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Immunosuppressant (Polyclonal Anti-T-Cell Immunoglobulin) Pregnancy: Animal reproduction studies have not been conducted with Thymoglobuline, and it is not known whether it can cause foetal harm or affect reproductive capacity. Thymoglobuline should be given to a pregnant woman only if clearly needed; it has not been studied in labour or delivery. Breastfeeding: not studied in nursing women and it is not known whether it is excreted in human milk; because other immunoglobulins are excreted in human milk, breast-feeding should be discontinued during Thymoglobuline therapy.

Antithymocyte Immunoglobulin (Rabbit)

Brand names: Thymoglobulin, ATG-Fresenius S

Rabbit antithymocyte immunoglobulin is a polyclonal antibody preparation used as a potent immunosuppressant, for example in solid-organ transplant induction or rejection and in aplastic anaemia.

Adult dose

Dose: Thymoglobuline 25 mg powder for solution for infusion (rabbit anti-human thymocyte immunoglobulin; 25 mg per vial, 5 mg per ml once reconstituted) - licensed for immunosuppression in solid organ transplantation only. Prophylaxis of graft rejection, kidney transplantation: 1 to 1.5 mg/kg/day for 3 to 9 days after transplantation (cumulative dose 3 to 13.5 mg/kg). Prophylaxis of graft rejection, heart transplantation: 1 to 2.5 mg/kg/day for 3 to 5 days after transplantation (cumulative dose 3 to 12.5 mg/kg). Treatment of steroid-resistant graft rejection, kidney transplantation: 1.5 mg/kg/day for 7 to 14 days (cumulative dose 10.5 to 21 mg/kg). Obese patients: dose on ideal weight rather than actual weight.
Route: Intravenous infusion, slowly into a high-flow vein after dilution in isotonic 0.9% sodium chloride or 5% glucose, through a 0.22 µm in-line filter; adjust the infusion rate so the total duration is not less than 6 hours
Frequency: Daily (the figures are per day) for 3 to 9 days (kidney prophylaxis), 3 to 5 days (heart prophylaxis) or 7 to 14 days (steroid-resistant kidney rejection)
SCOPE - PINNED PRODUCT ONLY: THYMOGLOBULINE 25MG POWDER FOR SOLUTION FOR INFUSION (MHRA PL123750021, Sanofi B.V.). This page is an umbrella page (it names Thymoglobulin and ATG-Fresenius S and its other content mentions aplastic anaemia and haematopoietic stem cell transplant conditioning). The only indications of this SPC (section 4.1) are prevention of graft rejection in renal transplantation, treatment of steroid-resistant graft rejection in renal transplantation and prevention of graft rejection in heart transplantation. No dose is given here for aplastic anaemia, stem cell transplant conditioning or ATG-Fresenius S, and other anti-thymocyte globulin products are not covered. SPC section 4.4: 'Appropriate dosing for Thymoglobuline is different from dosing for other anti-thymocyte globulin (ATG) products, as protein composition and concentrations vary depending on the source of ATG used. Physicians should therefore exercise care to ensure that the dose prescribed is appropriate for the ATG product being administered.' No maximum dose is printed (the cumulative figures are printed only as what the regimens correspond to), so none is stored. SPC section 4.2: the posology depends on the indication, the administration regimen and the combination with other immunosuppressive agents, and 'The following dosage may be used as a reference'; treatment can be discontinued without gradual tapering of the dose; Thymoglobuline must always be used under strict medical supervision and prescribed by physicians with experience in using immunosuppressive agents, and is usually administered within a regimen combining multiple immunosuppressive agents. Pre-medication with intravenous corticosteroids and antihistamines prior to infusion is recommended; anti-pyretic agents (e.g. paracetamol) may increase the tolerability of the initial infusion. Section 4.4 haematological effects (when thrombocytopenia and/or leukopenia are not part of the underlying disease or the condition being treated): consider a dose reduction if the platelet count is between 50,000 and 75,000 cells/mm3 or the white cell count is between 2,000 and 3,000 cells/mm3; consider stopping treatment if persistent and severe thrombocytopenia (below 50,000 cells/mm3) or leukopenia (below 2,000 cells/mm3) develops. Elderly: dose recommendations are the same as for adults. Children: the SPC says 'no recommendation on a posology can be made' (see paedDose, which is therefore null). Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

In view of the pharmacokinetics and metabolism, no dose adjustment is necessary in patients with renal impairment (SPC section 4.2). Children: the SPC states that currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made, and that available information indicates that paediatric patients do not require a different dosage than adult patients; no paediatric figure is given.

