Octaplex : Gold standard for emergency reversal of warfarin related bleeds

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1 Octaplex : Gold standard for emergency reversal of warfarin related bleeds Marnie Steele Key Account Manager, Octaplex and Wilate British Columbia and Alberta Octapharma Canada Inc. marnie.steele@octapharma.ca

2 Today s Objectives To enhance understanding of Octaplex What it is When to use How to use How to mix What to watch for post infusion Appropriate use of blood products FFP Octaplex

3 Anticoagulation effects of warfarin Warfarin achieves its anticoagulant effect by: blocking carboxylation of the Vitamin K-dependent clotting factors: II (FII), VII (FVII), IX (FIX), and X (FX) It thereby causes a functional deficiency of these procoagulants as well as the anticoagulation proteins C and S Anticoagulant effects are evaluated by the International Normalised Ratio (INR) BCSH Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryopsupernatant. Br J 2004: 126, 11-28

4 Clinical Applications of Oral Anticoagulant Therapy Warfarin is the oral anticoagulant most frequently used to control and prevent thromboembolic disorders. This medication is used to treat blood clots and/or to prevent new clots from forming. Preventing harmful blood clots helps to reduce the risk of a stroke or heart attack. Indications for Oral Anticoagulation Prophylaxis of venous thrombosis for high-risk surgery Treatment of venous thrombosis Treatment of pulmonary embolism Prevention of systemic embolism Atrial fibrillation High risk of recurrent thrombosis Thrombosis associated with antiphospholipid antibody High risk of recurrent embolism Tissue heart valves Acute myocardial infarction Valvular heart disease Chronic or intermittent Cardioversion Hirsh et al., CHEST 2001; 119:8S 21S Prosthetic heart valve

5 Complications associated with OAT OAT carries the inherent risk of hemorrhagic complications Cumulative bleeding of patients receiving warfarin 1 Excessive bleeding, or hemorrhage, can occur from any area of the body including: bleeding from the gums blood in the urine bloody or dark stool nosebleed vomiting blood Reported rate of major hemorrhage 7.2/100 persons-years in US with most events occurring in patients >80 years old 1. Gastrointestinal and urinary tract bleeds most frequently, affecting ~ 1-4% of patients. Intracranial hemorrhage (ICH) less common, 0.25%-1% of patients, however, it is the most life-threatening of bleeds and associated with a high mortality rate 2. 1 Hylek et al., Circulation 2007, 115: ; 2 Vigue, Critical Care 2009, 13:209

6 Patient Risk Factors Risk Factors for Hemorrhagic Complications of Anticoagulation Therapy Bleeding is more likely to occur during the starting period and with a higher dose (resulting in a higher INR). Risk factors for bleeding include : high intensity of anticoagulation (INR > 4.0) history of gastrointestinal bleeding hypertension cerebrovascular disease serious heart disease concomitant drugs long duration of warfarin therapy age 65 highly variable INRs anemia malignancy trauma renal insufficiency 1 Hylek et al., Circulation 2007, 115:

7 Management of excessive anticoagulation during warfarin therapy Options for warfarin reversal: Type of reversal Approach Rapid (complete) within minutes PCC (immediate replacement of vitamin K dependent coagulation factors) plus IV vitamin K Less quick (partial) within hours FFP (immediate replacement of vitamin K dependent coagulation factors but the correction of the coagulopathy is partial) Slow within 24 hours Oral vitamin K Ultraslow over days Omit warfarin dose (no vitamin K)

8 Management of excessive anticoagulation during warfarin therapy Prothrombin Complex Concentrate Fresh Frozen Plasma Not blood group specific Fast application: 10 mins Small volume, ml Infused in minutes Standardised content of coagulation factors (1:1:1:1 ratio of FII, FVII, FIX, FX) Protein C & S Predictable effect Virus inactivated/prion reduction process Less risk of transfusion reactions No risk of TRALI Good source of coagulation factors however: Blood group specific Slow process to acheive target international normalized ratio (INR) Takes time to thaw Large volumes needed (at 15ml/kg ~1000ml) Infused over hours Varying content of coagulation factors Unpredictable effect Not virus inactivated Risk of transfusion reactions: TRALI, TACO, anaphylaxis Vigue (2009) Critical Care, 13:209

