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Abatacept

Generic Medicine Info
Indications and Dosage
Intravenous
Acute graft-versus-host disease
Adult: As prophylaxis in patients undergoing haematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor: In combination with a calcineurin inhibitor and methotrexate: 10 mg/kg (Max: 1,000 mg) via IV infusion over 60 minutes for 4 doses given on the day before transplantation and on days 5, 14, and 28 post-transplant. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Child: As prophylaxis in patients undergoing haematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor: In combination with a calcineurin inhibitor and methotrexate: 2-<6 years 15 mg/kg via IV infusion over 60 minutes given on the day before transplantation, followed by 12 mg/kg via IV infusion over 60 minutes given on days 5, 14, and 28 post-transplant. ≥6 years Same as adult dose. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Rheumatoid arthritis
Adult: For moderate to severe active cases in patients who had an inadequate response to at least one other DMARDs: As monotherapy or in combination with methotrexate or other DMARDs: For patients weighing <60 kg: 500 mg; 60-100 kg: 750 mg; >100 kg: 1,000 mg. Doses are given via infusion over 30 minutes every 2 weeks for 3 doses, then every 4 weeks thereafter. Reconsider the continuation of treatment if no adequate response is observed within 6 months of therapy. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Polyarticular juvenile idiopathic arthritis
Child: For moderate to severe active cases in patients who had an inadequate response to previous DMARD therapy: As monotherapy or in combination with methotrexate: ≥6 years weighing <75 kg: 10 mg/kg; 75-100 kg: 750 mg; >100 kg: 1,000 mg. Doses are given via infusion over 30 minutes every 2 weeks for 3 doses, then every 4 weeks thereafter. Reconsider the continuation of treatment if no adequate response is observed within 6 months of therapy. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Psoriatic arthritis
Adult: In patients who had an inadequate response to previous DMARD therapy: As monotherapy or in combination with methotrexate: For patients weighing <60 kg: 500 mg; 60-100 kg: 750 mg; >100 kg: 1,000 mg. Doses are given via infusion over 30 minutes every 2 weeks for 3 doses, then every 4 weeks thereafter. Reconsider the continuation of treatment if no adequate response is observed within 6 months of therapy. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Rheumatoid arthritis
Adult: For moderate to severe active cases in patients who had an inadequate response to at least one other DMARDs: As monotherapy or in combination with methotrexate or other DMARDs: 125 mg once weekly via SC inj. Doses may be initiated with or without an IV loading dose. If the treatment is initiated with a single IV infusion dose, administer the 1st 125 mg SC dose within 24 hours of the IV infusion, followed by 125 mg weekly SC inj thereafter. If switching from IV therapy to SC therapy, administer the 1st SC dose instead of the next scheduled IV dose. Reconsider the continuation of treatment if no adequate response is observed within 6 months of therapy. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Polyarticular juvenile idiopathic arthritis
Child: For moderate to severe active cases in patients who had an inadequate response to previous DMARD therapy: As monotherapy or in combination with methotrexate: ≥2 years weighing 10-<25 kg: 50 mg once weekly; 25-<50 kg: 87.5 mg once weekly; ≥50 kg: 125 mg once weekly. Doses may be initiated without an IV loading dose. Reconsider the continuation of treatment if no adequate response is observed within 6 months of therapy. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Subcutaneous
Psoriatic arthritis
Adult: In patients who had an inadequate response to previous DMARD therapy: As monotherapy or in combination with methotrexate: 125 mg once weekly via SC inj. Doses may be initiated without an IV loading dose. If switching from IV therapy to SC therapy, administer the 1st SC dose instead of the next scheduled IV dose. Reconsider the continuation of treatment if no adequate response is observed within 6 months of therapy. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Reconstitution
Intravenous:
Powder for concentrate for solution for infusion: Reconstitute each vial with 10 mL of sterile water for inj using the provided silicone-free disposable syringe. To minimise foaming, gently swirl the vial without shaking until the contents are completely dissolved. Avoid vigorous or prolonged agitation. Vent the vial with a needle to allow any foam present to dissipate. Immediately after reconstitution, further dilute in 100 mL NaCl 0.9% solution for inj as follows: Withdraw from the 100 mL infusion bag or bottle a volume of NaCl 0.9% solution equivalent to the volume of the reconstituted vials or the required abatacept dose, then slowly add the reconstituted solution from each vial to the infusion bag or bottle to make a final volume of 100 mL. Gently mix; do not shake. The final concentration of the solution will depend on the amount of drug added but will be ≤10 mg/mL.
Contraindications
Hypersensitivity. Severe and uncontrolled infections (e.g. opportunistic infections, sepsis).
Special Precautions
Patient with chronic obstructive pulmonary disease (COPD); history of recurrent infections, pre-existing chronic, latent or localised infections, or underlying conditions that may predispose them to infections. Children and elderly. Pregnancy and lactation. Do not administer live vaccines concomitantly with abatacept or within 3 months following its discontinuation. Concomitant use with tumour necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, and other biologic DMARDs is not recommended.
Adverse Reactions
Significant: Hepatitis B reactivation; CMV invasive disease, post-transplant lymphoproliferative disorder associated with Epstein-Barr virus infection (in patients who received abatacept for prophylaxis of acute graft-versus-host disease during HSCT from an unrelated donor); malignancies, including skin cancer.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, dyspepsia, diarrhoea, mouth ulceration.
General disorders and administration site conditions: Fatigue, asthenia, pyrexia.
Immune system disorders: Antibody development.
Infections and infestations: UTI, influenza.
Investigations: Abnormal LFTs, decreased CD4 lymphocytes.
Metabolism and nutrition disorders: Hypermagnesaemia.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: Acute kidney injury.
Respiratory, thoracic and mediastinal disorders: URTI, epistaxis, sinusitis, nasopharyngitis, cough, bronchitis.
Skin and subcutaneous tissue disorders: Rash.
Vascular disorders: Hypertension.
Potentially Fatal: Hypersensitivity (e.g. anaphylaxis, angioedema) or anaphylactoid reactions; serious infections (including sepsis, tuberculosis, and pneumonia); progressive multifocal leucoencephalopathy (mostly when given in combination with other immunosuppressive agents).
Patient Counseling Information
Women of childbearing potential must use proven birth control methods during therapy and for 14 weeks after stopping the treatment. Avoid breastfeeding during therapy and for 14 weeks after the last dose.
Monitoring Parameters
Conduct hepatitis and tuberculosis screening before treatment initiation. Perform periodic skin examinations, particularly in patients with risk factors for skin cancer. Assess for signs or symptoms of hypersensitivity reaction and infections. For prophylaxis of acute graft-versus-host disease: Hepatitis B virus screening with HBsAg, hepatitis B core antibody, total Ig or IgG, and antibody to HBsAg is recommended before or at the beginning of systemic chemotherapy. Monitor for CMV infection or reactivation for 6 months post-transplant; post-transplant lymphoproliferative disorder and Epstein-Barr virus reactivation.
Drug Interactions
Increased risk of serious infections with TNF inhibitors. Potential additive immunosuppressive effects and increased risk of infection with JAK inhibitors and other biologic DMARDs. May reduce the therapeutic effects of live vaccines.
Action
Description:
Overview: Abatacept, a fully human recombinant fusion protein, is a biologic DMARD and a selective costimulation modulator that blocks T-cell (T-lymphocyte) activation.
Mechanism of Action: Abatacept blocks the required CD28 interaction between antigen-presenting cells (APC) and T cells by binding to CD80 and CD86 on APC, leading to inhibition of T-lymphocyte activation.
Pharmacodynamics: In vitro studies have shown that abatacept reduces T-cell proliferation and inhibits the production of pro-inflammatory cytokines, including tumour necrosis factor-α (TNF-α) and interferon-γ. Dose-dependent reductions in serum levels of soluble interleukin-2 receptor (a T-lymphocyte activation marker), interleukin-6 (produced by activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis), C-reactive protein (an acute phase reactant of inflammation), and rheumatoid factor (an autoantibody produced by plasma cells) have been observed with abatacept. Additionally, serum levels of matrix metalloproteinase-3, which is involved in cartilage destruction and tissue remodelling, are decreased. The relationship between these biological response markers and the mechanism through which abatacept produces its clinical effects is unknown.
Pharmacokinetics:
Absorption: Bioavailability: Approx 79% (SC).
Distribution: Enters breast milk.
Excretion: Elimination half-life: Rheumatoid arthritis: 13.1 days (IV); 14.3 days (SC). Acute graft-versus-host disease prophylaxis: Approx 21 days.
Storage
Intravenous:
Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Diluted solution for IV infusion: May store between 2-8°C for up to 24 hours.

