What is Bortezomib Hospira and what is it used for?
Bortezomib Hospira is an anticancer medicine used to treat multiple myeloma, a cancer of the blood, in the following patient groups:
- adult patients whose disease has progressed after at least one previous line of treatment and who have already undergone or are not eligible for blood stem cell transplantation. Bortezomib Hospira is used alone or in combination with pegylated liposomal doxorubicin or dexamethasone in these patients;
- 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 undergo high-dose chemotherapy and will be followed by a blood stem cell transplant. In this patient group, Bortezomib Hospira is used in combination with dexamethasone or with dexamethasone and thalidomide.
Bortezomib Hospira is also indicated for the treatment of mantle cell lymphoma, another blood cancer, in previously untreated adults who cannot undergo a blood stem cell transplant. 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 given under the supervision of a doctor experienced in the use of chemotherapeutic agents.
Bortezomib Hospira is available in 3.5 mg vials as a powder to be made up into a solution for injection into a vein or under the skin. Bortezomib Hospira must not be administered by other routes.
The recommended dose should be calculated based on the patient's height and weight. If given into a vein, the solution is delivered via a catheter (sterile tube). At least 72 hours should elapse between two consecutive doses of Bortezomib Hospira. If the medicine is administered. subcutaneously, the injection is given in the thigh or abdomen (belly).
Doses of Bortezomib Hospira are given intermittently, with rest periods between doses, in treatment courses 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 course of therapy, treatment should be suspended or delayed, or the dose changed.
Patients with moderate to severe hepatic impairment should be treated at reduced doses. For more information on using Bortezomib Hospira, please read the Summary of Product Characteristics (also part of the EPAR).
How does Bortezomib Hospira work?
The active substance in Bortezomib Hospira, bortezomib, is a proteasome inhibitor (a mechanism in cells that breaks down proteins that are no longer needed), which means that it works by blocking their activity. Blockage of the proteasome system causes cell death. 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 taken as being the same as the reference medicine's.
The company presented data on bortezomib from the scientific literature. No additional studies were needed as Bortezomib Hospira is a generic medicine that is 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 taken as being the same as the reference medicine's.
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 that Bortezomib Hospira be approved for use 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 educational material to healthcare professionals on how to set up and give the injection, calculate the dose, and prescribe and give the correct treatment to patients undergoing blood stem cell transplantation.
Recommendations and precautions regarding the safety and effective use of Bortezomib Hospira to be followed by healthcare professionals and patients have also been added to the summary of product characteristics and package leaflet.
More information about Bortezomib Hospira
For the complete version of Bortezomib Hospira's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Bortezomib Hospira therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The full EPAR version of the reference medicine can also be found on the Agency's website.
The information on Bortezomib Hospira published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
