syncope.
6
Adverse Reactions
6.1 Clinical Trials Experience
(Extensive revisions; please refer to label)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR)
Conversion; Additions and/or revisions are underlined)
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to LATUDA during pregnancy. For more
information, contact the National Pregnancy Registry for Atypical
Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-
researchprograms/pregnancyregistry/.
Risk Summary
…There are no studies of LATUDA use in pregnant women.
The limited available data are not sufficient to inform a drug-associated risk
of birth defects or miscarriage. In animal reproduction studies, no teratogenic
effects were seen in pregnant rats and rabbits given lurasidone during the
period of organogenesis at doses approximately 1.5- and 6-times, the maximum
recommended human dose (MRHD) of 160
mg/day, respectively based on mg/m2 body surface area.
The estimated background risk of major birth defects and
miscarriage for the indicated population(s) is unknown. All pregnancies have a
background risk of birth defect, loss or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and
miscarriage in clinically recognized pregnancies is 2-4% and 15-20%,
respectively.
Clinical Considerations
Fetal/Neonatal
Adverse Reactions
Extrapyramidal and/or withdrawal symptoms, including
agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and
feeding disorder have been reported in neonates who were exposed to
antipsychotic drugs during the third trimester of pregnancy. These symptoms
have varied in severity. Some neonates recovered within hours or days without
specific treatment; others required prolonged hospitalization. Monitor neonates
for extrapyramidal and/or withdrawal symptoms and manage symptoms
appropriately.
Data
Animal Data
Pregnant rats were treated with oral lurasidone at
doses of 3, 10, and 25 mg/kg/day during the period of organogenesis. These
doses are 0.2, 0.6, and 1.5 times the MRHD of 160 mg/day based on mg/m2
body surface area. No teratogenic or embryo-fetal effects were observed
up to 1.5 times the MHRD of 160 mg/day, based on mg/m2.
Pregnant rabbits were treated with oral
lurasidone at doses of 2, 10, and 50 mg/kg/day during the period of
organogenesis. These doses are 0.2, 1.2 and 6 times the
MRHD of 160 mg/day based on mg/m2 No
teratogenic or embryo-fetal effects were observed up to 6 times the MHRD
of 160 mg/day based on mg/m2.
Pregnant rats were treated with oral lurasidone at doses
of 0.4, 2, and 10 mg/kg/day during the periods of organogenesis and lactation.
These doses are 0.02, 0.1 and 0.6 times the MRHD of 160 mg/day based on mg/m2.
No pre- and postnatal developmental effects were observed up to 0.6 times the
MRHD of 160 mg/day, based on mg/m2.
8.2 Lactation
(Pregnancy and Lactation Labeling Rule (PLLR)
Conversion; Additions and/or revisions are underlined)
Risk Summary
Lactation studies have not been conducted to assess the
presence of lurasidone in human milk, the effects on the breastfed infant, or
the effects on milk production. Lurasidone is present in rat milk. The
development and health benefits of breastfeeding should be considered along
with the mother’s clinical need for LATUDA and any potential adverse effects on
the breastfed infant from LATUDA or from the underlying maternal condition.
8.4 Pediatric Use
(Additions and/or revisions are underlined)
Schizophrenia
The safety and effectiveness of LATUDA 40-mg/day and
80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years)
was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients.
Depression
The safety and effectiveness of LATUDA have not been
established with depression.
Irritability
Associated with Autistic Disorder
The effectiveness of LATUDA in pediatric patients for the
treatment of irritability associated with autistic disorder has not been
established.
Efficacy was not demonstrated in a 6-week study evaluating LATUDA 20 mg/day and 60 mg/day
for the treatment of pediatric patients 6 to 17 years of age with irritability
associated with autistic disorder diagnosed by Diagnostic and Statistical
Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria. The
primary objective of the study as
measured by improvement from Baseline in the irritability subscale of the
Aberrant Behavior Checklist (ABC) at Endpoint (Week 6) was not met. A total of
149 patients were randomized to LATUDA or placebo. Vomiting occurred at a
higher rate than reported in other LATUDA studies (4/49 or 8% for 20mg, 14/51
or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6
to 12 (13 out of 18 patients on LATUDA with vomiting).
