kcentra for eliquis

11/6/2013 2 Roadmap for today • Characteristics of novel anticoagulants • Approach to the bleeding patient • Specific reversal agents • UCSF guidelines Scope of Problem • Prevalence atrial fibrillation • 3.03 million in 2005 • 7.56 million by 2050 • VTE = 900K/yr in US • 1-2% of adults take warfarin Warfarin 1920s –Outbreak hemorrhagic disease in cattle in Check a STAT INR (lab draw) 30 minutes after PCC is finished infusing. 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 … Apixaban (Eliquis) 11 Edoxaban (Savaysa) 12 Thrombolytics Thrombolytics Alteplase (Activase) 13 Anti-Platelet Medications Other Platelet Inhibitors Aspirin 14 Dipyridamole (Persantine) 14 Aspirin-dipyridamole (Aggrenox) 14 P2Y12 Inhibitors ... 4-Factor PCC ( Kcentra). CONTENTS General considerations Warfarin Urgent reversal Non-urgent supratherapeutic INR DOACS Dabigatran Factor Xa inhibitors (riveroXABAN, apiXABAN, edoXABAN, fondaparinux) Thrombolytics (e.g. This group also had at least one additional risk factor for stroke (a prior stroke, age 75 or older, diabetes, heart failure, high blood pressure). Kcentra is for use in adults and dosing is based on body weight. August 2017. <> Ӥ�:���V����$Y�aa�_{���ʖ�֭�0�4�g����!5Ɔg Kcentra® 1,000 units was administered for non-ICH INR reversal indications in 25 (48%) cases. endobj Federal drug regulators have approved the use of a reversal agent for anticoagulation therapy, which will be marketed as Kcentra. 2. Kcentra (prothrombin complex) is a blood coagulation factor replacement product. Apixaban reversal Animal studies. Each vial has about 500 units of factor IX. There is a lack of data regarding its reversal in cases of acute bleeding or prior to emergency surgery that needs addressing. How much factor is in a vial of PCC versus a unit of FFP? Apixaban (Eliquis®) 8-15 hrs (longer in renal impairment) No: If ingested within 2 hours, administer activated charcoal; 4-factor PCC (Kcentra™)^ 25units/kg—max 2500 units for treatment of documented intracranial hemorrhage; 50 units/kg—max 5000 units for all other life-threatening bleeds; Edoxaban (Savaysa®) 10-14 hrs (longer in renal impairment) Major Bleeding Reversal - Protamine ineffective – Kcentra (4-factor PCC) 50 units/kg may be of use Dabigatran (Pradaxa®) Reverse if patient shows signs of intracranial hemorrhage 1. <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> INR 4.0-6.0: KCentra 35 units/kg x 1 (Max 3500 units) INR > 6.0: KCentra 50 units/kg x 1 (Max 5000 units) Recheck INR 10-30 minutes after 4-factor PCC administration. ����?bE��hm �x�r�vcDR��n�N���!��i@��s��7����i�䋷�Z-M����N��%:D�r���S� H���:V�M|�w��8.�tn���=]s�+�$������ $;6l��ul�]�V���,n85 4 0 obj ���;V��ɺC���g?xO{s!��"+��T:ߡ՛;p�}|d��r�CX���U\ݻAwv,}�Z �i�����e�r}�m;d���׾y�� ����DO����7�;Z�Gr���8!0�U,�b���(�}\��Gz���9Dxu�����hPZw\G�׈���?���q���'kj� ������}���V�ZLg"1� Subjects were given apixaban 0.4 mg/kg bolus, with 0.6 mg/kg/hr infusion then randomized to receive, rFVII 240 mcg/kg, PCC 60 IU/kg, or fibrinogen 300 mg/kg. <>>> 3 0 obj endobj Do not use if either is observed. Kcentra, trademarked Bebulin in Europe, is a four-factor PCC that has been available several years in Europe and was approved April, 2013 by the US FDA for reversal of bleeding that results from Coumadin overdose. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Kcentra compared to 0% for patients receiving 15-25 unit/kg Kcentra When do you re-dose PCC? Hello, Dr. Varadi, and thank you for your question. 