JAMA 2015;313(8):824-36. (Kcentra) preferred PCC = prothrombin complex concentrates Dosing: INR 2-3.9: 25 units/kg (max of 2500 units) + Vitamin K 2.5mg IVPB INR 4-6: 35 units/kg (max of 3500 units) + Vitamin K 5mg IVPB INR>6: 50 units/kg (max of 5000 units) + Vitamin K 10mg IVPB Rate of infusion: 0.12 ml/kg/min (~ 3 units/kg/min) up to max of 8.4 ml/min Dose to be given of high cost targeted medications within 5% (plus or minus) of the calculated prescribed In 2013, the FDA approved Kcentra for the urgent reversal of acquired coagulation factor (2.1) Administer reconstituted Kcentra at a rate of 0.12 kcentra - UpToDate. Storage following reconstitution: After reconstitution, administration should begin promptly or within 4 hours. Subcutaneous administration has erratic absorption. Check INR after infusion and may repeat dose if INR still elevated. This Repeat dosing with Kcentra is not supported by clinical data and is not recommended. CSL Behring 1.14.1.3 Draft Labeling Text Prothrombin Complex Concentrate (Human), Kcentra INR > 6.0: KCentra 50 units/kg x 1 (Max 5000 units) Recheck INR 10-30 minutes after 4-factor PCC administration. PRIMARY CONTAINERS WITH IMPROVED PROTEIN DRUG STABILITY AND LOWER IMMUNE RESPONSE is an invention by Robert S. Abrams, New York NY UNITED STATES. Can be given IV or PO. Drug Properties: Prothrombin Complex Concentrates (PCC) are hemostatic blood products that contain vitamin K-dependent clotting factors. This reduction in count should also coincide with heparin administration. (same dosing as Kcentra) Alternatively, consider giving FFP 10-15 mL/kg in addition to vitamin K in lieu of Kcentra/FEIBA If INR 1.4 within first 24-48 hours after reversal, consider additional 5 The PCC selection in our protocols for dabigatran, rivaroxaban, and apixaban-associated hemorrhage is based upon the available human and animal data presented in detail in Table 2 and summarized in Table 3. Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished. Administration: IV- dilute in 50 ml NS and give over 30 minutes Onset: PO=24 hours; IV=12 hours Caution: IV - may be associated with very small risk of anaphylaxis Use of KCentra: REQUIRES ATTENDING APPROVAL Document attending name in the order comments REPEAT INR 30 MINUTES AFTER END OF KCentra/FFP INFUSION. Indication: For urgent reversal of acquired coagulation factor deficiency induced by vitamin K Although expensive, these factors offer the advantage of more rapid administration and onset with significantly less fluid volume than blood products, while avoiding additional blood exposures and their well-documented risks. UW Health Warfarin Management - Adult - Ambulatory - Kcentra 35 units/kg IV one-time for INR 4 to 6. Gently swirl the KCENTRA vial with the transparent adapter attached until the substance is fully dissolved (Fig. 2. Place the Kcentra vial, diluent vial, and Mix2Vial transfer set on a flat surface. kcentra administration. NOTE: The risks and benefits of repeat idarucizumab administration are not known. 3) Evaluate the effect of fixed-dose Kcentra on warfarin reversal, as compared to INR and weight-based doses. Steps: A baseline INR will be drawn. Dose to be given of high cost targeted medications within 5% The most serious adverse reactions were Do not mix Kcentra with other medicinal products, and administer Kcentra through a separate infusion line Administer Kcentra at room temperature Administer Kcentra by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to 8.4 mL/min (~210 units/min) Four patients met inclusion for analysis. Providers should continue to order 4F-PCC (Kcentra) for Andexanet (dosing below) Edoxaban (Savaysa) Reverse if patient shows signs of life threatening bleeding 1. Platelet Inhibitors . Website Design, Development, SEO & Marketing 801-810-8878. Repeated dosing is not supported by clinical data and is not recommended. Do not freeze. Website Design, Development, SEO & Marketing 801-810-8878. Based on It contains the Vitamin K dependent Coagulation Factors II, VII, IX and X, and the antithrombotic Proteins C and S. Factor IX is the lead factor for the potency of the Home; About Us; Our Pricing; Contact Us; Ad Management; SEO Based on the information available, both time to administration (limited by thawing time) and dose of FFP play a role in rapid reversal of elevated INR levels. Plasma should not be used in an attempt to reverse NOACs. Ensure that the Kcentra vial and diluent vial are at room temperature. 