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Rixubis is a drug which was approved by US-FDA for the treatment of patients suffering from haemophilia B (age 16 years or above) on June 2013. It is recommended to be used for routine prophylactic treatment and to control continuous bleeding, perioperative management (the time interval from hospitalization for the surgery to the time of discharge) to avoid or lower the frequency of bleeding episodes. In last 15 years for the history of haemophilia B treatments, it is the first rF IX (recombinant factor IX) approved as drug for the treatment of haemophilia. It is the only rF IX, approved by the FDA for both routine prophylaxis as well as to control of bleeding episodes associated with this chronic condition. Haemophilia B is a blood clotting disorder triggered by a mutation in the Factor IX gene, leading to a deficiency of Factor IX. Factor IX is a one of the important blood clotting factor. Haemophilia B is the second most common form of haemophilia, but uncommon than Haemophilia A. When a person suffering from haemophilia gets injured, he bleeds for longer time compared to normal people because for these patients it takes much longer duration to clot the blood. Small cuts or surface bruises are usually not a problem, but more traumatic injuries may result in serious problems and potential disability. This is because, the proteins essential to form blood clots are missing or reduced in level. In about 30% of cases, there is no family history of the disorder and the condition is the effect of a spontaneous gene mutation. Approximately 26,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with haemophilia B. Haemophilia B is often an unbearable, chronic disease with complications that include bleeding episodes, haemophilic arthropathy which refers to a condition of bleeding into a joint and then hospitalization. Haemophilia B cannot be cured but it can be treated and managed safely. As haemophilia B caused by the deficiency of Factor IX in blood thus the two main array of treatment for haemophilia B include Factor IX replacement therapy, and the use of local clotting agents. Replacement therapy helps to increase the level of factor IX in the blood. While local clotting agents help to form blood clots and keep them in place to stop bleeding. In general, for mild haemophilia patient’s small cuts and scrapes are treated with typical first-aid – like cleaning the cut then apply pressure and cover with a band-aid. People with mild hemophilia can use a non-blood product called desmopressin acetate (DDAVP) to treat mild bleeds. But for these patients more complex treatment would be required for deep cuts or internal bleeding, such as bleeding into the joints or muscles. The missing clotting factor (VIII or IX) has to be replaced so that a clot is formed to stop the bleeding. The main aim for effective treatment of haemophilia is to increase or replace the level of factor IX in the blood. As a source of replacement therapy some products which are made from human blood such as donated plasma are used. The other kind of products which are made in a laboratory and do not use human blood products are referred as "recombinant factors”. Rixubis is such type of one product .All factor treatments are generally injected or infused directly into the veins. As factor IX concentration play a crucial role in the typical course of therapy for haemophilia B, thus in cases of severe hemophilia, doctors sometimes recommend a regimen of regular factor IX replacement treatments. This is referred as prophylaxis, and it prevents bleeding episodes before they occur. Rixubis is manufactured by Baxter Healthcare Corporation, a leading brand associated for long time to support of people living with bleeding disorders with their innovative products and support programs. Rixubis is a purified protein which is made with recombinant DNA technology, this can be used to prevent and control the excessive bleeding associated with haemophilia. It does not comprise of any human or animal proteins. It is supplied in single-use vials of freeze-dried powder and is administered by intravenous injection after reconstitution with sterile water for injection. When used for the routine prevention of bleeding episodes, it is administered twice weekly. The approval of this drug is given based on phase I/III study. The study was a prospective, open-label, uncontrolled, multicenter study that investigated the pharmacokinetics, efficacy and safety of Rixubis. The study was conducted in 73 previously-treated patients with severe (factor IX level <1 percent) or moderately severe (factor IX level =2 percent) Haemophilia B whose age group should be between 12 and 65 years. Patients received Rixubis either for prophylaxis and/or for the treatment of bleeding episodes on an on-demand basis, and were exposed to a factor IX-containing product on =150 days. Fifty-nine patients received Rixubis for prophylaxis twice-weekly, and 56 of them received treatment for a minimum of three months. An additional 14 patients received Rixubis for the treatment of bleeding episodes only, and had to have at least 12 documented bleeding episodes requiring treatment within 12 months prior to enrolment. There were no findings developed on an inhibitory antibody to rF IX and no cases of anaphylaxis in any patients. Rixubis is contraindicated in patients with known hypersensitivity towards Rixubis and its excipients including hamster protein. It is also contraindicated in patient’s experiencing disseminated intravascular coagulation and signs of fibrinolysis. Hypersensitivity reactions in addition toanaphylaxis have been reported with factor IX-containing products. Some early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest tightness, hypotension, lethargy, nausea, vomiting, paresthesia, restlessness, wheezing, and dyspnoea. Development of neutralizing antibodies (inhibitors) to factor IX may occur. Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis if re-exposed to Rixubis. The use of factor IX containing products has been associated with the development of thromboembolic complications. From the clinical findings of the study on Rixubis, it was found that Patients who received Rixubis for routine prophylaxis experienced a significant reduction in annual bleeding which was 75 percent lower compared to those who received other treatment options. Thus Rixubis has shown promising effect for the treatment of Haemophilia B for which for last 15 year there was no proper effective treatment available. Clinnovo is a clinical innovation company. It is pioneer CRO industry in India. Clinnovo offers professional Clinical Research Course , clinical data management course , SAS and imaging training. Clinnovo has been serving different bio-pharma industries across the world with excellence and high quality. For more information contact at +91 9912868928, 040 64635501
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