ALUNBRIG 90 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

BRIGATINIB

Διαθέσιμο από:

TAKEDA ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

L01XE43

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

BRIGATINIB 90 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TAKEDA PHARMA A/S, DENMARK

Θεραπευτική περιοχή:

BRIGATINIB

Θεραπευτικές ενδείξεις:

ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)

Ημερομηνία της άδειας:

2023-10-31

Φύλλο οδηγιών χρήσης

TAKEDA ISRAEL LTD.
25
Efal st., P.O.B 4140, Petach-Tikva 4951125
Tel:[phone] Fax (local) : + 972-3-3733150
18.5.2023
/
,
/
/
,
: (
35334
)
ALUNBRIG 30 MG
ALUNBRIG 90 MG (35335)
FILM COATED TABLETS
"
.
:
ALUNBRIG IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH
ANAPLASTIC LYMPHOMA
KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)
:
30mg FCT, BRIGATINIB 90mg FCT
BRIGATINIB
)
, ,
(
: DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
3.3
ADVERSE REACTION
_ _
SEVERITY*
_ _
DOSAGE MODIFICATIONS
_ _
HEPATOTOXICITY (ELEVATION OF
ALANINE AMINOTRANSFERASE
(ALT) OR ASPARTATE
AMINOTRANSFERASE (AST))
[SEE WARNINGS AND
PRECAUTIONS (6.7)]
GRADE 3 OR 4 ELEVATION (GREATER
THAN 5 × ULN) OF EITHER ALT OR
AST WITH BILIRUBIN LESS THAN OR
EQUAL TO 2 × ULN
WITHHOLD ALUNBRIG UNTIL RECOVERY TO GRADE 1
OR LESS (LESS THAN OR EQUAL TO 3X ULN) OR TO
BASELINE, THEN RESUME ALUNBRIG AT NEXT
LOWER DOSE (TABLE 1). GRADE 2 TO 4 ELEVATION (GREATER
THAN 3 × ULN) OF ALT OR AST WITH
CONCURRENT TOTAL BILIRUBIN
ELEVATION GREATER THAN 2 × ULN IN
THE ABSENCE OF CHOLESTASIS OR
HEMOLYSIS
PERMANENTLY DISCONTINUE ALUNBRIG.
…
.
TAKEDA ISRAEL LTD.
25
Efal st., P.O.B 4140, Petach-Tikva 4951125
Tel:[phone] Fax (local) : + 972-3-3733150 6.7 HEPATOTOXICITY
In ALTA 1L, aspartate aminotransferase (AST) elevations occurred in
72% of
patients and Grade 3 or 4 AST elevations occurred in 4.5% of patients.
Alanine
aminotransferase (ALT) elevations occurred in 52% of patients and
Grade 3 or
4 ALT elevations occurred in 5.2% of patients. One patient (0.7%) had
a
serious adverse reaction of hepatocellular injury.
In ALTA, AST elevations occurred in 38% of patients in the 90 mg group
and
65% of patients in the 90→180 mg group
. ALT elevations occurred in 34% of
patients in the 90 mg group and
40% of patients in the 90→180 mg group.
Grade 3 or 4 AST elevations occurred in 0.9% of patients in the 90 mg
group
and did not occur in any patients i
n the 90→180 mg group. Grade 3 or 4 ALT
elevations did not occur in any patients in the 90 mg

Αρχείο Π.Χ.Π.

1
1
NAME OF THE MEDICINAL PRODUCT
ALUNBRIG
®
30 MG
ALUNBRIG
®
90 MG
Brigatinib Film-Coated Tablets, for oral use.
2
THERAPEUTIC INDICATIONS
ALUNBRIG is indicated for the treatment of adult patients with
anaplastic lymphoma kinase (ALK)-
positive metastatic non-small cell lung cancer (NSCLC).
3
DOSAGE AND ADMINISTRATION
3.1 PATIENT SELECTION
Select patients for the treatment of metastatic NSCLC with ALUNBRIG
based on the presence of ALK
positivity in tumor specimens _[see Clinical Studies (13)]_.
3.2 RECOMMENDED DOSAGE
The recommended dosage for ALUNBRIG is:
•
90 mg orally once daily for the first 7 days; then increase the dose
to 180 mg orally once daily.
Administer ALUNBRIG until disease progression or unacceptable
toxicity.
If ALUNBRIG is interrupted for 14 days or longer for reasons other
than adverse reactions, resume
treatment at 90 mg once daily for
7 days before increasing to the previously tolerated dose.
ALUNBRIG may be taken with or without food. Instruct patients to
swallow tablets whole. Do not crush or
chew tablets, as the tablets are film-coated.
If a dose of ALUNBRIG is missed or vomiting occurs after taking a
dose, do not administer an additional
dose and take the next dose of ALUNBRIG at the scheduled time.
3.3 DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
ALUNBRIG dosage reductions for adverse reactions are summarized in
Table 1.
TABLE 1: RECOMMENDED ALUNBRIG Dosage reductions
DOSAGE
DOSAGE REDUCTION
FIRST
SECOND
THIRD
90 mg once daily
60 mg once daily
permanently
N/A
*
180 mg once daily
120 mg once daily
90 mg once daily
60 mg once daily
*
*Not applicable
Once reduced for adverse reactions, do not subsequently
increase the dosage of
ALUNBRIG.
Permanently discontinue ALUNBRIG if
patients are unable to tolerate the 60 mg once daily dose.
Recommendations for dosage modifications of ALUNBRIG for the
management of adverse reactions are
provided in Table 2.
TABLE 2: RECOMMENDED ALUNBRIG DOSAGE MODIFICATIONS FOR ADVERSE
REACTIONS
ADVERSE REACTION
SEVERITY*
DOSAGE MODIFICATIONS
2
Interstitial
Lung
Dis