Actemra

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Patient Information leaflet (PIL)

07-07-2023

Summary of Product characteristics (SPC)

21-11-2023

Active ingredient:

Tocilizumab 20mg; ; ;

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Tocilizumab 20 mg

Dosage:

20 mg/mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Tocilizumab 20mg Excipient: Dibasic sodium phosphate dodecahydrate Monobasic sodium phosphate dihydrate Polysorbate 80 Sucrose Water for injection

Units in package:

Vial, glass, 400mg/20mL, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Genentech Inc

Therapeutic indications:

ACTEMRA is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients: · in combination with methotrexate (MTX) in those not previously treated with MTX. · 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; or · 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

Product summary:

Package - Contents - Shelf Life: Vial, glass, 400mg/20mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at or below 30°C 14 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). When the solution has been prepared in controlled and validated aseptic conditions - Vial, glass, 200mg/10mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at or below 30°C 14 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). When the solution has been prepared in controlled and validated aseptic conditions - Vial, glass, 80mg/4mL - 1 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at or below 30°C 14 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). When the solution has been prepared in controlled and validated aseptic conditions

Authorization date:

2008-02-05

Patient Information leaflet

_ _
Actemra 230629
1
CONSUMER MEDICINE INFORMATION
ACTEMRA
® CONCENTRATE FOR INTRAVENOUS INFUSION
TOCILIZUMAB
80 mg in 4 mL, 200 mg in 10 mL and 400 mg in 20 mL concentrate for
solution for
infusion
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.
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 moderate to severe rheumatoid arthritis (RA)
in adults. Actemra is also used
to treat active systemic juvenile idiopathic arthritis (sJIA) and
active polyarticular juvenile idiopathic
arthritis (pJIA) in children over 2 years of age.
Actemra is used for the treatment of coronavirus disease 2019
(COVID-19) in adults who have been
hospitalised and are receiving systemic corticosteroids and require
supplemental oxygen or
mechanical ventilation.
For RA, Actemra can also prevent damage occurring to your joints and
improve your ability to do your
normal daily activities.
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). Actemra works by binding and blocking
IL-6R thereby helping to relieve
some of the signs and symptoms of RA, pJIA, sJIA and COVID-19.
Actemra is approved to treate RA, pJIA and sJIA, however your doctor
may have prescribed Actemra
for another purpose.
A

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Summary of Product characteristics

Actemra 231115
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Actemra
®
20 mg/mL, concentrate for solution for intravenous (IV) infusion
Actemra
®
162 mg/0.9 mL, solution for subcutaneous (SC) injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CONCENTRATE FOR SOLUTION FOR IV INFUSION
Each vial contains 20 mg/mL tocilizumab (vials: 80 mg tocilizumab in 4
mL, 200 mg
tocilizumab in 10 mL and 400 mg tocilizumab in 20 mL).
SOLUTION FOR SC INJECTION
Each pre-filled syringe contains 162 mg/0.9 mL tocilizumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Actemra concentrated solution for IV infusion is a clear to
opalescent, colourless to pale yellow
sterile solution.
Actemra solution for 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) in those not previously treated
with MTX;

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; or

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 alone or in combination with methotrexate.
GIANT CELL ARTERITIS (SC FORMULATION ONLY)
Actemra is indicated for the treatment of giant cell arteritis (GCA)
in adult patients.
Actemra 231115
2
CORONAVIRUS DISEASE 2019 (COVID-19) (IV FORMULATION ONLY)
Actemra is indicated for the treatment of coronavirus disease 2019
(COVID-19) in hospitalised
adults
who
are
receiving
systemic
corticosteroids
and
require
supplemental
oxygen
or
mechanical ventilation.
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA

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