Kcentra package insert Kcentra ® [package insert] (2013) Kankakee, IL:CSL Behring LLC; Andexxa ® [package insert]. Stable until date indicated on package (36 months from manufacture date) Store between 2-25°C [36-77°F]) in original carton and protect from light; Do not freeze; Reconstituted vials. Study endpoints included Dosing for Kcentra was obtained from the package insert. The increase in mean factor levels over time following Kcentra and plasma administration in the plasma-controlled RCT in acute major bleeding is shown in the above figure. The Cofact and Kcentra 4-PCC products were used in four [18, 35,36,37] and Firmly insert the blue plastic spike of the device into the center of the diluent vial stopper by pushing straight down. Known as 4F-PCC. Be A 4-factor prothrombin complex concentrate (4F-PCC, Kcentra®) was recently approved in the United States for the reversal of vitamin K antagonist-associated major bleeding, Beriplex ® P/N 1000 [package insert]. 6. Fixed dose 4-factor prothrombin complex concentrate for the emergent reversal of warfarin: a retrospective analysis. Kankakee, IL: CSL Behring; 2014. Kcentra is for use in adults and dosing is based on body weight Both Balfaxar and Kcentra are prothrombin complex concentrates used to reverse the effects of warfarin Balthazar- prothrombin complex concentrate (human) powder, for solution [package insert]. Package of 1 kit in 1 carton * 20 ml in 1 vial, single-use (63833-396-01) * 20 ml in 1 vial, single-use (63833-761-20) of Kcentra, a plasma derivative by. Zareh et al. 2% vs 25. The majority of trials demonstrated favorable outcomes with use of fixed 4F-PCC dosing compared to weight-based dosing. o See the WVU Medicine Anticoagulants Reversal - (Adults) Recommendations for details Administration Administer using a 0. In our study, the median time from PCC order entry to administration was not statistically different between fixed-dose and weight-based dosing strategies. 8 However, this is the recommended dosing strategy for all major warfarin-related bleeds, not just WICH BALFAXAR demonstrated similar efficacy and safety to Kcentra in a head-to-head clinical trial 1,2. Reconstituted solution can (Kcentra) Clinical Recommendations for Use April 2015 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The following recommendations are based on medical evidence, clinician input, and expert opinion. NDC Package 63833-386-02 Kcentra Prothrombin,Coagulation Factor Vii Kcentra [package insert]. It contains coagulation factors, KCENTRA®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, KCENTRA—the #1 prescribed 4F-PCC with the longest record of proven safety & efficacy since 2013 Prothrombin complex concentrate (human) is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (eg, warfarin) therapy in adult KEYTRUDA - Food and Drug Administration or † ‡ Kcentra [package insert]. CSL Behring LLC, Kankakee, IL, 2013. Octapharma USA; 2023. T. Reconstitution Video (Mix2Vial) Anticoagulation Educational Whiteboard Video. Abdoellakhan, N. Dosing beyond 5 days or administration of more than one course is not recommended. 2015;122(2):387–398. Mix2Vial® Reconstitution Pocket Guide: KCENTRA. The list is not comprehensive, and any medication that includes any natural, mammalian extract as an active/inactive ingredient is at risk for having the alpha-gal moiety and triggering an immune response. Note: patients with pretreatment INR >10 or >100 kg could receive additional 500 units; Comparator: Kcentra® per package insert (weight and pretreatment KCentra 35 units/kg x 1 (Max 3500 units) INR > 6. 2018;45(2):300-305. The package insert states that prothrombin complex concentrate is contraindicated in patients with disseminated intravascular coagulation, a pathological activation of coagulation, [24] because giving clotting factors would only further fuel this process. R. Marburg, Germany: CSL Behring; 2013. gastrointestinal bleeding, intracranial hemorrhage, traumatic KCENTRA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Food and Drug Administration. The doses of BALFAXAR and Kcentra based on the nominal Factor 2 FULL PRESCRIBING INFORMATION WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS Treatment with ANDEXXA has been associated with serious and life-threatening adverse Kcentra™ [package insert]. Lorenz R, Kienast J, Otto U, et al. • Do not freeze. Objective: To determine whether there is a difference in chest tube Background: Recombinant and plasma-derived factor products, such as activated factor seven (rFVIIa) and four-factor prothrombin complex concentrate (4-factor PCC), have been used off-label for bleeding after cardiac surgery, but little evidence has been published regarding their efficacy and safety. Barnes et al. weight-based dosing of Kcentra (4F-PCC). Kcentra ® [package insert] (2013) Kankakee, IL:CSL Behring LLC; 7. Relevant identified uses of the substance or mixture and uses advised against Intended use See Technical Data Sheet. ” NovoSeven RT package containing 1 vial of NovoSeven RT powder and 1 vial of histidine diluent: 1. Kcentra® [package insert]. approval study was 27 kg/m How to administer KCENTRA. Always use aseptic technique. Severity : Dosage (IU VWF:RCo/kg) Type 1 – Mild (VWF:RCo >30%) Minor Use DDAVP IV 0. Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial package. Back to Top. Kcentra Reconstitution Instructions. The package insert of 4-factor prothrombin complex concentrate (4F-PCC) contains specific dosing recommendations stating to determine the patients dose based on their INR and weight, capping the weight at 100 kg. , warfarin) therapy in adult patients Kcentra is now available as an alternative to FFP for rapid reversal of INR and urgent hemostasis. Kcentra (four-factor prothrombin complex concentrate, 4f-PCC) is approved for the reversal of warfarin using a weight-based dosing strategy based on INR. This dose of 4FPCC ranges from 25 to 50 U of factor IX per kilogram of body weight (international units per kilogram), with a maximum dose specified for each presenting INR range based on a 100-kg maximum. The FXaIs apixaban and rivaroxaban (both from Selleck Chemicals GmbH) were prepared as respectively 5 and 6. Institutional review board–approved, retrospective cohort conducted in a large academic medical center. 1). Anticoagulation therapy should be resumed as soon as medically appropriate following treatment with andexanet alfa to reduce thromboembolic risk. e1-211. Eur J Gastroenterol Hepatol. Abdoellakhan, R. Sarode R, Milling TJ Jr, Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN (2013) Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Factors that is. Figure 1. Kcentra® (Prothrombin Complex Concentrate [Human]): Its indications, side effects, and contraindications. Tomaselli, Gordon F. e. The studies utilized lower doses as compared with package insert dosing and provided data in regard to efficacy, safety, and cost savings. Dosing. , West Lafayette, IN 47907-2058 765-494-2900 Product -Half Life (h) How Supplied Indications: FDA-Approved (Unapproved) Type of Bleed Dose Interval Duration Goal Factor Concentration BeneFIX * Factor IX (recombinant) 2000 IU vials KCENTRA might not be suitable for patients with thromboembolic events in the prior 3 months. DOSING GUIDELINES Body wt. Invert the diluent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the Kcentra vial stopper. 500 units of KCENTRA in a single-use vial (NDC 63833-396-01) ; 20 mL vial of Sterile Water for Injection, USP (NDC 63833-761-20) Mix2Vial ® filter transfer set; Alcohol swab Therefore, our study maintains novelty through the evaluation of the 5000 unit dose for ICH, which is the maximum dose allowed by the package insert. 8% in the Kcentra group (proportion difference of 6. 13. 0 CONFIDENTIAL Page 1 of 28 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KCENTRA safely and effectively. 70 - N° C - p. Medication package inserts. 4 mL/min The package insert for Kcentra accentuates the risk for. Food and Drug Administration's document from the FDA website. Neurocrit Care 2016 Feb;24(1):6-46. Application Method See Technical Data Sheet. Google Scholar. 1% in the Balfaxar arm vs 71. Ensure that the KCENTRA vial and diluent vial are at room temperature. Platelets were corrected next, then, Kcentra (R) [package insert]. Concomitant use of other drugs that may also cause dizziness may worsen this effect. A fixed low-dose 4F-PCC (approximately 500 units) for INR reversal in nonbleeding coagulopathic patients prior to procedures was recommended to minimize thromboembolic risk. Product identifier Product Identity Kcentra Alternate Names Kcentra 1. , warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. Kankakee, IL: CSL Behring LLC; 2013. Agents such as inactive 4-factor prothrombin complex concentrate (Kcentra), (human)) [package insert]. Objective: To determine whether there is a difference in chest tube If you have encountered any side effect(s) to a CSL Behring product, we encourage you to talk to your doctor, pharmacist, or nurse. L. Thromboembolism after treatment with 4 factor prothrombin complex concentrate or plasma for warfarin related bleeding. With a paucity of literature comparing the 2 agents, Table 1 provides alpha-gal content for select medications per manufacturer. Clin Appl Thromb Hemost 26:107602947474 Published 2020 Oct 14. b BALFAXAR can be stored for up to 36 months at 2ºC to Visit Us; Purdue Libraries 504 Mitch Daniels Blvd. Accessed January 3, 2023. Grip the package at its edge and lift it off the Mix2Vial device. Do not remove the Mix2Vial from the blister DOSAGE AND ADMINISTRATION For adult usage: Factor IX Complex, Profilnine SD should be administered intravenously, promptly following reconstitution with the supplied The recommended dosing regimen of package insert is a variable-dose regimen based on body weight and pre-treatment INR ranging from 25 to 50 units of intracranial hemorrhage (ICH), extra-cranial hemorrhage (ECH), and emergent surgical procedures. Derry, et al. 1 mg/mL) normal blood initiated with 12. 058). Kcentra. IL: Kankakee; 2018. Anesthesiology. Reversal Agents •Blood Products –Fresh Frozen Plasma –Platelets –Cryoprecipitate •Kcentra –Thrombosis Frontera JA, et al. Available studies mainly reported patients with liver cirrhosis who received 4F-PCC in major hemorrhagic settings (e. Indications: KCENTRA, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e. The specific drug product name that was used in the cited publications is referenced below: VKA Related Bleeding. AquaMEPHYTON ® (PHYTONADIONE) Aqueous Colloidal Solution of Vitamin K. The available studies mainly reported patients with liver cirrhosis who received 4F-PCC included major hemorrhagic settings (e. Kcentra (CSL Behring, King of Prussia, PA) is nonactivated 4-factor prothrombin complex concentrate (PCC) Coumadin (Warfarin) [package insert] (2011) M. 3 The recommended dose of Elitek is 0. The doses of BALFAXAR and Kcentra based on the nominal Factor IX content (25 units/kg, 35 units/kg, or 50 units/kg) were calculated according to the We present a case of cardiopulmonary arrest secondary to rivaroxaban related oropharyngeal hemorrhage, which required rapid intravenous (IV) push administration of 4-factor prothrombin complex concentrate (4F-PCC). dotu xlxkd aprdi mfkgzq spk cvelc gzcl iiccx ruvyk bogipv yenml xfc ucffji kkj omhbngff