Carmustine Obvius

Carmustine Obvius is given by infusion (drip) into a vein. It must be given under the supervision of a doctor experienced in the use of cancer medicines and can only be obtained with a prescription. For the treatment of cancer, a dose based on the patient’s weight and height is given at intervals of at least 6 weeks, and should be adjusted according to the patient’s blood cell counts.

When used as a conditioning treatment, Carmustine Obvius is given before the cell transplant.

For more information about using Carmustine Obvius, see the package leaflet or contact your doctor or pharmacist.

Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent. It interferes with the normal function and repair of DNA and RNA, the genetic instructions that cells need to function and multiply. Because cancer cells tend to grow and multiply more than normal cells they are more vulnerable to the action of the medicine. By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading. When used as a conditioning treatment Carmustine helps clear the patient’s bone marrow cells as they multiply more quickly than normal cells and are therefore more vulnerable to the action of the medicine.

Studies on the benefits and risks of the active substance carmustine in the authorised uses as a cancer medicine have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius.

As for every medicine, the company provided studies on the quality of Carmustine Obvius. There was no need for ‘bioequivalence’ studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Carmustine Obvius is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

For use as a conditioning treatment, as Carmubris is not authorised for this use, the company provided data from the medical literature.

Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s for its authorised indications.

For use as a conditioning treatment, data from the literature showed that Carmustine Obvius is effective at preparing patients with Hodgkin’s lymphoma and non-Hodgkin’s lymphomas for transplantation of their own haematopoietic progenitor cells. However, the data provided were not sufficient to demonstrate effectiveness in patients with other types of cancer and in those who are to receive cell transplant from a donor.

The side effects associated with Carmustine Obvius when used as a conditioning treatment are generally in line with those seen with the other uses.

The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris. Therefore, the Agency’s view was that, as for Carmubris, the benefit of Carmustine Obvius in the treatment of cancer outweighs the identified risk and it can be authorised for use in the EU.

For use a conditioning treatment, for which Carmubris is not authorised, the Agency noted that the active substance in Carmustine Obvius has been used for decades as a part of different conditioning regimens, and that its effectiveness has been established. Its safety profile in this use is similar to that seen with other uses. Therefore, the Agency decided that the benefits of Carmustine Obvius outweigh its risks as a conditioning treatment in patients with Hodgkin’s lymphoma and non-Hodgkin’s lymphomas before transplantation of their own haematopoietic progenitor cells.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Carmustine Obvius are continuously monitored. Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients.

Carmustine Obvius received a marketing authorisation valid throughout the EU on 18 July 2018.