Orencia, lyophilizate 250 mg

Orencia is an immunosuppressant. Abatacept is a soluble protein consisting of the extracellular domain of cytotoxic T-lymphocyte antigen 4 (CTLA-4) bound to a modified Fc fragment of human immunoglobulin G1 (IgG1). Abatacept is a recombinant protein that is produced by genetic engineering on a mammalian cell system.

Abatacept selectively modulates the key co-stimulatory signal required for full activation of T-lymphocytes expressing cluster-differentiation 28 (CD28). In patients with rheumatoid arthritis, T-lymphocytes are found in synovial fluid.

Indications

Active ingredient

How to take, the dosage

Abatacept can be used as monotherapy or in combination with basal anti-inflammatory drugs (e.g., methotrexate).

The drug Orencia® is given by IV infusion for 30 minutes at the doses shown in the table.

In adults, after the first dose, the next doses are recommended after 2 and 4 weeks and then every 4 weeks thereafter.

In children aged 6 to 17 years with a body weight less than 75 kg, the drug dose is 10 mg/kg of body weight. The dose should be calculated individually just before each drug administration. For children with body weight of 75 kg or more the drug dosage regimen is the same as for adults. The maximum dose is 1000 mg.

Regulations for preparation of the infusion solution and administration of the drug

Abatacept solution must not be used with equipment containing silicone.

After removing the protective plastic cap, the stopper is wiped off with sterile absorbent cotton moistened in alcohol. The contents of one bottle is dissolved in 10 ml of water for injection, using a disposable silicone-free syringe supplied with the drug (the stream of water when dissolving the drug should be directed to the wall of the bottle). In order to reduce the formation of foam, the bottle should be turned gently until the powder has dissolved. Do not shake it! After the powder has dissolved, air must be bled out of the vial through the needle to remove any bubbles that may have formed. The resulting concentrate should be colorless or pale yellow. Do not use a cloudy solution, a different color solution, or one that contains foreign particles.

The obtained concentrate is immediately diluted to 100 ml with 0.9% sodium chloride solution for injection to obtain infusion solution as follows: from 100 ml of sodium chloride bottle 10 ml of solution is taken for each vial of abatacept added. Then the previously obtained concentrate is slowly added to the remaining solution using the disposable silicone-free syringe supplied with the preparation. The concentration of abatacept in the resulting solution is approximately 5, 7.5 or 10 mg/ml, respectively, using 2, 3 or 4 vials of the drug.

The prepared solution can be stored for 24 h in the refrigerator at 2° to 8°C. If foreign particles or color changes are observed in the solution prior to administration, the solution should be discarded. The prepared solution should be administered within 24 hours after opening the vial.

The prepared infusion solution is administered within 30 minutes through an infusion system with a sterile apyrogenic filter with low protein binding capacity (pore size from 0.2 to 1.2 µm). Abatacept should not be administered simultaneously with other drugs through the same infusion system.

Interaction

Special Instructions

Contraindications

Side effects

Overdose