Mubucho 63 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dasatinib

Available from:

Zentiva k.s.

ATC code:

L01XE06

INN (International Name):

Dasatinib

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

dasatinib

Authorization status:

Not marketed

Authorization date:

2022-11-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MUBUCHO 16 MG FILM-COATED TABLETS
MUBUCHO 40 MG FILM-COATED TABLETS
MUBUCHO 55 MG FILM-COATED TABLETS
MUBUCHO 63 MG FILM-COATED TABLETS
MUBUCHO 79 MG FILM-COATED TABLETS
MUBUCHO 111 MG FILM-COATED TABLETS
dasatinib
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mubucho is and what it is used for
2. What you need to know before you take Mubucho
3. How to take Mubucho
4. Possible side effects
5. How to store Mubucho
6. Contents of the pack and other information
1.
WHAT MUBUCHO IS AND WHAT IT IS USED FOR
Mubucho contains the active substance dasatinib. This medicine is used
to treat chronic
myeloid leukaemia (CML) in adults, adolescents and children at least 1
year of age. Leukaemia
is a cancer of white blood cells. These white cells usually help the
body to fight infection.
In people with CML, white cells called granulocytes start growing out
of control. Mubucho
inhibits the growth of these leukaemic cells.
Mubucho is also used to treat Philadelphia chromosome positive (Ph+)
acute lymphoblastic
leukaemia (ALL) in adults, adolescents and children at least 1 year of
age, and lymphoid blast
CML in adults who are not benefiting from prior therapies. In people
with ALL, white cells
called lymphocytes multiply too quickly and live too long. Mubucho
inhibits the growth
of these leukaemic cells.
If you have any questions about how Mubucho works or why this medicine
has been prescribed
for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUBU

Summary of Product characteristics

Health⎯Products⎯Regulatory⎯Authority
06⎯January⎯2023
CRN00D6HT
Page⎯1⎯of⎯29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mubucho⎯63⎯mg⎯film-coated⎯tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each⎯film-coated⎯tablet⎯contains⎯63.2⎯mg⎯dasatinib⎯(anhydrous).
Excipient⎯with⎯known⎯effect:⎯Each⎯film-coated⎯tablet⎯contains⎯85⎯mg⎯lactose⎯monohydrate.
For⎯the⎯full⎯list⎯of⎯excipients,⎯see⎯section⎯6.1.
3 PHARMACEUTICAL FORM
Film-coated⎯tablet.
White⎯to⎯off-white⎯round⎯film-coated⎯tablets⎯with⎯"63.2"⎯embossed⎯on⎯one⎯side⎯with⎯the
diameter⎯of⎯8.5⎯mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mubucho
⎯is⎯indicated⎯for⎯the⎯treatment⎯of⎯paediatric⎯patients⎯with:

Newly⎯diagnosed⎯Philadelphia⎯chromosome⎯positive⎯(Ph+)⎯chronic⎯myelogenous⎯leukaemia⎯(CML)⎯in⎯the⎯chronic⎯
phase⎯(CML-CP).

Chronic,⎯accelerated⎯or⎯blast⎯phase⎯CML⎯with⎯resistance⎯or⎯intolerance⎯to⎯prior⎯therapy⎯including⎯imatinib.

Ph+⎯acute⎯lymphoblastic⎯leukaemia⎯(ALL)⎯and⎯lymphoid⎯blast⎯CML⎯with⎯resistance⎯or
intolerance⎯to⎯prior⎯therapy.
Mubucho⎯is⎯indicated⎯for⎯the⎯treatment⎯of⎯paediatric⎯patients⎯with:

Newly⎯diagnosed⎯Ph+⎯CML⎯in⎯chronic⎯phase⎯(Ph+⎯CML-CP)⎯or⎯Ph+⎯CML-CP⎯resistant⎯or
intolerant⎯to⎯prior⎯therapy⎯
including⎯imatinib.

Newly⎯diagnosed⎯Ph+⎯ALL⎯in⎯combination⎯with⎯chemotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy⎯should⎯be⎯initiated⎯by⎯a⎯physician⎯experienced⎯in⎯the⎯diagnosis⎯and⎯treatment⎯of⎯patients⎯with⎯leukaemia.
MUBUCHO HAS A HIGHER BIOAVAILABILITY THAN OTHER DASATINIB-CONTAINING
PRODUCTS AND CANNOT BE USED INTERCHANGEABLY
WITH OTHER DASATINIB FORMULATIONS (SEE SECTION 4.4).⎯The
dose⎯of⎯Mubucho⎯have⎯been⎯reduced⎯by
21%⎯compared⎯to⎯other⎯
dasatinib⎯produ