Monitoring Factor VIII Activity of Jivi® antihemophilic factor (recombinant) PEGylated-aucl

Jivi® Prescribing Information
Section 5.4 Monitoring Laboratory Tests1
  • If monitoring of Factor VIII activity is performed, use a validated chromogenic assay or a selected validated one-stage clotting assay.
  • Laboratories intending to measure the Factor VIII activity of Jivi® should check their procedures for accuracy. For Jivi®, select silica-based one-stage assays may underestimate the Factor VIII activity of Jivi® in plasma samples; some reagents, e.g., with kaolin-based activators, have the potential for overestimation.2 Therefore, the suitability of the assay must be ascertained. If a validated one-stage clotting or chromogenic assay is not available locally, then use of a reference laboratory is recommended.
  • Monitor for development of Factor VIII inhibitors. Perform a Bethesda inhibitor assay if expected Factor VIII plasma levels are not attained or if bleeding is not controlled with the expected dose of Jivi®. Use Bethesda Units (BU) to report inhibitor titers.
For Jivi®, select silica-based one-stage assays may underestimate the Factor VIII activity. Based on the results from the field study, Jivi® FVIII activity can be monitored using either validated chromogenic substrate assays or selected, validated one-stage clotting assays, including1,2,*:
Chromogenic substrate assays One-stage clotting assays
Chromogenix Coamatic® (Instrumentation Laboratory)
(Distributed by Diapharma)
HemosIL® SynthASil (Instrumentation Laboratory)
Factor VIII Chromogenic Assay (Siemens) Dade Actin® FSL (Siemens)
Pathromtin® SL (Siemens)

Coamatic is a registered trademark of Instrumentation Laboratory S.P.A.; HemosIL is a registered trademark of Instrumentation Laboratory Company; Actin is a registered trademark of Siemens Healthcare Diagnostics Inc.; Pathromtin is a registered trademark of Siemens Healthcare Diagnostics Products GmbH.

*All assays listed here were validated in the field study and are FDA approved as of August 30, 2018.


Bayer has confirmed that Quest Diagnostics® and another nationally recognized laboratory company can perform validated chromogenic substrate and validated one-stage clotting assays to monitor Factor VIII activity for Jivi®.

Quest Diagnostics®

Standard One-stage Assay Test
Code 347 CPT 85240

Standard Chromogenic Test
Code 16049 CPT 85240

Quest Diagnostics®:
1-866-697-8378

www.QuestDiagnostics.com/
TestCode347

Quest Diagnostics is a registered trademark of Quest Diagnostics.

Contact Access Services by Bayer to learn more about the Lab Monitoring Co-pay Program for Jivi®
1-800-288-8374