Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
ORENCIA, in combination with methotrexate, is indicated for:
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
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.
ORENCIA 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.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
If a response to abatacept is not present within 6 months of treatment, the continuation of the treatment should be reconsidered (see section 5.1).
ORENCIA subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose. ORENCIA SC should be administered weekly at a dose of 125 mg abatacept by subcutaneous injection regardless of weight (see section 5.1). If a single IV infusion is given to initiate treatment (IV loading dose before SC administration), the first 125 mg abatacept SC should be administered within a day of the IV infusion, followed by the weekly 125 mg abatacept SC injections (for the posology of the intravenous loading dose, please refer to section 4.2 of ORENCIA 250 mg powder for concentrate for solution for infusion).
Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
ORENCIA should be administered weekly at a dose of 125 mg by subcutaneous (SC) injection without the need for an intravenous (IV) loading dose. Patients switching from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
The recommended weekly dose of ORENCIA solution for injection in pre-filled syringe for patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis should be initiated without an intravenous loading dose and administered utilizing the weight range-based dosing as specified in the table below:
Table 1. Weekly dose of ORENCIA:
| Body weight of patient | Dose |
|---|---|
| 10 kg to less than 25 kg | 50 mg |
| 25 kg to less than 50 kg | 87.5 mg |
| 50 kg or more | 125 mg |
Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
ORENCIA powder for concentrate for solution for infusion for intravenous administration is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).
If a patient misses an injection of abatacept and is within three days of the planned date, he/she should be instructed to take the missed dose immediately and remain on the original weekly schedule. If the dose is missed by more than three days, the patient should be instructed when to take the next dose based on medical judgment (condition of the patient, status of disease activity, etc).
No dose adjustment is required (see section 4.4).
ORENCIA has not been studied in these patient populations. No dose recommendations can be made.
The safety and efficacy of ORENCIA in children below 2 years of age have not been established. No data are available.
There is no relevant use of ORENCIA in children under two years old.
For subcutaneous use.
ORENCIA is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient or caregiver may inject with ORENCIA if a physician/healthcare professional determines that it is appropriate.
The total content of the pre-filled syringe should be administered as a subcutaneous injection only. Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.
Comprehensive instructions for the preparation and administration of ORENCIA in a pre-filled syringe are given in the package leaflet and "Important instructions for use".
Doses up to 50 mg/kg have been administered intravenously without apparent toxic effect. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
2 years.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package in order to protect from light.
ORENCIA 50 mg solution for injection in pre-filled syringe:
0.4 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (white plunger).
Packs of 4 pre-filled syringes with needle guard.
ORENCIA 87.5 mg solution for injection in pre-filled syringe:
0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Packs of 4 pre-filled syringes with needle guard.
ORENCIA 125 mg solution for injection in pre-filled syringe:
One mL pre-filled syringe (type 1 glass) with flange extenders or one mL pre-filled syringe with an automatic needle safety guard and flange extenders (orange plunger).
Packs of 1 or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of 4).
Packs of 1, 3 or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
The type 1 glass syringe has a coated bromobutyl stopper and fixed stainless steel needle covered with a rigid needle shield.
Not all pack sizes may be marketed.
The medicinal product is for single use only. After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature by waiting 30 minutes, before injecting ORENCIA. The syringe should not be shaken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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