Hepatic

In view of the pharmacokinetics and metabolism, no dose adjustment is necessary in patients with hepatic impairment (SPC section 4.2). Section 4.4: Thymoglobuline has to be administered with special caution in patients with hepatic diseases as pre-existing clotting disorders may aggravate; careful monitoring of thrombocytes and coagulation parameters is recommended.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to rabbit proteins or to any of the excipients listed in section 6.1
  • Active acute or chronic infections, which would contraindicate any additional immunosuppression

Side effects

  • Very common: anaemia, lymphopenia, neutropenia, thrombocytopenia; infection (including reactivation of infection); fever
  • Common: febrile neutropenia; sepsis; diarrhoea, dysphagia, nausea, vomiting; shivering; transaminases increased; myalgia; dyspnoea; pruritus, rash; hypotension; malignancy, lymphomas (which may be virally mediated) and solid tumours
  • Uncommon: infusion-associated reactions (IARs); serum sickness, cytokine release syndrome (CRS), anaphylactic reaction; hepatocellular injury, hepatotoxicity, hepatic failure; lymphoproliferative disorder
  • Frequency unknown: hyperbilirubinaemia
  • IARs may occur as soon as the first or second dose, with fever, chills/rigors, dyspnoea, nausea/vomiting, diarrhoea, hypotension or hypertension, malaise, rash, urticaria and/or headache; usually mild and transient and managed with reduced infusion rates and/or medications
  • Serious immune-mediated reactions (anaphylaxis, severe CRS) in rare instances; very rarely fatal anaphylaxis; rapid infusion rates have been associated with cases consistent with CRS, which can in rare instances be fatal
  • Infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly CMV) and sepsis in combination with other immunosuppressive agents; in rare cases fatal
  • Immunosuppressive agents including Thymoglobuline may increase the incidence of malignancies, lymphoma or lymphoproliferative disorders, sometimes with fatal outcomes
  • This side-effect list may be incomplete — check the full SPC.

Interactions

  • No drug interaction studies have been performed; interactions with food and drink are unlikely
  • Thymoglobuline can induce production of human anti-rabbit antibodies, which may interfere with rabbit antibody-based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays
  • Thymoglobuline may interfere with ELISA tests
  • Combined with other immunosuppressive agents it increases the risk of infection, reactivation of infection (particularly CMV) and sepsis (section 4.4)

Monitoring

  • Use under strict medical supervision in a hospital setting, on the instructions of a physician experienced in immunosuppressive therapy in the transplant setting
  • Monitor the patient carefully during the infusion and for a period afterwards until the patient is stable, with particular attention to symptoms of anaphylactic shock; medical personnel and emergency equipment must be readily at hand during the first days of therapy; terminate the infusion immediately if anaphylaxis occurs
  • Before administration it is advisable to determine whether the patient is allergic to rabbit proteins
  • White blood cell and platelet counts during and after therapy
  • In hepatic disease, monitor thrombocytes and coagulation parameters carefully
  • Careful patient monitoring and appropriate anti-infective prophylaxis are recommended because of the infection risk, particularly CMV reactivation
  • Confirm which ATG product is being prescribed: dosing differs between ATG products (section 4.4)

Clinical monograph

How it works

It contains antibodies against human T-lymphocyte antigens, causing depletion of circulating T cells and broad suppression of cell-mediated immune responses.

Prescribing in practice

  • Severe infusion reactions, including cytokine release syndrome and anaphylaxis, can occur, so give premedication and administer slowly by intravenous infusion under close supervision.
  • Profound immunosuppression raises the risk of serious infection and reactivation of latent viruses.
  • Thrombocytopenia and leucopenia are common and may require dose adjustment.

Monitoring

Monitor full blood count (particularly platelets and lymphocytes), watch for infusion reactions, and remain alert to infection and viral reactivation.

Counselling the patient

  • Infusion reactions such as fever, chills, and rash can occur, especially with early doses; report symptoms during infusion.
  • Report any signs of infection after treatment.
  • Long-term increased infection risk and the need for surveillance will be explained by the specialist team.

Evidence & guidelines

Antithymocyte immunoglobulin is an established immunosuppressant in transplantation and aplastic anaemia; consult the SPC and current prescribing references.

Reference: NICE NG234 (Aplastic anaemia: diagnosis and management, 2022); BSH Guidelines on aplastic anaemia (2015 updated); EBMT/EHA Guidelines; 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.

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