Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, The Netherlands
Thymoglobuline is usually used in combination with other immunosuppressive medicinal products.
Thymoglobuline must always be used under strict medical supervision and prescribed by physicians with experience in using immunosuppressive agents.
The posology depends on the indication, the administration regimen and the combination with other immunosuppressive agents.
The following dosage may be used as a reference. Treatment can be discontinued without gradual tapering of the dose.
1 to 1.5 mg/kg/day for 3 to 9 days after transplantation of a kidney, corresponding to a cumulative dose of 3 to 13.5 mg/kg.
1 to 2.5 mg/kg/day for 3 to 5 days after transplantation of a heart, corresponding to a cumulative dose of 3 to 12.5 mg/kg.
1.5 mg/kg/day for 7 to 14 days after transplantation of a kidney, corresponding to a cumulative dose of 10.5 to 21 mg/kg.
For obese patients dosing should be based on ideal weight rather than actual weight.
Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made. Available information indicates that paediatric patients do not require a different dosage than adult patients.
The dose recommendations in elderly patients are the same as for adults.
In view of the PK and metabolism no dose adjustment is necessary in patients with hepatic and/or renal impairment.
Thymoglobuline is usually administered in the context of a therapeutic regimen combining multiple immunosuppressive agents.
It is recommended to administer pre-medication with intravenous corticosteroids and antihistamines prior to infusion of rabbit anti-human thymocyte globulin. Anti-pyretic agents (e.g. paracetamol) may also increase the tolerability of the initial infusion.
Rabbit anti-human thymocyte globulin is infused after dilution in isotonic 0.9% sodium chloride or 5% glucose solution. Inspect solution for particulate matter after reconstitution. To avoid inadvertent administration of particulate matter from reconstitution, it is recommended that Thymoglobuline is administered through a 0.22 μm in-line filter.
Infuse slowly into a high-flow vein. Adjust the infusion rate so that the total duration of infusion is not less than 6 hours. See section 4.4 and section 4.8 for advice about the management of any adverse events associated with infusion.
Inadvertent overdose may induce leucopenia (including lymphopenia and neutropenia) and thrombocytopenia.
3 years.
Immediate use after dilution is recommended in order to prevent microbial contamination.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution or dilution has taken place in controlled and validated aseptic conditions.
Store and transport refrigerated (at 2°C to 8°C).
Do not freeze.
During transport a temperature excursion up to 25°C for 3 days will not alter the medicinal product characteristics.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Powder in a vial (type I glass) closed with a stopper (chlorobutyl). Each pack contains one 10 ml vial.
Reconstitute the powder with 5 ml of sterile water for injections to obtain a solution containing 5 mg protein per ml. The solution is clear or slightly opalescent. Reconstituted medicinal product should be inspected visually for particulate matter and discoloration. Should some particulate matter remain, continue to gently rotate the vial until no particulate matter is visible. If particulate matter persists, discard the vial. Immediate use of reconstituted product is recommended. Each vial is for single use only. Depending on the daily dose, reconstitution of several vials of Thymoglobuline powder might be needed. Determine the number of vials to be used and round up to the nearest vial.To avoid inadvertent administration of particulate matter from reconstitution, it is recommended that Thymoglobuline is administered through a 0.22 μm in-line filter.
The daily dose is diluted in an infusion solution (0.9% sodium chloride or 5% glucose solution) so as to obtain a total infusion volume of 50 to 500 ml (usually 50 ml/vial).
The medicinal product should be administered on the same day.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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