Anti-Thymocyte Globulin is an immunoglobulin G used for the prevention and treatment of acute rejection in patients undergoing kidney transplantation. It is administered along with other immunosuppressive therapies.

Each single-use 10 ml vial contains 25 mg of anti-thymocyte globulin (rabbit) in a sterile, lyophilized powder form.

The exact mechanism by which polyclonal antilymphocyte preparations suppress immune responses is not completely understood. However, several mechanisms are believed to contribute to its immunosuppressive effects, including: Removal of T-cells from circulation, Modulation of T-cell activation, migration, and cytotoxic function. Anti-Thymocyte Globulin contains antibodies directed against various T-cell surface markers such as CD2, CD3, CD4, CD8, CD11a, CD18, CD25, CD44, CD45, HLA-DR, HLA Class I heavy chains, and β2-microglobulin. In laboratory conditions, concentrations greater than 0.1 mg/mL have been shown to suppress T-cell activity by inhibiting their proliferation in response to different stimuli. In clinical use, depletion of T-cells is typically observed within one day after starting therapy. Anti-Thymocyte Globulin is not effective in treating antibody-mediated (humoral) rejection.

The first dose should be infused over at least 6 hours; doses on subsequent days should be infused over at least 4 hours.

Premedication with corticosteroids, acetaminophen, and/or an antihistamine prior to each infusion is recommended.

The Anti-Thymocyte Globulin dose should be reduced by one half if the white blood cell (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 Anti-Thymocyte Globulin treatment should be considered if the WBC count falls below 2,000 cells/mm3 or if the platelet count falls below 50,000 cells/mm3

• Prophylaxis of acute rejection: 1.5 mg/kg of body weight administered daily for 4 to 7 days .
• Treatment of acute rejection: 1.5 mg/kg of body weight administered daily for 7 to 14 days.

No formal studies have been conducted to evaluate drug interactions with Anti-Thymocyte Globulin.

This medication should not be used in patients who have a known allergy or severe hypersensitivity (including anaphylaxis) to rabbit proteins or any of its components. It is also contraindicated in patients with active acute or chronic infections where additional immunosuppression is unsafe.

Common adverse effects (more than 5% incidence compared to control) include urinary tract infection, abdominal pain, high blood pressure, nausea, shortness of breath, fever, headache, anxiety, chills, elevated potassium levels, and decreased platelet and white blood cell counts.

There are no animal reproduction studies available for Anti-Thymocyte Globulin, and its effects on the fetus are unknown. It should be used during pregnancy only if the potential benefit justifies the potential risk. The safety of Anti-Thymocyte Globulin in breastfeeding women has not been established. It is unclear whether the drug passes into breast milk. Since other immunoglobulins can be excreted in breast milk, breastfeeding should be discontinued during treatment.

Anti-Thymocyte Globulin should only be administered by physicians experienced in transplant-related immunosuppressive therapy.

Immune-mediated reactions: Infusion of Anti-Thymocyte Globulin may lead to severe allergic reactions, including anaphylaxis.

Infusion-associated reactions: Following the recommended infusion duration may help reduce both the frequency and severity of infusion-related reactions.

Hematologic effects: Decreases in platelet and white blood cell counts may occur but are usually reversible after adjusting the dose. Regular monitoring is necessary.

Infection: New infections or reactivation of existing infections may occur. Patients should be monitored, and preventive anti-infective treatment may be required.

Malignancy: There may be an increased risk of developing malignancies during treatment.

Vaccination & laboratory interference: Live attenuated vaccines are not recommended after recent use of THYMOGLOBULIN. It may also interfere with certain laboratory tests, including rabbit antibody-based immunoassays and cross-match assays.

Pediatric Use: The safety and efficacy of Anti-Thymocyte Globulin in children have not been fully established through controlled clinical trials. However, limited data from European studies and compassionate use in the United States suggest that dosing, effectiveness, and side effect profiles are generally similar to those observed in adults.

Vaccines, Anti-sera & Immunoglobulin

Store at a temperature of 2°C to 8°C in a refrigerator. Keep protected from light. Do not freeze.