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 proceed 3. Visually inspect the prepared Kcentra for particulate matter and/or discoloration. Do not use if either is observed. 4. The nurse should attach tubing to Kcentra bag and administer via IV pump at the maximum rate of 8.4mL/min (~500mL/hr) 5. After the infusion of Kcentra is complete, remove the empty bag and hang a 50mL NS bag using the same ...Oct 1, 2019 · Kcentra is preferred over a fresh frozen plasma infusion because of its smaller volume, faster infusion rate, and superior effectiveness in INR reduction. For nonmajor bleeding (defined as any ... Kcentra is a 4 factor PCC from CSL Behring, containing non-activated factors II, VII, IX and X. The current FDA indications for Kcentra is for reversal of vitamin K dependent procoagulant factors II, VII, IX and X induced by oral vitamin K antagonists such as warfarin or coumadin. There are case reports of Kcentra use in FXa DOAC reversal.What is Kcentra? Urgent warfarin reversal with fast and sustained action* Indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with: Need for urgent surgery/invasive procedure or Acute major bleedingKcentra - 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 ...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.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. 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 ...Type: Hemostatics, blood components. Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial. Common Trade Names: Kcentra. 3 factor PCC (Factors II, IX, and X), would need to supplement with factor VII for reversal if using 3 factor PCC. Approved for treatment of hemophilia B (factor IX deficiency) We would like to show you a description here but the site won’t allow us.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.(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 KProthrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available.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 Speak with a Kcentra Hotline 1-855-4KCENTRA (1-855-452-3687) Hotline TOLL-FREE: www.Kcentra.com 7. Place the Kcentra vial on an even and fi rm surface. 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. The diluent will automatically fl ...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 ...May 16, 2023 · 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). 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 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 ... 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. Nov 29, 2018 · Retrospective analysis of inpatients at UPMC Presbyterian, Shadyside and Mercy, admitted between February 2016 and 2017 was done. A total of 213 patients, with history of stroke / DVT / PE who received Kcentra were grouped based on the cause of coagulopathy, sites of bleed (CNS or non-CNS) or the clinical setting of Kcentra administration. 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.Nov 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. 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.For example, a Kcentra® 500 unit vial can contain 400-620 units and a 1000 unit vial can contain 800-1240 units [5]. Most hospitals are required to bill based on exact units administered, so pharmacies often need to adjust Kcentra® orders to reflect the units that will be administered. 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. 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.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 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 ... 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).DB13152. Prothrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. Kcentra is a 4 factor PCC from CSL Behring, containing non-activated factors II, VII, IX and X. The current FDA indications for Kcentra is for reversal of vitamin K dependent procoagulant factors II, VII, IX and X induced by oral vitamin K antagonists such as warfarin or coumadin. There are case reports of Kcentra use in FXa DOAC reversal. Kcentra is a blood coagulation factor replacement product. 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.380-800 units FII/500 units of Kcentra Non-activated form Units of FVII 10 ≤ 52.5 IU/mL (No more than 35 units/100 Factor IX units) -240 IU/mL 200-500 units FII/500 units of Kcentra Activated form Units of FIX 100-150 IU/mL 10-60 IU/mL 400-620 units FII/500 units of Kcentra Non-activated form Units of FXProthrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available.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. 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 ...• 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 to• The package insert for Kcentra® indicates dosing is to be based on both INR and weight, resulting in possible confusion and delayed time to administration of Kcentra®. • Multiple fixed-dose protocols have been proposed and analyzed including 500, 1000, 1500, or 2000 units. KCentra® Pharmacology 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. We would like to show you a description here but the site won’t allow us. 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 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).Jul 1, 2021 · 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 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 ...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.DB13152. Prothrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. 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 (~3 units/kg/min), up to 8.4 mL/min (~210 units/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. 