ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tocilizumab, Quantity: 162 mg

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections

Administration route:

Subcutaneous

Units in package:

1 syringe, 4 syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rheumatoid Arthritis (IV and SC formulations),Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease-modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.,Actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX.,In the two groups of patients above, Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.,Actemra has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.,Giant Cell Arteritis (SC formulations only),Actemra is indicated for the treatment of giant cell arteritis (GCA) in adult patients.,Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations),Actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Actemra can be given alone or in combination with MTX.,Systemic Juvenile Idiopathic Arthritis (IV and SC formulations),Intravenous formulation,Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,Subcutaneous formulation,Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,Actemra IV and SC can be given alone or in combination with methotrexate (MTX).

Product summary:

Visual Identification: Clear to strongly opalescent, colourless to slightly yellowish solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-02-15

Patient Information leaflet

ACTEMRA
® AND
ACTEMRA
® SC PRE-FILLED
PEN (ACTPEN)
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 pre-filled
pen for subcutaneous (under the skin)
injection.
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 for subcutaneous injection
is used to treat active moderate to
severe rheumatoid arthritis (RA) and
giant cell arteritis (GCA) in adults.
It is also used to treat moderate to
severe active polyarticular juvenile
idiopathic arthritis (pJIA) in children
over 2 years of age and active
systemic juvenile idiopathic arthritis
(sJIA) in children and adolescents,
aged 1 year and over.
Some of the signs and symptoms of
these conditions are caused by the
actions of a protein called
interleukin-6 receptor (IL-6R).
Actemra works by binding and
blocking IL-6R thereby helping to
relieve some of the signs and
symptoms of these conditions. For
patients with RA, Actemra can also
prevent damage occurring to your
joints.
There are different types of
medicines used to treat RA, GCA,
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 YO

Summary of Product characteristics

Actemra 20220902
1
This medicinal product is subject to additional monitoring in
Australia due to
provisional approval of an extension of indications. This will allow
quick identification
of new safety information. Healthcare professionals are asked to
report any suspected
adverse events at https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
ACTEMRA
® (TOCILIZUMAB)
1.
NAME OF THE MEDICINE
Tocilizumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Actemra 80 mg/ 4 mL concentrate solution for intravenous infusion vial
contains 80 mg
tocilizumab
Actemra 200 mg/ 10 mL concentrate solution for intravenous infusion
vial contains 200 mg
tocilizumab
Actemra 400 mg/ 20 mL concentrate solution for intravenous infusion
vial contains 400 mg
tocilizumab
Actemra 162 mg/ 0.9 mL solution for subcutaneous (SC) injection
contains 162 mg tocilizumab
Actemra SC 162 mg/ 0.9 mL solution for SC injection contains 162 mg
tocilizumab.
Excipients with known effect
Actemra concentrated solution for intravenous infusion contains
sodium.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
CONCENTRATED SOLUTION FOR INTRAVENOUS INFUSION
Actemra concentrated solution for intravenous (IV) infusion is a clear
to opalescent, colourless
to pale yellow sterile solution
SOLUTION FOR SUBCUTANEOUS INJECTION
Actemra solution for subcutaneous (SC) injection is a clear to
strongly opalescent, colourless
to slightly yellowish sterile solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS (IV AND SC FORMULATIONS)
Actemra is indicated for the treatment of moderate to severe active
rheumatoid arthritis (RA)
in adult patients in combination with methotrexate (MTX) or other
non-biological disease-
modifying anti-rheumatic drugs (DMARDs) in case of either an
inadequate response or
intolerance to previous therapy with one or more DMARDs.
▼

Actemra 20220902
2
Actemra is indicated for the treatment of moderate to severe active
rheumatoid arthritis in adult
patients with poo