What is NovoThirteen - catridecacog?
NovoThirteen is a medicine containing the active substance catridecacog, available as a powder and solvent for the preparation of a solution for injection.
What is NovoThirteen used for - catridecacog?
NovoThirteen is used in the long-term prevention of bleeding in patients with a condition known as "congenital deficit of the XIII subunit A". It is an inherited coagulation disorder characterized by bleeding episodes. The medicine can only be obtained with a prescription.
How is NovoThirteen used - catridecacog?
Treatment with NovoThirteen should be started under the supervision of a doctor experienced in the treatment of rare coagulation disorders. The disorder must be confirmed by appropriate tests before treatment. The recommended dose is 35 international units (IU) per kg of body weight once a month. The dose is administered by a single slow injection into a vein. In some situations the doctor may decide to adjust the dose to prevent bleeding, based on an analysis of factor XIII activity levels 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 effectiveness of the clot. Patients with congenital factor XIII subunit A deficiency do not possess sufficient A subunit or this component does not function properly, which predisposes the patient to bleeding episodes. The active substance in NovoThirteen, catridecacog, is structurally the same as the A human factor XIII subunit. NovoThirteen works by bringing the XIII subunit A, which helps prevent bleeding in these patients. NovoThirteen is not effective in patients with deficiency of factor XIII subunit B. The subunit A of factor XIII present in NovoThirteen is produced by a method known as "recombinant DNA technique": that is, it is obtained from yeast cells into which a gene (DNA) has been introduced that allows them to produce this substance
How has NovoThirteen been studied - catridecacog?
NovoThirteen was studied in one main study involving 41 adults and children over 6 years of age with congenital factor XIII subunit A who had previously been treated with factor XIII medicines. NovoThirteen was given to patients for one year as a preventive measure. The study examined the number of bleeding episodes that required treatment with a factor XIII-containing medicine observed in these subjects compared to patients not treated with NovoThirteen, based on previous data referring to 16 patients with congenital XIII subunit A deficiency. The study was extended by one year for 33 patients to analyze the safety of long-term treatment with NovoThirteen. The safety and efficacy of NovoThirteen in children younger than 6 years have been evidenced by preliminary data obtained from an ongoing long-term study during which 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 was previously lower than the rate observed on the basis of previous data, referring to patients treated on request with another medicine containing factor XIII. On average, for each patient treated as a preventative with NovoThirteen, approximately 0.15 bleeding episodes requiring factor XIII treatment were recorded each year. By comparison, approximately 2.9 episodes per patient per year were observed in subjects treated on demand with another factor XIII containing medicinal product. During the long-term study no bleeding episodes were observed in children younger than 6 years treated with NovoThirteen.
What is the risk associated with NovoThirteen - catridecacog?
The most common side effects of NovoThirteen (seen in between 1 and 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 the limbs, pain at the injection site as well as the presence in blood of antibodies that bind to factor XIII and small protein fragments called "D-dimer of fibrin". 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 significant side effects were 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 marketing authorization.
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 included in the summary of product characteristics and the 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 the doctors who could prescribe the medicine an information pack for doctors and patients containing important information on the correct use of the same. These include instructions on storage procedures, as improper storage after preparation can cause increased levels of activated NovoThirteen and therefore increase the risk of thrombosis (clot formation in blood vessels), and information on administration procedures, because the concentration of factor XIII in NovoThirteen is different from that of other medicines containing factor XIII. Further information is available in the summary of the risk management plan.
Other information on NovoThirteen - catridecacog
On 3 September 2012, the European Commission issued a marketing authorization for NovoThirteen, valid throughout the European Union. For more information about treatment with NovoThirteen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2014.
