Daurismo

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

Glasdegib maleate

Disponível em:

Pfizer Europe MA EEIG

Código ATC:

L01XX63

DCI (Denominação Comum Internacional):

glasdegib

Grupo terapêutico:

Antineoplastic agents

Área terapêutica:

Leukemia, Myeloid, Acute

Indicações terapêuticas:

Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.

Resumo do produto:

Revision: 4

Status de autorização:

Authorised

Data de autorização:

2020-06-26

Folheto informativo - Bula

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DAURISMO 25 MG FILM-COATED TABLETS
DAURISMO 100 MG FILM-COATED TABLETS
glasdegib
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, pharmacist or
nurse.
-
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 Daurismo is and what it is used for
2.
What you need to know before you take Daurismo
3.
How to take Daurismo
4.
Possible side effects
5.
How to store Daurismo
6.
Contents of the pack and other information
1.
WHAT DAURISMO IS AND WHAT IT IS USED FOR
Daurismo is a cancer medicine containing the active substance
glasdegib.
Daurismo is used with another cancer medicine, cytarabine, to treat
adults newly diagnosed with a
blood cancer called acute myeloid leukaemia (AML).
HOW DAURISMO WORKS
In AML, cancer cells called stem cells constantly make new leukaemic
cancer cells. Daurismo works
by blocking a key process in these stem cells, called the Hedgehog
(Hh) pathway. This reduces their
ability to make new cancer cells. By blocking the Hh pathway, Daurismo
can also make cancer cells
more sensitive to a cancer medicine, cytarabine, used to treat AML.
Combining Daurismo with the
medicine cytarabine may increase how long patients are likely to live
by decreasing growth of the
cancer and possibly by increasing cancer cell death.
If you have any questions about how Daurismo

Características técnicas

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
Daurismo 25 mg film-coated tablets
Daurismo 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daurismo 25 mg film-coated tablets
Each film-coated tablet contains glasdegib maleate equivalent to 25 mg
of glasdegib.
_Excipient with known effect_
Each film-coated tablet contains 1.3 mg of lactose monohydrate.
Daurismo 100 mg film-coated tablets
Each film-coated tablet contains glasdegib maleate equivalent to 100
mg of glasdegib.
_Excipient with known effect_
Each film-coated tablet contains 5.0 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Daurismo 25 mg film-coated tablets
7 mm round, yellow film-coated tablet debossed with “Pfizer” on
one side and “GLS 25” on the other
side.
Daurismo 100 mg film-coated tablets
11 mm round, pale orange film-coated tablet debossed with “Pfizer”
on one side and “GLS 100” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daurismo is indicated, in combination with low-dose cytarabine, for
the treatment of newly diagnosed
_de novo_ or secondary acute myeloid leukaemia (AML) in adult patients
who are not candidates for
standard induction chemotherapy.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Daurismo should only be prescribed by or under the supervision of a
physician experienced in the use
of anticancer medicinal products.
Posology
The recommended dose is 100 mg glasdegib once daily in combination
with low-dose cytarabine (see
section 5.1). Glasdegib should be continued as long as the patient is
deriving clinical benefit.
_Delayed or missed doses of glasdegib_
If a dose is vomited, a replacement dose should not be ad