Bosulif

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

bosutinib (as monohydrate)

MAH:

Pfizer Europe MA EEIG

ATC_code:

L01XE14

INN:

bosutinib

therapeutic_group:

Antineoplastic agents, Protein kinase inhibitors

therapeutic_area:

Leukemia, Myeloid

therapeutic_indication:

Bosulif is indicated for the treatment of adult patients with:newly‑diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

leaflet_short:

Revision: 24

authorization_status:

Authorised

authorization_date:

2013-03-27

PIL

47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSULIF 100 MG FILM-COATED TABLETS
BOSULIF 400 MG FILM-COATED TABLETS
BOSULIF 500 MG FILM-COATED TABLETS
bosutinib
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 or pharmacist.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bosulif is and what it is used for
2.
What you need to know before you take Bosulif
3.
How to take Bosulif
4.
Possible side effects
5.
How to store Bosulif
6.
Content of the pack and other information
1.
WHAT BOSULIF IS AND WHAT IT IS USED FOR
Bosulif contains the active substance bosutinib. It is used to treat
adult patients who have a type of
leukaemia called Philadelphia chromosome-positive (Ph-positive)
Chronic Myeloid Leukaemia
(CML) and are newly-diagnosed or for whom previous medicines to treat
CML have either not worked
or are not suitable. Ph-positive CML is a cancer of the blood which
makes the body produce too many
of a specific type of white blood cell called granulocytes.
If you have any questions about how Bosulif works or why this medicine
has been prescribed for you,
ask your doctor.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE BOSULIF
DO NOT TAKE BOSULIF
-
if you are allergic to bosutinib or any of the other ingredients of
this medicine (listed in
section 6).
-
if your doctor has told you that your liver has been damaged and is
not working normally.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Bosulif:
-
IF YOU HAVE, OR HAVE HAD IN THE PAST, LIVER PROBLEMS. Tell your doctor
if you have a history of
liver problems including hepatitis

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bosulif 100 mg film-coated tablets
Bosulif 400 mg film-coated tablets
Bosulif 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosulif 100 mg film-coated tablets
Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Bosulif 400 mg film-coated tablets
Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Bosulif 500 mg film-coated tablets
Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Bosulif 100 mg film-coated tablets
Yellow oval (width: 5.6 mm; length: 10.7 mm) biconvex, film-coated
tablet debossed with “Pfizer” on
one side and “100” on the other side.
Bosulif 400 mg film-coated tablets
Orange oval (width: 8.8 mm; length: 16.9 mm) biconvex, film-coated
tablet debossed with “Pfizer” on
one side and “400” on the other side.
Bosulif 500 mg film-coated tablets
Red oval (width: 9.5 mm; length: 18.3 mm) biconvex, film-coated tablet
debossed with “Pfizer” on
one side and “500” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bosulif is indicated for the treatment of adult patients with:

newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive
chronic myelogenous
leukaemia (Ph+ CML).

CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously
treated with one or
more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib,
nilotinib and dasatinib are
not considered appropriate treatment options.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
diagnosis and the treatment of patients
with CML.
3
Posology
_Newly-diagnosed CP Ph+ CML_
The recommended dose is 400 mg bosutinib once daily.
_CP, AP, or BP Ph+ CML with resistance or intolerance to prior
therapy_
The recommended dose is 500 mg bosutinib once daily.
In clinical trials for both indications, trea