Ruxience

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

rituximab

Saadav alates:

Pfizer Europe MA EEIG 

ATC kood:

L01XC02

INN (Rahvusvaheline Nimetus):

rituximab

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus

Näidustused:

Ruxience is indicated in adults for the following indications:Non‑Hodgkin’s lymphoma (NHL)Ruxience is indicated for the treatment of previously untreated patients with stage III‑IV follicular lymphoma in combination with chemotherapy.Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Ruxience monotherapy is indicated for treatment of patients with stage III‑IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.Ruxience 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)Ruxience 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 rituximab or patients refractory to previous rituximab plus chemotherapy.Rheumatoid arthritisRuxience 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.Ruxience 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 polyangiitisRuxience, 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 vulgarisRuxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Toote kokkuvõte:

Revision: 11

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-04-01

Infovoldik

70
B. PACKAGE LEAFLET
71
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RUXIENCE 100
MG CONCENTRATE FOR SOLUTION FOR INFUSION
RUXIENCE 500
MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Ruxience is and what it is used for
2.
What you need to know before you use Ruxience
3.
How to use Ruxience
4.
Possible side effects
5.
How to store Ruxience
6.
Contents of the pack and other information
1.
WHAT RUXIENCE IS AND WHAT IT IS USED FOR
WHAT RUXIENCE IS
Ruxience 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 RUXIENCE IS USED FOR
Ruxience may be used for the treatment of several different conditions
in adults and children. Your
doctor may prescribe Ruxience 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 Ruxience can be given alone or with other medicines called
“chemotherapy”.
In adult patients where the treatment is working, Ruxience may be used
as a maintenance treatment for
2 years after completing the initial treatment.
In children and adolescents, Ruxience is given in combination with
“chemotherapy”.
B

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Ruxience 100 mg concentrate for solution for infusion
Ruxience 500 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ruxience 100 mg concentrate for solution for infusion
Each mL contains 10 mg of rituximab.
Each 10 mL vial contains 100 mg of rituximab.
Ruxience 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.
Excipient with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale brownish-yellow
liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ruxience is indicated in adults for the following indications:
Non-Hodgkin’s lymphoma (NHL)
Ruxience is indicated for the treatment of previously untreated adult
patients with stage III-IV
follicular lymphoma in combination with chemotherapy.
Ruxience maintenance therapy is indicated for the treatment of adult
follicular lymphoma patients
responding to induction therapy.
Ruxience monotherapy is indicated for treatment of adult patients with
stage III-IV follicular
lymphoma who are chemoresist