Adult Dosing

Acute renal graft rejection

• Recommended dose: 1.5 mg/kg of body weight IV qd x 7-14 days
• Infuse over a minimum of 6 hrs for the first infusion and over at least 4 hrs on subsequent days of therapy
• Reduce dose to 50% if WBC count is 2000-3000 cells/mm³ or if platelet count is 50,000-75,000 cells/mm³; consider therapy discontinuation if WBC count falls below 2000 cells/mm³ or platelets below 50,000 cells/mm³

• Route of administration is IV infusion using a high-flow vein
• Refer to package insert for vial reconstitution, dilution in infusion solution, and infusion procedure
• Administer antiviral prophylactic therapy; premedicate with corticosteroids, acetaminophen, or an antihistamine 1 hr prior to infusion to reduce the incidence and intensity of side effects during infusion

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of renal transplant acute rejection in conjunction with immunosuppressive therapy

• Hypersensitivity to any of the ingredients of the product
• History of allergy or anaphylaxis to rabbit proteins
• Acute viral illness

• Therapy should only be administered by physicians experienced in immunosuppressive therapy for management of renal transplant patients

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Therapy should be administered by physicians experienced in immunosuppressive therapy for management of renal transplant patients [US Black Box Warning]. Medical surveillance is required during product infusion
• Therapy may cause serious immune-mediated reactions including anaphylaxis or severe cytokine release (CRS) syndrome; fatal anaphylaxis has been reported. Promptly discontinue infusion if such reactions occur; avoid readministration of therapy in such patients
• Medical personnel and emergency treatment including 0.3-0.5 mL aqueous epinephrine (1:1000 dilution) SC and other resuscitative measures including oxygen, IV fluids, antihistamines, corticosteroids, pressor amines, and airway management should be readily available for the management of anaphylaxis
• Therapy may cause thrombocytopenia or neutropenia; these hematologic effects are reversible following dose adjustments
• Therapy may produce fever and chills. Close compliance with recommended dose and infusion time may reduce the incidence and severity of infusion-associated reactions (IARs). Premedication with acetaminophen, corticosteroids, and antihistamine and/or slowing the infusion rate may help minimize reaction incidence and intensity
• Prolonged use or overdosage of therapy in combination with other immunosuppressive agents may lead to over-immunosuppression resulting in severe infections and may increase the incidence of lymphoma or post-transplant lymphoproliferative disease (PTLD) or other malignancies. Appropriate antiviral, antibacterial, antiprotozoal, and antifungal prophylaxis is recommended
• Therapy may cause infusion site reactions that may include pain, swelling, and erythema
• Monitor lymphocyte count, WBC and platelet counts during therapy
• Immunization with attenuated live vaccines is not indicated for patients who have recently received anti-thymocyte globulin
• Infuse therapy under strict medical supervision in a hospital setting; carefully monitor patients during infusion

Pregnancy Category:C

Breastfeeding: It is unknown whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, manufacturer advises to discontinue breast-feeding during therapy.

• CV: Hypertension, peripheral edema, tachycardia
• CNS: Headache, malaise, asthenia, dizziness
• GI: Abdominal pain, diarrhea, nausea, moniliasis
• GU: Urinary tract infection
• HEMA: Leukopenia, thrombocytopenia
• METABOLIC: Hyperkalemia
• RESP: Dyspnea
• LOCAL: Severe infusion reaction
• HYPERSENSITIVITY: Anaphylaxis, cytokine release syndrome
• MISC: Fever, chills, pain, infection, sepsis, serum sickness, serious infection, cytomegalovirus infection, malignancy, lymphoproliferative disorders

• Immunomodulatory agent; exact mechanism of action is not fully understood; possible mechanisms by which it may induce immunosuppression include T-cell clearance from the circulation and modulation of T-cell activation, homing, and cytotoxic activities
• Metabolism: Unknown; CYP450: Unknown
• Excretion: Unknown
• Half-life: 2-3 days

US Trade Name(s)

• Thymoglobulin

US Availability

Thymoglobulin

• PWDR for INJ: 25 mg/vial (10 mL vial)

Canadian Trade Name(s)

• Thymoglobulin

Canadian Availability

Thymoglobulin

• PWDR for INJ: 25 mg/vial

UK Trade Name(s)

• Thymoglobuline

UK Availability

Thymoglobuline

• PWDR for INJ: 25 mg/vial (10 mL vial)

Australian Trade Name(s)

• Thymoglobuline

Australian Availability

Thymoglobuline

• PWDR for INJ: 25 mg vials

[Outline]

Immunologic

Immune Globulins