Antithymocyte immunoglobulin, rabbit: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Singapore prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Treatment of kidney transplant rejection

Adult: For the treatment of corticosteroid-resistant cases: In combination with other immunosuppressive agents: 1.5 mg/kg daily for 7-14 days. Doses are given via IV infusion, using a 0.22 µmeter in-line filter; administer the 1st dose over at least 6 hours and then the subsequent doses over at least 4 hours. Premedicate with corticosteroids, antihistamines, and/or antipyretics 1 hour before administration. Dose interruption or discontinuation may be required according to individual safety or tolerability; dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: Same as adult dose.

Intravenous
Prophylaxis of rejection in kidney graft transplant

Adult: In combination with other immunosuppressive agents: 1-1.5 mg/kg daily for 3-9 days. Alternatively, 1.5 mg/kg daily for 4-7 days. Doses are given via IV infusion, using a 0.22 µmeter in-line filter; administer the 1st dose over at least 6 hours and then the subsequent doses over at least 4 hours. Premedicate with corticosteroids, antihistamines, and/or antipyretics 1 hour before administration. Dose interruption or discontinuation may be required according to individual safety or tolerability; dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: Same as adult dose.

Intravenous
Prophylaxis of rejection in cardiac graft transplant

Adult: In combination with other immunosuppressive agents: 1-2.5 mg/kg daily for 3-5 days. Doses are given via IV infusion, using a 0.22 µmeter in-line filter; administer the 1st dose over at least 6 hours and then the subsequent doses over at least 4 hours. Premedicate with corticosteroids, antihistamines, and/or antipyretics 1 hour before administration. Dose interruption or discontinuation may be required according to individual safety or tolerability; dosage and treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: Same as adult dose.

Reconstitution

Reconstitute with 5 mL of sterile water for inj. Gently rotate until completely dissolved. Further dilute the reconstituted solution with NaCl 0.9% or dextrose 5% in water to a total volume of 50-500 mL, depending on the total number of vials needed. Gently invert the infusion bag once or twice to mix.

Incompatibility

Precipitation may occur with heparin and hydrocortisone in a dextrose infusion solution.

Contraindications

Hypersensitivity. Active acute or chronic infections which prevent additional immunosuppression.

Special Precautions

Patients who have recently received antithymocyte immunoglobulin (rabbit) should not be given attenuated live vaccines. Obese patients. Hepatic impairment. Children. Pregnancy.

Adverse Reactions

Significant: Haematologic effects (e.g. thrombocytopenia, leucopenia, neutropenia, lymphopenia), hypersensitivity.
Blood and lymphatic system disorders: Febrile neutropenia.
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Nausea, diarrhoea, dysphagia, vomiting, constipation.
General disorders and administration site conditions: Inj site pain, swelling, erythema; fever, shivering.
Hepatobiliary disorders: Hepatocellular injury, hepatotoxicity, hepatic failure.
Infections and infestations: UTI.
Investigations: Increased transaminases.
Metabolism and nutrition disorders: Hyperkalaemia, hypokalaemia, acidosis, hyperphosphataemia, hyperlipidaemia.
Musculoskeletal and connective tissue disorders: Myalgia.
Psychiatric disorders: Insomnia, anxiety.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Vascular disorders: Hypotension, hypertension.
Potentially Fatal: Cytokine release syndrome (including cardiopulmonary events); malignancies (e.g. lymphoma, lymphoproliferative disorders). Rarely, anaphylactic reactions, infections (bacterial, fungal, viral, and protozoal), reactivation of infection (e.g. cytomegalovirus infection), sepsis.

Monitoring Parameters

Evaluate patient for sensitivity to rabbit protein before administration. Monitor lymphocyte count (total lymphocyte and/or T-cell subset), CBC with differential, platelet count, vital signs. Assess for signs and symptoms of anaphylactic shock and infection.

Drug Interactions

May increase the risk of vaccine-associated infection.

Lab Interference

May interfere with rabbit antibody-based immunoassays, cross-match or panel-reactive antibody cytotoxicity assays, and enzyme-linked immunosorbent assay (ELISA) tests.

Action

Description:
Mechanism of Action: Antithymocyte immunoglobulin (rabbit), a polyclonal antibody preparation, is a selective immunosuppressive agent (primarily acting on T lymphocytes). The exact mechanism of immunosuppression has not been fully elucidated; however, it may be attributed to peripheral and central lymphocyte depletion.
Synonym(s): Antilymphocyte immunoglobulin, rabbit.
Onset: T-cell depletion: Within 24 hours.
Duration: Lymphopenia: Up to 1 year.
Pharmacokinetics:
Excretion: Elimination half-life: 2-3 days.

Storage

Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Reconstituted or diluted solution: Store between 2-8°C for 24 hours. Storage recommendations may vary among countries or individual products. Refer to specific product guidelines.

MIMS Class

Immunosuppressants

ATC Classification

L04AA04 - antithymocyte immunoglobulin (rabbit) ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.

References

Anon. Antithymocyte Globulin (Rabbit). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 24/05/2023.

Anon. Antithymocyte Globulin (Rabbit). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/05/2023.

Buckingham R (ed). Antilymphocyte Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2023.

Joint Formulary Committee. Antithymocyte Immunoglobulin (Rabbit). British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2023.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Thymoglobuline Powder for Infusion data sheet 20 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 24/05/2023.

Thymoglobulin Injection, Powder, Lyophilized, for Solution (Genzyme Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 24/05/2023.

Thymoglobuline 25 mg Powder for Solution for Infusion (Genzyme Europe B.V.). MHRA. https://products.mhra.gov.uk. Accessed 24/05/2023.

Thymoglobuline 5 mg/mL (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/05/2023.

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