antithymocyte globulin rabbit (Rx)

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Brand and Other Names:Thymoglobulin, ATG rabbit

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 25mg/vial
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Acute Renal Graft Rejection

Indicated for treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression

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

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

Other Information

Administration: may premedicate with corticosteroids, acetaminophen, antihistamines to reduce fever/chills

Monitor: WBCs, Plts

Other Indications & Uses

Off-label: heart/lung/bone marrow transplantation, aplastic anemia (if bone marrow transplant unsuitable)

Safety & efficacy not established

Similar to adult suggested

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

            Acute viral illness

            Cautions

            Leukopenia, thrombocytopenic disorder

            Prolonged use may result in severe infections, lymphoma, post-transplant lymphoproliferative disease

            Reduce dose by half if WBC 2000-3000/mm³ or platelets 50-75 K/mm³

            Discontinue if WBC <2000/mm³ or platelets <50 K/mm³

            Terminate immediately if anaphylaxis occurs

            Not for antibody-mediated rejections

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Excretion in milk unknown/not recommended

            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

            Infuse through 0.22 micron filter into high-flow vein

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

            Storage

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

            Protect from light

            Protect from freezing

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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