Venclyxto
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
05-03-2018
Charakterystyka produktu
(SPC)
05-03-2018
Sprawozdanie z oceny publicznego
(PAR)
21-12-2016
Składnik aktywny:
venetoclax
Dostępny od:
AbbVie Ltd
Kod ATC:
L01XX52
INN (International Nazwa):
venetoclax
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Leukemia, Lymphocytic, Chronic, B-Cell
Wskazania:
Venclyxto monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor.
Status autoryzacji:
Authorised
Data autoryzacji:
2016-12-05
Ulotka dla pacjenta
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VENCLYXTO 10 MG FILM-COATED TABLETS
VENCLYXTO 50 MG FILM-COATED TABLETS
VENCLYXTO 100 MG FILM-COATED TABLETS
venetoclax
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Venclyxto is and what it is used for
2.
What you need to know before you take Venclyxto
3.
How to take Venclyxto
4.
Possible side effects
5.
How to store Venclyxto
6.
Contents of the pack and other information
1.
WHAT VENCLYXTO IS AND WHAT IT IS USED FOR
WHAT VENCLYXTO IS
Venclyxto is a cancer medicine that contains the active substance
venetoclax. It belongs to a group of
medicines called “BCL-2 inhibitors”.
WHAT VENCLYXTO IS USED FOR
Venclyxto is used to treat patients with chronic lymphocytic leukaemia
(CLL) with or without certain
changes called “17p deletion” or “_TP53_ mutation” in their
genes.
For CLL with “17p deletion” or “_TP53_ mutation”, this
medicine is used to treat patients who are
unsuitable for or have been treated with one or more other types of
medicines for their disease.
For CLL without “17p deletion” or _“TP53_ mutation”, this
medicine is used to treat patients who
have been treated with two or more other types of medicines for their
disease.
CLL is a type of cancer affecting white blood
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Venclyxto 10 mg film-coated tablets
Venclyxto 50 mg film-coated tablets
Venclyxto 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Venclyxto 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of venetoclax.
Venclyxto 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of venetoclax.
Venclyxto 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of venetoclax.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Venclyxto 10 mg film-coated tablet
Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with
V on one side and 10 on the other.
Venclyxto 50 mg film-coated tablet
Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed
with V on one side and 50 on the
other.
Venclyxto 100 mg film-coated tablet
Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide
debossed with V on one side and
100 on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Venclyxto monotherapy is indicated for the treatment of chronic
lymphocytic leukaemia (CLL) in the
presence of 17p deletion or _TP53_ mutation in adult patients who are
unsuitable for or have failed a B-cell
receptor pathway inhibitor.
Venclyxto monotherapy is indicated for the treatment of CLL in the
absence of 17p deletion or _TP53_
mutation in adult patients who have failed both chemoimmunotherapy and
a B-cell receptor pathway
inhibitor.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with venetoclax should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
Posology
The starting dose is 20 mg of venetoclax once daily for 7 days. T
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