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abatacept (Orencia)

Tradename: Orencia (FDA-approved 2005) Indications: - FDA-approved for treatment of rheumatoid arthritis that does not respond adequately to methotrexate [3] - rheumatoid arthritis with inadequate response to etanercept (Enbrel) or infliximab (Remicade) - 50% response rate in clinical trial - may be used concurrently with methotrexate or glucocorticoids * preferred for patients with a history of severe infection [3] Contraindications: - concurrent use of other biologic agent (TNF inhibitor, rituximab, anakinra) - relatively contraindicated with COPD [3] Pregnancy category: C [3] Dosage: - IV infusion over 30 minutes every 28 days, with additional dose on day 14 - adult weight-based dosing - < 132 lbs (< 60 kg): 500 mg (2 vials) - 132-220 lbs (60-100 kg): 750 mg (3 vials) - > 220 lbs ( > 100 kg): 1000 mg (4 vials) [4] - subcutaneous: 125 mg SC injection in a prefilled syringe weekly [4] * injection: - 250 mg white lyophilized powder in a single-dose vial - 125 mg/mL pack of 4 syringes with a passive needle safety guard [4] Storage: refrigerate ar 2-8 C Monitor: - screening for tuberculosis [3] - CBC, LFTs, serum creatinine baseline & every 3-6 months thereafter Adverse effects: 1) immunosuppression [2] 2) exacerbation of COPD [2] 3) similar to placebo [1] Drug interactions: - do NOT use in combination with Enbrel, Humira or Remicade combination increases risk of infaction without increase in benefit [2] Mechanism of action: 1) soluble CTLA4 receptor/IgG Fc segment chimer 2) inhibits T-cell activation - interferes with antigen presentation to T-cells 3) targets CD80//CD86 [3] 4) diminishes production of TNF & other immune modulators Management: - whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent [3]

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

General

biologic immunosuppressive agent (biologic agent, biologic immune modulator) disease-modifying antirheumatic agent (DMARD)

References

  1. Genovese MC et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005 Sep 15; 353:1114-23. PMID: 16162882
  2. Prescriber's Letter 13(2): 2006 Detail-Document#: 220207 (subscription needed) http://www.prescribersletter.com
  3. Medical Knowledge Self Assessment Program (MKSAP) 15, 16, 17, 18, 19. American College of Physicians, Philadelphia 2009, 2012, 2015, 2018, 2022.
  4. ORENCIA. Information for Health Care Professionals https://www.orenciahcp.com/dosing-and-administration/intravenous https://www.orenciahcp.com/dosing-and-administration/subcutaneous