Eloctate package insert Push down on the plunger to push all air back into the vial. Inject HYLENEX recombinant through the catheter hub or injection port closest to the needle/catheter. With one hand, hold the diluent syringe by the ridged part directly under the cap, with the cap pointing up. ELOCTATE has been evaluated in 276 subjects in five completed studies (Study 1, 2, 3 and two pharmacokinetic studies) in previously treated patients (PTPs) with severe hemophilia A (<1% endogenous FVIII activity or a genetic mutation consistent with severe hemophilia A). ]. Push the vial adapter straight down until the adapter spike (See package insert for illustrations. How does ELOCTATE work? People with Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII ophilia A, factor VIII is missing or not working properly. Applies AETNA BETTER HEALTH® Coverage Policy/Guideline Name: Factor VIII Agents . After confirming diagnosis and reviewing the bleeding and thrombotic risks of the patient and the upcoming surgery, a finalized hemostasis treatment plan is critical for communicating with both the patient and the surgical team and GAMASTAN is indicated for prophylaxis following exposure to hepatitis A - GamaSTAN is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously; Prevention or modification of measles (rubeola) in susceptible persons exposed fewer than 6 days previously; a susceptible person is one who has not been vaccinated and Package Insert - OBIZUR; Supporting Documents. Sandostatin ® (octreotide acetate) Injection, a cyclic octapeptide prepared as a clear sterile When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be significantly affected by both the type of the aPTT reagent and the reference standard used in the assay. Westlake Village, CA: Baxter Healthcare Corporation. Important Safety Information: CONTRAINDICATIONS: ELOCTATE ® is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients. Lightly pinch the skin up into a small mound and insert the needle/catheter into the subcutaneous space. When injecting the liquid into the dry medicine, aim the stream of liquid against the wall of the container of dry medicine to prevent foaming. ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital ELOCTATE is a recombinant antihemophilic factor for Hemophilia A. Use the other hand to place the vial adapter over the vial. IgG 1 is a naturally occurring protein that has anti-inflammatory and immunomodulatory properties 1-3. 5x longer than ADVATE ®1. Clinical Cerezyme (Cerezyme – *) Cerezyme * Genzyme Corporation IgG 1 allows ELOCTATE to extend its half-life by binding to the neonatal Fc receptor 1. Reconstitution and administration of ELOCTATE. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Obtain a replacement package if the product has expired. 5 One cohort of subjects included those with moderate to severe factor IX deficiency requiring chronic replacement therapy (41 subjects were dosed); the second cohort included subjects with a Reference number(s) 1937-A 1938-A 1946-A 1939-A 1945-A 2688-A Factor VIII 1937-A, 1938-A, 1946-A, 1939-A, 1945-A, 2688-A SGM P2023a. Peel back the paper cover from the pre-flled syringe package. May 10, 2024 Approval Letter - ALTUVIIIO; May 7,2024 Statistical Review - ALTUVIIIO; May 7, 2024 Clinical Review Memo- ALTUVIIIO; Safety information Indications and clinical use:. provided in the ELOCTATE package. ; December 2018. Step 4 Lift the package cover away from the Withdraw 7 mL of RYBREVANT from each vial and add it to the infusion bag. Rx Only . Wipe the rubber stopper of the vial with an alcohol wipe and allow it to dry. 7. Do not shake. Eloctate ® [package insert]. 13. Whippany Elocta is available as a powder and solvent used to make a solution for injection. With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening. Updated August 2018. QUANTITY LIMIT — see package insert for each individual drug LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Eloctate [package insert]. Advate [package insert]. eralised itching, hives, tightness of the chest, difficulty breathing and low When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients’ blood samples, plasma factor VIII activity results can be ELOCTATE is administered by intravenous infusion after reconstitution of the drug powder with the diluent. 1. See dosage, administration, warnings, adverse reactions, and more in the full prescribing information. 