Orencia

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Abatacept

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

L04AA24

INN (International Name):

abatacept

Therapeutic group:

Immunosuppressants

Therapeutic area:

Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid

Therapeutic indications:

Rheumatoid arthritisOrencia, in combination with methotrexate, is indicated for:the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.Psoriatic arthritisOrencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. Polyarticular juvenile idiopathic arthritisOrencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy.Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

Product summary:

Revision: 38

Authorization status:

Authorised

Authorization date:

2007-05-21

Patient Information leaflet

119
ORENCIA IV PATIENT ALERT CARD TEXT
ORENCIA PATIENT ALERT CARD
This
alert
card
contains
important
safety
information that you need to be aware of before
you are given ORENCIA and during treatment
with ORENCIA.
•
Show this card to any doctor involved in
your treatment.
INFECTIONS
ORENCIA
increases
the
risk
of
getting
infections.
-
You must not be treated with ORENCIA if
you have severe infection.
-
You
should
be
screened
for
certain
infections
prior
to
treatment
with
ORENCIA.
TUBERCULOSIS (TB):
You should be screened
for TB prior to ORENCIA treatment. It is
very important that you tell your doctor if
you have ever had TB, or if you have been
in close contact with someone who has had
TB.
HEPATITIS:
Anti-rheumatic
therapies
have
been associated with hepatitis B reactivation.
You should be screened for viral hepatitis in
accordance with published guidelines.
INFECTIONS
−
If you develop symptoms suggestive of
infections,
such
as
fever,
persistent
cough, weight loss, or listlessness, seek
medical attention immediately.
ALLERGIC REACTIONS
Allergic reactions may occur after the use of
ORENCIA. If you experience symptoms such
as chest tightness, wheezing, severe dizziness,
or
lightheadedness,
seek
medical
attention
immediately.
DATES OF ORENCIA TREATMENT:
Start:
____________________
Most recent:
____________________
•
See
the
ORENCIA
package
leaflet
for
more information.
•
Please make sure you also have a list of all
your other medicines with you at any visit
to a health care professional.
Patient’s Name: ____________________
Doctor’s Name: ____________________
Doctor’s Phone: ____________________
Keep this card with you for 3 months after the
last ORENCIA dose, since side effects may
occur
a
long
time
after
your
last
dose
of
ORENCIA.
ORENCIA
should
not
be
used
in
pregnant
women unless clearly necessary. If you have
received ORENCIA while you were pregnant,
it
is
important
that
you
inform
the
baby’s
health care personnel before any vaccinations
are given to your baby. Your baby may be at
risk
of
severe

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ORENCIA 250 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg of abatacept.
Each mL contains 25 mg of abatacept, after reconstitution.
Abatacept is a fusion protein produced by recombinant DNA technology
in Chinese hamster ovary
cells.
Excipient with known effect
sodium: 0.375 mmol (8.625 mg) per vial
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
The powder is a white to off-white whole or fragmented cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
ORENCIA, in combination with methotrexate, is indicated for:

the treatment of moderate to severe active rheumatoid arthritis (RA)
in adult patients who
responded inadequately to previous therapy with one or more
disease-modifying anti-rheumatic
drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis
factor (TNF)-alpha
inhibitor.

the treatment of highly active and progressive disease in adult
patients with rheumatoid arthritis
not previously treated with methotrexate.
A reduction in the progression of joint damage and improvement of
physical function have been
demonstrated during combination treatment with abatacept and
methotrexate.
Psoriatic arthritis
ORENCIA, alone or in combination with methotrexate (MTX), is indicated
for the treatment of active
psoriatic arthritis (PsA) in adult patients when the response to
previous DMARD therapy including
MTX has been inadequate, and for whom additional systemic therapy for
psoriatic skin lesions is not
required.
Polyarticular juvenile idiopathic arthritis
ORENCIA in combination with methotrexate is indicated for the
treatment of moderate to severe
active polyarticular juvenile idiopathic arthritis (pJIA) in
paediatric patients 6 years of age and older
who have had an inadequate response to previous DMARD therapy.
3
ORENCIA can be given as monotherapy in cas