If idarucizumab is not available, consider 4-factor PCC (KCentra) 2000 units NOTE: idarucizumab will likely correct aPTT and plasma-diluted thrombin time but the correlation of lab results with improved outcomes is not established NOTE: Plasma dabigatran concentrations can increase more than 12-24 hours after idarucizumab, 4-factor PCC (Kcentra) If INR 2-4: 25 units/kg (not to exceed 2500 units) If INR 4-6: 35 units/kg (not to exceed 3500 units) If INR > 6: 50 units/kg (not to exceed 5000 units) References: 1. Beshay JE, Morgan H, Madden C, Yu W, Sarode R. Emergency reversal of anticoagulation and antiplatelet therapies in neurosurgical patients. KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation. Kcentra® is a 4-factor PCC that is FDA approved for the reversal of warfarin. Kcentra® contains factors II, VII, IX, and X but also contain other components like heparin, Antithrombin III, protein C, and Protein S. Kcentra is dosed based off of the Factor IX content and this can vary to a small extent from one lot to the next.Beatrice McLaughlin, NP. Emergency Care. Psychiatric Inpatient Geriatric and Adult. Psychiatric & Behavioral Health. Centra Lynchburg General Hospital 1901 Tate Springs Rd. Lynchburg, VA 24501. Centra Provider.KCentra as a means to reverse apixaban or rivaroxaban, against a targeted approach using Andexanet Alfa, which is associated with significantly more cost but which may be more efficacious given its mechanism of action. References:1-4 1. Babilonia K, Trujillo T. The role of prothrombin complex concentrates in reversal of target specific ... May 21, 2023 · 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.g., warfarin) therapy in adult patients with: need for an urgent surgery/invasive procedure. 2. KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation. • Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished. • The safety and effectiveness of repeat dosing have not been established and it is not recommended. (2.1) • Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up toKcentra - WikEM. Please donate! Funds go solely to hosting and development costs that allow medical practitioners around the globe to freely access WikEM.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, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure ...of thromboembolic events. KCENTRA was not studied in subjects who had a throm-botic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) • KCENTRA is made from human blood and may carry a risk of transmitting infectiousnanofiltered, and lyophilized into a powder for reconstitution. Kcentra® is supplied as a 500-unit single dose vial. Kcentra® is dosed according to Factor IX potency and is individualized based on the patient’s baseline International Normalized Ratio (INR) and body weight. The cost of Kcentra® is $1.27 per unit; a single dose of Kcentra ...• Administer Vitamin K concurrently to patients receiving Kcentra to maintain factor levels once the effects of Kcentra have diminished. • The safety and effectiveness of repeat dosing have not been established and it is not recommended. (2.1) • Administer reconstituted Kcentra at a rate of 0.12 mL/kg/min (~3 units/kg/min) up toMay 3, 2015 · Kcentra 072913 final. Kcentra: A 4-Factor Prothrombin Concentrate Sylvia Doyle, Pharm.D. Elva Angelique Van Devender, Ph.D., Pharm.D., BCPS Legacy Good Samaritan Emergency Department. May 3, 2015 2 Background Kcentra is the first four-factor prothrombin complex concentrate approved for the urgent reversal of vitamin K antagonist-related major ... Call the Kcentra Hotline at 1-855-452-3687; Adverse reactions: If your patient is having an adverse reaction to Kcentra, contact or have them contact CSL Behring Pharmacovigilance at 1-866-915-6958. For any other concern related to treatment with Kcentra, you can call the Kcentra Hotline at 1-855-452-3687 to speak with them about how to proceedFigure 1. The vitamin K cycle and its link to carboxylation of glutamic acid residues on vitamin K–dependent coagulation proteins. Vitamin K 1 obtained from food sources is reduced to vitamin KH 2 by a warfarin-resistant vitamin K reductase.KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state. In this randomized, two-period crossover, assessor-blinded trial, 12 healthy subjects received 5 mg apixaban every 12 h.