ACTEMRA

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

TOCILIZUMAB

Available from:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (International Name):

TOCILIZUMAB

Dosage:

20 MG/ML

Pharmaceutical form:

INFUS

Units in package:

DUS, 1 VIAL @ 80 MG (4 ML)

Manufactured by:

F HOFFMANN LA ROCHE - Switzerland

Authorization date:

2016-10-31

Summary of Product characteristics

_Draft_Actemra SC_PI_New Drug Application_CDS11.0_EN_v1 _
ACTEMRA
®
Tocilizumab
ANTI-HUMAN INTERLEUKIN-6 (IL-6) RECEPTOR
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6)
receptor monoclonal
antibody of the immunoglobulin (Ig) IgG
1
subclass.
ATC Code: L04AC07
1.2 TYPE OF DOSAGE FORM
Intravenous (IV) formulation/Actemra IV: Concentrate solution for
infusion
Subcutaneous (SC) formulation/Actemra SC: Ready-to-use sterile liquid
solution in a single-use
pre-filled syringe (PFS) with needle safety device (NSD)
1.3 ROUTE OF ADMINISTRATION
Intravenous (IV) infusion
Subcutaneous (SC) injection
1.4 STERILE/RADIOACTIVE STATEMENT
Sterile
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
tocilizumab
Actemra IV is a clear to opalescent, colourless to pale yellow liquid,
supplied in preservative-
free, non-pyrogenic single-use vials. Actemra IV is supplied in vials
containing 4 mL or 20 mL
of tocilizumab (20 mg/mL)
Excipients:
Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium
Actemra SC is a yellowish, preservative-free liquid supplied in a
ready-to-use, single-use pre-
filled syringe with needle safety device (PFS+NSD). Each device
delivers 0.9 mL (162 mg) of
tocilizumab
2.
CLINICAL
PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
RHEUMATOID ARTHRITIS (RA) [IV AND SC FORMULATION]
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 or inappropriate
with MTX, DMARD, anti TNF and other established drugs for RA. Actemra
has been shown to
inhibit progression of joint damage as measured by X-ray and to
improve physic