Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
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.
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 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 ORENCIA 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.
If a patient misses an injection of ORENCIA 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). Renal and hepatic impairment ORENCIA has not been studied in these patient populations. No dose recommendations can be made.
The safety and efficacy of ORENCIA subcutaneous administration in children below 18 years of age have not been established. No data are available.
The safety and efficacy of ORENCIA intravenous administration have been studied in children. The currently available data are described in the Summary of Product Characteristics of ORENCIA 250 mg powder for concentrate for solution for infusion.
For subcutaneous use.
ORENCIA is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient may self-inject with ORENCIA if a physician/healthcare professional determines that it is appropriate.
The total content (1 mL) 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. For instructions on preparation, see section 6.6.
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.
Shelf life: 2 years.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package in order to protect from light.
One mL pre-filled syringe (Type 1 glass) with flange extenders or one mL pre-filled syringe with a passive needle safety guard and flange extenders. The Type 1 glass syringe has a coated stopper and fixed stainless steel needle covered with a rigid needle shield.
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).
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 product or waste material should be disposed of in accordance with local requirements.
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