- Approval Id
- 163cf55dc6d31a54
- Drug Name
- THYMOGLOBULINE 5MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Product Name
- THYMOGLOBULINE 5MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Approval Number
- SIN03951P
- Approval Date
- 1990-03-07
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>Posology and method of administration</strong><br>
<u>Posology</u><br>
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.</p>
<p><u>Immunosuppression in transplantation:</u><br>
<em>Prophylaxis of acute graft rejection:</em><br>
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.</p>
<p><em>Treatment of acute graft rejection:</em><br>
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.</p>
<p><u>Prophylaxis of acute and chronic graft versus host disease:</u><br>
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.<br>
The dosage must be determined on an individual basis.</p>
<p><u>Treatment of steroid-resistant, acute graft versus host disease:</u><br>
The dosage must be determined on an individual basis. It is usually between 2 and 5 mg/kg/day for 5 days.</p>
<p><u>Treatment of Aplastic anemia:</u><br>
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.</p>
<p><u>Dose adjustments</u><br>
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:</p>
<ul>
<li>a reduction in dosage must be envisaged if the platelet count is between 50,000 and 75,000 cells/mm<sup>3</sup> or if the number of white blood cell count is between 2,000 and 3,000 cells/mm<sup>3</sup>;</li>
<li>stopping Thymoglobuline® treatment must be considered if persistent and severe thrombocytopenia (< 50,000 cells/mm<sup>3</sup>) or development of leucopenia (< 2,000 cells/mm<sup>3</sup>)</li>
</ul>
<p><u>Method of administration</u><br>
Rabbit anti-human thymocyte immunoglobulin is usually administered in the context of a therapeutic regimen combining several immunosuppressive agents.</p>
<p>Administer the dose of intravenous corticosteroids and antihistamines required prior to infusion of rabbit anti-human thymocyte immunoglobulin.</p>
<p>The reconstituted solution is clear or slightly opalescent.</p>
<p>Infuse into a large vein. Adjust the infusion rate so that the total duration of infusion is at least 4 hours.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Therapeutic indications</strong></p>
<ul>
<li>Immunosuppression in transplantation: prophylaxis and treatment of graft rejection.</li>
<li>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</li>
<li>Treatment of steroid-resistant, acute graft versus host disease (GvHD).</li>
<li>Haematology: treatment of aplastic anemia.</li>
</ul>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul>
<li>Active, acute or chronic infections, which would contraindicate any additional immunosuppression.</li>
<li>Hypersensitivity to rabbit proteins or any of the excipients.</li>
</ul>
- Atc Code
- L04AA04
- Atc Item Name
- antithymocyte immunoglobulin (rabbit)
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd
