Lapine t-lymphocyte immune globulin

THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression. THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in adult and pediatric patients receiving a kidney transplant in conjunction with concomitant immunosuppression.

The mechanism of action by which polyclonal antilymphocyte preparations suppress immune responses is not fully understood. Possible mechanisms by which THYMOGLOBULIN may induce immunosuppression in vivo include: T-cell clearance from the circulation and modulation of T-cell activation, homing, and cytotoxic activities. THYMOGLOBULIN 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, THYMOGLOBULIN (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 THYMOGLOBULIN therapy. THYMOGLOBULIN has not been shown to be effective for treating antibody-mediated (humoral) rejections.

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 THYMOGLOBULIN dose should be reduced by one-half if the white blood cell (WBC) count is between 2,000 and 3,000 cells/mm 3 or if the platelet count is between 50,000 and 75,000 cells/mm 3. Stopping THYMOGLOBULIN treatment should be considered if the WBC count falls below 2,000 cells/mm 3 or if the platelet count falls below 50,000 cells/mm 3. Indication Dose 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 For complete dosing instructions, see full prescribing information.

THYMOGLOBULIN is contraindicated in patients with history of allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or who have active acute or chronic infections that contraindicate any additional immunosuppression. Allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or active acute or chronic infections which contraindicate any additional immunosuppression

THYMOGLOBULIN should only be used by physicians experienced in immunosuppressant therapy in transplantation. Hypersensitivity and infusion-related reactions: THYMOGLOBULIN infusion could result in an anaphylactic reaction. Close compliance with the recommended infusion time may reduce the incidence and severity of infusion-related reactions. Cytopenias including anemia, neutropenia, and thrombocytopenia have occurred with THYMOGLOBULIN administration and require monitoring of blood counts. Adjust dose accordingly to reverse cytopenias. Thrombotic microangiopathy (TMA) has occurred in patients treated with THYMOGLOBULIN for kidney transplantation, particularly when concomitantly administered with calcineurin inhibitors. Infection: Infections and reactivation of infections have been reported. Monitor patients and administer anti-infective prophylaxis.

The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, low counts of platelets and white blood cells.

No drug interaction studies have been performed. THYMOGLOBULIN can stimulate the production of antibodies that cross-react with rabbit immune globulins.

Store in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Reconstituted THYMOGLOBULIN is physically and chemically stable for up to 24 hours at room temperature, however, room temperature storage is not recommended.