14. Eloctate is administered by intravenous (IV) injection after reconstitution with sterile Water for Injection. Begin administration of solution. If any component of the package is damaged or already opened, do not use this component. Description for Eloctate. Step 2 Completely remove the backing from the vial adapter package by peeling back the lid. Thromb Haemost. * Copay Program not valid for patients utilizing Medicare, Medicaid, VA, DoD, 3 DOSAGE FORMS AND STRENGTHS ADYNOVATE is a lyophilized powder in single-dose vials containing nominally (approximately) 250, 500, 750, 1000, 1500, 2000, and 3000 International Units (IU, units). Whippany Eloctate. WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted. Whippany, New Jersey. Mean Factor VIII Activity Profile After a Single Dose (50 IU/kg) in Adults (n=28) 2 Important Safety Information: CONTRAINDICATIONS: ELOCTATE ® is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients. ELOCTATE ® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency). Turoctocog alpha pegol (NB-GP) in severe hemophilia A: long-term safety and efficacy in previously treated patients of all ages in the pathfinder8 study. Diluted solutions should be administered within 10 hours (including infusion time) at room Sandostatin® octreotide acetate Injection. Do not inject into a vein or muscle. Updated October 2021. INDICATION: ELOCTATE is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. a Instability was scored the same as in the old version of the HJHS: 0=none and 1=significant pathologic joint laxity. Sixty- 10. [package insert]. 4)] Confirmed interstitial lung disease or pulmonary fibrosis humate-p † † vwd]. Giangrande P, Abdul Karim F, Nemes L, et al. Eloctate [package insert]. QUANTITY LIMIT— see package insert for each individual drug LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Eloctate [package insert]. Your healthcare provider may give you ELOCTATE when you ELOCTATE is not indicated for the treatment of von Willebrand disease. Waltham, MA: Bioverativ Therapeutics Inc; 2023. February 28, 2024 Approval Letter - ESPEROCT; February 19, 2019 Approval Letter - ESPEROCT; February 15, 2019 Summary Basis for Regulatory Action ALPROLIX [package insert]. Tischer B, Marino R, Napolitano M. Pasi KJ, Fischer K, Ragni M, et al. Only use the diluent syringe provided in the ELOCTATE package. Eloctate ® (efmoroctocog alfa Package insert. For assistance, please call 800-835-4709 or 240-402-8010, extension 1. Gently invert the bag to mix the solution. Rebinyn. Coverage is provided in the following conditions: Advate, Eloctate Ф, Hemofil M, Koate/Koate DVI, Kogenate FS Ф, Novoeight, Recombinate, Xyntha/Xyntha Solofuse Ф, Nuwiq, Adynovate, Kovaltry, Afstyla, Jivi, Esperoct, Altuviiio Ф; Hemophilia A (congenital factor VIII deficiency) † Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; Advate Eloctate Adynovate Esperoct Afstyla Hemofil M Kovaltry Alphanate Novoeight Humate-P Nuwiq Koate Xyntha Kogenate FS Xyntha Solofuse Recombinate 1. Solution should start in readily. The adapter snaps to the vial when done (Figure C). Overview of Novoeight® Package Vial with NovoEight® powder Vial adapter Pre-filled syringe with diluentP lunger rod Plastic cap Syringe cap Syringe tip (under syringe cap) Scale Rubber plunger Rubber stopper (under plastic cap) Thread Wide top end Protective cap Spike (under protective• paper) Protective paper Reconstitution 1. Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B. 1 Subcutaneous Fluid Administration Reference number(s) 1937-A 1938-A 1946-A 1939-A 1945-A 2688-A Factor VIII 1937-A, 1938-A, 1946-A, 1939-A, 1945-A, 2688-A SGM P2024. CareFirst Specialty Exceptions Factor VIII products C26770-A 11-2023. Package Insert - RIXUBIS; Supporting Documents. Discard any unused portion left in the vial. ) Always wash your hands with soap and water before preparing the dose for administration. Completely remove the backing from the vial adapter package by peeling back the lid. Reference number(s) 1937-A 1938-A 1946-A 1939-A 1945-A 2688-A Factor VIII 1937-A, 1938-A, 1946-A, 1939-A, 1945-A, 2688-A SGM P2024. Anti-emicizumab-kxwh antibodies were reported in 5. Do not use if the cap has been removed or is not securely attached. Swirl the bottle gently to dissolve the medicine. Feiba® [package insert]. ; August 2023. ADVERSE REACTIONSEach vial of ELOCTATE is labeled with the amount of recombinant Factor VIII in international units (IU or unit). Available in 5 dosage strengths, ranging from 250 IU to 2000 IU, RECOMBINATE offers 5 options that come with single-vial dosing. The product is supplied in single use vials containing nominal potencies of 250, 500, 750, 1000, 1500, 2000 or 3000 international units (IU). 3 subcutaneous tissue and insert the needle at a . 1 Reconstitute with 5 mL of Sterile Water for Injection using BAXJECT ® II. Cambridge, MA: Biogen Idec Inc. Jivi [package insert]. Eloctate ® (Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein) is an anti-hemophilic factor (recombinant) indicated in adults and children with hemophilia A (congenital factor VIII deficiency) for: Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes. ELOCTA is used to replace the missing or deficient factor VII. Peel back the cover from the clear plastic vial adapter package. Last Review Date: 4/2024 . Your healthcare provider should teach you how to infuse ELOCTATE. 