2013 Dec. Four factor PCC (Kcentra) is dosed on the amount of factor IX. In one study of 52 patients with acute dabigatran, rivaroxaban, or apixaban over‐dosage, 7 (13%) presented with major bleeding, 2 presented with minor bleeding, and 43 were asymptomatic. 4 0 obj • Kcentra • currently the only 4 PCC available in US • approved for urgent reversal of Vit K antagonist (warfarin) in acute major bleeding • thromboembolic events ~5-9% (vs. ~4-6% for FFP) • reversal can be achieved in 10-30 min Kcentra (Prothrombin Complex Concentrate) [prescribing information]. One vial of PCC also contains factors II, VII, IX, X, Proteins C and S, Antithrombin III and a small amount of heparin. § Likely is a combination of both, can’t use just one in isolation o Could argue administering an additional fixed dose of Kcentra if the ICH endobj Visually inspect the prepared Kcentra for particulate matter and/or discoloration. xx)$�m�HǕ�"W�鞹�&p.+� �΁g�`TB&�y{�jP�+>��O��K. An in vivo study evaluated the effect of rFVII (Novoseven), PCC (Kanokad) and fibrinogen (Clottafact) in rabbits administered apixaban . <> Though its use for neutralizing the direct oral anticoagulants (DOACs) is off-label, it appears to partially reverse rivaroxaban and apixaban overdose-generated bleeding per the attached meta-analysis, Kreuziger LMB, Keenan JC, Morton CT, Dries DJ. † Patients enrolled were taking apixaban, rivaroxaban, edoxaban, or enoxaparin ‡ The independent adjudication committee reviewed each case to determine hemostatic efficacy on the basis of predetermined criteria, to provide a rating of excellent or good (effective hemostasis) or poor/none (noneffective hemostasis) 3 • <> Kcentra® 1,500 units was administered for INR reversal in the setting of warfarin-induced ICH in 19 (36.5%) cases. Four of these new drugs received Food and Drug Administration approval in the last few years: Apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa) and rivaroxaban (Xarelto). In this randomized, two-period crossover, assessor-blinded trial, 12 healthy subjects receiv … 1 0 obj x��][s�6�~O��_N��֊".������%�Y�v�r����4����w4r�}��~� �C��R�ڭ�[���_h4}����ns�:�%_}�p�[��[�%��On>�~|�������bs��mn���{����[���ۿ�-���䛓_?e ci&���_�$S�W�Tu���"9�z�U�\��o|�z�,ON���WO���x������K���I�xZT��������c����v7W�.��n�Y�fy���S�Y3�Q(�iޣ���Q��.Y��,���~$�z��lY�_ܯ�e�2?�~F�k�H������obj�o��,��,�s䈂�D�d�~�կJ���ӂ+j !K�,k�h��yr�0��_�Vu��&�� 9~���g���Ø���U�V�u�9�����׋oa�~~������j�ly$/�r��'�K�/�G��G5�ɏ��_�,�X��ӲX. V��>Z����W��a}����9|��8��%�.��2E�{M*�ܓDs^��p|�;�O�ՎV�r�n�����j'��Ю�(�P�y���Yo]������3b &�L��[t}��g�Fa/��W��n�����ކ0-��|��i��!��\���0�}�j��i�)�R�y�`�zhK�42v������$/��Y�P�:���-�/ib:�6T.�bJ�� �Dw�e�V��]�[��n��K���+��������Rf����i���[�����@�&�,�I&]�\��gɮ���z}���� �KSx��� t-L㋾ �r�u,yv���I*���1"m?�m ��ٱ@1���N�T��j)�AʐT~v|d^���$���II���q��%�ZIT�u�"�8>�.lo�7;��B؞�!��h����V�/�c!���9�ᙪ��\k:.�O�+�#=r�Z�+{m�S_N_+�m�ɤL��Gґ���F�'3k�;�5�^3҈�rr䱐�5�H:F����+:��*I��0��.���A���;��!�9�&��+u�i.pa�s�S�#�� "SS������æ���]����*q�!�V��d�f�����/pww���= �e���Zq���~ck����S��9,����Ps���aׂ��J_��5���]�F�l��(���/�w0�@ •Eliquis had a 27% relative risk reduction in the rate of all-cause major bleeding compared to Coumadin (p<0.001) •Major GI bleeding not as impressive –Coumadin: 141 of 9052 (0.93% per year) –Eliquis: 128 of 9088 (0.83% per year) (p=0.37) •Eliquis appeared to have lower rates of major bleeding and GI bleeding compared to Pradaxa apixaban (UWMedicine: (Eliquis) 8-15 hours (longer in renal impairment) NO Drug activity can be assessed with anti-factor Xa activity assay apixaban assay [APIXN1]) If ingested within 2 hours, administer activated