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, but it is often used to reverse coagulopathy in patients with liver disease (LD). This single-center, retrospective study analyzed the efficacy and safety of 4F-PCC ... Prothrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available.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. 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)Nov 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 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).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).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 ... 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) 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. The content of the document is dynamic and will be revised as new information becomes available.K+K Hotel Central | Hybernská 10 | 110 00 Prague 1 | Czech Republic | [email protected] | +420 225 022 000. Art Nouveau architecture, elegant interiors, and superior service combine to make K+K Hotel Central the place to stay in Prague’s historic Old Town. K+K Hotel Central is one of the oldest Art Nouveau buildings in the city.Kcentra was infused at a rate of 0.12 mL/kg/min, with a similar duration for matched placebo saline. Blood was collected for analysis of thrombin generation, anti‐factor Xa (anti‐Xa) activity, prothrombin time (PT) and activated partial thromboplastin time (PTT).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.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: 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.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 ...We randomly assigned patients in a 1:1 ratio to receive vitamin K concomitant with a single dose of either 4F-PCC (Beriplex/Kcentra/Confidex; CSL Behring, Marburg, Germany) or plasma, with dosing based on international normalised ratio (INR) and weight.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 ...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. 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 (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 ...Sleep is a swiftly reversible state of decreased metabolism, responsiveness and, motor activity, which is broadly categorized into rapid eye movement (REM) and non-rapid eye movement (NREM).[1] The NREM sleep phase again subdivides into stage N1, stage N2, and stage N3. The K-Complex is a waveform identified on electroencephalography (EEG), which primarily occurs during Stage 2 (N2) of NREM ...Kcentra Speak with a Kcentra Hotline 1-855-4KCENTRA (1-855-452-3687) Hotline TOLL-FREE: www.Kcentra.com 7. Place the Kcentra vial on an even and fi rm surface. 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. The diluent will automatically fl ...Jul 1, 2021 · 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. Medical question support Kcentra Hotline representatives are trained to answer medical and treatment questions, which differentiates them from other hotlines that are strictly for product information and ordering/reimbursement support. Treating a patient and want to talk with a healthcare professional? Call the Kcentra Hotline at 1-855-452-3687Nov 18, 2021 · 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). Oct 1, 2019 · Kcentra is preferred over a fresh frozen plasma infusion because of its smaller volume, faster infusion rate, and superior effectiveness in INR reduction. For nonmajor bleeding (defined as any ... 3. Visually inspect the prepared Kcentra for particulate matter and/or discoloration. Do not use if either is observed. 4. The nurse should attach tubing to Kcentra bag and administer via IV pump at the maximum rate of 8.4mL/min (~500mL/hr) 5. After the infusion of Kcentra is complete, remove the empty bag and hang a 50mL NS bag using the same ...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。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,
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).. H e b on 410 and bandera
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) 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. The content of the document is dynamic and will be revised as new information becomes available. 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.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 .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 ... 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.DB13152. Prothrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available.DB13152. Prothrombin complex concentrate ( PCC ), also known as factor IX complex, sold under the brand name Kcentra among others, is a combination medication made up of blood clotting factors II, IX, and X. [7] Some versions also contain factor VII. [8] It is used to treat and prevent bleeding in hemophilia B if pure factor IX is not available. 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.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). 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. 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. 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 27, 2020 · A commercially available 4F-PCC (Kcentra/Beriplex, CSL Behring LLC, Kankakee, IL, USA) was added to PPP (0-1.0 IU/mL). Dosing for Kcentra was obtained from the package insert. 32 The recommended Kcentra dose of 50 IU/kg is equivalent to ~1.0 IU/mL 4F-PCC plasma level. To eliminate the potential effect of heparin in Kcentra, 4F-PCC was used with ... Type: Hemostatics, blood components. Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial. Common Trade Names: Kcentra. 3 factor PCC (Factors II, IX, and X), would need to supplement with factor VII for reversal if using 3 factor PCC. Approved for treatment of hemophilia B (factor IX deficiency)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. .
