Imatinib 400mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Imatinib mesilate

Available from:

Dr Reddy's Laboratories (UK

ATC code:

L01XE01

INN (International Name):

Imatinib mesilate

Dosage:

400mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1.
WHAT IMATINIB IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE IMATINIB
3.
HOW TO TAKE IMATINIB
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE IMATINIB
6.
CONTENTS OF THE PACK AND
OTHER INFORMATION
1.
WHAT IMATINIB IS AND WHAT IT IS
USED FOR
Imatinib capsules are 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 IS A TREATMENT FOR ADULTS AND
CHILDREN 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 inhibits the growth of these cells
IMATINIB IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE
DISEASES (MDS/MPD). These are a group
of blood diseases in which some blood
cells start growing out of control. Imatinib
inhibits the growth of these cells in a
certain subtype of these diseases
•
HYPEREOSINOPHILIC SYNDROME (HES)
AND/OR CHRONIC EOSINOPHILIC LEUKAEMIA
(CEL). These are blood diseases in which
some blood cells (named eosinophils) start
growing out of control. Imatinib inhibits the
growth of these cells in a certain subtype of
these diseases
•
DERMATOFIBROSARCOMA PROTUBERANS
(DFSP). DFSP is a cancer of the tissue
beneath the skin in which some cells start
growing out of control. Imatinib inhibits the
growth of these cells.
In the rest of this leaflet, we will use the
abbreviations when talking about
these diseases.
If you have any quest

Summary of Product characteristics

OBJECT 1
IMATINIB DR. REDDY'S 400MG CAPSULES, HARD
Summary of Product Characteristics Updated 19-Apr-2018 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Imatinib Dr. Reddy's 400 mg Capsules, Hard
2. Qualitative and quantitative composition
Each Imatinib 400 mg capsule contains 400 mg imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule (capsule)
Off-white to brownish yellow color granular powder in a very dark
yellow to brownish-orange opaque
capsule (size 00) imprinted with 'RDY' on cap and '400' on body with
red ink.
4. Clinical particulars
4.1 Therapeutic indications
Imatinib 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 is indicated for
- the treatment of adult patients with unresectable
dermatofibrosarcoma protuberans (DFSP) and adult
patients with recurrent and/or metastatic DFSP who are not eligible
for surgery.
In adult and paediatric patients, the effectiveness of imatinib is
based on overall haematological and
cytogenetic response rates and progression-fre