Author: Janssen-Cilag International NV


Long information

What is it?

Velcade is a powder that is made up into a solution for injection. It contains the active substance bortezomib.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Velcade is used to treat patients 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 bone marrow transplant. In these patients, Velcade is used in combination with melphalan and prednisone other medicines for multiple myeloma

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 bone marrow transplant. Velcade is used on its own in these patients.

The medicine can only be obtained with a prescription.

How is it 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.

The recommended starting dose is 1.3 mg per square metre body surface area (calculated using the patient?s height and weight). The solution is given as a three- to five-second injection through a catheter (a thin sterile tube) into a vein.

When used in combination with melphalan and prednisone, Velcade is given twice a week on weeks 1, 2, 4 and 5 of a six-week treatment cycle. This cycle is repeated three more times, followed by five cycles of once-weekly injections. When used on its own, Velcade is given twice a week on weeks 1 and 2 of a three-week treatment cycle. Patients who respond fully to treatment should receive two more cycles, but patients who only partially respond to treatment should receive up to eight cycles. If a patient develops severe side effects after a treatment cycle, the treatment must be suspended and the dose adjusted.

How does it 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 it been studied?

Velcade has been studied in four main studies:

the first study involved 682 patients who had not been treated before and were not suitable for high-dose chemotherapy with a bone marrow transplant. The study compared the combination of Velcade, melphalan and prednisone with the combination of melphalan and prednisone without Velcade

the other three 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.

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 benefits has it 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.

What is the risk associated?

The most common side effects with Velcade (seen in more than 1 patient in 10) are herpes zoster (shingles), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), reduced appetite, peripheral neuropathy with paraesthesia (unusual sensations like pins and needles), headache, dyspnoea (difficulty breathing), nausea (feeling sick), diarrhoea, vomiting, constipation, rash, myalgia (muscle pain), fatigue (tiredness) and pyrexia (fever). For the full list of all side effects reported with Velcade, see the package leaflet.

Velcade should not be used in people who may be hypersensitive (allergic) to bortezomib, boron or to any of the other ingredients. It must not be given to patients with severe liver disease, ?acute diffuse infiltrative pulmonary disease? (a severe lung problem) or pericardial disease (disease affecting the sac that surrounds the heart).

Why has it been approved?

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

Velcade has been authorised under ?exceptional circumstances?, because, for scientific reasons, it has not been possible to obtain complete information on the medicine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

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