HUMIRA adalimumab (rch) 10 mg solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Adalimumab

Available from:

Abbvie Pty Ltd

INN (International Name):

Adalimumab

Authorization status:

Registered

Patient Information leaflet

HUMIRA PRE-FILLED SYRINGE 17 JULY 2019 VERSION 05
1
HUMIRA PRE-FILLED
SYRINGE
_Adalimumab (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Humira.
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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU USE HUMIRA AND KEEP IT WITH
THE MEDICINE.
You may need to read it again.
WHAT HUMIRA IS USED
FOR
The active ingredient in this
medicine is adalimumab, which is a
fully human monoclonal antibody.
Monoclonal antibodies are proteins
made by a type of blood cell to fight
a foreign protein in the body.
Adalimumab recognises and binds to
a specific protein (tumour necrosis
factor or TNF-alpha), which is
present at higher levels in some
inflammatory diseases.
Humira is used for the treatment of a
number of inflammatory diseases:

Rheumatoid arthritis
Rheumatoid arthritis is an
inflammatory disease of the joints.
Signs and symptoms of rheumatoid
arthritis include joint pain,
tenderness, swelling and stiffness.
Humira is used to reduce the signs
and symptoms of moderate to
severely active rheumatoid arthritis,
as well as to slow down and protect
the joints from further damage to
help them move more freely.
Your doctor will decide if Humira
should be used with another
medicine called methotrexate, or on
its own.
Humira can also be used to treat
severe, active and progressive
rheumatoid arthritis without previous
methotrexate treatment.

Polyarticular Juvenile Idiopathic
Arthritis (pJIA)
pJIA is an inflammatory disease of
the joints. Humira is used to reduce
the signs and symptoms of moderate
to severely active pJIA, in patients 2
years of age and older, when other
medicines are not appropriate. Your
doctor will decide wheth

Summary of Product characteristics

HUMIRA PI
Version 47
17 June 2019
Page 1 of 87
AUSTRALIAN PI – HUMIRA
®
(ADALIMUMAB) – SOLUTION FOR SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Adalimumab (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Humira
(adalimumab)
is
a
recombinant
human
immunoglobulin
(IgG1)
monoclonal
antibody
containing only human peptide sequences. Humira was created using
phage display technology
resulting in fully human heavy and light chain variable regions, which
confer specificity to human
tumour necrosis factor (TNF), and human IgG1 heavy chain and kappa
light chain sequences. Humira
binds
with
high
affinity
and
specificity
to
soluble
tumour
necrosis
factor
(TNF-alpha)
but
not
lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA
technology in a mammalian
cell expression system. It consists of 1330 amino acids and has a
molecular weight of approximately
148 kilodaltons.
Adult presentations contain 80 mg adalimumab per 0.8 mL (100 mg/mL),
40 mg adalimumab per 0.8
mL (50 mg/mL) or 40 mg adalimumab per 0.4 mL (100 mg/mL).
Presentations for paediatric use only
contain either 20 mg adalimumab per 0.4 mL (50 mg/mL), 20 mg
adalimumab per 0.2 mL (100
mg/mL) or 10 mg adalimumab per 0.2 mL (50 mg/mL).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Humira
is
supplied
as
a
sterile,
preservative-free
solution
of
adalimumab
for
subcutaneous
administration. The solution of Humira is clear and colourless and
isotonic with a pH of 5.2. The drug
product is supplied as either a single-use pre-filled glass syringe,
vial or as a single use, pre-filled pen
(Humira Pen). Enclosed within the pen is a single-use, pre-filled
glass syringe.
HUMIRA PI
Version 47
17 June 2019
Page 2 of 87
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis
Humira is indicated for reducing signs and symptoms, as well as
inhibiting the progression of
structural damage in adult patients with moderate to severely active
rheumatoid arthritis. This includes
the treatment of patients with recently