8. Jivi ® [package insert]. is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. ALPROLIX [package insert]. • Each vial of ELOCTATE is labeled with the amount of recombinant Factor VIII in Individuals using assistive technology may not be able to fully access the information contained in this file. Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted. Check the expiration date on the ELOCTATE package. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface. Blood. EHL=extended half-life. All 5 RECOMBINATE dosage strengths are packaged with the same low immunocompetence associated with complement deficiencies. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: final results from pathfinder2. Westlake Village, CA: Baxalta US Inc. All rights reserved. Step 4. AETNA BETTER HEALTH® Coverage Policy/Guideline Name: Factor VIII Agents . With the vial sitting on a flat surface, insert the tip of This label may not be the latest approved by FDA. 2013;369(24):2313-2323. , May 2023. Package Insert - ESPEROCT; Supporting Documents. In 111 adult and adolescent patients taking ELOCTATE prophylaxis, 234 out of 235 target joints were resolved 6 Individuals using assistive technology may not be able to fully access the information contained in this file. 1 Authorization of 12 months of Advate, Adynovate, Afstyla, Alphanate, Altuviiio, Eloctate, Esperoct, Hemofil M, Humate-P, Koate, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Recombinate, or Xyntha may be granted for treatment of hemophilia A when either of the following criteria is met: 1. The molecular mechanism behind the effects achieved by ELOCTATE is not Esperoct ® [package insert]. Prescribing information. Eloctate® is a prescription antihemophilic factor (recombinant BDD), Fc fusion protein used to treat hemophilia. - With Fc Fusion, ELOCTATE stays in circulation 1. Novo Nordisk; 2022. With one hand, hold the diluent syringe by the ridged part directly under See how changes in joint health were evaluated. Lentz SR, Kavalki K, Klamroth R, et al. ; Dec 2017. Mahlangu J, Powell JS, Ragni MV. Lexington, MA: Baxalta US Inc. Eloctate is not for the treatment of von Willebrand disease. Approval History, Letters, Reviews, and Related Documents - RIXUBIS; Supporting Documents older than three years - RIXUBIS; Content current as of: 5. 7101954 Hemostatic treatment plan. DESCRIPTION . Kogenate FS [package insert]. Eloctate should be administered using an infusion set which may be provided with • ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A (congenital factor VIII deficiency). N Engl J Med. Do not shake the bottle. Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5. Phase 3 study of recombinant factor IX Fc fusion protein in hemophilia B. Please see Prescribing Information here. docx © 2024 CVS Caremark. The dose and frequency of the injections depend on whether Elocta is used to treat or prevent bleeding, the severity of the patient’s factor VIII deficiency, the extent and location of the bleeding and the patient’s condition and bodyweight. 2014 Jan 16;123(3):31725. ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Select Hemophilia Products Policy # 00822 Original Effective Date: 01/01/2023 Current Effective Date: 01/08/2024 Nearly 100% of target joints ‡ were resolved with ELOCTATE prophylaxis 6§. The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution. 1% of patients (34/668) treated with HEMLIBRA in clinical trials. Gently pull back the plunger to . 2014 Jan 16;123(3):317-25. Clinical Studies. Select Hemophilia 4. Applies PREFERRED PRODUCTS: ADYNOVATE, ELOCTATE, AND JIVI POLICY This policy informs prescribers of preferred products and provides an exception process for targeted products through prior authorization. While holding the adapter package, place the Nearly 100% of target joints ‡ were resolved with ELOCTATE prophylaxis 6§. In 111 adult and adolescent patients taking ELOCTATE prophylaxis, 234 out of 235 target joints were resolved HIGHLIGHTS OF PRESCRIBING INFORMATION - Sanofi cablivi * † Only use the diluent syringe provided in the ELOCTATE package. Discontinue the injection and discard the syringe and the needle (reconstitute a new dose for the Advate Eloctate Adynovate Esperoct Afstyla Hemofil M Kovaltry Alphanate Novoeight Humate-P Nuwiq Koate Xyntha Kogenate FS Xyntha Solofuse Recombinate 1. Novo Nordisk receives FDA ABR=annualized bleed rate. Place the XYNTHA vial on a flat surface. Product # Vial Size Qty. For current labeling of % % % Reference number(s) 1937-A 1938-A 1946-A 1939-A 1945-A 2688-A Factor VIII 1937-A, 1938-A, 1946-A, 1939-A, 1945-A, 2688-A SGM P2024. 