The prescribed dosage of medications, including TGlobulin 25, is typically weight-based. This means the recommended dose is expressed as milligrams per kilogram of body weight. The appropriate dosage of TGlobulin 25 varies from other anti-thymocyte globulin products due to differing protein compositions and concentrations. Consequently, administration should occur under strict medical supervision in a hospital setting to ensure the correct dosage. TGlobulin 25 suppresses the immune system; excessive administration can lead to leukopenia. Therefore, monitoring of white blood cell (WBC) and platelet counts is crucial throughout treatment to assess therapeutic efficacy.
TGlobulin 25 is supplied as a 10 ml single-dose vial containing 25 mg of sterile lyophilized powder. Reconstitute with 5 mL sterile water for injection before use.
Storage conditions: Store in a refrigerator (2 to 8 degrees Celsius), away from light and freezing.
Expiration: Do not use after the expiry date printed on the vial label.
Stability: After reconstitution, the product should be used immediately. Do not store or reuse the remaining solution.
Administration
Premedication: Pre-treatment with corticosteroids, acetaminophen, with or without antihistamines, one hour before each TGlobulin 25 infusion is recommended to reduce the incidence and severity of infusion-related reactions.
Infusion Route: TGlobulin 25 should be administered intravenously via a central venous line (CV line) using a 0.22-micron filter. The initial infusion should last at least 6 hours, and subsequent doses at least 4 hours.
Peripheral Venous Administration: If central venous access is not feasible, TGlobulin 25 may be administered via a high-flow peripheral vein with an anticoagulant (e.g., heparin) and a corticosteroid (e.g., hydrocortisone) in a 500 mL bag of 0.9% sodium chloride. The first two doses should be infused over at least 6 hours, and subsequent doses over at least 4 hours.
Dosage Adjustments: The dosage may need to be adjusted based on the patient's response and adverse effects. Blood cell counts should be monitored throughout and after treatment.
Dose Reduction: If platelet counts are between 50,000-75,000 cells/mm³ or WBC counts are between 2,000-3,000 cellsd/mm³, the TGlobulin 25 dose should be halved.
Treatment Discontinuation: In cases of severe thrombocytopenia (less than 50,000 cells/mm³) or severe leukopenia (less than 2,000 cells/mm³), TGlobulin 25 treatment should be discontinued.
Preparation
Calculate Dose: Calculate the dose based on body weight and determine the number of vials required.
Allow to Warm: Bring the required number of vials to room temperature.
Aseptic Technique: Aseptically remove the vial caps and disinfect the rubber stoppers with 70% alcohol.
Reconstitution: Aseptically reconstitute each vial with 5 mL of sterile water for injection. Gently invert the vials to dissolve the powder completely. Inspect the solution for particulate matter.
Transfer: Transfer the calculated amount of TGlobulin 25 to an infusion bag (saline or dextrose). The recommended volume for infusion is 50 mL for every 25 mg of TGlobulin 25 (one vial). The total infusion volume is typically 50-500 mL. Gently invert the bag one or two times to mix.