9 Volume of FFP Necessary to Normalize INR Holland et al., (2006) calculated the volume of FFP likely to achieve a target INR assuming no significant change in the synthesis or destruction of clotting factors. Factors VII and IX had the smallest change, with an increment of ~5% per 500 ml of FFP. The difference in volume between a goal of 1.3 and 1.7 is 2 L of plasma at all initial INRs. This represents a significant volume load for a patient. Target INR Initial INR Vol (L) Dose (ml/kg) Factor (%) Vol (L) Dose (ml/kg) Factor (%) Vol (L) Dose (ml/kg) Factor (%) Vol (L) Dose (ml/kg) Factor (%) Holland et al., Am J Clin Pathol :

10 Differences between FFP and Octaplex Parameters What is in FFP? (Reference Range FFP 1 ) What is in Octaplex? What is missing from Warfarin Patients? Fibrinogen [mg/ml] Factor II [IU/ml] Factor V [IU/ml] Factor VII [IU/ml] Factor VIII [IU/ml] Factor IX [IU/ml] Factor X [IU/ml] Factor XI [IU/ml] Factor XII [IU/ml] Factor XIII [IU/ml] X concentrated, levels seen in plasma Protein C [IU/ml] Protein S [IU/ml] Beeck H & Hellstern P. Vox Sang 1998; 74:219-23

11 FFP use in Canada Clinical Indication Reason Bleeding Liver disease or DIC with INR above 1.5 Emergency surgery or major procedure (within 6 hours) Situations in which the transfusion of FFP is reasonable: Massive transfusion (expect more than 10 RBC units transfused in 24 hours) with INR above 1.5 (or rapidity of bleeding does not allow for MD to wait for results) Reversal of warfarin or vitamin K deficiency only where intravenous vitamin K would not suffice and prothrombin complex concentrate (Octaplex ) is not available Inherited or acquired single factor deficiencies where specific factor concentrate is unavailable Reversal of warfarin or vitamin K deficiency only where intravenous vitamin K would not suffice and prothrombin complex concentrate (Octaplex ) is not available

12 Clinical Trial Riess et al., (2007) Objective Efficacy and safety of Octaplex in patients under oral anticoagulant therapy and undergoing surgery or invasive procedures. Study Design Prospective nonrandomized Control bleeding = 3 patients Major surgery = 19 patients Minor surgery = 38 patients Initial Median Dose: 40.9 IU/kg Total N = 60 Riess et al, Thromb Res 2007;121:9-16

13 No. of patients Clinical Trial Riess et al., (2007) Dosing and Infusion Rate In 32/60 patients more than 3 ml/min Octaplex were infused Infusion rate of Octaplex The average infusion rate was 6.42 ml/min (160 IU/min). In 19 patients an average infusion rate of 8 ml/min (200 IU/ml) or more was used. This demonstrates that infusion rates significantly higher than recommended (3 ml/min) were well tolerated by all patients Infusion rate (ml/min)

14 INR results pre and up to 1 hours post first infusion Mean +/- standard deviation, N=56 6 Efficacy/Safety Riess et al., (2007) Safety In none of the patients severe adverse drug reactions occurred. No evidence of treatmentrelated DIC or thromboembolic complications was observed. Three patients out of 60 had minor adverse events possibly related to Octaplex. 1 0 Pre Infusion 10 min post 30 min post 1 hr post Median INR declined from 2.8 ( ) to 1.1 ( ) within 10 minutes In 92.9% the INR decreased to a value <1.4 within one hr 91% (51/56) pts achieved the primary objective The corrected INR remained stable for at least 1 hr following infusion and the coagulation factor levels remained stable for 4 to 6 hrs. This time period was in general long enough to cover the time span of the surgical intervention.

