REXULTI 1 MG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

BREXPIPRAZOLE

זמין מ:

LUNDBECK ISRAEL LTD.

קוד ATC:

N05AX16

טופס פרצבטיות:

FILM COATED TABLETS

הרכב:

BREXPIPRAZOLE 1 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

H. LUNDBECK A/S, DENMARK

איזור תרפויטי:

BREXPIPRAZOLE

סממני תרפויטית:

REXULTI is indicated for:- As adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults- For treatment of schizophrenia in adults and pediatric patients ages 13 years and older.

תאריך אישור:

2020-01-16

עלון מידע

PATIENT LEAFLET IN ACCORDANCE WITH PHARMACIST’S REGULATIONS
(PREPARATIONS) 1986
The medicine is marketed according to doctor’s prescription only.
REXULTI 0.5 MG, REXULTI 1 MG, REXULTI 2 MG, REXULTI 3 MG, REXULTI 4 MG
FILM COATED TABLETS
COMPOSITION
Each film coated tablet of Rexulti contains the active ingredient:
Rexulti 0.5 mg: Brexpiprazole 0.5 mg
Rexulti 1 mg: Brexpiprazole 1 mg
Rexulti 2 mg: Brexpiprazole 2 mg
Rexulti 3 mg: Brexpiprazole 3 mg
Rexulti 4 mg: Brexpiprazole 4 mg
INACTIVE INGREDIENTS
See section 6.
- READ THE LEAFLET CAREFULLY UNTIL THE END BEFORE USING THE
MEDICATION. This leaflet
contains concise information about the medicine. If you have further
questions, refer to the
doctor or the pharmacist.
- This medicine was prescribed for you. Do not pass it on to others.
It may harm them even
if their ailment/ medical condition seems similar to yours.
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. REXULTI IS NOT INTENDED FOR THE TREATMENT
IN CASES OF
DEMENTIA-RELATED PSYCHOSIS.
SUICIDAL THOUGHTS AND BEHAVIORS
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN YOUNG PATIENTS
AGED UP TO 24 YEARS IN SHORT-TERM STUDIES. MONITOR CLOSELY FOR
CLINICAL WORSENING AND FOR
EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. REXULTI IS NOT INTENDED
FOR CHILDREN.
1. WHAT IS THE MEDICINE FOR?
REXULTI is intended for the treatment of adults with:
•
Major depressive disorder (MDD) in combination with antidepressant
medicines.
•
Schizophrenia.
THERAPEUTIC GROUP: atypical antipsychotic drugs
2. BEFORE USING THE MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
REXULTI MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
•
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS. REXULTI IS
NOT INTENDED FOR THE TREATMENT IN CASES OF DEMENTIA-RELATED PSYCHOSIS. (see framed
warning at the beginning of the leaflet)
•
RISK OF SUICIDAL THOUGHT

מאפייני מוצר

REXULTI® 0.5 MG (BREXPIPRAZOLE 0.5 MG FILM COATED TABLETS)
REXULTI® 1 MG (BREXPIPRAZOLE 1 MG FILM COATED TABLETS)
REXULTI® 2 MG (BREXPIPRAZOLE 2 MG FILM COATED TABLETS)
REXULTI® 3 MG (BREXPIPRAZOLE 3 MG FILM COATED TABLETS)
REXULTI® 4 MG (BREXPIPRAZOLE 4 MG FILM COATED TABLETS)
WARNING: 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. REXULTI IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS _[SEE WARNINGS _
_AND PRECAUTIONS (5.1)]_.
SUICIDAL THOUGHTS AND BEHAVIORS
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
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 REXULTI HAVE NOT BEEN ESTABLISHED IN
PEDIATRIC PATIENTS WITH MDD _[SEE WARNINGS _
_AND PRECAUTIONS (5.2)_, _USE IN SPECIFIC POPULATIONS (8.4)]_.
1 INDICATIONS AND USAGE
REXULTI is indicated for:
•
As adjunctive therapy to antidepressants for the treatment of major
depressive disorder (MDD) in adults.
•
For treatment of schizophrenia in adults and pediatric patients ages
13 years and older.
2 DOSAGE AND ADMINISTRATION
2.1 ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (ADULTS)
The recommended starting dosage for REXULTI as adjunctive treatment of
MDD in adults is 0.5 mg or 1 mg once daily,
taken orally with or without food_ [see Clinical Pharmacology
(12.3)]._
Titrate to 1 mg once daily, then up to the target dosage of 2 mg once
daily. Dosage increases should occur at weekly intervals
based on the patient’s clinical response and tolerability. The
maximum recommended daily dosage is 3 mg. Periodically
reassess to determine the continued need and appropriate dosage for
treatment.
2.2
TREATMENT OF SCHIZOPHRENIA (ADULTS AND P