antithymocyte globulin rabbit (Thymoglobulin, ATG rabbit)

Dosing and uses of Thymoglobulin, ATG rabbit (antithymocyte globulin rabbit)

• Adult
• Pediatric

 

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