15 Treatment Guidelines for Warfarin Reversal International Guidelines British Committee for Standards in Hematology, Blood Transfusion Task Force FFP has only a partial effect, is not the optimal treatment, and should never be used for the reversal of warfarin anticoagulation in the absence of severe bleeding (grade B recommendation, level IIa evidence). PCC (50 units/kg) is preferred to FFP American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) For patients with life threatening bleeding or intracranial hemorrhage, we recommend the use of PCC or recombinant factor VIIa to immediately reverse the INR (Grade 1C). For patients who are actively bleeding, immediate warfarin reversal can be achieved with factor concentrates, i.e. PCCs or recombinant factor VIIa along with repeated daily administration of vitamin K BCSH Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryopsupernatant. Br J 2004: 126, Ansell et al.,chest June :6 suppl 160S-198S

16 Treatment Guidelines Canadian Guidelines National Advisory Committee on Blood and Blood Products Octaplex recommended in: A. Reversal of warfarin therapy or vitamin K deficiency in patients exhibiting major bleeding manifestations. B. Reversal of warfarin therapy or vitamin K deficiency in patients requiring urgent (<6 hour) surgical procedures NAC Recommendations for use of Octaplex in Canada

17 Recommendations for the use of Octaplex in Canada (Pre-2011) The National Advisory Committee on Blood and Blood Products (NAC) released recommendations for the use of Octaplex Recommendations based on literature review and the desire to prevent thrombotic complications Dosage Adult Patients Maximum total dose: One standard starting dose for all 40 ml Octaplex (1000 IU Factor IX activity*) and 10 mg Vitamin K IV. A higher or second dose may be needed in extremes of INR or weight 120 ml or 3000 IU Factor IX activity Administration: Should not exceed 2-3mL/min (15 mins/1000 IU) Post dose monitoring: INR immediate post infusion Clinical outcomes (incl. Thrombotic events). With the time constraints around administration of FFP, in addition to the risk of hypervolemia, the administration of PCCs with vitamin K supplementation is the most effective method for rapid reversal of anticoagulation therapy.

18 Dosing Recommendations as per product monograph Dose will depend on the INR before treatment and the targeted INR Initial INR >3.5 Approximate dose* (ml octaplex / kg body weight) >1.9 *Approximate doses (ml / kg BW of the reconstituted product) required for normalization of INR ( 1.2 within 1 hour) at different initial INR levels are given. For example: Recommended dose of Octaplex for a 70 kg patient with starting INR of 2.5: 1.3 ml x 70 kg = 91 ml Octaplex One vial of octaplex is 20 ml and contains 500 IU FIX 91 ml Octaplex / 20 ml per vial = 4.55 vials Octaplex (2275 IU Octaplex ) octaplex summary of product characteristics 2010

19 Individualized dosing regimen for PCC more effective than standard treatment in the reversal of oral anticoagulant therapy van Aart et al., 2006 Objective To compare the efficacy of a standard dosage of PCC to an individualized dosage. Study Design An open, prospective, randomized, controlled trial N = 93 patients with major bleedings or admitted for urgent (surgical) interventions Treatment A: dose of 40 ml of PCC (the standard dose). Treatment B: consisted of a dose taking into account the target-inr, the initial-inr and the body weight of the patient (the individualized dosing regimen)

20 Individualized dosing regimen for PCC more effective than standard treatment in the reversal of oral anticoagulant therapy van Aart et al., 2006 For reaching the target INR at 15 min after the first dosage of PCC, a statistically significant difference was found in the number of patients receiving the individualized dose (89%) compared with the number of patients receiving the standard dose (43%) (p<0.001) Time after infusion Before 15 min 1 h 3 h 5 h Time after infusion 15 min 1 h 3 h 5 h Treatment A Median INR Treatment B Median INR Treatment A: standard dose Treatment B: individualized dosing regimen P-value Treatment A Treatment B P-value Target-INR reached 20/47 17/47 18/47 20/47 % Target-INR reached /46 40/45 39/46 40/46 %

21 Canadian Experience with Octaplex Lin et al., 2009 Objective To investigate the implementation of Octaplex guidelines at an academic teaching hospital. Study Design Retrospective chart review (August to December 31,2008) N = 40 patients Dose: at Sunnybrook hospital the NAC guidelines are followed; in addition, 2000 units are issued for INR > 4 or wt > 90kg

22 Pre-INR Canadian Experience with Octaplex Lin et al., 2009 Octaplex Dose and Effect on INR (N=40) Octaplex dose recommended by NAC may be suboptimal For INR > 3, 2000 IU Octaplex may be more effective IU 1000 IU Pre-INR Effect of Octaplex 1000 IU on INR No. of pts Post-INR 1.5 Post-INR Post-INR Range (80%) 1 (20%) (60%) 4 (27%) (0%) 7 (88%) (20%) 1 (20%) Immediate Post-INR

