RIXIMYO rituximab (rch) 100mg/10mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rituximab, Quantity: 10 mg/mL

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium chloride; citric acid monohydrate; hydrochloric acid; water for injections; sodium hydroxide; polysorbate 80

Administration route:

Intravenous Infusion

Units in package:

2 vials of 10mL each, 3 vials of 10mL each

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Non-Hodgkin?s Lymphoma (NHL),RIXIMYO (rituximab) is indicated for treatment of patients with:,? CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin?s lymphoma,,? CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma,,? CD20 positive, diffuse large B-cell non-Hodgkin?s lymphoma, in combination with chemotherapy.,Chronic Lymphocytic Leukaemia (CLL),RIXIMYO (rituximab) is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,Rheumatoid Arthritis (RA),RIXIMYO (rituximab) 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 at least one tumour necrosis factor (TNF) inhibitor therapy. Rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,Granulomatosis with polyangiitis (Wegener?s) (GPA) and Microscopic polyangiitis (MPA),RIXIMYO (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener?s granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with rituximab have not been established.

Product summary:

Visual Identification: Clear, colourless to slightly yellowish solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2017-11-30

Patient Information leaflet

RIXIMYO-RA/GPA/MPA rix_imm211117c
1
RIXIMYO
_rituximab (rch) _
_FOR TREATMENT OF RHEUMATOID ARTHRITIS, GRANULOMATOSIS WITH
POLYANGIITIS, MICROSCOPIC POLYANGIITIS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RIXIMYO.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM WWW.TGA.GOV.AU
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT RIXIMYO IS USED
FOR
RIXIMYO contains the active
ingredient rituximab, which is a
monoclonal antibodies.
Monoclonal antibodies are proteins
which specifically recognise and bind
to other unique proteins in the body.
RIXIMYO is used to treat
rheumatoid arthritis (RA),
granulamatosis with polyangiitis
(Wegener’s or GPA) and
Microscopic polyangiitis (MPA).
RA is an inflammatory disease of the
joints, while GPA and MPA are
inflammatory diseases of the blood
vessels.
Rituximab works by binding to a
protein on the surface of certain
white blood cells known as B
lymphocytes, which play a role in
inflammation observed in RA, GPA
and MPA. By binding to the protein,
rituximab reduces the ability of B
lymphocytes to cause inflammation.
In RA, rituximab can also slow down
the damage to your joints and
improve your ability to do your
normal daily activities.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS A

Summary of Product characteristics

220412-riximyo-pi
1
AUSTRALIAN PRODUCT INFORMATION – RIXIMYO
®
(RITUXIMAB)
CONCENTRATED SOLUTION FOR INJECTION
WARNING
USE
OF
RIXIMYO
®
MAY
BE
ASSOCIATED
WITH
AN
INCREASED
RISK
OF
PROGRESSIVE
MULTIFOCAL
LEUKOENCEPHALOPATHY (PML), AN OPPORTUNISTIC VIRAL INFECTION OF THE
BRAIN THAT USUALLY LEADS TO
DEATH OR SEVERE DISABILITY. PATIENTS MUST BE MONITORED FOR ANY NEW OR
WORSENING NEUROLOGICAL
SYMPTOMS OR SIGNS SUGGESTIVE OF PML. IF SUCH SYMPTOMS OCCUR, FURTHER
ADMINISTRATION OF
RIXIMYO
® SHOULD BE IMMEDIATELY SUSPENDED UNTIL A DIAGNOSIS OF PML HAS BEEN
EXCLUDED. TO
ESTABLISH OR EXCLUDE A DIAGNOSIS OF PML EVALUATION INCLUDING MRI SCAN,
CSF TESTING FOR JC VIRAL DNA
AND REPEAT NEUROLOGICAL ASSESSMENTS, SHOULD BE CONSIDERED. IF A
DIAGNOSIS OF PML IS CONFIRMED,
RIXIMYO
® MUST BE PERMANENTLY DISCONTINUED (SEE SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE).
1
NAME OF THE MEDICINE
Rituximab
RIXIMYO
®
(rituximab) is a medicine biosimilar to MABTHERA
®
(rituximab).
The
comparability
of
RIXIMYO
®
with
MABTHERA
®
has
been
demonstrated
with
regard
to
physicochemical characteristics and pharmacology, efficacy and safety
outcomes [see Section 5.1
Pharmacodynamic
properties
–
CLINICAL
TRIALS
and
Section
4.8
Adverse
effects
(Undesirable
effects)]. The evidence for comparability supports the use of RIXIMYO
®
for the listed indications.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIXIMYO® is supplied at a concentration of 10 mg/mL in either 100 mg
(10 mL) or 500 mg (50 mL)
single-use vials.
Rituximab is a genetically engineered chimeric murine/human monoclonal
antibody directed against
the CD20 antigen found on the surface of normal and malignant B
lymphocytes. The chimeric anti-
CD20 antibody is produced by recombinant DNA technology in a mammalian
(Chinese hamster ovary)
cell expression system. The anti-CD20 antibody is purified by affinity
chromatography and ion
exchange, including specific viral inactivation and removal
procedures.
_Excipients with known effects:_ Riximyo contains 9.0 mg/mL of sodium
chloride as