Actemra

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tocilizumab 162mg;  ;  ;  ; Tocilizumab 162mg

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Tocilizumab 162 mg

Dosage:

162 mg/0.9mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Tocilizumab 162mg       Excipient: Arginine Arginine hydrochloride Histidine Histidine hydrochloride monohydrate Methionine Polysorbate 80 Water for injection Active: Tocilizumab 162mg Excipient: Arginine hydrochloride Histidine Histidine hydrochloride monohydrate Methionine Polysorbate 20 Water for injection

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 - 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: Syringe, prefilled type 1 glass, with needle safety device - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 30°C protect from light

Authorization date:

2013-03-05

Patient Information leaflet

_ _
Actemra 230629
1
CONSUMER MEDICINE INFORMATION
ACTEMRA
® SOLUTION FOR SUBCUTANEOUS INJECTION
TOCILIZUMAB
162 mg/0.9 mL solution for subcutaneous injection
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Actemra pre-filled
syringe 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.
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.For RA, Actemra can
also prevent damage occurring to your joints and improve your ability
to do your normal daily
activities. Actemra is also used to treat giant cell arteritis (GCA).
Some of the signs and symptoms of RA and GCA are caused by the actions
of a protein called
interleukin-6 (IL-6) binding to the 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 and GCA.
Actemra is approved to treat GCA and RA, however your doctor 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.
BEFORE YOU USE ACTEMRA
_WHEN YOU MUST NOT USE ACTEMRA _
DO NOT USE ACTEMRA IF:
1.
YOU HAVE HAD AN ALLERGIC REACTION TO ACTEMRA OR ANY ING

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