Subcutaneous:
Pre-filled syringe, pen, or auto-injectors: Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AA24 - abatacept ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Abatacept. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 16/12/2025.

Abatacept. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/12/2025.

Abatacept. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/12/2025.

Brayfield A, Cadart C (eds). Abatacept. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/12/2025.

Joint Formulary Committee. Abatacept. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/12/2025.

Orencia 125 mg Solution for Injection in Pre-filled Pen (Bristol-Myers Squibb Pharma EEIG). MHRA. https://products.mhra.gov.uk. Accessed 04/12/2025.

Orencia 250 mg Powder for Concentrate for Solution for Infusion (Bristol-Myers Squibb Pharma EEIG). MHRA. https://products.mhra.gov.uk. Accessed 04/12/2025.

Orencia 50 mg Solution for Injection in Pre-filled Syringe (Bristol-Myers Squibb Pharma EEIG). MHRA. https://products.mhra.gov.uk. Accessed 04/12/2025.

Orencia Injection, Powder, Lyophilized, for Solution; Orencia Injection, Solution (E.R. Squibb & Sons, L.L.C.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/12/2025.

Paediatric Formulary Committee. Abatacept. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 16/12/2025.

Disclaimer: This information is independently developed by MIMS based on Abatacept from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2026 MIMS. All rights reserved. Powered by MIMS.com
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