Dasatinib Clonmel 100 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dasatinib

Available from:

Clonmel Healthcare Ltd

ATC code:

L01EA02

INN (International Name):

Dasatinib

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

dasatinib

Authorization status:

Marketed

Authorization date:

2020-03-06

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE
USER
DASATINIB CLONMEL 20 MG FILM-COATED
TABLETS
DASATINIB CLONMEL 50 MG FILM-COATED
TABLETS
DASATINIB CLONMEL 70 MG FILM-COATED
TABLETS
DASATINIB CLONMEL 100 MG FILM-COATED T
ABLETS
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 Dasatinib Clonmel is and what it is used for
2.
What you need to know before you take Dasatinib Clonmel
3.
How to take Dasatinib Clonmel
4.
Possible side effects
5.
How to store Dasatinib Clonmel
6.
Contents of the pack and other information
1.
WHAT DASATINIB CLONMEL IS AND WHAT IT IS USED FOR
Dasatinib Clonmel is used to treat Philadelphia chromosome positive
(Ph+) acute lymphoblastic
leukaemia (ALL) in adults who are not benefiting from prior therapies,
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 ALL, white cells called lymphocytes
multiply too quickly and live too
long. Dasatinib Clonmel inhibits the growth of these leukaemic cells.
If you have any questions about how Dasatinib Clonmel works or why
this medicine has been prescribed
for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DASATINIB CLONMEL
DO NOT TAKE DASATINIB CLONMEL
•
if you are
ALLERGIC
to dasatinib or any of the other ingredients of this medicine (listed
in section 6).
IF YOU COULD BE ALLERGIC
,
ASK YOUR DOCTOR FOR ADVICE
.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using D

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2023
CRN00D79T
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dasatinib Clonmel 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg dasatinib.
_Excipient with known effect_
Each film-coated tablet contains 138 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white, biconvex, oval film-coated tablet with "100"
debossed on one side and plain on the other, with dimensions
14.8 mm x 7.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dasatinib Clonmel is indicated for the treatment of adult patients
with:

Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance
to prior therapy.
Dasatinib Clonmel is indicated for the treatment of paediatric
patients with:

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.
Posology
_Adult patients_
The recommended starting dose for Ph+ ALL is 140 mg once daily (see
section 4.4).
_Paediatric population (Ph+ ALL)_
Dosing for children and adolescents is on the basis of body weight
(see Table 1). Dasatinib is administered orally once daily in
the form of either dasatinib film-coated tablets or dasatinib powder
for oral suspension (see Summary of Product
Characteristics for dasatinib powder for oral suspension). The dose
should be recalculated every 3 months based on changes in
body weight, or more often if necessary. The tablet is not recommended
for patients weighing less than 10 kg; the powder for
oral suspension should be used for these patients. Dose increase or
reduction is recommended based on individual patient
response and tolerability. There is no experience with dasatinib
treatment in children under 1 year of age.
Patients who are able to swallow tablets and who de