Velcade

bortezomib

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This is a summary of the European public assessment report (EPAR) for Velcade. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velcade.

What is Velcade?

Velcade is a medicine that contains the active substance bortezomib. It is available in vials (1 and 3.5 mg) as a powder to be made up into a solution for injection.

What is Velcade used for?

Velcade is used to treat adults with multiple myeloma, a cancer of the plasma cells in the bone marrow. Velcade is used in the following groups:

  • patients who have not been treated before and who are not suitable for high-dose chemotherapy (medicines to treat cancer) with a blood stem-cell transplant. In these patients, Velcade is used in combination with melphalan and prednisone (other medicines for multiple myeloma);
  • patients who have not been treated before and who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant. In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
  • patients whose disease is progressive (getting worse) and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a blood stem-cell transplant. Velcade is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.

The medicine can only be obtained with a prescription.

How is Velcade used?

Treatment with Velcade should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy. Velcade 1 mg must only be given by injection into a vein, while Velcade 3.5 mg is only given either by injection into a vein or under the skin. Velcade must not be given by other routes.

The recommended starting dose is 1.3 mg per square metre body surface area (calculated using the patient’s height and weight). When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube). At least 72 hours must pass between two consecutive doses of Velcade. When injected under the skin, it is given in the thigh or abdomen (tummy).

Doses of Velcade are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Velcade is given alone or in combination with other medicines. If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, 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 Velcade, see the summary of product characteristics (also part of the EPAR).

How does Velcade work?

The active substance in Velcade, bortezomib, is a proteasome inhibitor. It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed. When the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.

How has Velcade been studied?

Velcade has been studied in eight main studies:

  • the first study involved 682 patients who had not been treated before and were not suitable for high-dose chemotherapy with a blood stem-cell transplant. The study compared the combination of Velcade, melphalan and prednisone with the combination of melphalan and prednisone without Velcade;
  • three other studies looked at patients who had received at least one previous treatment and whose disease was getting worse during their most recent treatment. In one study, Velcade was compared with high-dose dexamethasone (another medicine for multiple myeloma) in 669 patients. In the other two studies, including a total of 256 patients, Velcade was not compared with any other treatments;
  • a fifth study compared Velcade given by injection into a vein with Velcade given by injection under the skin in 222 patients who had received one to three previous treatments other than Velcade and whose disease was getting worse during their most recent treatment;
  • a further three studies involving 1,701 patients who had not been treated before and who were candidates for high-dose chemotherapy with a blood stem-cell transplant looked at combinations of Velcade with other medicines, including Velcade with dexamethasone and Velcade, dexamethasone and thalidomide. The Velcade-containing combinations were compared with treatments that did not include Velcade.
  • a study in 646 patients whose disease was getting worse and failed to respond to at least one other treatment compared Velcade alone with a combination of Velcade and pegylated liposomal doxorubicin.
  • a study in 163 patients whose disease was getting worse, had come back or failed to respond to at least one other treatment. In this study, patients were all treated with a combination of Velcade and dexamethasone and some were also given other medicines (cyclophosphamide and lenalidomide).

The main measures of effectiveness were the number of patients who responded to treatment and how long the patients lived without their disease getting worse.

What benefit has Velcade shown during the studies?

Patients who had not been treated before lived for an average of 20.7 months without their disease getting worse when they received Velcade together with melphalan and prednisone. This compared with 15.0 months in the patients receiving only melphalan and prednisone.

In the comparative study of patients who had been treated before, patients receiving Velcade lived for an average of 6.2 months without their disease getting worse, compared with 3.5 months in those receiving dexamethasone. In the other two studies, around 34% of the patients responded partially or completely to treatment with Velcade.

The study that compared Velcade given under the skin with Velcade given into a vein showed that the percentage of patients who responded partially or completely to treatment was the same (42%) when using either route of administration.

Studies also showed the benefit of Velcade-containing combinations in patients who were candidates for high-dose chemotherapy with a blood stem-cell transplant. In one of these studies that compared Velcade plus dexamethasonewith standard combinations of other anticancer drugs, around 15% of patients given Velcade plus dexamethasone responded, compared with 6% of those given standard combinations. In another study, Velcade plus thalidomide and dexamethasone produced a response in 49% of patients, compared with about 26% for a treatment containing Velcade plus other anticancer drugs, and 17% of those given thalidomide and dexamethasone alone.