Juvenile animal
studies
Adverse effects were seen on growth, physical and
neurobehavioral development at doses as low as 0.2 times the MRHD based on
mg/m2.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Pregnancy
Advise patients that LATUDA may cause extrapyramidal
and/or withdrawal symptoms in a neonate. Advise patients to notify their
healthcare provider with a known or suspected pregnancy.
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What is the most important information I should know
about LATUDA? LATUDA may cause serious side effects, including:
Increased
risk of death in elderly people who are confused, have memory loss and
have lost touch with reality (dementia-related psychosis). Medicines
like LATUDA can increase the risk of death in elderly people who are confused,
have memory loss and have lost touch with reality (dementia-related
psychosis). LATUDA should not be used to treat people with
dementia-related psychosis.
Increased
risk of suicidal thoughts or actions (antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions).
Depression and other serious mental illnesses
are the most important causes of suicidal thoughts and actions. Some people may
have a particularly high risk of having suicidal thoughts or actions. These
include people who have (or have a family history of) depression, bipolar
illness (also called manic-depressive illness), or a history of suicidal
thoughts or actions.
What is LATUDA?
LATUDA is a prescription medicine used to treat:
schizophrenia in people 13 years of age or
older
depressive episodes associated with bipolar I
disorder, alone or with lithium or valproate in adults
It is not known if LATUDA is safe and effective
in people under 13 years of age.
Do not take LATUDA if you are:
taking certain other medicines called CYP3A4
inhibitors or inducers including ketoconazole, clarithromycin, ritonavir,
voriconazole, mibefradil, rifampin, avasimibe, St. John’s wort, phenytoin, or
carbamazepine. Ask your healthcare provider if you are not sure if you are
taking any of these medicines.
Before taking LATUDA, tell your healthcare provider about
all of your medical conditions, including if you:
are pregnant or plan to become pregnant.
It is not known if LATUDA will harm your unborn baby. Using LATUDA in
the last trimester of pregnancy may cause muscle movement problems, medicine
withdrawal symptoms, or both in your newborn.
If you become pregnant while taking LATUDA,
talk to your healthcare provider about registering with the National Pregnancy
Registry for Atypical Antipsychotics at 1-866-961-2388 or visit
http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.
are breastfeeding or plan to breastfeed. It
is not known if LATUDA passes into your breast milk.
Especially tell your healthcare provider if you take or plan
to take medicines for:
Know the medicines you take. Keep a list of your
medicines to show your healthcare provider and pharmacist when you
get a new medicine.
What should I avoid while taking LATUDA?
The most common side effects of LATUDA in adults
include:
The most common side effects of LATUDA in adolescents
(13 to 17 years old) include:
How should I store LATUDA?
Approved Drug Label (PDF)
Boxed Warning
(section
revised, additions underlined)
WARNINGS: INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
Increased Mortality in Elderly Patients with
Dementia-Related Psychosis
Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk of death
LATUDA is not approved for use in patients with dementia-related
psychosis.
Suicidal Thoughts and Behaviors
Antidepressants increased the risk of
suicidal thoughts and behavior in patients aged 24 years and younger in
short-term studies. Monitor closely for
clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of LATUDA have not
been established in pediatric patients.
5
Warnings and Precautions
5.2 Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults
(section
revised, additions underlined)
In
pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and
other antidepressant classes) that included approximately 77,000 adult
patients, and over 4,400 pediatric patients, the incidence of suicidal thoughts
and behaviors in patients aged 24 years and younger was greater in
antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of
cases of suicidal thoughts and behaviors per 1000 patients treated are provided
in Table 2.
No
suicides occurred in any of the pediatric studies. There were suicides in the adults studies,
but the number was not sufficient to reach any conclusion about antidepressant
drug effect on suicide.
Table 2: Risk Differences of the Number of Patients with Suicidal
Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of
Antidepressants in Pediatric and Adult Patients
(please
refer to label for Table 2)
It
is unknown whether the risk of suicidal thoughts and behaviors in children,
adolescents, and young adults extends to longer-term use, i.e., beyond four
months. However, there is substantial
evidence from placebo-controlled maintenance studies in adults with MDD that
antidepressants delay the recurrence of depression.
Monitor
all antidepressant-treated patients for clinical worsening and emergence of
suicidal thoughts and behaviors, especially during the initial few months of
drug therapy and at times of dosage changes.
Counsel family members or caregivers of patients to monitor for changes
in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen,
including possibly discontinuing LATUDA, in patients whose depression is
persistently worse, or who are experiencing emergent suicidal thoughts or
behaviors.