charcoal Consider 4-factor PCC (KCentra) 2000 units It was hypothesized that the four-factor prothrombin complex concentrate (4F-PCC) Kcentra 25 unit/kg would reverse impairment of thrombin generation in healthy volunteers dosed with apixaban to steady state. Kcentra needs to be administered within 4 hours of reconstitution 3. endobj 7��ʑ1rs��� endobj 2 0 obj Phytonadione, exogenous vitamin K, is commonly use… Due to short half-life of PCC, check INR q6hrs for 24 hours Serious, life threatening bleed at ANY INR in the ED Yes Vitamin K 10 mg IV + KCentra … %���� 7����E�9εb��\�'�8W1��)�r[̡+n���1�P'R=��ܶSt��Nѕ+;��D��J�CNO�y(dD5��}bږb����X~m���1�am�� �n��Q] ���To�հ����P���p*P/�k�y�^e�A�U��e�TS����p=��j���t$?�/��8p\77u}�Oj8F�aCy��⦻��vd������M�NY7Efap��RS������(`��v�t q� 7A՞� �WO@�����Y1A��S���8��3ȁ.7�%�:�m�G���v�A#����劔�%�g�,/�2�K�D=p���"�(�B}���n��i�PP;� .QW+��.gW����v'*�}r}Ej�q���cV?о��Nv�P@�N���s�S� �A��f�|�z�U4�2\+�(Õ}R�p�Q��bep�妒9��J���'�����NP�'��R���\�QE���e����נ�2Qs�DŽP���W�D�|@� � ����d����}[4T���D�(�� =���g��X���� �z� Call Anticoagulation Service, CPCS, or ED Pharmacist for assistance with dosing. Y�IZ��@B��u���xz���Ϙ ���FX뷹�~}��?�0r*�au��UH9�!oN �b�n ���sQ!���)V3�zT��5���3�u"��w� �{�t���n� � w��(�jf7 Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months. Apixaban 1-2 8-14 25% Edoxaban 1-2 6-11 26-45%. Data on the agent and dose to reverse the effects of apixaban has stream �%�?ef��v �8`v�ج`�>$�Q�-��1�/!% ���^�[�i��M��d9*Qғ��G���[�� 8��r����x�z�������ˮQ�C�$�� W!5�)u�f��)"M��ܣ_�Pb��q��Þ� PCC/Kcentra®) as described below. It contains clotting factors II, VII, IX and X derived from donated blood and could be effective in reversing the anticoagulation effects of the factor Xa inhibitor, apixaban. %PDF-1.5 SBP <160 mmHg at 4 hours after admission was associated with lower risk of HE . 4. They are now used for a growing number of indications — both on- and off-label — including treatment of deep vein thrombosis and pulmonary embolism as well as stroke prevention. Resumption of anticoagulation therapy should be carefully considered o… Based on laboratory findings only or clinical findings as well? Trial One: Compared ELIQUIS to warfarin in people with AFib not caused by a heart valve problem. Patients who had clinically significant bleeding and received Kcentra for treatment of coagulopathy of chronic liver disease (CCLD) were included in the study. Kcentra is a 4-factor PCC, indicating it provides therapeutic levels of factors II, VII, IX, and X, whereas current PCCs provide little VII. Apixaban Hepatic/Renal 9-14 hours Chromogenic anti-factor Xa calibrated for apixaban, INRa Kentra™, FEIA™ FEIA™ is preferred for major or life threatening bleeding with doses ranging 8-25 units/kg. The nurse should attach tubing to Kcentra bag and administer via IV pump … Anticoagulation Reversal in the Hemorrhagic Stroke Patient April 29th, 2016 Nicholas G. Panos, PharmD, BCPS Rush University Medical Center The off-label use of Kcentra, Feiba, Novoseven, tranexamic acid and aminocaproic acid will be discussed and I have no actual or With warfarin, the gradual diminishing effect on coagulation is dependent on hepatic function. endobj Fixed Kcentra® dosing deviated from our institutional dosing protocol in … However, safety of 4F-PCC and its risk of thrombosis when used for … {�t����f�P��,m��_��՝�샒fz֡�@f~ �a����/�����G�x^1��. ��޷���O�o'z��]�k�i%qQ���'�!��$+;fq�#�,9?^n d!���ijV�N:��٤�Y1A:��S���8�t�3H�.7�9� Urgency of Reversal •Life threatening bleeding •Major often defined as: hemodynamic instability, Hgb decrease by ≥ 2 g/dL or ≥ 2 U PRBCs ... Kcentra® (prothrombin complex concentrate human) [prescribing information]. 