Imatinib Accord
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
14-12-2022
Summary of Product characteristics
(SPC)
14-12-2022
Public Assessment Report
(PAR)
19-07-2017
Active ingredient:
imatinib
Available from:
Accord Healthcare S.L.U.
ATC code:
L01EA01
INN (International Name):
imatinib
Therapeutic group:
imatinib
Therapeutic area:
Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Therapeutic indications:
Imatinib Accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.- adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.- adult patients with relapsed or refractory Ph+ ALL as monotherapy.- adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.- adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.- adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.- the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).- the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatmentThe effect of imatinib on the outcome of bone marrow transplantation has not been determined.In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Product summary:
Revision: 20
Authorization status:
Authorised
Authorization date:
2013-06-30
Patient Information leaflet
48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB ACCORD 100 MG FILM-COATED TABLETS
IMATINIB ACCORD 400 MG FILM-COATED TABLETS
imatinib
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 Imatinib Accord is and what it is used for
2.
What you need to know before you take Imatinib Accord
3.
How to take Imatinib Accord
4.
Possible side effects
5.
How to store Imatinib Accord
6.
Contents of the pack and other information
1.
WHAT IMATINIB ACCORD IS AND WHAT IT IS USED FOR
Imatinib Accord is a medicine containing an active substance called
imatinib. This medicine works by
inhibiting the growth of abnormal cells in the diseases listed below.
These include some types of
cancer.
IMATINIB ACCORD IS A TREATMENT FOR ADULTS AND CHILDREN AND ADOLESCENTS
FOR:
−
CHRONIC MYELOID LEUKAEMIA (CML).
Leukaemia is a cancer of white blood cells. These white
cells usually help the body to fight infection. Chronic myeloid
leukaemia is a form of leukaemia
in which certain abnormal white cells (named myeloid cells) start
growing out of control.
−
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL)
.
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight
infection. Acute lymphoblastic leukaemia is a form of leukaemia in
which certain abnormal
white cells (named lymphoblasts) start growing out of control.
Imatinib Accord inhibits the
growth of these cells.
IMATINIB ACCORD IS A TREATMENT FOR ADULTS FOR:
−
MYELODYSPLAS
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF MEDICINAL PRODUCT
Imatinib Accord 100 mg film-coated tablets
Imatinib Accord 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_ _
Imatinib Accord 100 mg film-coated tablets
Brownish orange, round, biconvex, film-coated tablets, debossed on one
side with ‘IM’ and ‘T1’ on
either side of breakline and plain on the other side.
Imatinib Accord 400 mg film-coated tablets
Brownish orange, oval shaped, biconvex, film-coated tablets, debossed
on one side with ‘IM’ and ‘T2’
on either side of breakline and plain on the other side.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imatinib Accord is indicated for the treatment of
•
adult and paediatric patients with newly diagnosed Philadelphia
chromosome (bcr-abl) positive
(Ph+) chronic myeloid leukaemia (CML) for whom bone marrow
transplantation is not
considered as the first line of treatment.
•
adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha
therapy, or in accelerated phase or blast crisis.
•
Adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive acute
lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
•
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
•
adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with
platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
•
adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic
leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
The effect of imatinib on the outcome of bone marrow transplantation
has not been determined.
Imatinib Accord is indicated for
•
th
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