SCEMBLIX 40 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

ASCIMINIB AS HYDROCHLORIDE

Disponível em:

NOVARTIS ISRAEL LTD

Código ATC:

L01EA06

Forma farmacêutica:

FILM COATED TABLETS

Composição:

ASCIMINIB AS HYDROCHLORIDE 40 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Área terapêutica:

ASCIMINIB

Indicações terapêuticas:

SCEMBLIX is indicated for the treatment of adult patients with:• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).• Ph+ CML in CP with the T315I mutation

Data de autorização:

2023-04-30

Folheto informativo - Bula

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Patient leaflet in accordance with the Pharmacists’
Regulations )PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription only
Scemblix
®
20 mg
Scemblix
®
40 mg
Film-coated tablets
Active ingredient
Scemblix
20
mg:
e a c h
f i l m - c o a t e d
t a b l e t
c o n t a i n s
a s c i m i n i b
h y d r o c h l o r i d e ,
e q u i v a l e n t
t o
a s c i m i n i b
2 0
mg
Scemblix
40
mg:
e a c h
f i l m - c o a t e d
t a b l e t
c o n t a i n s
a s c i m i n i b
h y d r o c h l o r i d e ,
e q u i v a l e n t
t o
a s c i m i n i b
4 0
mg
I n a c t i v e
i n g r e d i e n t s
a n d
a l l e r g e n s
i n
t h e
m e d i c i n e
-
s e e
s e c t i o n
2
u n d e r
‘ I m p o r t a n t
i n f o r m a t i o n
a b o u t
s o m e
o f
t h i s
m e d i c i n e ’ s
i n g r e d i e n t s ’ ,
a n d
s e c t i o n
6
‘ A d d i t i o n a l
information’.
Read
the
entire
leaflet
carefully
before
you
start
using
this
m e d i c i n e .
T h i s
l e a f l e t
c o n t a i n s
c o n c i s e
i n f o r m a t i o n
a b o u t
t h i s
m e d i c i n e .
I f
y o u
h a v e
a n y
f u r t h e r
q u e s t i o n s ,
c o n s u l t
y o u r
d o c t o r
o r
pharmacist.
T h i s
m e d i c i n e
h a s
b e e n
p r e s c r i b e d
f o r
y o u .
D o
n o t
p a s s
i t
o n
t o
o t h e r s .
I t
m a y
h a r m
t h e m ,
e v e n
i f
i t
s e e m s
t o
y o u
t h a t
t h e i r
m e d i c a l
c o n d i t i o n
i s
s i m i l a r
t o
yours.
1. What is this medicine intended for?
For the treatment of adult patients with:
Philadelphia
chromosome-positive
chronic
myeloid
leukemia
)Ph+ CML( in chronic phase )CP(, previously treated with two or
more tyrosine kinase inhibitors )TKIs(.
Philadelphia
chromosome-positive
chronic
myeloid
leukemia
)Ph+ CML( in chronic phase )CP( with the T315I mutation.
THERAPEUTIC GROUP: Antineoplastic agents, tyrosine kinase inhibi

Características técnicas

SCE API DEC23 V4
FULL PRESCRIBING INFORMATION
SCEMBLIX 20 mg
SCEMBLIX 40 mg
Film coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
SCEMBLIX 20 mg: each film coated tablet contains 21.62 mg asciminib
hydrochloride, equivalent to 20 mg
asciminib.
Excipient with known effect
Each film-coated tablet contains 43 mg lactose monohydrate.
SCEMBLIX 40 mg: each film coated tablet contains 43.24 mg asciminib
hydrochloride, equivalent to 40 mg
asciminib.
Excipient with known effect
Each film-coated tablet contains 86 mg lactose monohydrate.
For the full list of excipients, see section 11.
1.
INDICATIONS AND USAGE
•
SCEMBLIX is indicated for the treatment of adult patients with:
Philadelphia chromosome-positive chronic
myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated
with two or more tyrosine kinase
inhibitors (TKIs).
•
Ph+ CML in CP with the T315I mutation.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosage in Patients with Ph+ CML-CP, Previously Treated
with Two or More TKIs
The recommended dose of SCEMBLIX is 80 mg taken orally once daily at
approximately the same time each day or 40
mg orally twice daily at approximately 12-hour intervals. The
recommended dose of SCEMBLIX is taken orally without
food. Avoid food consumption for at least 2 hours before and 1 hour
after taking SCEMBLIX
_[see Clinical Pharmacology _
_(12.2)]_
.
Continue treatment with SCEMBLIX as long as clinical benefit is
observed or until unacceptable toxicity occurs.
2.2
Recommended Dosage in Patients with Ph+ CML-CP with the T315I Mutation
The recommended dose of SCEMBLIX is 200 mg taken orally twice daily at
approximately 12-hour intervals. The
recommended dose of SCEMBLIX is taken orally without food. Avoid food
consumption for at least 2 hours before and 1
hour after taking SCEMBLIX
_[see Clinical Pharmacology (12.2)]_
.
2.3
Missed Dose
Once Daily Dosage Regimen: If a SCEMBLIX dose is missed by more than
approximately 12 hours, skip the dose and
take the next dose as scheduled.
Twice Daily Dosage Regimens: I
f a SCEMBLIX