IntravenousAplastic anaemiaAdult: For the treatment of moderate to severe cases in patients who are ineligible for bone marrow transplantation: In combination with other immunosuppressive agents: 10-20 mg/kg once daily for 8-14 days, then every other day, if needed, up to a total of 21 doses in 28 days. Doses are given via IV infusion over at least 4 hours using a 0.2-1 µmeter in-line filter. Premedicate with corticosteroids, antihistamines, and/or antipyretics prior to infusion. Dose reduction, dose interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
Elderly: Initiate at the lower end of the dosing range.
IntravenousTreatment of kidney transplant rejectionAdult: In combination with other immunosuppressive agents: 10-15 mg/kg once daily for 14 days, then every other day, if needed, up to a total of 21 doses in 28 days. Doses are given via IV infusion over at least 4 hours using a 0.2-1 µmeter in-line filter. Premedicate with corticosteroids, antihistamines, and/or antipyretics prior to infusion.
Elderly: Initiate at the lower end of the dosing range.
IntravenousProphylaxis of rejection in kidney graft transplantAdult: In combination with other immunosuppressive agents: 15 mg/kg once daily for 14 days, then every other day, if needed, up to a total of 21 doses in 28 days. Administer the 1st dose within 24 hours before or after transplantation. Doses are given via IV infusion over at least 4 hours using a 0.2-1 µmeter in-line filter. Premedicate with corticosteroids, antihistamines, and/or antipyretics prior to infusion. Dosage and treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Elderly: Initiate at the lower end of the dosing range.
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Dilute in an inverted bag/bottle (to prevent contact of the undiluted solution to air) with an appropriate volume of NaCl 0.9%, dextrose 5% and NaCl 0.225%, or dextrose 5% and NaCl 0.45% to a final concentration not exceeding 4 mg/mL. Mix by gently swirling or rotating the bag/bottle. Do not shake.
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Precipitation may occur with dextrose-only solutions. Incompatible with highly acidic solutions.
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Hypersensitivity to equine gamma globulin preparations. Concomitant administration of live vaccines.
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Children and elderly. Pregnancy and lactation.
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Significant: Severe infusion reactions (e.g. pain, swelling, redness), serum sickness, sepsis, opportunistic infections (e.g. bacterial, fungal, viral), viral reactivation (e.g. cytomegalovirus, EBV, HSV), Creutzfeldt-Jakob disease, haematologic toxicity (e.g. thrombocytopenia, neutropenia), abnormal LFTs and renal function tests.
Blood and lymphatic system disorders: Leucopenia, lymphadenopathy, haemolysis.
Cardiac disorders: Bradycardia, tachycardia.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain, stomatitis, gastrointestinal haemorrhage.
General disorders and administration site conditions: Fever, chills, malaise.
Metabolism and nutrition disorders: Hyperglycaemia.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, back pain.
Nervous system disorders: Headache, dizziness, syncope, paraesthesia, convulsion.
Renal and urinary disorders: Proteinuria.
Respiratory, thoracic and mediastinal disorders: Cough, epistaxis, pleural effusion, dyspnoea.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.
Vascular disorders: Thrombophlebitis, hypotension, hypertension.
Potentially Fatal: Anaphylaxis, cytokine release syndrome.
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This drug may cause dizziness, syncope, convulsion, or confusional state; if affected, do not drive or operate machinery. Women of childbearing potential must use proven birth control methods during treatment and for at least 10 weeks after stopping the treatment. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 10 weeks after stopping treatment.
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Perform skin testing prior to initiation of therapy. Monitor vital signs, CBC with differential and platelet count, renal function and LFTs (as necessary). Assess for signs and symptoms of anaphylaxis (during and at least 24 hours after administration), cytokine release syndrome, infusion reactions, infection, or serum sickness.
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May unmask certain adverse reactions during dose reduction of concomitant corticosteroids and other immunosuppressants.
Potentially Fatal: Increased risk of uncontrolled viral replication with live vaccines.
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Description:
Mechanism of Action: Antithymocyte immunoglobulin (equine) is a lymphocyte-selective immunosuppressant. Its exact mechanism of action in immunosuppression has not been determined; however, it appears to be involved in the depletion of antigen-reactive T-lymphocytes (killer cells) in peripheral blood or in alteration of T-cell function. It also directly stimulates the growth of haematopoietic stem cells and release of haematopoietic growth factors such as interleukin-3 and granulocyte or macrophage colony stimulating factor.
Synonym(s): Antilymphocyte immunoglobulin, horse.
Pharmacokinetics:
Distribution: Binds to circulating lymphocytes, granulocytes, platelets, and bone marrow cells.
Excretion: Via urine (approx 1%). Elimination half-life: 5.7 ± 3 days.
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Intact ampoule/vial: Store between 2-8°C. Do not freeze. Protect from light. Diluted solution for infusion: Stable for up to 24 hours (including infusion time) between 2-8°C; allow solution for infusion to reach room temperature before administration.
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L04AA03 - antilymphocyte immunoglobulin (horse) ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
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Anon. Antithymocyte Globulin (Equine). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 26/05/2023. Anon. Antithymocyte Globulin (Equine). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 26/05/2023. Atgam 50 mg/mL Concentrate for Solution for Infusion (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 26/05/2023. Atgam Injection, Solution (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 26/05/2023. Buckingham R (ed). Antilymphocyte Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/05/2023. Pfizer New Zealand Limited. Atgam 250 mg/5 mL data sheet 11 November 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 26/05/2023. Thymogam (Bharat Serums and Vaccines Limited). MIMS Philippines. http://www.mims.com/philippines. Accessed 26/05/2023.
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