Basic Information
Bortezomib Fresenius Kabi
Regulatory Information
EMEA/H/C/005074
November 14, 2019
September 19, 2019
7
February 13, 2025
Company Information
Germany
Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe
Fresenius Kabi Deutschland Gmbh
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Overview Summary
Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients: - previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant. In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone; - previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant. In this group of patients, Bortezomib Fresenius Kabi is used in combination with dexamethasone, or with dexamethasone plus thalidomide; - adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant. Bortezomib Fresenius Kabi is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone. Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation. For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone. Bortezomib Fresenius Kabi is a ‘generic medicine’. This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine’ already authorised in the EU called Velcade.