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T-cell Co-stimulation Inhibitor (CTLA4-Ig) Pregnancy: There are no adequate data from use in pregnant women. ORENCIA should not be used during pregnancy unless the clinical condition of the woman requires treatment with abatacept. Women of childbearing potential must use effective contraception during treatment and for up to 14 weeks after the last dose. Abatacept may cross the placenta into the serum of infants born to treated women, who may therefore be at increased risk of infection; live vaccines are not recommended in such infants for 14 weeks following the mother's last exposure during pregnancy. Breast-feeding should be discontinued during treatment and for up to 14 weeks after the last dose. Fertility: no formal human studies; no undesirable effects on male or female fertility in rats.

Abatacept

Brand names: Orencia

Abatacept is a biologic disease-modifying antirheumatic drug (a selective T-cell co-stimulation modulator) used for moderate to severe rheumatoid arthritis and certain other autoimmune conditions.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Rheumatoid arthritis and psoriatic arthritis: 125 mg subcutaneously once weekly, regardless of body weight
Route: Subcutaneous injection (the total content of the pre-filled syringe is given as a subcutaneous injection only) — source product: ORENCIA 125 mg solution for injection (pre-filled syringe)
Frequency: Weekly
Source: UK SPC (eMC) §4.2 for ORENCIA 125 mg solution for injection, pre-filled syringe (https://www.medicines.org.uk/emc/product/2877/smpc). VERBATIM (RA): 'ORENCIA SC should be administered weekly at a dose of 125 mg abatacept by subcutaneous injection regardless of weight.' Subcutaneous treatment may be initiated with or without an intravenous loading dose; if a single IV infusion is given to initiate treatment, the first 125 mg SC dose should be administered within a day of the IV infusion, followed by weekly 125 mg SC injections. THE INTRAVENOUS LOADING/MAINTENANCE POSOLOGY IS NOT IN THIS BUNDLE — the SPC cross-refers to §4.2 of ORENCIA 250 mg powder for concentrate for solution for infusion; source that separately if the IV regimen is needed. PSORIATIC ARTHRITIS: 125 mg weekly by subcutaneous injection without the need for an IV loading dose. SWITCHING FROM IV: patients switching from intravenous therapy should administer the first subcutaneous dose instead of the next scheduled intravenous dose. No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, NSAIDs or analgesics. REVIEW: treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis; if a response is not present within 6 months of treatment, continuation should be reconsidered. MISSED DOSE: if within three days of the planned date, take the missed dose immediately and remain on the original weekly schedule; if missed by more than three days, the timing of the next dose should be based on medical judgment. ELDERLY: no dose adjustment required. ADMINISTRATION: rotate injection sites; never inject into areas where the skin is tender, bruised, red or hard. PAEDIATRIC (weight-band fixed doses, NOT per-kg, so paedDose is null): for polyarticular juvenile idiopathic arthritis in patients 2 to 17 years of age the recommended WEEKLY subcutaneous dose is initiated without an IV loading dose and given by weight band — 10 kg to less than 25 kg: 50 mg; 25 kg to less than 50 kg: 87.5 mg; 50 kg or more: 125 mg. Safety and efficacy in children below 2 years of age have not been established and there is no relevant use under two years old. The intravenous powder for concentrate is available for paediatric pJIA patients 6 years of age and older (separate SPC). Verify any under-18 use against a children's formulary. §4.5 was not retrieved from the UK SPC in this bundle — interactions below come from the §4.4 text and the US ORENCIA label §7.

Dose adjustments

Renal

ORENCIA has not been studied in patients with renal or hepatic impairment. No dose recommendations can be made.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Severe and uncontrolled infections such as sepsis and opportunistic infections

Side effects

  • Upper respiratory tract infection including tracheitis, nasopharyngitis and sinusitis (very common)
  • Headache and dizziness (common); nausea, abdominal pain, diarrhoea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting (common)
  • Lower respiratory tract infection including bronchitis, urinary tract infection, herpes infections, pneumonia, influenza (common); sepsis and tuberculosis reported (uncommon/rare)
  • Hypertension and blood pressure increased (common); cough (common)
  • Abnormal liver function tests including increased transaminases (common); hypersensitivity, thrombocytopenia and leukopenia (uncommon). Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening (a fatal case has been reported post-marketing)

Interactions

  • TNF-inhibitors — not recommended in combination; increased overall and serious infections with no significant additional efficacy over TNF antagonists alone
  • Other biologic immunosuppressive or immunomodulatory agents (e.g. anakinra, other biologic therapies) and JAK inhibitors — could potentiate the effects on the immune system; concurrent use is not recommended (insufficient experience)
  • Live vaccines — vaccination responses may be affected; live vaccines are not recommended in infants exposed to abatacept in utero for 14 weeks after the mother's last exposure
  • Blood glucose monitors using GDH-PQQ test strips — maltose in intravenous ORENCIA may cause falsely elevated blood glucose readings on the day of infusion (does not apply to the subcutaneous presentation)
  • No dose adjustment is required when abatacept is combined with other DMARDs, corticosteroids, salicylates, NSAIDs or analgesics
  • Note: the UK §4.5 section was not retrieved in this bundle

Clinical monograph

How it works

It is a fusion protein that binds CD80/CD86 on antigen-presenting cells, blocking the CD28 co-stimulatory signal required for full T-lymphocyte activation.

Prescribing in practice

  • Screen for and treat latent tuberculosis and other chronic infections before starting, and avoid initiation during active serious infection because of increased infection risk.
  • Avoid combining with TNF inhibitors or other biologics because of the increased risk of serious infection without added benefit.
  • Live vaccines should not be given during treatment or for a period afterwards; update vaccinations before starting where possible.

Monitoring

Monitor for signs of infection throughout treatment and review COPD patients and those with chronic respiratory disease closely, as exacerbations have been reported.

Counselling the patient

  • Tell your team promptly about fever, persistent cough or any signs of infection.
  • Avoid live vaccines and discuss any planned immunisations with your specialist.
  • Carry a biologic alert card and keep your screening and follow-up appointments.

Evidence & guidelines

NICE technology appraisals support abatacept for rheumatoid arthritis in defined patient groups after inadequate response to conventional DMARDs.

Reference: NICE TA375; ASSURE trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.