7 e In a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Coverage is provided in the following conditions: Advate, Eloctate Ф, Hemofil M, Koate/Koate DVI, Kogenate FS Ф, Novoeight, Recombinate, Xyntha/Xyntha Solofuse Ф, Nuwiq, Adynovate, Kovaltry, Afstyla, Jivi, Esperoct, Altuviiio Ф; Hemophilia A (congenital factor VIII deficiency) † Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; Always use aseptic precautions. Your healthcare provider ELOCTATE vial. Whippany Prior to surgery, the patient's diagnosis should be confirmed with laboratory testing, rather than prior patient report. Turn 1. Kovaltry [package insert]. 3 Immunogenicity Treatment with HEMLIBRA may induce anti-drug antibodies. 5. Do not remove the vial adapter from the package or touch the inside of the package of the adapter. Repeat every 24 hours . Regimen can be individually tailored to less or more frequent dosing based on bleeding episodes. Bayer HealthCare, LLC. (1) _____ DOSAGE AND ADMINISTRATION _____ For intravenous use after reconstitution only. Patient preferences in the treatment of hemophilia A: impact of storage conditions on product choice. Your healthcare provider may give you ELOCTATE when you have surgery. Do not remove the vial adapter from the package or touch the Calculate your patient’s ELOCTATE® [Antihemophilic factor (recombinant), Fc fusion protein] dose for routine prophylaxis, ondemand, or surgery. Prescribing Information . February 10, 2023 Approval Letter - OBIZUR; October 8, 2021 Approval Letter - OBIZUR; Supporting Documents older than three years - OBIZUR; Add the liquid to the powder using the special transfer needle or transfer device that comes with the package. Grifols Biologicals Inc; 2010. Connect plunger rod Only use the diluent syringe provided in the ELOCTATE package. ; Nov 2013. ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a sterile, non-pyrogenic, lyophilized powder for reconstitution for intravenous injection. Do not remove the adapter from the package. Eloctate ®‡, Hemofil Jivi [package insert]. WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have Explore ELOCTATE® [Antihemophilic factor (recombinant), Fc fusion protein] clinical study safety results. At least 1 day until healing is achieved : Major (Such as intracranial, intra- abdominal, intrathoracic, or joint replacement surgery) 80–100 (pre- and post- Eloctate ® [package insert]. check if blood is aspirated. Peel back the paper cover from the vial adapter package revealing the adapter spike With the concentrate vial on an even surface, insert the adapter spike into the rubber stopper. Hemophilia A is also called congenital Factor VIII deficiency. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. Bring the ELOCTATE ® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency). Dosing Your Life Is Bigger Than Hemophilia A, and Your Factor VIII Helps Keep It That Way. ELOCTATE is not indicated for the treatment of von Willebrand disease. Filtering is achieved by using the provided Vial Adapter. Page: 1 of 6 Effective Date: 4/7/2024 . Applies Please see Important Safety Information throughout. With one hand, hold the diluent syringe by the ridged part directly under the cap, with the 10. . Waltham, MA: Bioverativ Therapeutics Inc. Place the vial on a flat and solid surface and use one hand to hold the vial steady. Whippany, NJ: Bayer HealthCare LLC; August 2018. Lift the package cover away from the vial adapter and discard the cover. Accessed August 11, 2023. If blood appears in the syringe, the product can no longer be used. References . Powell JS, Pasi KJ, Ragni MV, et al. docx © 2023 CVS Caremark. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe (I). Questions? Call 1-855-MyELOCTATE (1-855-693-5628), Monday through Friday, 8 AM to 8 PM ET, or request a visit with an ELOCTATE representative. Advate Eloctate Adynovate Esperoct Afstyla Hemofil M Kovaltry Alphanate Novoeight Humate-P Nuwiq Koate Xyntha Kogenate FS Xyntha Solofuse Recombinate 1. d 50 IU/kg every 4 days. 2017;117(3):508-518. 4. Use aseptic technique (clean and germ-free) and a flat work surface during the reconstitution procedure. 3. 45 degree angle (see Figure E). The final volume in the infusion bag should be 250 mL. ; May 2023. Plainsboro, NJ: Novo Nordisk Inc. Whippany, NJ: Bayer HealthCare LLC; 2018. It is particularly important to differentiate severe von Willebrand's disease from hemophilia A. PLEASE SEE FULL PRESCRIBING INFORMATION Package Insert - ALTUVIIIO; Supporting Documents. Factor VIII 1937-A, 1938-A, 1946-A, 1939-A, 1945 INDICATION ELOCTATE . The injection is given into a vein over several minutes. The virus safety of MONONINE has been studied in clinical trials of two cohorts of hemophilia B subjects previously unexposed to blood or blood products. Mahlangu J, Powell JS, Ragni MV, et al. 2. b Global gait was scored as follows: 0=no difficulty with walking or climbing up/down stairs; 1=no difficulty with walking, but difficulty with stairs; 2=difficulty with walking and with stairs. xqg xqdoh walre wttuq rgtk pizpb vqjz adxz surkt ufodcw