What is Busulfan Fresenius Kabi - Busulfan and what is it 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 haematopoietic progenitor cells (cells that are capable of generating red blood cells) in adults and children. This type of transplant is performed in people with blood disorders (for example, a rare form of anemia) or blood cell tumors, in which it is therefore necessary to replace the hematopoietic cells. For conventional conditioning treatment, Busulfan Fresenius Kabi is given 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 on a 'reduced intensity' conditioning regimen, Busulfan Fresenius Kabi is given 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, please see the questions and answers by clicking here.
How is Busulfan Fresenius Kabi used?
Busulfan Fresenius Kabi can only be obtained with a prescription and can only be used by a doctor who has experience in preparing for a transplant. 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 for 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 for two hours and is performed every six hours for four consecutive days prior to cyclophosphamide or melphalan treatment and transplantation. When used in combination with fludarabine, the recommended dose of Busulfan Fresenius Kabi is 3.2 mg / kg once daily administered as a three-hour infusion, immediately following 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 medicines called 'alkylating agents'. These substances are cytotoxic. This means that they kill cells, especially those that develop quickly, such as cancer or progenitor (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". Treatment with cyclophosphamide or melphalan is then used to induce immunosuppression, to decrease the body's natural defenses. This favors 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 additional studies in patients were required as 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 taken as being the same as the reference medicine's.
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 added to the summary of product characteristics and package leaflet for Busulfan Fresenius Kabi, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found 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 on Busulfan Fresenius Kabi therapy, please read the package leaflet (included in the EPAR). or consult your doctor or pharmacist. The full EPAR version of the reference medicine is also available on the agency's website. Last update of this summary: 03-2015.
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