Highlights of prescribing information these highlights do not. All prescribers can obtain information regarding contribution of patient data. Novo nordisk novoseven rt coagulation factor viia recombinant. Novoseven rt is structurally similar to human plasmaderived factor viia. Novoseven rt is administered by intravenous bolus injection over a period of 25 minutes and should not be mixed with infusion solutions or be given in a drip. Highlights of prescribing information these highlights do not include all the information needed to use zoladex safely and effectively. See safety information and prescribing information. Highlights of prescribing information these highlights do not include all the information needed to use hemlibra safely and effectively. Novoseven rt is recombinant human coagulation factor viia rfviia, intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. Caution should be exercised in prescribing novoseven rt for. Novoseven, inneptacog alfa activated european medicines. Our institution has created protocols to help direct the use of factor concentrates in the treatment of life threatening bleeding in patients taking new oral anticoagulants figure 1.
Novoseven is supplied as a sterile, white lyophilized powder of rfviia in singleuse vials. See full prescribing information for complete boxed warning life threatening and f atal meningococcal infections have occurred in patients treated with soliris and may become rapidly life threatening or fatal if not recognized and treated early 5. Novoseven used under these conditions is an offlabel use outside the terms of the drug licence, for which the trust and the prescribing clinician must carry responsibility. These highlights do not include all the information needed to use hemlibra safely and effectively. Benefix, coagulation factor ix recombinant for intravenous use, lyophilized powder for reconstitution initial u. Mims full prescribing information for novoseven rt powder for injection eptacog alfa. Soliris eculizumab injection, for intravenous use initial u. See full prescribing information for complete boxed warning.
Novoseven rt coagulation factor viia, recombinant for hcp. Novoseven rt name of the medicine recombinant coagulation factor viia rfviia eptacog alfa activated bhk cas number. Download the complete prescribing information for kcentra. Novoseven is supplied as a sterile, white lyophilized powder of rfviia in single use vials. It is important that the recommendations for dosage and administration be followed closely see dosage and administration 2. Novoseven rt is intended for intravenous bolus administration only. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when. Novoseven cooperative registry surveillance program is designed to collect data on all uses of novoseven to expand the base of experience regarding the use of novoseven. Prescribing information kcentra prothrombin complex. Prescribing information contains a warning that patients with dic, advanced atherosclerotic disease, crush injury, or septicemia may have an.
This should be considered during the preparation and administration of benefix, including storage time elapsed in a pvc container following reconstitution. Learn more here and see safety information and prescribing information. Novoseven rt coagulation factor viia recombinant novo nordiskhighlights of prescribing information these highlights do not include all the information needed to use novoseven rt safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use novoseven rt safely and effectively. Recombinate antihemophilic factor recombinant official site. Factor vii deficiency, glanzmanns thrombasthenia with refractoriness to platelets, and acquired hemophilia. Policycriteria it is the policy of tmhealth plans affiliated with envolve pharmacy solutions that factor viia novoseven rt is medically necessary when the following criteria are met. Prescribed by or in consultation with a hematologist. Novoseven rt coagulation factor viia, recombinant is a drug focused on effective bleed control treatment for your patients with hemophilia a or b with inhibitors, congenital factor vii deficiency, glanzmanns thrombasthenia with refractoriness to platelets, and acquired hemophilia. Prescribing information contains a warning that patients with dic, advanced atherosclerotic disease, crush injury, or septicemia may have an increased risk of developing thrombosis due to circulating tissue factor or predisposing coagulopathy.
Novoseveno coagulation factor viia recombinant for. Recombinate is a prescription medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a also called classic hemophilia. Recombinant activated factor vii queensland health. The food and drug administration fda approved rfviia in march of 1999 for the treatment of bleeding episodes. Each vial of benefix has the recombinant factor ix rfix potency in the international units iu stated on the vial. This clinical policy is consistent with standards of medical. Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Highlights of prescribing information nmosd in adult these highlights do not include all the information needed to use soliris safely and effectively. Novoseven is recombinant factor viia and, when complexed with tissue factor can activate coagulation factor x to factor xa, as well as coagulation factor ix to factor ixa. Novoseven rt contains activated recombinant coagulation actor vii of approximate f. Variation assessment report as adopted by the chmp with all information of a commercially confidential nature deleted. Management of the bleeding patient receiving new oral. Humatep antihemophilic factorvon willebrand factor complex human lyophilized powder for reconstitution for intravenous use only. Novoseven rt coagulation factor viia, recombinant has a long history of helping people control their bleeds effectively.