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, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure ...Introduction. In 2013, the United States Food and Drug Administration (FDA) approved Kcentra ® (CSL Behring GmbH, Kankakee, IL, USA), for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (e.g. warfarin) in adult patients with acute major bleeding or need for urgent surgery/invasive procedure. Aug 19, 2022 · Dosing: 20 to 50 units/kg, do not exceed 2500 to 5000 units. Dosage forms: Kcentra is available as a single-use vial containing coagulation factors II, VII, IX and X, and antithrombotic proteins C and S as a lyophilized concentrate. Adverse events: The most common adverse reactions (frequency ≥2.8%) observed in subjects receiving Kcentra were ... of thromboembolic events. KCENTRA was not studied in subjects who had a throm-botic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) • KCENTRA is made from human blood and may carry a risk of transmitting infectious Aug 30, 2016 · Conclusions. On the basis of a descriptive preliminary analysis, an initial bolus and subsequent 2-hour infusion of andexanet substantially reduced anti–factor Xa activity in patients with acute ... Kcentra is a purified, heat-treated, nanofiltered, lyophilized, non-activated 4-factor prothrombin complex concentrate (4F-PCC) made from pooled human plasma. Kcentra contains all 4 vitamin–K dependent coagulation factors (II, VII, IX and X), and the antithrombotic Proteins C and S.医療関係者の方に向け、日本初のビタミンK 拮抗薬療法中の迅速なPT-INR是正・止血をサポートする4-Factor PCC「ケイセントラ静注用」についての情報をお届けしています。May 3, 2015 · Kcentra 072913 final. Kcentra: A 4-Factor Prothrombin Concentrate Sylvia Doyle, Pharm.D. Elva Angelique Van Devender, Ph.D., Pharm.D., BCPS Legacy Good Samaritan Emergency Department. May 3, 2015 2 Background Kcentra is the first four-factor prothrombin complex concentrate approved for the urgent reversal of vitamin K antagonist-related major ... Apr 22, 2023 · Kcentra is essentially a dose of coagulation factors called prothrombin complex concentrate which doctors use when they need patients’ blood to clot quickly again due to overdosing on another type of medicine similar to Warfarin i.e Vitamin k antagonist group OR urgent surgery needed where coagulation state should balanced immediately. 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.g., warfarin) therapy in adult patients with: acute major bleeding or.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. 4 Factor PCC (KCentra) contains factors II, IX, X and inactivated VII and is indicated for moderately severe, refractory ...Dec 27, 2012 · Kcentra Marketing Approval Date: 12/13/2013 Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. Exclusivity End Date: KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.Kcentra (prothrombin complex) is a member of the anticoagulant reversal agents drug class and is commonly used for Reversal of Acquired Coagulation Factor Deficiency. The cost for Kcentra intravenous powder for injection - is around $13 for a supply of 1 powder for injection, depending on the pharmacy you visit.KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.Kcentra (prothrombin complex) is a member of the anticoagulant reversal agents drug class and is commonly used for Reversal of Acquired Coagulation Factor Deficiency. The cost for Kcentra intravenous powder for injection - is around $13 for a supply of 1 powder for injection, depending on the pharmacy you visit.Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. May 3, 2015 · Kcentra 072913 final. Kcentra: A 4-Factor Prothrombin Concentrate Sylvia Doyle, Pharm.D. Elva Angelique Van Devender, Ph.D., Pharm.D., BCPS Legacy Good Samaritan Emergency Department. May 3, 2015 2 Background Kcentra is the first four-factor prothrombin complex concentrate approved for the urgent reversal of vitamin K antagonist-related major ... Conclusions. On the basis of a descriptive preliminary analysis, an initial bolus and subsequent 2-hour infusion of andexanet substantially reduced anti–factor Xa activity in patients with acute ...医療関係者の方に向け、日本初のビタミンK 拮抗薬療法中の迅速なPT-INR是正・止血をサポートする4-Factor PCC「ケイセントラ静注用」についての情報をお届けしています。 K-centra. (Kontaktní a poradenská centra) Kontaktní centra hrají důležitou roli zejména v prevenci škodlivých následků užívání drog – snaží se zmírnit dopad a škody způsobené drogami. Jde o takzvaná „nízkoprahová zařízení“ – podmínky jsou nastaveny tak, aby sem mohl přijít každý, kdo potřebuje pomoc a je ...Obtain PT/INR/PTT prior to initiating Kcentra® and 2 hours after administration. Notes regarding Kcentra® dosing administration Each 500 unit vial contains 400 – 620 units factor IX. Pharmacy will enter the exact dose provide in factor IX units for billing purposes. Kcentra®should be infused through a separate infusion line.Kcentra Reconstitution Instructions. Ensure that the KCENTRA vial and diluent vial are at room temperature. Remove flip caps from the KCENTRA and diluent vials. Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial package. Open the Mix2Vial package by peeling off the lid (Fig. 1).May 12, 2016 · Results demonstrate that 25 unit/kg Kcentra reversed the anticoagulant effect of apixaban 5 mg twice daily in healthy human volunteers. The primary end point of the study, peak thrombin generation, increased significantly after treatment with Kcentra compared with placebo. May 3, 2023 · Kcentra. STN: BL 125421. Proper Name: Prothrombin Complex Concentrate (Human) Tradename: Kcentra. Manufacturer: CSL Behring GmbH. Indication: The urgent reversal of acquired coagulation factor ... INTRODUCTION. Prothrombin complex concentrate use (PCC) may be complicated by thrombosis, and increased factor II levels are recognized as a risk factor. 1 When administering PCCs in cardiac surgery patients using K Centra ®, a 4-factor PCC for warfarin reversal, or Profilnine®, a 3-factor PCC for refractory hemorrhage, we administer a low-dose of 1000-2000 units and initially measured post ...K-Centra contains trace amounts of heparin (to mitigate thrombotic potential) and should not be used in bleeding patients with active or recent (last 100 days) heparin-induced thrombocytopenia (HIT). In this instance, please contact pharmacy to discuss possible use of the alternative procoagulant FEIBA for reversal. rFVIIa (if refractory to ...Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Beatrice McLaughlin, NP. Emergency Care. Psychiatric Inpatient Geriatric and Adult. Psychiatric & Behavioral Health. Centra Lynchburg General Hospital 1901 Tate Springs Rd. Lynchburg, VA 24501. Centra Provider. 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, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure ...Dec 4, 2017 · K-Centra contains trace amounts of heparin (to mitigate thrombotic potential) and should not be used in bleeding patients with active or recent (last 100 days) heparin-induced thrombocytopenia (HIT). In this instance, please contact pharmacy to discuss possible use of the alternative procoagulant FEIBA for reversal. rFVIIa (if refractory to ... (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 5-10 mg IV vitamin K Recheck INR 30 minutes after Kcentra®/FEIBA® given, then q6 hours for 24-48 hours Recheck INR the next day after vitamin K Kcentra® is a 4-factor PCC that is FDA approved for the reversal of warfarin. Kcentra® contains factors II, VII, IX, and X but also contain other components like heparin, Antithrombin III, protein C, and Protein S. Kcentra is dosed based off of the Factor IX content and this can vary to a small extent from one lot to the next.KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation. KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.PURPOSE: Four factor prothrombin complex concentrate (Kcentra) is a product that contains the vitamin K-dependent coagulation factors II, VII, IX, and X and protein C and S. It allows for urgent reversal of acquired coagulation factor deficiency and reduction in international normalized ratio (INR). PURPOSE: Four factor prothrombin complex concentrate (Kcentra) is a product that contains the vitamin K-dependent coagulation factors II, VII, IX, and X and protein C and S. It allows for urgent reversal of acquired coagulation factor deficiency and reduction in international normalized ratio (INR). KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation. (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 5-10 mg IV vitamin K Recheck INR 30 minutes after Kcentra®/FEIBA® given, then q6 hours for 24-48 hours Recheck INR the next day after vitamin KNov 18, 2013 · Posted November 19, 2013. We are trying to utilize Kcentra and tranexamic acid here as part of our blood management program. We're thinking about Kcentra more for intracranial hemorrhages, and TXA for trauma/massive bleeds and knee replacements. I believe both will be used in trauma at some point. Kcentra Marketing Approval Date: 12/13/2013 Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. Exclusivity End Date:Introduction: Liver disease is often marked by changes in hemostasis. Vitamin K is frequently administered to cirrhotic patients with an elevated INR to improve their coagulopathy, though strong evidence justifying this approach is lacking.Mar 7, 2015 · Figure 1. The vitamin K cycle and its link to carboxylation of glutamic acid residues on vitamin K–dependent coagulation proteins. Vitamin K 1 obtained from food sources is reduced to vitamin KH 2 by a warfarin-resistant vitamin K reductase. Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please call 800-835-4709 or 240-402-8010, extension 1. Apr 21, 2014 · Kcentra (human prothrombin complex concentrate) is the first nonactivated 4-factor prothrombin complex concentrate for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy (eg, warfarin) in adult patients with acute major bleeding. Each year, approximately 3 to 4 million people in the ... KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.Kcentra® is a 4-factor PCC that is FDA approved for the reversal of warfarin. Kcentra® contains factors II, VII, IX, and X but also contain other components like heparin, Antithrombin III, protein C, and Protein S. Kcentra is dosed based off of the Factor IX content and this can vary to a small extent from one lot to the next.1. Consider 4-factor PCC* (Kcentra®) 50 units/kg [total body weight] pharmacy will round to the nearest whole vial ‡ Contraindications to PCC use: known anaphylactic or severe systemic reactions to Kcentra®, disseminated intravascular coagulation, patients with known heparin-induced thrombocytopenia (Kcentra® contains heparin). of thromboembolic events. KCENTRA was not studied in subjects who had a throm-botic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) • KCENTRA is made from human blood and may carry a risk of transmitting infectiousJan 22, 2019 · In September 2018, the Pharmacy and Therapeutics Committee approved a new protocol for Emergent Vitamin K Antagonist (Warfarin) reversal via fixed dose Kcentra (PCC). We will go live with this protocol on January 22, 2019 . Consider 4-factor PCC (KCentra) 2000 units NOTE: PCC may partially correct PT/aPTT but will not affect anti-factor Xa activity and will not increase drug clearance; correlation of shortening PT/aPTT with reduction in bleeding risk is unknown bivalirudin Degree of reversal c (Angiomax) 25 minutes (up to 1 hr in severe renal impairment)Storage of Kcentra after reconstitution: After reconstitution, administer immediately or within 4 hours. Reconstituted Kcentra can be stored at 2 to 25 degrees C (36 to 77 degrees F). If cooled, warm to 20 to 25 degrees C (68 to 77 degrees F) prior to administration. Do not freeze. Each vial contains no preservatives and is for single use only. Concentration: Final concentration in Factor IX units will range from 20–31 units/mL when reconstituted. Actual potency is listed on carton. If patient is to receive multiple vials, may pool contents; use a separate unused Mix2Vial transfer set for each vial. Administration should begin promptly or within 4 hrs of reconstitution.However, there is limited data on the efficacy and adverse effects of the commercial Kcentra used in these patients. Kcentra, the only approved PCC in the USA, is FDA approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy in adult patients with acute major bleeding or need for an ...KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.However, there is limited data on the efficacy and adverse effects of the commercial Kcentra used in these patients. Kcentra, the only approved PCC in the USA, is FDA approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA) therapy in adult patients with acute major bleeding or need for an ...KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state. In this randomized, two-period crossover, assessor-blinded trial, 12 healthy subjects received 5 mg apixaban every 12 h.Kcentra is a 4-factor prothrombin complex concentrate containing four vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. Kcentra is specifically indicated for for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA ... Beatrice McLaughlin, NP. Emergency Care. Psychiatric Inpatient Geriatric and Adult. Psychiatric & Behavioral Health. Centra Lynchburg General Hospital 1901 Tate Springs Rd. Lynchburg, VA 24501. Centra Provider. Kcentra is a purified, heat-treated, nanofiltered, lyophilized, non-activated 4-factor prothrombin complex concentrate (4F-PCC) made from pooled human plasma. Kcentra contains all 4 vitamin–K dependent coagulation factors (II, VII, IX and X), and the antithrombotic Proteins C and S.Kcentra Reconstitution Instructions. Ensure that the KCENTRA vial and diluent vial are at room temperature. Remove flip caps from the KCENTRA and diluent vials. Wipe the stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial package. Open the Mix2Vial package by peeling off the lid (Fig. 1).KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.
