What is Bortezomib Hospira and what is it used for?
Bortezomib Hospira is an anticancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
- adult patients whose disease is progressing after at least one previous line of treatment and who have already undergone or are not eligible for blood stem cell transplantation. In these patients Bortezomib Hospira is used as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone;
- previously untreated adult patients who cannot undergo high dose chemotherapy with blood stem cell transplantation. In these patients, Bortezomib Hospira is used in combination with melphalan and prednisone;
- previously untreated adult patients who will be receiving high-dose chemotherapy and followed by a blood stem cell transplant. In this group of patients, Bortezomib Hospira is used in combination with dexamethasone or with dexamethasone and thalidomide.
Bortezomib Hospira is also indicated in the treatment of mantle cell lymphoma, another blood cancer, in previously untreated adult subjects who cannot be subjected to blood stem cell transplantation. For mantle cell lymphoma, Bortezomib Hospira is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Bortezomib Hospira is a "generic medicine". This means that Bortezomib Hospira 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 Hospira contains the active substance bortezomib.
How is Bortezomib Hospira used?
The medicine 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 chemotherapeutic agents.
Bortezomib Hospira is available in vials of 3.5 mg as a powder to be made up into a solution for injection in a vein or under the skin. Bortezomib Hospira should not be given by other means.
The recommended dose should be calculated based on the patient's height and weight. If given into a vein, the solution is dispensed through a catheter (sterile tube). At least 72 hours must pass between two consecutive doses of Bortezomib Hospira. If the medicine is administered subcutaneously, the injection should be made in the thigh or in the abdomen (belly).
Bortezomib Hospira doses are given intermittently, with resting periods between doses, in treatment cycles of three to six weeks, depending on whether Bortezomib Hospira is given as monotherapy or in combination with other drugs. If serious side effects occur after a therapeutic cycle, treatment should be suspended or delayed, or the dose should be changed.
Patients with moderate to severe hepatic impairment should be treated at reduced doses. For more information on the use of Bortezomib Hospira, read the summary of product characteristics (also part of the EPAR).
How does Bortezomib Hospira work?
The active substance of Bortezomib Hospira, bortezomib, is a proteasome inhibitor (a mechanism inside cells that degrades proteins that are no longer needed), which means that it acts by blocking its activity. The blockage of the proteosome system 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 Hospira shown during the studies?
Because Bortezomib Hospira is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
The company presented bortezomib data from the scientific literature. No further studies were needed because Bortezomib Hospira is a generic medicine given by injection and contains the same active substance as the reference medicine, Velcade.
What are the risks associated with Bortezomib Hospira?
Because Bortezomib Hospira is a generic medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Bortezomib Hospira been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Hospira 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 Hospira in the EU.
What measures are being taken to ensure the safe and effective use of Bortezomib Hospira?
The company that markets Bortezomib Hospira will provide information material to healthcare professionals on how to build and administer the injection, calculate the dose, and prescribe and administer the correct treatment to patients undergoing blood stem cell transplantation.
Recommendations and precautions related to the safety and effective use of Bortezomib Hospira that health professionals and patients must take are also included in the summary of product characteristics and the package leaflet.
More information on Bortezomib Hospira
For the full EPAR of Bortezomib Hospira, refer to the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Bortezomib Hospira, 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.
