Overview

This is a summary of the European public assessment report (EPAR) for Bortezomib Sun. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Bortezomib Sun.

For practical information about using Bortezomib Sun, patients should read the package leaflet or contact their doctor or pharmacist.

Bortezomib Sun is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:

  • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, blood stem-cell transplantation. Bortezomib Sun is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone;
  • previously untreated adults who cannot have high-dose chemotherapy with blood stem-cell transplantation. In these patients, Bortezomib Sun is used in combination with melphalan and prednisone;
  • previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation. In this group of patients, Bortezomib Sun is used in combination with dexamethasone, or with dexamethasone plus thalidomide.

Bortezomib Sun 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 Sun is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.

Bortezomib Sun is a ‘generic medicine’. This means that Bortezomib Sun is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Velcade.

Bortezomib Sun contains the active substance bortezomib.

The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.

Bortezomib Sun is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin. Bortezomib Sun must not be given by other routes.

The recommended dose is calculated using the patient’s height and weight). When given into a vein, the solution is injected through a catheter (a thin sterile tube). At least 72 hours must pass between two doses of Bortezomib Sun. When injected under the skin, it is given in the thigh or abdomen (tummy).

Doses of Bortezomib Sun are given with rest periods between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Sun is given alone or in combination with other medicines. If a patient develops severe side effects, treatment must be discontinued, delayed or the dose adjusted.

Patients with moderate or severe liver problems should be treated with lower doses. For more information on the use of Bortezomib Sun see the summary of product characteristics (also part of the EPAR).

The active substance in Bortezomib Sun, bortezomib, is a proteasome inhibitor. It blocks proteasome, which is a system in cells that breaks down proteins that are no longer needed. Blocking the proteasome system causes the cell to die. Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors like bortezomib.

The company provided data from the published literature on bortezomib. No additional studies were needed as Bortezomib Sun is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.

Because Bortezomib Sun is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Sun has been shown to be comparable to Velcade. Therefore, the CHMP’s view was that, as for Velcade, the benefit outweighs the identified risk. The Committee recommended that Bortezomib Sun be approved for use in the EU.

The company that markets Bortezomib Sun will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Sun have also been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Bortezomib Sun on 22 July 2016.

For more information about treatment with Bortezomib Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Bortezomib Sun : EPAR - Summary for the public

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Product information

Bortezomib Sun : EPAR - Product Information

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Latest procedure affecting product information: IB/0019/G

31/08/2021

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Bortezomib Sun : EPAR - All Authorised presentations

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Product details

Name of medicine
Bortezomib Sun
Active substance
bortezomib
International non-proprietary name (INN) or common name
bortezomib
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XG01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Bortezomib SUN 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 SUN 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 SUN 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 SUN 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.

Authorisation details

EMA product number
EMEA/H/C/004076

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
SUN Pharmaceutical Industries (Europe) B.V.

Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Opinion adopted
26/03/2016
Marketing authorisation issued
22/07/2016
Revision
12

Assessment history

Bortezomib Sun : EPAR - Procedural steps taken and scientific information after authorisation

Bortezomib Sun-H-C-PSUSA-00000424-202004: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Bortezomib Sun-H-C-PSUSA-00000424-201804 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Bortezomib Sun : EPAR - Public assessment report

CHMP summary of opinion for Bortezomib Sun

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