antithymocyte globulin rabbit (Rx)

Brand and Other Names:Thymoglobulin, ATG rabbit
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 25mg/vial
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Acute Renal Graft Rejection

Indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant in conjunction with concomitant immunosuppression

Treatment: 1.5 mg/kg IV infusion qDay x 7-14 days 

Prophylaxis: 1.5 mg/kg IV qDay with the first dose initiated prior to reperfusion of the donor kidney; usual duration is 4-7 days

Also see Administration

Recommended concomitant medications

  • Use with concomitant immunosuppressants
  • Administer prophylactic antifungal and antibacterial therapy if clinically indicated
  • Antiviral prophylactic therapy is recommended for patients who are seropositive for CMV at the time of transplant and for CMV-seronegative patients scheduled to receive a kidney from a CMV-seropositive donor

Dosage Modifications

Monitor patients for adverse reactions during and after infusion

Monitor total WBC and platelet counts during and after therapy

WBCs 2000-3000 cells/mm³ or platelets 50,000-75,000 cell/mm³: Reduce dose by 50%

WBCs <2000 cell/mm³ or platelets <50,000 cell/mm³: Consider discontinuing

Aplastic Anemia (Off-label)

1.5 mg/kg IV infusion qDay for 7-14 days OR 

3.5 mg/kg IV infusion qDay x 5 days, together with cyclosporine + G-CSF

Myelodysplastic Syndrome (Orphan)

Treatment of myelodysplastic syndrome Data limited; 3.75 mg/kg IV infusion qDay x 5 days 

Orphan indication sponsor

  • Genzyme Corporation; 500 Kendall Street; Cambridge, MA 02142

Solid Organ Transplant Rejection (Orphan)

Indicated for prophylaxis of acute allograft rejection in adult recipients in solid organ transplantation

Orphan indication sponsor

  • Fresenius Biotech North America; 920 Winter Street; Waltham, MA 02451

Graft Versus Host Disease (Orphan)

Indicated for prevention of graft vs host disease; 2 mg/kg IV infusion qDay x 3-4 days

Orphan indication sponsor

  • Fresenius Biotech North America; 920 Winter Street; Waltham, MA 02451

Prophylaxis of Renal Transplant Rejection (Orphan)

Indicated for prophylaxis of acute organ rejection in renal transplant recipients

Orphan indication sponsor

  • Genzyme Corporation; 500 Kendall Street; Cambridge, MA 02142

Safety and efficacy not established

Liver Transplant Rejection (Orphan)

Induction treatment to prevent rejection and to minimize maintenance immunosupression in pediatric liver transplant recipients

Orphan indication sponsor

  • Children's Hospital of Pittsburgh, University of Pittsburgh; Pittsburgh, PA 15213
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Interactions

Interaction Checker

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            Adverse Effects

            >10%

            Abdominal pain (38%)

            Asthenia (27%)

            Chills (57%)

            Diarrhea (37%)

            Dyspnea (28%)

            Fever (63%),

            Headache (40%)

            HTN (37%)

            Hyperkalemia (27%)

            Infection (37%)

            Leukopenia (57%)

            Malaise (13%)

            Nausea (37%)

            Pain (46%)

            Peripheral edema (34%)

            Tachycardia (27%)

            Thrombocytopenia (37%)

            1-10%

            Dizziness

            Digestive

            Gastritis

            Oral moniliasis

            Herpes simplex infection

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            Warnings

            Black Box Warnings

            Should only be prescribed by physicians experienced in immunosuppressive therapy for renal transplant recipients

            Contraindications

            History of allergy or anaphylaxis to rabbit proteins

            Active acute or chronic infections that contraindicate any additional immunosuppression

            Cautions

            To prevent overimmunosuppression, physicians may decrease the dose of the maintenance immunosuppression regimen during the period of antithymocyte globulin rabbit use

            Serious immune-mediated reactions, including anaphylaxis (including fatal anaphylaxis) or severe cytokine release syndrome (CRS), reported; if an anaphylactic reaction occurs, terminate the infusion immediately and implement emergency treatment (eg, 0.3-0.5 mL epinephrine (1 mg/mL) SC and other resuscitative measures including oxygen, IV fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated

            CRS reported with rapid infusion rates; CRS is attributed to the release of cytokines by activated monocytes and lymphocytes; severe acute CRS can cause serious cardiorespiratory events and/or death; close compliance with the recommended dosage and infusion time may reduce the incidence and severity of infusion-associated reactions; slowing the infusion rate may minimize many of this risk (see Administration)

            Low counts of platelets and WBCs (including low counts of lymphocytes and neutrophils) have been identified and are reversible following dose adjustments (see Dosage Modifications)

            Routinely used in combination with other immunosuppressive agents; infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly CMV), and sepsis reported; these infections can be fatal; monitor carefully and administer appropriate anti-infective treatment when indicated

            Immunosuppressives may increase the incidence of malignancies, including lymphoma or lymphoproliferative disorders

            Safety of immunization with attenuated live vaccines following antithymocyte globulin rabbit therapy has not been studied, and therefore, is not recommended following recent therapy

            May interfere with rabbit antibody–based immunoassays and with crossmatch or panel-reactive antibody cytotoxicity assays

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            Pregnancy & Lactation

            Pregnancy

            Unknown whether antithymocyte globulin rabbit therapy can cause fetal harm; use only if benefit outweighs risk

            Animal reproduction studies have not been conducted

            Lactation

            Has not been studied in breastfeeding women; unknown if excreted in human milk

            Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during antithymocyte globulin rabbit therapy

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Rabbit gamma-globulins that may cause immunosuppression by acting against human T cell surface antigens and depleting CD4 lymphocytes

            Pharmacokinetics

            Half-Life: 2-3 days

            Peak Plasma: 23-170 mcg/mL

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            Administration

            IV Preparation

            Aseptically reconstitute required number of vials with 5 mL supplied diluent (SWI) immediately before use

            Gently rotate vials to dissolve particulate matters if any; discard if particulate matters persist

            Transfer all reconstituted drug into infusion bag containing saline or dextrose, invert bag to mix

            Recommended volume: 50 mL of infusion solution per vial (total volume between 50-500 mL)

            IV Administration

            Premedicate recommended with corticosteroids, acetaminophen, and/or an antihistamine 1 hr before each infusion; may reduce the incidence and intensity of infusion-associated reactions

            Infuse IV through 0.22 micron filter into high-flow vein

            Infuse first dose over at least 6 hr and subsequent doses over at least 4 hr

            Storage

            Store refrigerated between 2-8°C (36-46°F)

            Protect from light

            Protect from freezing

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            Formulary

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            Tier Description
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            NC NOT COVERED – Drugs that are not covered by the plan.
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