R ECOMBINANT FACTOR VIII COMPARISON CHART

Transcription

1 R ECOMBINANT FACTOR VIII COMPARISON CHART Advate by Shire. of 13 1, BAXJECT II monograph: 28 C for up to 6 Available in Quebec. Being phased out in rest of Canada in Afstyla Antihemophilic Factor VIII (Recombinant), SingleChain manufactured by CSL Behring deleted. The single chain design results in high binding affinity of Afstyla to von Willebrand factor. of 14 Nanofiltration IUs IUs IUs 1, IUs IUs Mix2Vial 25 C for up to 3 all and children to control and prevent bleeds, for prophylaxis and for surgery. Not distributed in Canada. monograph: Monograph.pdf 1

2 Eloctate by Biogen Idec embryonic kidney (HEK) deleted FVIII linked to the Fc domain of immunoglobulin to extend halflife. of 19 Detergent viral inactivation step and multiple viral clearance steps, including an affinity step and a 15 nm virusretaining nanofiltration step 750 1, 3 ml diluent in prefilled syringe, provided with 1 infusion set, 2 alcohol pads, 1 gauze pad, and 2 bandages 2 8 C for 30, room temperature up to 30 C for a single period of up to 6 and indicated in and children. Available on a limited basis for specific needs (short, venous access difficulties) in Quebec. Available for most patients in rest of Canada. Health Canada Basis of Decision: sc.gc.ca/dhp mps/prodpharma/sbd smd/drug med/sbd_smd_2014_eloctate_ eng.php monograph: ELOCTATE PM_E.pdf Helixate FS by Bayer and distributed by CSL Behring. of 12 Solvent Detergent: TNBP/ IUs Mix2Vial monograph: FS Monograph.pdf Licensed, but no longer distributed by CBS or Héma 2

3 Kogenate FS by Bayer. of 12 Solvent Detergent: TNBP/ BIO SET Distributed in all provinces except Quebec. Being replaced by Kovaltry in monograh: fs pm en bio set.pdf Kovaltry by Bayer. of Detergent virus inactivation step, 20 nm filtration step IUs with 2.5 ml diluent with 5 ml diluent BIO SET Health Canada Basis of Decision: sc.gc.ca/dhp mps/prodpharma/rds sdr/drug med/rds sdr kovaltry eng.php monograph: pm en.pdf in 2016 for the treatment and prophylaxis of bleeding, and surgery in patients of Not currently distributed in Available in rest of Canada. 3

4 Nuwiq by Octapharma embryonic kidney (HEK) deleted FVIII. of 15 A series of purification steps, virus inactivation, further purification by, a second dedicated viral removal step by nanofiltration, and a final purification step by size exclusion IUs 2.5 ml diluent 2 to 8 C for up to 18, room 25 C for up to 1 month Health Canada Basis of Decision: sc.gc.ca/dhp mps/prodpharma/sbd smd/drug med/sbd_smd_2015_nuwiq_ eng.php monograph: for the treatment and prophylaxis of bleeding in patients of Not currently distributed in Available in rest of Canada. Xyntha by Pfizer deleted. of Nanofiltration R2 Kit Xyntha Solofuse all in one reconstitution monograph: 25 C for up to 3 Distributed in all provinces. 4

5 Zonovate (NovoEight in the rest of the world) by Novo Nordisk truncated FVIII. of Purification steps include using a FVIII specific monoclonal antibody (mab) immune affinity column and sterile filtration 1, MixPro with 4 ml diluent 2 8 C for 24, room temperature up to 30 C for a single period of up to 6 Health Canada Basis of Decision: sc.gc.ca/dhp mps/prodpharma/sbd smd/drug med/sbd_smd_2015_zonovate_ eng.php monograph: novonordisk ca/ours/pdf/zonovate_pm_english.pdf for the peri operative management treatment and prophylaxis of bleeding in patients of Not currently distributed by CBS or Héma Last revised March 29,