Highlights of prescribing information these highlights do not include all the information needed to use wilate safely and effectively. Original prescription information, requested amount to be dispensed, vial sizes. Novo nordisk product information and resources novo nordisk. Dailymed novoseven rt coagulation factor viia recombinant kit. Novoseven rt coagulation factor viia recombinant novo nordiskhighlights of prescribing information these highlights do not include all the information needed to. Recombinate antihemophilic factor recombinant important information what is recombinate. These highlights do not include all the information needed to use novoseven rt safely and effectively. Nephrotoxicity, ototoxicity, neuromuscular blockade and fetal harm nephrotoxicity has been reported with zemdri. This document is provided in portable document format pdf.
Bleeding risk see full prescribing information for complete boxed warning. Novoseven rt coagulation factor viia, recombinant lyophilized powder for solution, for intravenous use initial u. Novoseven rt coagulation factor viia, recombinant lyophilized powder for solution, for intravenous. Fda approved indications novoseven rt is indicated for the treatment of bleeding episodes and perioperative management in. Recombinant activated factor rfviia eptacog alfa novoseven rt. The initial measures are the same for any bleeding. Copay assistance and product assistance for novoseven rt. Official patient website for novoseven rt coagulation. Access information and resources on each of novo nordisks available products for the treatment of diabetes, obesity, growth hormone disorders, hemophilia and rare bleeding disorders. Product support is available to help qualifying patients through the novosecure program. Evaluation of hemostasis should be used to determine the effectiveness of novoseven rt and to provide a basis for modification of the novoseven rt treatment schedule. Plasma products carry a risk of transmitting infectious agents, including viruses, and theoretically, the creutzfeldtjakob disease cjd agent, despite steps designed to reduce this risk. Novoseven rt fda prescribing information, side effects.
Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively. Recombinant activated coagulation factor viia novoseven in cases of massive haemorrhage, which has proved unresponsive to all other methods of intervention. Novoseven package insert page 1 novoseveno coagulation factor viia recombinant for intravenous use only description novoseven is recombinant human coagulation factor viia rfviia, intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. Monthly, rendering provider must submit for authorization of dispensing quantity before delivering factor product. Benefix nonacog alfa dosage and administration pfizer. Novoseven is structurally similar to human plasmaderived factor viia. Highlights of prescribing information these highlights do not include all the information needed to use idelvion safely and effectively. Australian product information novoseven rt eptacog. Please see accompanying prescribing information, including boxed warning. These highlights do not include all of the information needed to use alprolix safely and effectively.
Highlights of prescribing information initiate promacta at. Jul 29, 2019 novoseven rt is intended for intravenous bolus administration only. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. Highlights of prescribing information these highlights do not include all the information needed to use neupogen safely and effectively. Hemlibra emicizumabkxwh injection, for subcutaneous use initial u. In order to redeem this offer patient must have a valid prescription for the brand being filled. Do not use novoseven rt exhibiting particulates or discoloration. The health plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. Advate antihemophilic factor recombinant prescribing information. Novoseven rt coagulation factor viia, recombinant is a coagulation factor. Zemdri prescribing information 3 full prescribing information warning.
Novosecure assists in supporting treatment costs novoseven. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. Dr ulla hedner 30 years of novoseven rt coagulation. These highlights do not include all the information needed to use aranesp safely and effectively. Prescribing information pdf open prescribing information.
In order to view pdf documents, you must have adobe reader software installed on your computer. Coagulation parameters do not necessarily correlate with or predict the effectiveness of novoseven rt. Hemophilia and blood factor products molina health care. Description factor viia, recombinant novoseven rt is a coagulation factor. Jul 22, 2019 novoseven rt is recombinant human coagulation factor viia rfviia, intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade.
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