Cimzia

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Certolizumab pegol 200mg

Available from:

Seqirus (NZ) Ltd

INN (International Name):

Certolizumab pegol 200 mg

Dosage:

200 mg

Pharmaceutical form:

Solution for injection

Composition:

Active: Certolizumab pegol 200mg Excipient: Sodium acetate Sodium chloride Water for injection

Units in package:

Syringe, glass, 2 x 1mL, 400 mg

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz GmbH

Therapeutic indications:

CIMZIA is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients. · combined with MTX in case of either an inadequate response or intolerance to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or · as monotherapy in case of a contraindication or intolerance to MTX

Product summary:

Package - Contents - Shelf Life: Syringe, glass, 2 x 1mL - 400 mg - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2010-12-14

Summary of Product characteristics

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NAME OF THE MEDICINE 
Cimzia
®
 (certolizumab pegol) 
CIMZIA 200 mg/mL Injection.

Chemical structure:  
_CH_
_ _
_3_
_ _
_O(CH_
_ _
_2_
_ _
_CH_
_ _
_2_
_ _
_O)_
_ _
_N_
_ _
_CONH_
_ _
_CONH_
_ _
_NH_
_ _
_N_
_CH_
_ _
_3_
_ _
_O(CH_
_ _
_2_
_ _
_CH_
_ _
_2_
_ _
_O)_
_ _
_N_
_ _
_CONH_
_ _
_O_
_O_
_O_
_S_
PEG 
FAB' 
N = ~450 

Chemical Name: gHTNF40 Fab'40 kDa PEG 
MW: approximately 90,000 Da 
CAS number: [428863-50-7] 
DESCRIPTION 
Certolizumab pegol is a recombinant, humanised antibody
Fab' fragment that is expressed in 
an _Escherichia coli_ bacterial expression system,
subsequently purified and conjugated to 
polyethylene glycol (PEG). 
_200 MG/ML INJECTION IN A SINGLE-USE PRE-FILLED SYRINGE _
Cimzia
®
 injection is a sterile clear to opalescent solution that is
colourless to yellow, 
essentially free of visible
particles, containing 200 mg certolizumab pegol per mL. The 
inactive ingredients are sodium chloride, sodium acetate
and water for injections. The pH of 
the solution is approximately 4.7. 
PHARMACOLOGY 
MECHANISM OF ACTION 
Certolizumab pegol has a high affinity for human TNFα and binds
with a dissociation factor 
(K
D
) of 90pM. TNFα is a key pro-inflammatory cytokine with
a central role in inflammatory 
processes. Certolizumab pegol
selectively neutralises TNFα (90% inhibitory concentration 
[IC
90
]) of 4 ng/mL for inhibition of human TNFα in the _in
vitro_ L929 murine fibrosarcoma 
cytotoxicity assay) but does not
neutralise lymphotoxin α (TNFβ). Certolizumab pegol 
cross-reacts poorly with TNF from rodents and
rabbits, therefore _in vivo_  efficacy was 
evaluated using animal models in which human TNFα was the
physiologically active 

2 of 23 
molecule.  
Certolizumab pegol was shown to
neutralise membrane associated and soluble human TNFα 
in a dose-de