ACTEMRA 162 MG S.C.

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TOCILIZUMAB

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC code:

L04AC07

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TOCILIZUMAB 162 MG / 0.9 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Therapeutic area:

TOCILIZUMAB

Therapeutic indications:

- Actemra in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (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 tumor necrosis factor (TNF) antagonists. In these patients, 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 reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. - Actemra in combination with methotrexate (MTX) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX - Actemra (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. - Actemra 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. Actemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. - Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Actemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

Authorization date:

2019-11-30

Patient Information leaflet

• Disinfect the selected injection site using an
alcohol pad )see Fig. C(, to reduce the risk
of infection.
• Let the skin dry for approximately 10
seconds.
• Be sure not to touch the disinfected area
prior to the injection. Do not fan or blow on
the disinfected area.
STEP 5. REMOVE NEEDLE-CAP
• Do not hold the syringe by the plunger while
removing the needle-cap.
• Hold the body of the syringe steadily with
one hand and pull off the needle-cap with
the other hand )see Fig. D(. If you cannot
remove the needle-cap, you should ask for
assistance.
• Do not touch the needle or let it touch any
surface.
• You may notice a drop of liquid at the end
of the needle. This is normal.
• Throw the needle-cap into a closed and safe
sharps container.
NOTE: Once the needle-cap is removed, use
the syringe immediately.
• If the syringe was not used within 5 minutes,
it should be disposed of in a closed safe
sharps container and a new syringe should
be used. If the needle-cap is removed for
more than 5 minutes, it may be more difficult
to perform an injection as the medicine can
dry out and block the needle.
• Never try to re-attach the needle-cap after
removing it.
STEP 6. GIVING THE INJECTION
• Hold the syringe comfortably in one hand.
• To make sure the needle can be inserted
correctly under the skin, pinch a fold of
loose skin at the disinfected injection site
with your free hand. Pinching the skin is
important to ensure that you inject into fatty
tissue under the skin but not any deeper
)into the muscle(. Injection into muscle
could cause discomfort.
• Do not hold or push on the plunger while
inserting the needle into the skin.
• Quickly and steadily insert the needle all
the way into the pinched skin at a 45°-90°
angle )see Fig. E(.
It is important to choose the correct angle
to ensure that the medicine is delivered into
the fatty tissue under the skin, otherwise the
injection could be painful and the medicine
may not work.
• Hold the syringe in position and let go of
the pinched skin.
• Slow

Summary of Product characteristics

1
ACTEMRA 162 MG SC PI VER 11
ACTEMRA
® 162MG SC

TOCILIZUMAB
Solution for injection in pre-filled syringe
1.
NAME OF THE MEDICINAL PRODUCT
Actemra 162 mg S.C. 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 in pre-filled syringe.
A colourless to slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Actemra, in combination with methotrexate (MTX) is indicated for the
treatment of moderate to severe
active rheumatoid arthritis (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, 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 reduce the rate of progression of joint
damage as measured by X-ray and
to improve physical function when given in combination with
methotrexate.
Actemra is indicated for the treatment of active systemic juvenile
idiopathic arthritis (sJIA) in patients
1 year of age and older, who have responded inadequately to previous
therapy with NSAIDs and
systemic corticosteroids. Actemra can be given as monotherapy (in case
of intolerance to MTX or
where treatment with MTX is inappropriate) or in combination with MTX.
Actemra 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. Actemra can