ORENCIA Powder for concentrate for solution for infusion Ref.[6045] Active ingredients: Abatacept

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).

Posology

Rheumatoid arthritis

Adults

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 ORENCIA^a:

^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.

Psoriatic arthritis

Adults

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.

Paediatric population

Polyarticular juvenile idiopathic arthritis

The recommended dose of ORENCIA for patients 6 to 17 years of age with polyarticular 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 intravenous ORENCIA in children below 6 years of age have not been studied and therefore, intravenous ORENCIA is not recommended for use in children under six years old.

ORENCIA solution for injection in pre-filled syringe for subcutaneous administration is available for paediatric patients 2 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA solution for injection in pre-filled syringe).

Special population

Elderly patients

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.

Method of administration

For intravenous use.

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). For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

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 in-use 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.

Vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium).

Pack of 1 vial and 1 silicone-free syringe (polyethylene), and multipacks containing 2, or 3 vials and 2, or 3 silicone-free 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.

• Remove the flip-top from the vial and wipe the top with an alcohol swab.
• Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
• Do not use the vial if the vacuum is not present.
• Remove the syringe and needle after 10 mL of water for injections have been injected into the vial.
• To minimise foam formation in solutions of ORENCIA, the vial should be rotated with gentle swirling until the contents are completely dissolved. Do not shake. Avoid prolonged or vigorous agitation.
• Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
• After reconstitution the solution should be clear and colourless to pale yellow. Do not use if opaque particles, discolouration, or other foreign particles are present.

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.

• From a 100 mL infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/mL (0.9%) solution for injection equal to the volume of the reconstituted vials.
• Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.
• Gently mix. The final concentration of abatacept in the bag or bottle will depend upon the amount of active substance added, but will be no more than 10 mg/mL.
• Any unused portion in the vials must be immediately discarded in accordance with local requirements.

4. When reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C. Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration. Discard the solution if any particulate matter or discolouration is observed.

• Do not store any unused portion of the infusion solution for reuse.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.