antithymocyte globulin rabbit (Thymoglobulin, ATG rabbit)
Classes: Immunosuppressants; Immune Globulins
Dosing and uses of Thymoglobulin, ATG rabbit (antithymocyte globulin rabbit)
Adult dosage forms and strengths
powder for injection
- 25mg/vial
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)
Pediatric dosage forms and strengths
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
Thymoglobulin, ATG rabbit (antithymocyte globulin rabbit) adverse (side) 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
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
Pregnancy and 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.
Pharmacology of Thymoglobulin, ATG rabbit (antithymocyte globulin rabbit)
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
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