Factor VIII Inhibitor Bypassing Activity ( FEIBA ) Injection - Administration Guide

Factor VIII Inhibitor Bypassing Activity ( FEIBA ) INJECTION  500 UNITS
ROUTE	DILUTION	INFUSION RATE
INFUSION WITH NEEDLES	Reconstitute with 20ml of the included WFI1,2	Max: 2 Units/kg/min1,2   For the set up and reconstitution of FEIBA, kindly refer to the following PDF file: https://www.feiba.com/us/content/hcp/pdf/baxjectII_hi_flow_patient_user_guide_digital.pdf   There is some quick demonstration video on Youtube (however NOT the full set up), as follow: https://www.youtube.com/watch?v=0od6cVTLiNE
INFUSION WITH BAXJECT II HI-FLOW
Diluent	Use only the included WFI1
Stability	·         3 hours after reconstituted, at room temperature (up to 25°C)1,2 ·         Reconstituted product must not be refrigerated1,2
DOSE	Indication Dosage Recommended Spontaneous bleeding Joint, muscle, soft tissue haemorrhage ·     50-75 U/kg BW q12h is recommended for minor to moderately severe bleeding. ·     To be continued until clear improvement of clinical symptoms, e.g. reduction of pain, decrease of swelling, increase of joint mobility, occurs. ·     For severe muscle and soft tissue bleeding, a dose of 100 U/kg BW q12h is recommended. Mucous membrane haemorrhage ·     50 U/kg BW q6h with close monitoring. ·     If bleeding persists, may increase to 100 IU/kg BW. However do NOT exceed max daily dose of 200 IU/kg BW Other severe haemorrhages ·     e.g. CNS bleeding ·     100 IU BW q12h is recommended. In certain individual cases, the dose may be given at 6-hour intervals. ·     However do NOT exceed max daily dose of 200 IU/kg BW Surgery ·     100 U/kg BW preoperatively ·     Then another dose of 50-100 U/kg BW maybe given after 6-12 hours ·     For maintenance, may consider 50-100 U/kg q6-12h ·     However do NOT exceed max daily dose of 200 IU/kg BW Prophylaxis of bleeding in haemophilia A with inhibitors (high inhibitor titre) Frequent haemorrhages after failed ITI / ITI is not considered ·      70-100 IU BW EOD ·      May increase to 100 IU BW OD or decrease gradually During ITI ·      May give FEIBA concomitantly with factor VIII ·      50-100 IU BW q12h ·      Until the Factor VIII inhibitor titre reduced to < 2 B.U. * BW = Body weight                                                   * ITI = Immune tolerance induction
REMARKS	·         Do not exceed a single dose of 100 units/kg and a maximum daily dose of 200 units/kg 1,2 ·         1 vial of FEIBA 25 U/ml contains 500 U factor VIII inhibitor bypassing activity in 200 – 600 mg human plasma protein. FEIBA also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VII. Factor VIII coagulation antigen (F VIII C:Ag) is present at a concentration up to  0.1 U/ 1U FEIBA1 ·         Sodium content: 3.6 mmol sodium (80 mg) per vial   ·         Warm the unopened solvent vial (WFI) to room temperature if necessary 1 ·         Gently swirl (do not shake)2 until all material is dissolved (ensure that FEIBA is completely dissolved; otherwise less FEIBA units will pass through the device filter) 1 ·         Use only the included Water for Injections and the included device for reconstitution. If devices other than those enclosed are used, ensure the use of an adequate filter with a pore size of at least 149 µm1 ·         After reconstitution, the solution should be inspected for particulate matter and discoloration prior to administration. The appearance of the solution should be colourless to slight yellowish.2 Do not use solutions which are cloudy or have deposits.1,2 ·         Flush venous access lines with isotonic saline prior to and after infusion of FEIBA.2 Do not administer in the same tubing or container with other medications.1,2 *Kindly refer to product leaflet for details
References	1.        Product Leaflet (FEIBA Powder and Solvent for solution for intravenous injection 500 U – Shire ; updated July 2018). 2.        Product Leaflet FEIBA (USA) - Shire: Accessed at: https://www.shirecontent.com/PI/PDFs/FEIBA_USA_ENG.pdf

 

Prepared by Syahmi ; Edited by J. Ho [21.10.2020]