In the study patients whose disease was getting worse after having failed to respond to at least one other treatment, patients receiving Velcade with pegylated liposomal doxorubicin had an average time until the disease got worse of 9.3 months compared to 6.5 months for patients receiving Velcade alone.

The Velcade-dexamethasone combination was also shown to be beneficial in patients with worsening disease that had come back or failed to respond to at least one other treatment, with 70% of the patients responding to treatment.

What is the risk associated with Velcade?

The most commonly reported side effects during treatment with Velcade are nausea (feeling sick), diarrhoea, constipation, vomiting, fatigue (tiredness), pyrexia (fever), thrombocytopenia (low blood platelets count), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), peripheral neuropathy (nerve damage in the hands and feet), headache, paraesthesia (unusual sensations like pins and needles), decreased appetite, dyspnoea (difficulty breathing), rash, herpes zoster (shingles) and myalgia (muscle pain). The most serious adverse reactions include heart failure, tumour lysis syndrome (complications due to breakdown of cancer cells), pulmonary hypertension (high blood pressure in the arteries of the lungs), posterior reversible encephalopathy syndrome (a reversible brain disorder), acute diffuse infiltrative pulmonary disease (a severe lung problem), and autonomic neuropathy (damage to nerves controlling organs such as the bladder, eyes, gut, heart and blood vessels). For the full list of all side effects reported with Velcade, see the package leaflet.

Velcade must not be used in people who are hypersensitive (allergic) to bortezomib, boron or to any of the other ingredients. It must not be given to patients with acute diffuse infiltrative pulmonary disease or pericardial disease (disease affecting the sac that surrounds the heart). When Velcade is used with other medicines the restrictions for those medicines must also be taken into account, including the requirements for pregnancy testing and prevention with thalidomide.

Why has Velcade been approved?

The CHMP decided that Velcade’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Velcade was originally authorised under ‘exceptional circumstances’, because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 19 March 2012.

What measures are being taken to ensure the safe and effective use of Velcade?

A risk management plan has been developed to ensure that Velcade is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velcade, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Velcade will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.

Other information about Velcade

The European Commission granted a marketing authorisation valid throughout the European Union for Velcade on 26 April 2004.

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

Name Language First published Last updated
Velcade : EPAR - Summary for the public BG = bălgarski 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public ES = español 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public CS = čeština 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public DA = dansk 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public DE = Deutsch 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public ET = eesti keel 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public EL = elliniká 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public EN = English 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public FR = français 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public IT = italiano 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public LV = latviešu valoda 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public LT = lietuvių kalba 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public HU = magyar 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public MT = Malti 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public NL = Nederlands 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public PL = polski 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public PT = português 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public RO = română 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public SK = slovenčina 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public SL = slovenščina 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public FI = suomi 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public SV = svenska 16/04/2009 19/02/2014
Velcade : EPAR - Summary for the public HR = Hrvatski 16/04/2009 19/02/2014

This EPAR was last updated on 11/04/2014 .

Authorisation details

Product details

Product details for Velcade
NameVelcade
Agency product numberEMEA/H/C/000539
Active substance

bortezomib

International non-proprietary name (INN) or common name

bortezomib

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L01XX32

Publication details

Publication details for Velcade
Marketing-authorisation holder

Janssen-Cilag International NV

Revision34
Date of issue of marketing authorisation valid throughout the European Union26/04/2004

Contact address:

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

Product information

18/03/2014  Velcade -EMEA/H/C/000539 -N/0071

Name Language First published Last updated
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014
Velcade : EPAR - Product Information HR = Hrvatski 02/12/2009 11/04/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012
Velcade : EPAR - All Authorised presentations HR = Hrvatski 03/06/2008 17/10/2012

Name Language First published Last updated
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  
Velcade : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 17/10/2012  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Velcade 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.

Velcade 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.

Velcade 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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Velcade : EPAR - Procedural steps taken before authorisation HR = Hrvatski 15/08/2006  
Velcade : EPAR - Scientific Discussion HR = Hrvatski 15/08/2006  

Authorised

This medicine is approved for use in the European Union

News

More information on Velcade