IDACIO adalimumab (rch) 40 mg solution for injection pre-filled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Adalimumab, Quantity: 40 mg

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium citrate dihydrate; sodium hydroxide; water for injections; citric acid monohydrate; polysorbate 80; mannitol; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate

Administration route:

Subcutaneous

Units in package:

2, 6, 4, 1, 3

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rheumatoid Arthritis Idacio 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 diagnosed moderate to severely active disease who have not received methotrexate.,Idacio can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis Idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis Idacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,Psoriatic Arthritis Idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis Idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn?s Disease in Adults and Children (? 6 years) Idacio is indicated for the treatment of moderate to severe Crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,Ulcerative colitis Idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 PHARMACODYNAMIC PROPERTIES-CLINICAL TRIALS).,Psoriasis in Adults and Children Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age) Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis Idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Product summary:

Visual Identification: a clear solution for injection, practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-06-17

Patient Information leaflet

Page 1 of 12
IDACIO 40MG SOLUTION FOR INJECTION
IN PREFILLED PEN
Adalimumab (rch)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Idacio.
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 IDACIO AND KEEP IT WITH
THE MEDICINE.
You may need to read it again.
WHAT IDACIO IS USED FOR
The
active
ingredient
in
this
medicine is adalimumab, which is
a
fully
human
monoclonal
antibody. Adalimumab recognises
and
binds
to
a
specific
protein
(tumour
necrosis
factor
or
TNF-
alpha), which is present at higher
levels
in
some
inflammatory
diseases.
Idacio is intended 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.
Idacio 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 Idacio
should
be
used
with
another
medicine called methotrexate, or
on its own.
Idacio 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. Idacio 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
whether
Idacio should be used with another
medicine
called
methotrexate
or
used alone.

Enthesitis-related arthritis

Summary of Product characteristics

Page 1 of 79
AUSTRALIAN PI – IDACIO
®
(ADALIMUMAB) – SOLUTION FOR SUBCUTANEOUS INJECTION
1
NAME OF THE MEDICINE
Adalimumab (rch)
Idacio (adalimumab) is a biosimilar of Humira
®
.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Idacio 40 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 40 mg of adalimumab in
0.8 mL solution.
Idacio 40 mg solution for injection in pre-filled pen
Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL
solution.
Idacio 40 mg/0.8 mL solution for injection in a vial
Each single dose vial contains 40 mg of adalimumab in 0.8 mL solution.
Adalimumab is a recombinant human monoclonal antibody (mAb) which
binds to Tumor Necrosis
Factor-alpha (TNF) and blocks TNF interaction with the p55 and p75
cell surface receptors and inhibits
the biological function of TNF.
Adalimumab is an IgG1 antibody composed of two kappa light chains each
with a molecular weight of
approximately 24 kilo Daltons (kDa) and two IgG1 heavy chains each
with a molecular weight of
approximately 49 kDa based on the amino acid sequence. The total
molecular weight of adalimumab
with post-translational modifications is approximately 148 kDa. Each
light chain consists of 214 amino
acid residues and each heavy chain consists of 451 amino acid residues
resulting in a total of 1330
amino acids for the entire IgG1 molecule. For the full list of
excipients, SEE SECTION 6.1 LIST OF
EXCIPIENTS.
3
PHARMACEUTICAL FORM
Idacio is a clear solution for injection for subcutaneous
administration and is to be used on one patient
on one occasion only. Idacio is practically free from visible
particles with, pH 5.2 with an osmolality of
approximately 325 mOsm/Kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis
Idacio 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 diagnosed moderate