It (Anti-thymocyte Globulin [Rabbit]) is indicated for the treatment of renal transplant acute rejection in conjunction with concomitant immunosuppression and for induction in adult renal transplant recipients
The mechanism of action by which polyclonal antilymphocyte preparations suppress immune responses is not fully understood. Possible mechanisms by which Anti-Thymocyte Globulin may induce immunosuppression in vivo include: T-cell clearance from the circulation and modulation of T-cell activation, homing, and cytotoxic activities. Anti-Thymocyte Globulin includes antibodies against T-cell markers such as CD2, CD3, CD4, CD8, CD11a, CD18, CD25, CD44, CD45, HLA-DR, HLA Class I heavy chains, and ß2 micro-globulin. In vitro, Anti-Thymocyte Globulin (concentrations >0.1 mg/mL) mediates T-cell suppressive effects via inhibition of proliferative responses to several mitogens. In patients, T-cell depletion is usually observed within a day after initiating Anti-Thymocyte Globulin therapy. Anti-Thymocyte Globulin has not been shown to be effective for treating antibody-mediated (humoral) rejections.
Dosing Considerations Appropriate dosing for It (Anti-thymocyte Globulin [Rabbit]) is different from dosing for other anti-thymocyte globulin (ATG) products, as protein composition and concentrations vary depending on the source of ATG used. Physicians should therefore exercise care to ensure that the dose prescribed is appropriate for the ATG product being administered. Recommended Dose and Dosage Adjustment The recommended dosage of It for treatment of acute renal graft rejection is 1.5 mg/kg of body weight administered daily for 7 to 14 days. For prophylaxis in adult renal transplant recipients the recommended dose is 1.5 mg/kg/day intravenously for at least seven days beginning intraoperatively, through a high-flow vein. It should be infused over a minimum of 6 hours for the first infusion and over at least 4 hours on subsequent days of therapy. For vial reconstitution, dilution in infusion solution and infusion procedure. (See Preparation for Administration) Investigations indicate that It is well tolerated and less likely to produce side effects when administered at the recommended rate. Additionally, reducing the infusion rate may minimize IARs. (See WARNINGS AND PRECAUTIONS, General) The It dose should be reduced by one-half if the WBC count is between 2,000 and 3,000 cells/mm3 or if the platelet count is between 50,000 and 75,000 cells/mm3 . Stopping It treatment should be considered if the WBC counts falls below 2,000 cells/mm3 or platelets below 50,000 cells/mm3 . Administration The recommended route of administration is intravenous infusion using a high-flow vein; however, it may be administered through a peripheral vein. When It is administered through a peripheral vein, concomitant use of heparin and hydrocortisone in an infusion solution of 0.9% sodium chloride may minimize the potential for superficial thrombophlebitis and deep vein thrombosis. The combination of It, heparin, and hydrocortisone in a dextrose infusion solution has been noted to precipitate and is not recommended (See Pharmaceutical Incompatibilities). It should be administered through an in-line 0.22 ?m filter. Administration of antiviral prophylactic therapy is recommended. Premedication with corticosteroids, acetaminophen, and/or antihistamine one hour prior to the infusion is recommended and may reduce the incidence and intensity of side effects during the infusion. Medical personnel should monitor patients for adverse events during and after infusion. Monitoring T-cell counts (absolute and/or subsets) to assess the level .of T-cell depletion is recommended. Total white blood cell and platelet counts should be monitored.
No drug interaction studies have been performed.
It (Anti-thymocyte Globulin [Rabbit]) is contraindicated in patients with: ? Hypersensitivity to rabbit proteins or to any product excipients ? Active acute or chronic infections, which would contraindicate any additional immunosuppression
fever, chills, leukopenia, pain, headache, abdominal pain, diarrhea, hypertension, nausea, thrombocytopenia, peripheral edema, dyspnea, asthenia, hyperkalemia, tachycardia, and infection.
Pregnant Women: Females of childbearing age should be informed of the lack of information on the risks associated with the administration of It during pregnancy and that adequate/appropriate contraception is recommended, during, and for a period after treatment. Therefore, It should only be given to a pregnant woman if the benefits clearly outweigh the risks. Animal reproduction studies have not been conducted with It. It is also not known whether It can cause fetal harm or can affect reproduction capacity.It has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during It therapy
Overdosage may result in leukopenia (including lymphopenia and
neutropenia) and/ or thrombocytopenia, which can be managed with dose reduction
Store in refrigerator at 2°C to 8°C. Protect from light. Do not freeze.
Single-use 10 ml vial containing 25 mg of anti-thymocyte globulin (rabbit) lyophilized, sterile powder.
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