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. Coagulation parameters do not necessarily correlate with or predict the effectiveness of novoseven rt. Recombinant activated coagulation factor viia novoseven in cases of massive haemorrhage, which has proved unresponsive to all other methods of intervention. These highlights do not include all of the information needed to use alprolix safely and effectively.
Each vial of novoseven rt contains no antimicrobial preservative and is intended for use in one patient on one occasion. These highlights do not include all the information needed to use hemlibra safely and effectively. In order to redeem this offer patient must have a valid prescription for the brand being filled. Novoseven is structurally similar to human plasmaderived factor viia.
Caution should be exercised in prescribing novoseven rt for. Product support is available to help qualifying patients through the novosecure program. Dr ulla hedner 30 years of novoseven rt coagulation. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. Australian product information novoseven rt eptacog. Variation assessment report as adopted by the chmp with all information of a commercially confidential nature deleted. Prescribed by or in consultation with a hematologist. 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.
Do not use novoseven rt exhibiting particulates or discoloration. Highlights of prescribing information these highlights do not include all the information needed to use novoseven rt safely and effectively. Hemophilia and blood factor products molina health care. Humatep antihemophilic factorvon willebrand factor complex human lyophilized powder for reconstitution for intravenous use only. Please see accompanying prescribing information, including boxed warning. Highlights of prescribing information these highlights do not.
Prescribing information contains a warning that patients with dic, advanced atherosclerotic disease, crush injury, or septicemia may have an. Novoseven, inneptacog alfa activated european medicines. Novo nordisk product information and resources novo. Idelvion coagulation factor ix recombinant, albumin fusion protein rixfp lyophilized powder for solution for intravenous injection initial u. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. 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. Highlights of prescribing information nmosd in adult these highlights do not include all the information needed to use soliris safely and effectively. Original prescription information, requested amount to be dispensed, vial sizes. All prescribers can obtain information regarding contribution of patient data.
Highlights of prescribing information these highlights do not include all the information needed to use idelvion safely and effectively. Description factor viia, recombinant novoseven rt is a coagulation factor. Novoseven rt fda prescribing information, side effects and uses. The initial measures are the same for any bleeding. 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. Novoseven is supplied as a sterile, white lyophilized powder of rfviia in singleuse vials. Highlights of prescribing information these highlights do not include all the information needed to use wilate safely and effectively. Novoseven rt coagulation factor viia recombinant novo nordiskhighlights of prescribing information these highlights do not include all the information needed to. 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. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively. 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. All prescribers can obtain information regarding contribution of patient data to this program by calling 18773627355. Novoseven rt fda prescribing information, side effects. Novoseven rt contains activated recombinant coagulation actor vii of approximate f.
Copay assistance and product assistance for novoseven rt. The food and drug administration fda approved rfviia in march of 1999 for the treatment of bleeding episodes. Novoseven rt coagulation factor viia, recombinant has a long history of helping people control their bleeds effectively. Highlights of prescribing information major surgery. Highlights of prescribing information initiate promacta at. Highlights of prescribing information these highlights do not include all the information needed to use hemlibra safely and effectively. Prescribing information kcentra prothrombin complex. Each vial of benefix has the recombinant factor ix rfix potency in the international units iu stated on the vial.
These highlights do not include all the information needed to use novoseven rt safely and effectively. Dailymed novoseven rt coagulation factor viia recombinant kit. Promacta eltrombopag tablets, for oral use promacta eltrombopag for oral suspension initial u. This clinical policy is consistent with standards of medical. Novosecure assists in supporting treatment costs novoseven. Novoseven rt coagulation factor viia, recombinant for hcp. Bleeding risk see full prescribing information for complete boxed warning.
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. Fda approved indications novoseven rt is indicated for the treatment of bleeding episodes and perioperative management in. 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. Recombinate antihemophilic factor recombinant important information what is recombinate. Novo nordisk novoseven rt coagulation factor viia recombinant. See full prescribing information for complete boxed warning. Nephrotoxicity, ototoxicity, neuromuscular blockade and fetal harm nephrotoxicity has been reported with zemdri.
Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Monthly, rendering provider must submit for authorization of dispensing quantity before delivering factor product. Benefix, coagulation factor ix recombinant for intravenous use, lyophilized powder for reconstitution initial u. Novoseven rt name of the medicine recombinant coagulation factor viia rfviia eptacog alfa activated bhk cas number. 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. Novoseven rt is recombinant human coagulation factor viia rfviia, intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively.
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. Highlights of prescribing information these highlights do not include all the information needed to use neupogen safely and effectively. Recombinate antihemophilic factor recombinant official site. Learn more here and see safety information and prescribing information. These highlights do not include all the information needed to use benefix safely and effectively. 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. This document is provided in portable document format pdf.
Novoseven rt is structurally similar to human plasmaderived factor viia. This should be considered during the preparation and administration of benefix, including storage time elapsed in a pvc container following reconstitution. Recombinant activated factor rfviia eptacog alfa novoseven rt. It is important that the recommendations for dosage and administration be followed closely see dosage and administration 2. 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. These highlights do not include all the information needed to use aranesp safely and effectively. Advate antihemophilic factor recombinant prescribing information. Hemlibra emicizumabkxwh injection, for subcutaneous use initial u.
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when. Novoseven rt coagulation factor viia, recombinant is a coagulation factor. Benefix nonacog alfa dosage and administration pfizer. Novoseven rt coagulation factor viia, recombinant lyophilized powder for solution, for intravenous use initial u. Recombinant activated factor vii queensland health. 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. In order to view pdf documents, you must have adobe reader software installed on your computer. Prescribing information pdf open prescribing information.
Soliris eculizumab injection, for intravenous use initial u. Novoseveno coagulation factor viia recombinant for. Jul 29, 2019 novoseven rt is intended for intravenous bolus administration only. Factor vii deficiency, glanzmanns thrombasthenia with refractoriness to platelets, and acquired hemophilia. Highlights of prescribing information these highlights do not include all the information needed to use zoladex safely and effectively. Official patient website for novoseven rt coagulation. Download the complete prescribing information for kcentra. 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 is supplied as a sterile, white lyophilized powder of rfviia in single use vials. 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. 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 rt coagulation factor viia, recombinant lyophilized powder for solution, for intravenous. Mims full prescribing information for novoseven rt powder for injection eptacog alfa. Zemdri prescribing information 3 full prescribing information warning. Jul 20, 2014 management of the bleeding patient receiving new oral anticoagulants. 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. Management of the bleeding patient receiving new oral. Highlights of prescribing information surgery these. Novo nordisk product information and resources novo nordisk.
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