19 Duration is 1224 hours, and co-administration of vitamin K prevents rebound Kcentra Administration Reminders anemia. Due to short half-life of PCC, check INR q6hrs for 24 hours Serious, life threatening bleed at ANY INR in the ED Yes Vitamin K 10 mg IV + KCentra (4-factor PCC) (stocked in Pharmacy) INR 2.0-3.9: KCentra 25 units/kg x 1 Twenty-eight (71.7%) of patients included in the efficacy analysis achieved an INR of < 1.7 following Kcentra administration. Home; About Us; Our Pricing; Contact Us; Ad Management; SEO We will go live with this protocol on January 22, 2019. Kcentra is for intravenous use only.-----The Kcentra App provides fast access to helpful tools and information from the Kcentra website without the need for an internet connection. Potential limitations include that analysis occurred immediately Expert consensus and international guidelines recommend urgent co-administration of vitamin K and 4-factor prothrombin complex concentrates (4F-PCCs) to rapidly reverse VKA-related Administer Kcentra: By intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min. Kcentra (4 factor PCC) 50 units/kg 2. Development of standard protocols, policies, or order sets developed to guide prescribers needed for safety purposes? See Table 3 for dosing. Do not shake. Reversal of anticoagulation in intracranial hemorrhage. Human in vitro and animal studies have shown improved thrombin generation after administration of aPCCs in dabigatran treated animals [13, 14]. Hypersensitivity reactions to Kcentra may occur. INR was normalized to 1.2 within 30 minutes Blood should be prevented from entering into the syringe as fibrin clot formation might occur. Initiation of a fixeddose fourfactor prothrombin complex concentrate protocol. fixed-dose protocol Retrospective review Results, n =39 71.8% were ICH Median pre-treatment INR = 3.3, post-treatment INR 1.14 (p < 0.001) 92.3% (36 of 39) achieved INR < 2; 71.8% (28) Kcentra is available in 2 vial sizes for added convenience 500 units for use with 20-mL vial of Sterile Water for Injection, USP 1000 units for use with 40-mL vial of Sterile Water for injection, USP Administration and reimbursement support; Unable to play video. Membership: American Society of Anesthesiologists. Active bleeding requiring operation or angioembolization 3. Kcentra protocol at a large academic medical center has proven to be effective in terms of INR reversal and clinical outcomes. Unlike KCentra, does not include any endogenous anticoagulants. Massive transfusion protocol (replacement of numerous factors and blood). For reversal of warfarin, Kcentra 25 units/kg x 110 kg (2500 units) was given along with a vitamin K 10 mg IV infusion. The change in INR before and after Kcentra administration is shown in Figure 1. Study objective: This study compares the safety and efficacy of a fixed dose of 4-factor prothrombin complex concentrate (4FPCC) to the FDA-approved variable dosing for reversal of Prepare and administer using aseptic technique. So if the patients platelets were 300k on Monday, then heparin was started and the patients platelets were 150k on Wednesday, that's the beginning of a HIT diagnosis. Based on the INR following 4F-PCC administration, 11 patients (17%) were eligible to receive a Remove Kcentra and diluent vial flip caps. Kcentra does contain heparin and may not be option in patients who are sensitive to heparin or have a recent diagnosis of heparin-induced thrombocytopenia. Kcntra costs roughly $1.27 per unit. kcentra dosing protocol (Appendix 1 for dosing) Call the anticoagulation service for advice on dosing. Fuh L, Goldstein JN, Hayes BD. INR (baseline and at 30 minutes post dose) Clinical response during and after treatment Signs of It is administered by IV infusion at a maximum 210 units/minute C oagulopathy in Patients Actively Bleeding or Requiring Emergent Reversal for a Procedure on New Oral Kcentra (4 factor PCC) 50 units/kg 2. The 2012 ACCP guidelines recommend PO or IV vitamin K. Nowhere is sub Q after administration of low dose IV or PO vitamin K, but IV vitamin K starts working much faster than Reconstituted product can be stored at 225 degrees C (3677 degrees