6
Adverse Reactions
6.2 Postmarketing Experience
(New
subsection added)
Hypersensitivity has been
identified as an adverse drug reaction with LATUDA during postapproval
use. Hypersensitivity may include
symptoms such as angioedema, pruritus, rash, throat swelling, tongue swelling,
urticaria and cutaneous reactions such as dermatitis bullous, rash
maculopapular, rash pustular, skin eruption and skin exfoliation. As this
reaction is reported voluntarily from a population of uncertain size, the
incidence rates of this adverse reaction (hypersensitivity) and its symptoms
cannot be estimated.
7
Drug Interactions
7.1 Drugs Having Clinically Important Interactions with Latuda
(Extensive
additions, please refer to Table 24 in label)
7.2 Drugs Having No Clinically Important Interactions With LATUDA
(New
subsection added)
Based
on pharmacokinetic studies, no dosage adjustment of LATUDA is required when
administered concomitantly with lithium, substrates of P-gp, CYP3A4 or
valproate.
8
Use in Specific Populations
8.4 Pediatric Use
(subsection
revised, additions underlined)
The
safety and effectiveness of LATUDA in pediatric patients have not been
established. Antidepressants increased
the risk of suicidal thoughts and behaviors in pediatric patients.
Juvenile animal studies
Lurasidone
was orally administered to juvenile rats at doses of 3, 30, and 150 (males) or
300 (females) mg/kg/day which are 0.2 to 10 times (males) and 0.2 to 20 times
(females) the maximum recommended adult human dose (MRHD) of 160 mg/day (on
mg/m (squared) basis), from postnatal days 21 through 91 (this
period corresponds to childhood, adolescence, and young adulthood in
humans). Adverse effects were seen on
physical growth and development as well as on neurobehavior at doses as low as
0.2 times the MRHD on mg/m(suared) basis. These effects included dose-dependent
decreased in femoral length, bone mineral content, body and brain weights at 2
times the MRHD of 160 mg/day on mg/m(squared) basis in both sexes,
as well as motor hyperactivity in males and females at 2 and 0.2 times the
MRHD, respectively. In females, there
was a delay in attainment of sexual maturity at 2 times the MRHD, associated
with decreased serum estradiol.
Mortality occurred in both sexes during early post-weaning period and
some of the male weanlings died after only 4 treatments at doses as low as 2
times the MRHD of 160 mg/day on mg/m(squared) basis. Histopathological findings included increased
colloid in the thyroids and inflammation of the prostate in males at 10 times
MRHD of 160 mg/day on mg/m(squared) basis and mammary gland
hyperplasia, increased mucification of the vagina, and increased ovarian
atretic follicles in females at
doses as low as 0.2 times the MRHD of 160 mg/day on mg/m(squared)
basis. Some of these findings were
attributed to transiently elevated serum prolactin which was seen in both sexes
at all doses. However, there were no
deviations in reproductive parameters (fertility, conception indices,
spermatogenesis, estrous cycle, gestation length, parturition, number of pups
born) at any dose level. The no effect
dose for neurobehavioral changes (motor hyperactivity) in males is 3 mg/kg/day
which is 0.2 times the MHRD on mg/m2 basis and could not be determined in
females. The no effect dose for growth
and physical development for males and females is 3 mg/kg/day which is 0.2
times the MRHD of 160 mg/day on mg/m(squared) basis.
8.6 Renal Impairment
(New
subsection added)
Reduce
the maximum recommended dosage in patients with moderate or severe renal
impairment (CLcr<50 mL/minute). Patients with impaired renal function
(CLcr<50 mL/minute) had higher exposure to lurasidone than patients with
normal renal function. Greater exposure may increase the risk of
LATUDA-associated adverse reactions.
8.7 Hepatic Impairment
(New
subsection added)
Reduce
the maximum recommended dosage in patients with moderate to severe hepatic
impairment (Child-Pugh score greater than or equal to7). Patients with moderate
to severe hepatic impairment (Child-Pugh score greater than or equal to 7 )
generally had higher exposure to lurasidone than patients with normal hepatic
function. Greater exposure may increase the risk of LATUDA-associated adverse
reactions.
8.8 Other Specific Populations
(New
subsection added)
No
dosage adjustment for LATUDA is required on the basis of a patient’s sex, race,
or smoking status.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Extensive
revisions, please refer to label)
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