RoActemra 162mg0.9ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tocilizumab

Available from:

Roche Products Ltd

ATC code:

L04AC07

INN (International Name):

Tocilizumab

Dosage:

180mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

1
uk-ie-mt-pil-RoActemra-clean-180412-162mg-pfs
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROACTEMRA 162 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Tocilizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 onto
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.
In addition to this leaflet, you will be given a PATIENT ALERT CARD,
which contains important safety
information that you need to be aware of before and during treatment
with RoActemra.
WHAT IS IN THIS LEAFLET:
1.
WHAT ROACTEMRA IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ROACTEMRA
3.
HOW TO USE ROACTEMRA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ROACTEMRA
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ROACTEMRA IS AND WHAT IT IS USED FOR
RoActemra contains the active substance tocilizumab, which is a
protein made from specific immune
cells (monoclonal antibody), that blocks the action of a specific
protein (cytokine) called interleukin-6.
This protein is involved in inflammatory processes of the body, and
blocking it can reduce the
inflammation in your body. RoActemra is used to treat:
•
ADULTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS (RA), an
autoimmune disease, if
previous therapies did not work well enough.
•
ADULTS WITH SEVERE, ACTIVE AND PROGRESSIVE RHEUMATOID ARTHRITIS (RA),
who have not had
previous treatment with methotrexate.
RoActemra helps to reduce RA symptoms such as pain and swelling in
your joints, and can also
improve your performance of daily tasks. RoActemra has been shown to
slow the damage to the
cartilage and bone of the joints caused

Summary of Product characteristics

OBJECT 1
ROACTEMRA 162 MG SOLUTION FOR INJECTION IN PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 27-Apr-2018 | Roche
Products Limited
1. Name of the medicinal product
RoActemra 162 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 ml.
Tocilizumab is a recombinant humanized, anti-human monoclonal antibody
of the immunoglobulin G1
(IgG1) sub-class directed against soluble and membrane-bound
interleukin 6 receptors.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
A colourless to slightly yellowish solution.
4. Clinical particulars
4.1 Therapeutic indications
RoActemra, in combination with methotrexate (MTX), is indicated for
• the treatment of severe, active and progressive rheumatoid
arthritis (RA) in adults not previously treated
with MTX.
• the treatment of moderate to severe active RA in adult patients
who have either responded inadequately
to, or who were intolerant to, previous therapy with one or more
disease-modifying anti-rheumatic drugs
(DMARDs) or tumour necrosis factor (TNF) antagonists.
In these patients, RoActemra can be given as monotherapy in case of
intolerance to MTX or where
continued treatment with MTX is inappropriate.
RoActemra 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.
RoActemra in combination with methotrexate (MTX) is indicated for the
treatment of juvenile idiopathic
polyarthritis (pJIA; rheumatoid factor positive or negative and
extended oligoarthritis) in patients 2 years
of age and older, who have responded inadequately to previous therapy
with MTX.
RoActemra can be given as monotherapy in case of intolerance to MTX or
where continued treatment
with MTX is inappropriate.
RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA)
in adult patients.
4.2 Posology and method o