F). A. 7 Draw air into an empty, sterile syringe. one of these should be used, along with vitamin K: 4-factor PCC We generally give 4-factor PCC ( Kcentra in the PCC4 (KCentraTM ) for temporary Send PT/INR INR 1.4- 3.9 25 units/kg IV x 1 Max dose: 2500 units INR 4-6 35 units/kg IV x 1 Max dose: 3500 units INR >6 50 units/kg IV x 1 Max dose: 5000 units 5-10 mg Vitamin K IV over 30 minutes x 1 Send PT/INR Inject air into the KCENTRA vial (Fig. 8). A randomized controlled trial comparing Kcentra to FFP in patients with acute major bleeding demonstrated that 7). Kcentra is used to quickly reverse the effects of a blood-thinning medicine (such as warfarin) during a major bleeding episode, or when there is a need for emergency surgery or invasive medical procedure. Kcentra is dosed according to Factor IX potency and is individualized based on the patients baseline International Normalized Ratio (INR) and kcentra dosing protocol (Appendix 1 for dosing) Call the anticoagulation service for advice on dosing. World Neurosurg 2014;81(1):110-15;Kuamatsu JB, et al. After KCentra dose is complete, administer a 50 mL bag of normal saline using the same IV tubing at the same rate as KCentradose to ensure administration of full dose. A total of 48 patients met inclusion criteria for the study with 24 patients in each protocol group. In September 2018, the Pharmacy and Therapeutics Committee approved a new protocol for Emergent Vitamin K Antagonist (Warfarin) reversal via fixed dose Kcentra (PCC). Concurrently with vitamin K. Through a separate infusion line. It is recommended to give KCentra 1500 units x 1 dose, wait 30-60 minutes post dose and then recheck the INR. This gives Factor IX complex a greater tendency to promote thrombosis. 5. Effective July 1, 2021, the Centers for Medicare and Medicaid Services (CMS) has established a permanent, product-specific HCPCS code for Kcentra 21 For services on or after July 1, 2021, use the permanent J-code when administrating Kcentra J7168 Prothrombin complex concentrate (human), Kcentra, per IU of Factor IX activity If the INR 2, a supplemental dose based upon the INR reading should be given. Board Certification: Diplomate of the American Board of Anesthesiology. Reversal of anticoagulation in intracranial hemorrhage. with a repeat INR taken 30-60 minutes post dose administration. If cooled, warm to 2025 degrees C (6877 degrees F) prior to administration. We developed a low dose 4-factor PCC protocol (LDPCC) for patients on warfarin with INR 1.6-1.9 and major hemorrhage or impending surgery. Storage following reconstitution: After reconstitution, administration should begin promptly or within 4 hours. The Each vial contains no preservatives and is for single use only. Appendix F Literature Summary for Low Fixed Dose PCC 7. B. Coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa) 1. Administration Package insert recommends administering at a rate of ~3 units/kg/min (over about 5-10 minutes), though multiple sites report giving via IV push. ATLS Soporte Vital Avanzado en Trauma Manual del Curso para Estudiantes Presidente del Comit de Trauma: Ronald M. Stewart, MD, FACS Director Mdico del Programa de Trauma: Michael F. Rotondo, MD, FACS Presidenta del Comit de ATLS: Sharon M. Henry, MD, FACS Gerente del Programa de ATLS: Monique Drago, MA, EdD Editora Ejecutiva: Claire Merrick Gerente del How to calculate dosage. We will be implementing this on May 8, 2018. An initial dose of 1,500 units of Kcentra and 2 mg of vitamin K will be ordered. Blood Clots: Blood is supposed to clot to help repair a blood vessel that is injured.Clots or thrombi become a problem when they form inappropriately. The dose should not be exceeded beyond 8.4 mL/minute (~210 units/minute). Fig. kcentra - UpToDate. 1. If Reconstituted product can be stored at 225 degrees C (3677 degrees F). Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT). APP signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or. Kcentra potency (units) is defined by Factor IX content. PK/PD INR is expected to decrease within 15-30 minutes, with effects lasting approximately 6-8 hours. Proper Name: Prothrombin Complex Concentrate (Human) Tradename: Kcentra. *****Andexanet alfa (Andexxa) was NOT ADDED to the UW Medicine formulary at this time due to unclear risk vs benefit and high cost.