1 0 obj <>>> Background: Apixaban is a direct factor Xa inhibitor approved for the treatment and prevention of thromboembolic disease. 3 0 obj The drug is designed to help prevent patients given Coumadin or its g 2 0 obj Idarucizumab 5 grams (two 2.5g vials) Xa Inhibitors Apixaban (Eliquis) ® Reverse if patient shows signs of life threatening bleeding 1. Kcentra is used to quickly reverse the effects of a blood-thinning medicine (such as warfarin) during a major bleeding episode, or when there is a need for emergency surgery or invasive medical procedure. o For Rivaroxaban (Xarelto) or Apixaban (Eliquis: see procedure PROC_CM_A-30C) • If patient stable (does not require emergent OR) consider: Plasmapheresis for Rivaroxaban (Recommendation based on professional opinion, no clinical data) • Consider STAT Hematology consult • Give Kcentra (50 units/kg, maximum 5,000 units) if x��\�n��}7��K�a ��/C�,ɻN�ͮ�$vF��Y]]]�uNU�9ы���/_�;}s���ѫ������g/^�H�$�����g"J�?�,ʵI�"����?������4��oE�����>.���ş�? Given the scarce evidence and the possible ;m����(r�ݮdRf^W��UD�JI�}\��B-~��X\�B/����4��/qi�}狿�f�6κ�P�;��u�C�8w�Dk�� %PDF-1.5 %���� In nonurgent cases, including planned procedures, reversal of anticoagulant agents can be achieved by withholding the medication.1Anticoagulant interruption may suffice if reversal is desired in a few days to within a week. <> WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Currently, 4-factor prothrombin complex concentrate (4F-PCC) is considered the treatment of choice for factor Xa inhibitor-related major bleeding. No significant association between 4F-PCC administration and HE (RR = 1.057, 95% CI 0.565 – 1.977) N = 146 patients with spontaneous ICH; rivaroxaban 110 (75.3%), apixaban 21 (14.4%), dabigatran 15 (10.3%) SBP reduction at 4 hours . a. Kcentra (4 factor PCC) IV once at 100 units/minute (usually 10 to 50 minutes) INR Kcentra dose 1.5 to 4 25 units/kg, maximum 2,500 units 4.1 to 6 35 units/kg, maximum 3,500 units Greater than 6 50 units/kg, maximum 5,000 units b. Kcentra is a four factor prothrombin complex concentrate that was FDA approved in 2013 and is used as an antidote to treat people with bleeding associated with taking warfarin. Hematoma expansion . Although factor Xa inhibitors have become a popular choice for chronic oral anticoagulation, effective drug reversal remains difficult due to a lack of specific antidote. ���a 4-factor PCC/Kcentra is approved for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in patients with acute major bleeding or a need for an urgent surgery/invasive procedure. If rapid reversal is necessary, interventions may be warranted. �Y��0K�A��LCg\ED�����(��Q�[�AX����]�"\AL�:�8�D�����-G1���>b�~��Z����oE-�`:�� ��u}��H���J��}�Ϳ��M�l�[�&1�o{�/��ٓe級W���K����P�0P� ���u���h�dٸ L�%-��rFV�A=6p����8t�p> ts���a�,Jܩ�44�--�'��b An automated query of patients who received Kcentra between January 2014 and March 2016 was performed. stream ڀM>Ť��y�� Approximately 24,000 people participated in the 2 studies, including more than 11,000 people who took ELIQUIS. 41 Management of such patients in published case reports is highly variable. <>/XObject<>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> tPA) Heparin reversal Anti-platelet agent reversal Tranexamic acid Pre-procedure coagulation management for common procedures Algorithm Podcast Questions & discussion Pitfalls …

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