** ADCETRIS® 50 mg (brentuximab vedotin) powder for concentrate for solution for infusion. 1 vial.
** For intravenous use after reconstitution and dilution. For single use only.
Each vial contains 50 mg of brentuximab vedotin.
After reconstitution, each ml contains 5 mg of brentuximab vedotin.
Excipients: Citric acid monohydrate, sodium citrate dihydrate, alpha, alpha-trehalose dihydrate, polysorbate 80
** Therapeutic indications:
– Classical Hodgkin Lymphoma (HL) / Classical Hodgkin Lymphoma (HL) Post-auto-HSCT Consolidation
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30 + Hodgkin lymphoma (HL):
1. Following autologous hematopoietic stem cell transplantation (auto-HSCT) or
2. Following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
– Systemic Anaplastic Large Cell Lymphoma (sALCL)
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
** Pharmacotherapeutic group:
Antineoplastic agents; other antineoplastic agents; monoclonal antibodies, ATC code: L01XC12
** Mechanism Of Action:
Brentuximab vedotin is an antibody drug conjugate (ADC). The antibody is a chimeric IgG1 directed against CD30. The small molecule, MMAE, is a microtubule disrupting agent. MMAE is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of ADCETRIS is due to the binding of the ADC to CD30-expressing cells, followed by internalization of the ADC-CD30 complex, and the release of MMAE via proteolytic cleavage. Binding of MMAE to tubulin disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic death of the cells.
** The recommended dose is 1.8 mg / kg administered as an intravenous infusion over 30 minutes every 3 weeks.
** Medicinal product subject to medical prescription.
** Store in a refrigerator. Do not freeze. Keep the vial in the outer carton in order to protect from light.
BRENTUXIMAB VEDOTIN 50 MG - (FOR IV INFUSION AFTER RECONSTITUTION AND DILUTION) - Indications: Classical Hodgkin Lymphoma (HL), Classical Hodgkin Lymphoma (HL) Post-auto-HSCT Consolidation & Systemic Anaplastic Large Cell Lymphoma (sALCL)