What is Busulfan Fresenius Kabi - Busulfan used for?
Busulfan Fresenius Kabi is a medicine that contains the active substance busulfan . It is indicated in the conditioning (preparatory) treatment prior to transplantation of hematopoietic progenitor cells (cells that are able to generate red blood cells) in adult and child patients. This type of transplant is performed in subjects suffering from alterations of the blood (for example, a rare form of anemia) or tumors of blood cells, in which it is therefore necessary to replace the hematopoietic cells. For a conventional conditioning treatment, Busulfan Fresenius Kabi is administered before treatment with a second drug, cyclophosphamide, in adult patients and cyclophosphamide or melphalan, an alternative drug, in pediatric patients. In adults who are advised to have a "reduced intensity" conditioning regimen, Busulfan Fresenius Kabi is administered after treatment with another drug, fludarabine. Busulfan Fresenius Kabi is a "generic" medicine. This means that Busulfan Fresenius Kabi is similar to a 'reference medicine' already authorized in the European Union (EU) called Busilvex. For more information on generic medicines, see the questions and answers by clicking here.
How is Busulfan Fresenius Kabi - Busulfan used?
Busulfan Fresenius Kabi can only be obtained with a prescription and can only be used by a physician experienced in preparatory treatments for transplantation. It is available as a concentrate for solution for central intravenous infusion (drip into a central vein in the chest). When used in combination with cyclophosphamide or melphalan, the recommended dosage of Busilvex in adults is 0.8 mg / kg body weight. In children and adolescents (0 to 17 years), the recommended dosage of Busulfan Fresenius Kabi depends on the child's body weight and ranges from 0.8 to 1.2 mg / kg. Each infusion lasts two hours and is performed every six hours for four consecutive days before treatment with cyclophosphamide or melphalan and transplantation. When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg / kg once a day given as a three-hour infusion, immediately after fludarabine, for 2 or 3 consecutive days. Before receiving Busulfan Fresenius Kabi, patients should be pretreated with anticonvulsant drugs (to prevent seizures) and anti-emetic drugs (to prevent vomiting).
How does Busulfan Fresenius Kabi - Busulfan work?
The active substance in Busulfan Fresenius Kabi, busulfan, belongs to a group of so-called "alkylating agents". These substances are cytotoxic. This means that they kill cells, especially those that develop quickly, such as cancer or progenitor cells (or stem cells) (cells that make other types of cells). Busulfan is used before transplantation to neutralize abnormal cells and hematopoietic progenitor cells. This process is called "myeloablation". The treatment with cyclophosphamide or melphalan is then used to induce immunosuppression, to decrease the body's natural defenses. This promotes the "grafting" of the transplanted cells (that is, the cells begin to grow and produce normal blood cells).
How has Busulfan Fresenius Kabi - Busulfan been studied?
The company provided data on busulfan from the published literature. No further studies in patients were necessary, since Busulfan Fresenius Kabi is a generic medicine given by infusion and contains the same active substance as the reference medicine, Busilvex.
What are the benefits and risks of Busulfan Fresenius Kabi - Busulfan?
Because Busulfan Fresenius Kabi is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Busulfan Fresenius Kabi - Busulfan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Busulfan Fresenius Kabi has been shown to be comparable to Busilvex and therefore considered that, as in the case of Busilvex, the benefits are greater than the risks identified. The committee recommended the approval of Busulfan Fresenius Kabi in the EU.
What measures are being taken to ensure the safe and effective use of Busulfan Fresenius Kabi - Busulfan?
A risk management plan has been developed to ensure that Busulfan Fresenius Kabi 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 Busulfan Fresenius Kabi, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information about Busulfan Fresenius Kabi - Busulfan
On 22 September 2014, the European Commission issued a marketing authorization for Busulgan Fresenius Kabi, valid throughout the European Union. For more information about treatment with Busulfan Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR of the reference medicine is also available on the agency's website. Last update of this summary: 03-2015.
