What is NovoThirteen - catridecacog?
NovoThirteen is a medicine that contains the active substance catridecacog, which is available as a powder and solvent to make up a solution for injection.
What is NovoThirteen used for - catridecacog?
NovoThirteen is used for the long-term prevention of bleeding in patients with a condition known as 'congenital factor XIII A-subunit deficiency'. It is an inherited bleeding disorder characterized by bleeding episodes. The medicine can only be obtained with a prescription.
How is NovoThirteen used - catridecacog?
Treatment with NovoThirteen should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders. The disorder must be confirmed by adequate tests before treatment. The recommended dose is 35 international units (IU) per kg of body weight once a month. The dose is given as a single slow injection into a vein. In some situations, the doctor may decide to adjust the dose to prevent bleeding, based on the analysis of the activity levels of factor XIII in the blood.
How does NovoThirteen - catridecacog work?
Factor XIII is a protein that participates in the blood clotting process. A specific component of factor XIII, called subunit A, helps to stabilize blood clots and increase the efficacy of the clot. Patients with congenital deficiency of the factor XIII A subunit do not have a sufficient amount of subunit A or this component does not works properly, which predisposes the patient to bleeding episodes. The active substance in NovoThirteen, catridecacog, is structurally the same as subunit A of human factor XIII. NovoThirteen works by providing subunit A of factor XIII, which helps prevent bleeding in these patients . NovoThirteen is not effective in patients with deficiency of the factor XIII B subunit. The A subunit of factor XIII present in NovoThirteen is produced by a method known as "recombinant DNA technique": that is, it is obtained from yeast cells in which it has been entered a gene (DNA) that allows them to produce this substance
How has NovoThirteen - catridecacog been studied?
NovoThirteen was investigated in one main study involving 41 adults and children over 6 years of age with congenital factor XIII A-subunit deficiency who had previously been treated with factor XIII-containing medicines. NovoThirteen was administered to patients for one year for preventive purposes. The study looked at the number of bleeding episodes requiring treatment with a factor XIII medicine seen in these subjects compared to patients not treated with NovoThirteen, based on previous data in 16 patients with congenital factor XIII A-subunit deficiency. The study was extended by one year for 33 patients to investigate the safety of long-term treatment with NovoThirteen. The safety and efficacy of NovoThirteen in children under 6 years of age are been highlighted by preliminary data obtained from an ongoing long-term study during which a patients were given NovoThirteen to prevent bleeding episodes.
What benefit has NovoThirteen - catridecacog shown during the studies?
The rate of bleeding episodes in patients treated with NovoThirteen preventive was lower than the rate observed based on previous data for patients treated on demand with another medicine containing factor XIII. On average, for each patient treated preventively with NovoThirteen, there were approximately 0.15 bleeding episodes requiring factor XIII treatment each year. In comparison, in subjects treated on demand with another drug containing factor XIII, approximately 2.9 episodes per patient year were observed. During the long-term study, no bleeding episodes were observed in children under the age of 6 years treated with NovoThirteen.
What is the risk associated with NovoThirteen - catridecacog?
The most common side effects with NovoThirteen (seen in 1 to 10 patients in 100) are headache, leukopenia (low white blood cell count), aggravated neutropenia (low number of neutrophils, a type of white blood cell), pain in limb, pain at the injection site and the presence of antibodies in the blood that bind to factor XIII and small fragments of proteins called 'fibrin D-dimer'. For the full list of side effects and limitations, see the package leaflet.
Why has NovoThirteen - catridecacog been approved?
The CHMP concluded that the main study showed satisfactory results in terms of efficacy, as no serious or life-threatening bleeding was observed during treatment with NovoThirteen. Furthermore, no major side effects have been recorded during long-term use of NovoThirteen. The CHMP decided that NovoThirteen's benefits are greater than its risks and recommended that it be given a marketing authorization for the medicine.
What measures are being taken to ensure the safe and effective use of NovoThirteen - catridecacog?
A risk management plan has been developed to ensure that NovoThirteen 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 NovoThirteen, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets NovoThirteen will provide all doctors who may prescribe the medicine with an information pack for doctors and patients containing important information on its correct use. This includes instructions on storage procedures, as incorrect storage after preparation may cause increased levels of activated NovoThirteen and thus increase the risk of thrombosis (formation of clots in the blood vessels), and information on administration procedures, as the concentration of factor XIII in NovoThirteen is different from that of other medicines containing factor XIII. Further information can be found in the summary of the risk management plan.
More information about NovoThirteen - catridecacog
On 3 September 2012, the European Commission granted a "Marketing Authorization" for NovoThirteen, valid throughout the European Union. For more information on NovoThirteen therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 02-2014.
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