Active Ingredient: Tabelecleucel
Tabelecleucel is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 2,000,000 cells tabelecleucel per kilogram of body weight, one dose, over the duration of 7 days. Afterwards, intravenous, 2,000,000 cells tabelecleucel per kilogram of body weight, one dose, over the duration of 7 days. Afterwards, intravenous, 2,000,000 cells tabelecleucel per kilogram of body weight, one dose, over the duration of 20 days.
Treatment consists of multiple doses for injection containing a dispersion of viable T cells in one or more vials.
The recommended dose of tabelecleucel contains 2 × 106 viable T cells per kg of the patient’s body weight.
Patient weight (kg) × target dose (2 × 106 viable T cells/kg) = Viable T cells to be administered
Viable T cells to be administered ÷ Actual concentration (viable T cells/mL)* = Volume of thawed cell dispersion required (mL)
* See the accompanying Lot Information Sheet (LIS) and carton for information pertaining to the actual concentration of cells per vial.
Note: The viable T-cell concentration on the LIS and carton is the actual concentration of each vial. This may be different than the nominal concentration listed on the vial label, which should not be used for dose preparation calculations. Each vial contains 1 mL deliverable volume.
The medicinal product is administered over multiple 35-day cycles, during which patients receive tabelecleucel on days 1, 8 and 15, followed by observation through day 35. A response is assessed at approximately day 28.
The number of cycles of the medicinal product to be administered is determined by the response to treatment shown in the following table. If a complete or partial response is not obtained, patients may be switched to an tabelecleucel lot with a different HLA restriction (up to 4 different restrictions) selected from the existing product inventory.
Treatment algorithm:
| Response observeda | Action |
|---|---|
| Complete response (CR) | Administer another cycle of tabelecleucel with the same HLA restriction. If the patient achieves 2 consecutive CRs (maximal response), no further treatment with tabelecleucel is recommended. |
| Partial response (PR) | Administer another cycle of tabelecleucel with the same HLA restriction. If the patient achieves 3 consecutive PRs (maximal response), no further treatment with tabelecleucel is recommended. |
| Stable disease (SD) | Administer another cycle of tabelecleucel with the same HLA restriction. If the subsequent cycle results in a second SD, administer tabelecleucel with a different HLA restriction. |
| Progressive disease (PD) | Administer another cycle of tabelecleucel with a different HLA restriction. |
| Indeterminate response (IR) | Administer another cycle of tabelecleucel with the same HLA restriction. If the subsequent cycle results in a second IR, administer tabelecleucel with a different HLA restriction. |
a Complete response at the end of a cycle followed by partial response or other response at any subsequent cycle is considered progressive disease.
It is recommended to monitor vital signs immediately prior to each tabelecleucel injection, within 10 minutes following the conclusion of the injection and 1 hour after the initiation of the injection.
If a patient misses a dose, the missed dose should be given as soon as reasonably possible.
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