Truxima

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

rituximab

Available from:

Celltrion Healthcare Hungary Kft.

ATC code:

L01FA01

INN (International Name):

rituximab

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis

Therapeutic indications:

Truxima is indicated in adults for the following indications:Non-Hodgkin’s lymphoma (NHL)Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy.Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.Chronic lymphocytic leukaemia (CLL)Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy.Rheumatoid arthritisTruxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.Truxima has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with methotrexate.Granulomatosis with polyangiitis and microscopic polyangiitisTruxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).Pemphigus vulgarisTruxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Product summary:

Revision: 20

Authorization status:

Authorised

Authorization date:

2017-02-17

Patient Information leaflet

69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRUXIMA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
TRUXIMA 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
READ 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.
•
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 Truxima is and what it is used for
2.
What you need to know before you use Truxima
3.
How to use Truxima
4.
Possible side effects
5.
How to store Truxima
6.
Contents of the pack and other information
1.
WHAT TRUXIMA IS AND WHAT IT IS USED FOR
WHAT TRUXIMA IS
Truxima contains the active substance “rituximab”. This is a type
of protein called a “monoclonal
antibody”. It sticks to the surface of a type of white blood cell
called “B-Lymphocyte”. When
rituximab sticks to the surface of this cell, the cell dies.
WHAT TRUXIMA IS USED FOR
Truxima may be used for the treatment of several different conditions
in adults and children. Your
doctor may prescribe Truxima for the treatment of:
A)
NON-HODGKIN’S LYMPHOMA
This is a disease of the lymph tissue (part of the immune system) that
affects a type of white blood cell
called B-Lymphocytes.
In adults, Truxima can be given alone or with other medicines called
“chemotherapy”.
In adult patients where the treatment is working, Truxima may be used
as a maintenance treatment
for 2 years after completing the initial treatment.
In children and adolescents, Truxima is given in combination with
“chemotherapy”.
B)
CHRONIC LYMPHOCYTIC LEUKAEMIA
Chronic lymphocytic leukaemia (CLL) is the most common form of adult
leukaemia. CLL affects a
particular lymphocyte, the B cell, which originates from the bone
marrow and develops in the lymph
nodes. Patients with

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Truxima 100 mg concentrate for solution for infusion
Truxima 500 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Truxima 100mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Truxima 500 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 50 mL vial contains 500 mg of rituximab.
Rituximab is a genetically engineered chimeric mouse/human monoclonal
antibody representing a
glycosylated immunoglobulin with human IgG1 constant regions and
murine light-chain and heavy-chain
variable region sequences. The antibody is produced by mammalian
(Chinese hamster ovary) cell
suspension culture and purified by affinity chromatography and ion
exchange, including specific viral
inactivation and removal procedures.
Excipients with known effects
Each 10 mL vial contains 2.3 mmol (52. 6 mg) sodium.
Each 50 mL vial contains 11.5 mmol (263.2 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless liquid with pH of 6.3 – 6.8 and osmolality of 329
- 387 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Truxima is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Truxima is indicated for the treatment of previously untreated adult
patients with stage III-IV follicular
lymphoma in combination with chemotherapy.
Truxima maintenance therapy is indicated for the treatment of adult
follicular lymphoma patients
responding to induction therapy.
Truxima monotherapy is indicated for treatment of adult patients with
stage III-IV follicular lymphoma
who are chemo-resistant or are in their second or subsequent relapse
after chemotherapy.
Truxima is indicated for the treatment of adult patients with CD20
positive diffuse large B cell
non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide,
d