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FIRST EXPERIENCES WITH GENERIC BORTEZOMIB ADMINISTRATION ?ONE CENTRE EXPERIENCE
Author(s): ,
Alexandra Jungova
Affiliations:
Hemato-oncology department,CHARLES UNIVERSITY HOSPITAL PILSEN,Pilsen,Czech Republic
,
Samuel Vokurka
Affiliations:
Hemato-oncology department,CHARLES UNIVERSITY HOSPITAL PILSEN,Pilsen,Czech Republic
Pavel Jindra
Affiliations:
Hemato-oncology department,CHARLES UNIVERSITY HOSPITAL PILSEN,Pilsen,Czech Republic
(Abstract release date: 05/19/16) EHA Library. JUNGOVA A. 06/09/16; 134906; PB2006
Dr. Alexandra JUNGOVA
Dr. Alexandra JUNGOVA
Contributions
Abstract
Abstract: PB2006

Type: Publication Only

Background
Multiple myeloma (MM) is malignant haemato-oncology disease characterised by clonal proliferation of plasmocytomas. Disease treatment is started with induction therapy  in the symptomatic phase of the disease. Regimens with combination of vincristine, doxorubicin and corticoid were used in the last century. From 2002 are used in the Czech Republic “new drugs” as thalidomide and bortezomib (several years later also lenalidomide). As standard induction regimen is VTD regimen recommended (bortezomib, thalidomide and dexamethasone). Original drugs with bortezomib (Velcade) are still used, but generics drugs with equivalent active substance are also on the market now. These generics should be equivalent with originals. According our first experiences none serious adverse events were presented, other complications were of similar character as with original bortezomib.

Aims
First experiences in administration of generic bortezomib, adverse events, patient’s toleration.

Methods
During 11-12/2015 generic bortezomib was administered to 28 patients (altogether 80 applications) at our department

Results
Adverse events after generic bortezomib applications occurred in 28 patients. Anaemia (c.18 %) and thrombocytopenia (c. 14 %) were between most often complications. From complication of lower grade occurred tiredness (17 %), infection (3 %), neuropathy (8 %) and diarrhoea (3 %).

Conclusion
We administered altogether 80 generic bortezomib applications to 28 patients at Haematology and oncology department in 11-12/2015. During this time none serious complication occur and most of adverse effects were of I. and II. grade. These complications were similar to original bortezomib complications. Other comparison with original product in longer time is necessary.

Session topic: E-poster

Keyword(s): Generic drugs, Multiple myeloma, Toxicity
Abstract: PB2006

Type: Publication Only

Background
Multiple myeloma (MM) is malignant haemato-oncology disease characterised by clonal proliferation of plasmocytomas. Disease treatment is started with induction therapy  in the symptomatic phase of the disease. Regimens with combination of vincristine, doxorubicin and corticoid were used in the last century. From 2002 are used in the Czech Republic “new drugs” as thalidomide and bortezomib (several years later also lenalidomide). As standard induction regimen is VTD regimen recommended (bortezomib, thalidomide and dexamethasone). Original drugs with bortezomib (Velcade) are still used, but generics drugs with equivalent active substance are also on the market now. These generics should be equivalent with originals. According our first experiences none serious adverse events were presented, other complications were of similar character as with original bortezomib.

Aims
First experiences in administration of generic bortezomib, adverse events, patient’s toleration.

Methods
During 11-12/2015 generic bortezomib was administered to 28 patients (altogether 80 applications) at our department

Results
Adverse events after generic bortezomib applications occurred in 28 patients. Anaemia (c.18 %) and thrombocytopenia (c. 14 %) were between most often complications. From complication of lower grade occurred tiredness (17 %), infection (3 %), neuropathy (8 %) and diarrhoea (3 %).

Conclusion
We administered altogether 80 generic bortezomib applications to 28 patients at Haematology and oncology department in 11-12/2015. During this time none serious complication occur and most of adverse effects were of I. and II. grade. These complications were similar to original bortezomib complications. Other comparison with original product in longer time is necessary.

Session topic: E-poster

Keyword(s): Generic drugs, Multiple myeloma, Toxicity

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