23 Recommendations for the use of Octaplex in Canada The National Advisory Committee on Blood and Blood Products (NAC) released recommendations for the use of Octaplex (June 29, 2011 revision) Dosing of prothrombin complex concentrate should be based on the INR as per the table below. If the INR is unknown and major bleeding is present, 80 ml should be administered. Dosage Adult Patients: Dose of PCC Maximum total dose: Post dose monitoring: INR<3.0 INR INR> ml (1000 IU) 80 ml (2000 IU) 120 ml (3000 IU) 120 ml or 3000 IU Factor IX activity INR immediate post infusion Clinical outcomes (incl. Thrombotic events). With the time constraints around administration of FFP, in addition to the risk of hypervolemia, the administration of PCCs with vitamin K supplementation is the most effective method for rapid reversal of anticoagulation therapy.

24 Octaplex is not recommended* for: A. Elective reversal of oral anticoagulant therapy pre invasive procedure. B. Treatment of elevated INRs without bleeding or need for surgical intervention. C. Massive transfusion D. Coagulopathy associated with Liver dysfunction E. Patients with recent history of thrombosis, myocardial infarction or Disseminated Intravascular Coagulation (DIC) Contraindicated in: A. Patients with a history of Heparin Induced Thrombocytopenia * There may be extenuating clinical circumstances necessitating use of prothrombin complex concentrates in these clinical situations. They should be evaluated on a case-by-case basis with a physician experienced in the use of this product. If the decision is to use the product off-label in liver dysfunction and DIC, please consult the product monograph for further recommendations

25 FFP use in Canada 2008 Ontario audit of Frozen Plasma Of the 573 requests for Frozen Plasma Transfusion of Frozen Plasma has a constellation of adverse consequences, especially transfusion-related acute lung injury (TRALI) and transfusion associated circulatory overload (TACO).

26 Plasma product safety Plasma products are produced from large pools of human plasma and may contain infectious agents Potential risks for transmission of infection is first reduced by: Selection of plasma donors Screening of donations and plasma pools (i.e.. testing HIV, HBV, HVC) Octaplex manufacturing process additionally reduces viruses by: Viral inactivation process: solvent/detergent Virus removal process: nanofiltration Octaplex manufacturing process has been assessed to remove prions using a three-step approach: QAE-Sephadex A-50, S/D + DEAE Sepharose FF chromatography and Nanofiltration To date, no viral transmission reported

27 Available through CBS After reconstituting, the product must be infused immediately Once reconstituted, the vial contains 20 ml or 500 IU of PCC Octaplex Incidence of reported thrombotic events of approximately 1 in 45,000 patient episodes octaplex summary of product characteristics 2010

28 Administration Crossmatch is not required Octaplex must be administered intravenously Do not mix with other medication Reconstituted products are clear, colorless to slightly blue and do not contain particulate matter After reconstituting, the product must be infused immediately Once reconstituted, the vial contains 20 ml or 500 IU of PCC Octaplex should be injected initially at 1ml per minute, then to a faster rate of 2-3mls per minute octaplex summary of product characteristics 2010

29

30 Monitoring of Octaplex 1. Monitor vital signs as per any blood/product a. Prior to the transfusion b. Hourly and c. At completion 2. Patients given PCC should be observed closely for signs and symptoms of intravascular coagulation or thrombosis 3. INR should be monitored minutes post infusion and 6 hours (or prior to discharge). Note: The patient should be monitored for clinical outcomes at 24 hours and at day 30 (A letter will be sent from Transfusion Laboratory to patients indicating the need for follow-up)

31 Fast, Safe, Precise Rapid and complete INR reversal (6.1 to 1.5) with in 10 minutes 1,2 No thromboembolic deaths associated with use over a decade 2,3,4 Readily available through CBS, HQ New and easy to use Mix 2 Vial for convenient, precise reconstitution 1. Lubetsky et al. Thromb Res 2004;113: Reiss et al, Thromb Res 2007;121: Dargaud et al. J Thromb Haemost Jun;6(6): Epub 2008 Mar Lutze G, Heim M. Haemostasiologie 2004; 24: Gilmore et al. J Thromb Haemost 2009; 7:

32 Thank You

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