IDACIO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ADALIMUMAB

Available from:

NEOPHARM (ISRAEL)1996 LTD

ATC code:

L04AB04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ADALIMUMAB 50 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AUSTRIA GmbH

Therapeutic area:

ADALIMUMAB

Therapeutic indications:

• Rheumatoid arthritis: Idacio in combination with methotrexate is indicated for:- The treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.- The treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab 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.• Axial spondyloarthritis:-Ankylosing spondylitis (AS): Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.-Axial spondyloarthritis without radiographic evidence of AS: Idacio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS, but with objective signs of inflammation by radiological and/or laboratory tests including MRI and serum CRP levels, who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs.• Psoriatic arthritis: Idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.• Psoriasis: Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.• Hidradenitis suppurativa (HS): Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.• Crohn’s disease: Idacio is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Idacio is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. • Ulcerative colitis: Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. • Uveitis:Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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.• Intestinal Behcet's disease: Idacio is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.

Authorization date:

2020-11-12

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
IDACIO
®
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
Active ingredient and its concentration: adalimumab 50 mg/ml
Each Idacio pre-filled pen contains: adalimumab 40 mg/0.8 ml
For the list of inactive ingredients and allergens - see section 6
"Additional
information" in this leaflet.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have
any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness
/ for you. Do not pass
it on to others. It may harm them, even if it seems to you that their
illness /
medical condition is similar to yours.
In addition to the leaflet, Idacio has a ‘Patient safety information
card’.
This card includes important safety information, which you should know
and follow before starting treatment and during the treatment with
Idacio.
Review the ‘Patient safety information card’ and the patient
leaflet before
starting treatment with the medicine. Keep the card for further review
if
required.
Idacio is a biosimilar medicinal product. For further information
regarding
biosimilar
products
refer
to
the
Israeli
ministry
of
health
website:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Bio
similars.as px
Please note that every time you get this medicine at the pharmacy, it
is
important that you check that you have been given the same medicine
that
your attending specialist has prescribed to you. If the medicine you
have
been given looks different from what you usually receive, or if the
instructions
for use have changed, please contact your pharmacist immediately to
make
sure you received the correct medicine. Only your attending specialist
can
switch
your
medicine
or
change
the
dosage
of
medicine
containing
adalimumab (the active ingredient in this medicine). Please check that
the

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Idacio
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Idacio 40 mg solution for injection in pre-filled syringe
Each 0.8 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Idacio 40 mg solution for injection in pre-filled pen
Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection. (injection) Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Rheumatoid arthritis
Idacio in combination with methotrexate is indicated for:
▪
The treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response
to disease-modifying anti-rheumatic drugs including methotrexate has
been inadequate.
▪
The treatment of severe, active and progressive rheumatoid arthritis
in adults not previously
treated with methotrexate.
Idacio can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Adalimumab 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.
Axial spondyloarthritis
_Ankylosing spondylitis (AS): _
_ _
Idacio is indicated for the treatment of adults with severe active
ankylosing spondylitis who have had an
inadequate response to conventional therapy.
_Axial spondyloarthritis without radiographic evidence of AS: _
PATIENT SAFETY INFORMATION CARD
The marketing of Idacio is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety information card',
emphasizes important safety
information that the patient should be aware of before and during
treatment. Please explain
to the patient the need to review the card before starting treatment.
_ _
Idacio is indicated for the treatment of adults with severe axia