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. 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.

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.

Studies on the benefits and risks of the active substance carmustine in the authorised uses 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.

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

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 outweighs the identified risk and it can be authorised for use in the EU.

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.

Information on the reference medicine can also be found on the Agency’s website.