drugs

Bortezomib Sun

What is Bortezomib Sun and what is it used for?

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

  • adults with a worsening disease after at least one other treatment and who have already undergone, or cannot undergo, a blood stem cell transplant. Bortezomib Sun is used in these patients alone or in combination with pegylated liposomal doxorubicin or dexamethasone;
  • previously untreated adults who cannot receive high doses of chemotherapy with blood stem cell transplantation. In these patients, Bortezomib Sun is used in combination with melphalan and prednisone;
  • previously untreated adults destined to receive high doses of chemotherapy, followed by blood stem cell transplantation. In this group of patients,

Bortezomib Sun is used in combination with dexamethasone or dexamethasone plus thalidomide. Bortezomib Sun is also used in the treatment of mantle cell lymphoma, another blood cancer, in untreated adults who cannot undergo 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 it is similar to a 'reference medicine' already authorized in the European Union (EU) called Velcade.

For more information on generic medicines, see the questions and answers by clicking here. Bortezomib Sun contains the active substance bortezomib.

How is Bortezomib Sun used?

Bortezomib Sun can only be obtained with a prescription and treatment should only be started and administered under the supervision of a doctor experienced in the use of anticancer chemotherapy.

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

The dose to be administered is calculated based on the patient's height and weight. If given into a vein, the solution is dispensed through a catheter (thin sterile tube). At least 72 hours must elapse between the administration of two consecutive Bortezomib Sun doses. In case of administration under the skin, the medicine is injected into the thigh or abdomen (belly).

Bortezomib Sun doses are given intermittently, with rest periods between one and the other, in treatment cycles lasting from three to six weeks, depending on whether Bortezomib Sun is given alone or in combination with other medicines . If the patient experiences serious side effects, treatment should be stopped or postponed 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).

How does Bortezomib Sun work?

The active substance in Bortezomib Sun, bortezomib, is a proteasome inhibitor, which blocks its activity. The proteosome is a complex present inside the cells that breaks down proteins that are no longer needed. The blockage of the proteosomal complex causes the death of the cell. Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors such as bortezomib.

What benefit has Bortezomib Sun shown during the studies?

The company presented bortezomib data from the scientific literature. No further studies were needed because Bortezomib Sun is a generic medicine 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.

What are the risks associated with Bortezomib Sun?

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

Why has Bortezomib Sun been approved?

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 considered that, as in the case of Velcade, the benefits outweigh the identified risks and recommended to approve the use of Bortezomib Sun in the EU.

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

The company that markets Bortezomib Sun will provide educational material to healthcare professionals on how to build the solution and give the injection, calculate the dose and prescribe and administer the correct treatment to patients undergoing 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.

More information on Bortezomib Sun

For the full EPAR of Bortezomib Sun, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Bortezomib Sun therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.