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Introduction of Orencia

Orencia (Abatacept) is a medicine that is often used in combination with methotrexate to treat:

  • Adult Rheumatoid Arthritis (RA)
    moderately to severely active RA in adults. Orencia may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.
  • Juvenile Idiopathic Arthritis
    moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 6 years of age and older. Orencia may be used as monotherapy or concomitantly with methotrexate.

Orencia (abatacept) is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system.

Dosage and Administration

Orencia comes in the form of 250 mg lyophilized powder in a single-use vial for intravenous infusion and in 125 mg/mL solution in a single-dose prefilled syringe.

Subcutaneous Administration for Adult RA

Administer by subcutaneous injection once weekly with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, administer a single intravenous infusion, followed by the first Orencia 125 mg subcutaneous injection given within a day of the intravenous infusion.

Patients transitioning from Orencia intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.

Juvenile Idiopathic Arthritis
Pediatric patients weighing less than 75 kg receive 10 mg/kg intravenously based on the patient’s body weight. Pediatric patients weighing 75 kg or more should be administered Orencia following the adult intravenous dosing regimen, not to exceed a maximum dose of 1000 mg.

General Dosing Information for Intravenous Administration

  • Administer as a 30-minute intravenous infusion
  • Following initial dose, give at 2 and 4 weeks, then every 4 weeks
  • Prepare Orencia using only the silicone-free disposable syringe
  • Use only sterile water to reconstitute the powder
  • The reconstituted product must be administered using a filter

Side-effects of Orencia

One should administer Orencia 250 mg under the supervision of qualified healthcare professional. The common side-effects of Orencia are headache, upper respiratory tract infection, nasopharyngitis, and nausea.

Warnings & Precautions

  • Concomitant use with a TNF antagonist can increase the risk of infections and serious infections.
    Hypersensitivity, anaphylaxis, and anaphylactoid reactions.
  • Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections.
  • Discontinue if a serious infection develops.
  • Screen for latent TB infection prior to initiating therapy. Patients testing positive should be treated prior to initiating Orencia.
  • Live vaccines should not be given concurrently or within 3 months of discontinuation.
  • Patients with juvenile idiopathic arthritis should be brought up to date with all immunizations prior to Orencia therapy.
  • Based on its mechanism of action, Orencia may blunt the effectiveness of some immunizations.
    COPD patients may develop more frequent respiratory adverse events.

Storage and Handling

Orencia lyophilized powder supplied in a vial should be refrigerated at 2C-8C (36F to 46F). One should not use beyond the expiration date on the vial. Protect the vials from light by storing in the original package until time of use.

Orencia solution supplied in a prefilled syringe should be refrigerated at 2C-8C (36F to 46F). One should not use beyond the expiration date on the prefilled syringe. Protect from light by storing in the original package until time of use. Do not allow the prefilled syringe to freeze.

Nitin Goswami

Nitin Goswami joined us as an Editor in 2020. He covers all the updates in the field of Pharmaceutical, Business Healthcare, Health News, Medical News, and Pharma News.

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