Introduction. In 2013, the United States Food and Drug Administration (FDA) approved Kcentra ® (CSL Behring GmbH, Kankakee, IL, USA), for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (e.g. warfarin) in adult patients with acute major bleeding or need for urgent surgery/invasive procedure. . Hilgy
KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.The primary outcome was coagulopathy reversal, defined as a post-Kcentra INR of This study included 31 patients with acute or chronic liver failure and 54 patients without liver failure. Both groups of patients were similar at baseline, except those that had liver failure were younger (58 vs 70 years, P < 0.01).of thromboembolic events. KCENTRA was not studied in subjects who had a throm-botic or thromboembolic (TE) event within the prior 3 months. KCENTRA may not be suitable in patients with thromboembolic events in the prior 3 months. (5.2) • KCENTRA is made from human blood and may carry a risk of transmitting infectious Kcentra Marketing Approval Date: 12/13/2013 Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. Exclusivity End Date:Dosing: 20 to 50 units/kg, do not exceed 2500 to 5000 units. Dosage forms: Kcentra is available as a single-use vial containing coagulation factors II, VII, IX and X, and antithrombotic proteins C and S as a lyophilized concentrate. Adverse events: The most common adverse reactions (frequency ≥2.8%) observed in subjects receiving Kcentra were ...Kcentra contains factors II, VII, IX, and X and Protein C and S and Bebulin contains factors II, IX, and X Both Bebulin and Kcentra are made from pooled human plasma 6. Riastap** Riastap is a human fibrinogen concentrate made from pooled human plasma and used to replace low or missing fibrinogen proteinNov 13, 2019 · The change in INR before and after Kcentra® administration is shown in Figure 1. Thirty-seven (94.8%) patients included in the efficacy analysis achieved an INR measurement < 2 following Kcentra® administration. Twenty-eight (71.7%) of patients included in the efficacy analysis achieved an INR of < 1.7 following Kcentra® administration. Kcentra contains factors II, VII, IX, and X and Protein C and S and Bebulin contains factors II, IX, and X Both Bebulin and Kcentra are made from pooled human plasma 6. Riastap** Riastap is a human fibrinogen concentrate made from pooled human plasma and used to replace low or missing fibrinogen proteinCall the Kcentra Hotline at 1-855-452-3687; Adverse reactions: If your patient is having an adverse reaction to Kcentra, contact or have them contact CSL Behring Pharmacovigilance at 1-866-915-6958. For any other concern related to treatment with Kcentra, you can call the Kcentra Hotline at 1-855-452-3687 to speak with them about how to proceedwww.CSLBehring-us.com www.Kcentra.com US-KCT-0012 3/2017 Kcentra Administration Reminders 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 KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.KCENTRA is contraindicated in patients with known anaphylactic or severe systemic reactions to KCENTRA or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). KCENTRA is also contraindicated in patients with disseminated intravascular coagulation.Reversal of anticoagulation in intracranial hemorrhage. … one of these should be used, along with vitamin K: 4-factor PCC – We generally give 4-factor PCC ( Kcentra in the United States and Japan; Beriplex or Octaplex in Canada; Octaplex, Cofact, or Proplex in many …. Management of warfarin-associated bleeding or supratherapeutic INR.Kcntra costs roughly $1.27 per unit. Kcentra® is dosed according to Factor IX potency and is individualized based on the patient’s baseline International Normalized Ratio (INR) and body weight. The cost of Kcentra® is $1.27 per unit; a single dose of Kcentra® for an 80 kg patient costs $5,080. A single 90 µg/kg dose of Factor VII to a 80 ...We would like to show you a description here but the site won’t allow us. www.CSLBehring-us.com www.Kcentra.com US-KCT-0012 3/2017 Kcentra Administration Reminders 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 .
