THYMOGLOBULINE 5MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION [SIN03951P]

Product Info

THYMOGLOBULINE 5MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

[SIN03951P]

Therapeutic indications

• Immunosuppression in transplantation: prophylaxis and treatment of graft rejection.

• Prophylaxis of acute and chronic graft versus host disease, after haematopoietic stem cell transplantation related non-HLA-identical donors or from unrelated HLA-identical donors

• Treatment of steroid-resistant, acute graft versus host disease (GvHD).

• Haematology: treatment of aplastic anemia.

Posology and method of administration
Posology
The posology depends on the indication, the administration regimen and possible association of combination with other immunosuppressive agents. The following dosage recommendations may be used as a reference. Treatment can be discontinued without gradual tapering of the dose.

Immunosuppression in transplantation:
Prophylaxis of acute graft rejection:
1 to 1.5 mg/kg/day for 2 to 9 days after transplantation of a kidney, pancreas or liver and for 2 to 5 days after heart transplantation, corresponding to a cumulative dose of 2 to 7.5 mg/kg in heart transplantation and 2 to 13.5 mg/kg for other organs. The dosage must be determined on an individual basis.

Treatment of acute graft rejection:
1.5 mg/kg/day for 3 to 14 days, corresponding to a cumulative dose of 4.5 to 21 mg/kg.The dosage must be determined on an individual basis.

Prophylaxis of acute and chronic graft versus host disease:
In transplantation of grafts (bone marrow or haematopoietic stem cells from peripheral blood) from related non-HLA-identical donors or from unrelated HLA-identical donors, it is recommended in adult patients that Thymoglobuline be administered, as a preliminary therapy, at a dose of 2.5 mg/kg/day from day -4 to day -2 or -1, corresponding to a cumulative dose of 7.5 to 10 mg/kg.
The dosage must be determined on an individual basis.

Treatment of steroid-resistant, acute graft versus host disease:
The dosage must be determined on an individual basis. It is usually between 2 and 5 mg/kg/day for 5 days.

Treatment of Aplastic anemia:
2.5 to 3.5 mg/kg/day for 5 consecutive days or a cumulative dose of 12.5 to 17.5 mg/kg. The indication for aplastic anemia has not been established by controlled clinical trials carried out with this medicinal product. The dosage must be determined on an individual basis.

Dose adjustments
Thrombocytopenia and/or leucopenia (including lymphocytopenia and neutropenia) have been identified; these conditions are reversible after dose adjustments. When thrombocytopenia and/or leucopenia are not part of the underlying condition or are not associated with the condition for which Thymoglobuline® is being administered, the following dose reductions are suggested:

• a reduction in dosage must be envisaged if the platelet count is between 50,000 and 75,000 cells/mm³ or if the number of white blood cell count is between 2,000 and 3,000 cells/mm³;

• stopping Thymoglobuline® treatment must be considered if persistent and severe thrombocytopenia (< 50,000 cells/mm³) or development of leucopenia (< 2,000 cells/mm³)

Method of administration
Rabbit anti-human thymocyte immunoglobulin is usually administered in the context of a therapeutic regimen combining several immunosuppressive agents.

Administer the dose of intravenous corticosteroids and antihistamines required prior to infusion of rabbit anti-human thymocyte immunoglobulin.

The reconstituted solution is clear or slightly opalescent.

Infuse into a large vein. Adjust the infusion rate so that the total duration of infusion is at least 4 hours.

Contraindications

• Active, acute or chronic infections, which would contraindicate any additional immunosuppression.

• Hypersensitivity to rabbit proteins or any of the excipients.