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.
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.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis or JIA. 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).
To be administered as a 30-minute intravenous infusion at the dose specified in Table 1. Following the initial administration, ORENCIA should be given 2 and 4 weeks after the first infusion, then every 4 weeks thereafter.
Table 1. Dose of ORENCIAa:
| Body Weight of Patient | Dose Number of Vialsb | |
|---|---|---|
| <60 kg | 500 mg | 2 |
| ≥60 kg to ≤100 kg | 750 mg | 3 |
| >100 kg | 1,000 mg | 4 |
a Approximating 10 mg/kg.
b Each vial provides 250 mg of abatacept for administration.
No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
To be administered as a 30-minute intravenous infusion at the dose specified in Table 1. Following the initial administration, ORENCIA should be given 2 and 4 weeks after the first infusion, then every 4 weeks thereafter.
The recommended dose of ORENCIA for patients 6 to 17 years of age with juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient’s body weight at each administration. Paediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen, not to exceed a maximum dose of 1,000 mg. ORENCIA should be administered as a 30-minute intravenous infusion. Following the initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.
The safety and efficacy of ORENCIA in children below 6 years of age have not been studied and therefore, ORENCIA is not recommended for use in children under six years old.
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 entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm). See section 6.6 for information on reconstitution and dilution.
Doses up to 50 mg/kg have been administered 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.
Unopened vial: 3 years
After reconstitution: chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C. From a microbiological point of view, the reconstituted solution should be diluted immediately.
After dilution: when the reconstituted solution is diluted immediately, the chemical and physical inuse stability of the diluted infusion solution has been demonstrated for 24 hours at 2°C-8°C. From a microbiological point of view, the product should be used immediately.
Store in a refrigerator (2°C-8°C).
Store in the original package in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Powder in a vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium) with a silicone-free syringe (polyethylene).
Pack of 1 vial and 1 silicone-free syringe, and multipacks containing 2, or 3 vials and 2, or 3 siliconefree syringes (2 or 3 packs of 1).
Not all pack-sizes may be marketed.
Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Reconstitution:
1. Determine the dose and the number of ORENCIA vials needed (see section 4.2).
2. Under aseptic conditions, reconstitute each vial with 10 mL of water for injections, using the silicone-free disposable syringe provided with each vial (see section 6.2) and an 18-21 gauge needle.
Dilution:
3. Immediately after reconstitution, the concentrate must be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
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