ORENCIA 250 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ABATACEPT

Available from:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC code:

L04AA24

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ABATACEPT 250 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BRISTOL MYERS SQUIBB COMPANY, USA

Therapeutic group:

ABATACEPT

Therapeutic area:

ABATACEPT

Therapeutic indications:

ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. Polyarticular juvenile idiopathic arthritis: Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor. Orencia has not been studied in children under 6 years old.ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).ORENCIA is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 6 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

Authorization date:

2015-04-30

Patient Information leaflet

February
2023
BMS ISRAEL
18 Aharon Bart St, PO BOX 3661, Kiryat Arie Petach-Tikva 4951448
Tel: [phone]; Fax: [phone]
2200001
-
IL
-
427
nternal reference:
I
DIRECT HEALTHCARE PROFESSIONAL COMMUNICATION
To: Physicians/Prescribers in transplant centers in Israel who may
perform HSCT
From: BMS Israel Medical director
Subject: PTLD or CMV reactivation in Patients Undergoing
Unrelated-Donor Hematopoietic Stem
Cell Transplantation (HSCT) with Intravenous ORENCIA in Israel
:ריצקת
לש תוצרפתהל תורשפאה יבגל עדימ ליכמ
יאופרה תווצל הז בתכמ
EBV
וא
CMV
היסנרואב שומיש ןמזב
)
abatacept
(
םילפוטמב
לש עזג יאת תלתשה םירבועה
םדה תכרעמ
)
HSCT
.(
בתכמה
ץפוי
לארשיב הלתשה יזכרמב םיאפורל
.
ב שומישב
abatacept
םע בולישב
methotrexate (MTX)
יבכעמו
calcineurin
)
CNI
(
לחמ תעינמל
ת
דגנ לתש
הפירח ןסכאמ
(aGVHD)
,
לש תוצרפתה ןכתת
CMV
וא
EBV
םג ומכ
םוהיז
,םיוולינ םיכוביס
CMV
וא ינשלופ
Post-transplant
lymphoproliferative disease (PTLD)
.
תוצרפתה יוהיזל רוטינ לוקשל שי
CMV
וא
EBV
ענומ לופיט ןתמ םג ומכ
.
הזאפ רקחמ
II
לש שומישה תא ססיבש
abatacept
תעינמב
aGVHD
בקע
תוצרפתה רחא
EBV
ו
CMV
םאתהב םילפוטמב
זכרמב תוגוהנה תוילופיט תוקיטקרפל
יאופרה
.
תליחת ינפל
ה
תוצרפתה תעינמל ילאריו יטנא לופיט לש
ןתמ ץלמומ היסנרואב לופיט
EBV
ךשמל
6
עינמל הלתשהה ןמזמ םישדוח
ת
EBV-associated PTLD
.
ךשמל םילפוטמ רחא בוקעל ץלמומ ןכ ומכ
6
ןמזמ םישדוח
לש תוצרפתה וא םוהיז יוהיז ךרוצל הלתשהה
CMV
,
וקידבה תואצותב תולת אלל
תויגולורסה ת
ה ףיגנ יוליגל
-
CMV
םרט ועצובש
הלתשהה
,
לש ןה
םרותה
םרת

Summary of Product characteristics

ORENCIA_SPI_MoH_Jun2022
1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
ORENCIA 125 MG SC AND ORENCIA 250 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
For Orencia 250 mg IV: 250 mg white to off-white lyophilized powder in
a single-dose vial (one
may use less than the full contents of the vial or use more than one
vial)
_[see Dosage and _
_Administration (2.1, 2.2, 2.3)]. _
For Orencia 125 mg SC: 125 mg/mL of a clear to slightly opalescent,
colorless to pale-yellow
solution in a single-dose prefilled glass syringe
PHARMACEUTICAL FORM
Orencia 250 mg IV- Powder (lyophilized) for concentrate for solution
for IV infusion.
Orencia 125 mg SC- Solution for Subcutaneous Injection
1.
THERAPEUTIC INDICATIONS
1.1
ORENCIA 125 MG:
ADULT RHEUMATOID ARTHRITIS (RA)
ORENCIA is indicated for reducing signs and symptoms, inducing major
clinical response,
inhibiting the progression of structural damage, and improving
physical function in adult patients
with moderately to severely active rheumatoid arthritis.
ORENCIA may be used as monotherapy or concomitantly with
disease-modifying antirheumatic
drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
ADULT PSORIATIC ARTHRITIS (PSA)
ORENCIA is indicated for the treatment of adult patients with active
psoriatic arthritis (PsA).
ORENCIA_SPI_MoH_Jun2022
2
1.2
ORENCIA 250 MG:
ADULT RHEUMATOID ARTHRITIS (RA)
ORENCIA is indicated for reducing signs and symptoms, inducing major
clinical response,
inhibiting the progression of structural damage, and improving
physical function in adult patients
with moderately to severely active rheumatoid arthritis.
ORENCIA may be used as monotherapy or concomitantly with
disease-modifying antirheumatic
drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS:
ORENCIA in combination with methotrexate is indicated for the
treatment of moderate to severe
active polyarticular juvenile idiopathic arthritis (JIA) in pediatric
patients 6 years of age and older
who have had an insufficient