PIL
ACTEMRA
®
PRONOUNCED (ACT-TEM-RA)
_contains the active ingredient tocilizumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACTEMRA
infusion.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ACTEMRA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ACTEMRA IS
USED FOR
ACTEMRA contains the active
ingredient tocilizumab.
ACTEMRA belongs to a group of
medicines called anti-rheumatic
agents. There are many different
classes of anti-rheumatic agents.
ACTEMRA belongs to a class called
monoclonal antibodies.
Monoclonal antibodies are proteins
which specifically recognise and bind
to other unique proteins in the body.
ACTEMRA is used to treat active
moderate to severe rheumatoid
arthritis (RA).
ACTEMRA is also used to treat
active systemic juvenile idiopathic
arthritis (sJIA) and active moderate
to severe polyarticular juvenile
idiopathic arthritis (pJIA) in children
over 2 years of age.
Some of the signs and symptoms of
RA, pJIA and sJIA are caused by the
actions of a protein called
interleukin-6 receptor (IL-6R).
For RA ACTEMRA can also prevent
damage occurring to your joints and
improve your ability to do your
normal daily activities.
ACTEMRA works by binding and
blocking IL-6R thereby helping to
relieve some of the signs and
symptoms of RA, pJIA or sJIA.
There are many different types of
medicines used to treat RA, pJIA and
sJIA. Your doctor, however, may
have prescribed ACTEMRA for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ACTEMRA
HAS BEEN PRESCRIBED FOR YOU.
ACTEMRA is not addictive.
This medicine is available only with
a doctor's prescription. For pJIA and
sJIA ACTEMRA should be
prescribed by a
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SPC
Actemra
®
PI 131004
1 of 37
CDS 8.0
ACTEMRA
_Tocilizumab (rch) _
CAS 375823-41-9
Tocilizumab is a recombinant humanised monoclonal antibody of the immunoglobulin
(Ig) IgG1 subclass which binds to human interleukin 6 (IL-6) receptors. It is composed of
two heterodimers, each of which consists of a heavy and a light polypeptide chain. The
light chain contains of 214 amino acids and the heavy chain 448 amino acids. The four
polypeptide chains are linked intra- and inter-molecularly by disulfide bonds.
Tocilizumab has a molecular weight of approximately 148,000 Daltons. Tocilizumab
binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and
mIL-6R).
DESCRIPTION
ACTEMRA is a clear to opalescent, colourless to pale yellow sterile solution for
intravenous (IV) infusion. ACTEMRA is supplied in preservative-free, non-pyrogenic
single-use, clear glass vials. ACTEMRA is available in 10 mL and 20 mL vials
containing 4 mL, 10 mL or 20 mL of tocilizumab concentrate (20 mg/mL). ACTEMRA
also contains polysorbate 80, sucrose, dibasic sodium phosphate dodecahydrate,
monobasic sodium phosphate dihydrate and water for injections.
PHARMACOLOGY
_MECHANISM OF ACTION_
Tocilizumab is a recombinant humanised monoclonal antibody of the immunoglobulin
(Ig) IgG1 subclass. Tocilizumab binds specifically to both soluble and membrane-bound
IL-6 receptors, and has been shown to inhibit sIL-6R and mIL-6R-mediated signaling.
IL-6 is a multi-functional cytokine, produced by a variety of cell types involved in local
paracrine function as well as regulation of syst
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