SELECTED IMPORTANT SAFETY INFORMATION: Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product. CONTINUE READING BELOW

Jivi® antihemophilic factor (recombinant), PEGylated-aucl Logo

SELECTED IMPORTANT SAFETY INFORMATION: Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product. CONTINUE READING BELOW

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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 logo

Quest Diagnostics®

Standard One-stage Assay Test Code 347 CPT 85240

Standard Chromogenic Test Code 16049 CPT 85240

Quest Diagnostics®: 1-866-697-8378

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®

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

1-800-288-8374

INDICATIONS

Jivi antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes

Perioperative management of bleeding

Routine prophylaxis to reduce the frequency of bleeding episodes

Limitations of use:

Jivi is not indicated for use in children less than 12 years of age due to a greater risk for hypersensitivity reactions.

Jivi is not indicated for use in previously untreated patients (PUPs).

Jivi is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product.

Hypersensitivity reactions, including severe allergic reactions, have occurred with Jivi. Monitor patients for hypersensitivity symptoms. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. If hypersensitivity reactions occur, immediately discontinue administration and initiate appropriate treatment.

Jivi may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

Hypersensitivity reactions may also be related to antibodies against polyethylene glycol (PEG).

Neutralizing antibody (inhibitor) formation can occur following administration of Jivi. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor (neutralizing antibody).

A clinical immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed primarily in patients < 6 years of age. The symptoms of the clinical immune response were transient. Anti-PEG IgM titers decreased over time to undetectable levels. No immunoglobulin class switching was observed.

In case of clinical suspicion of loss of drug effect, conduct testing for Factor VIII inhibitors and Factor VIII recovery. A low post-infusion Factor VIII level in the absence of detectable Factor VIII inhibitors indicates that loss of drug effect is likely due to anti-PEG antibodies. Discontinue Jivi and switch patients to a previously effective Factor VIII product.

The most frequently (≥5%) reported adverse reactions in clinical trials in previously treated patients (PTPs) ≥12 years of age were headache, cough, nausea, and fever.

For additional important risk and use information, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

INDICATIONS

Jivi antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes

Perioperative management of bleeding

Routine prophylaxis to reduce the frequency of bleeding episodes

Limitations of use:

Jivi is not indicated for use in children less than 12 years of age due to a greater risk for hypersensitivity reactions.

Jivi is not indicated for use in previously untreated patients (PUPs).

Jivi is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

Jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product.

Hypersensitivity reactions, including severe allergic reactions, have occurred with Jivi. Monitor patients for hypersensitivity symptoms. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. If hypersensitivity reactions occur, immediately discontinue administration and initiate appropriate treatment.

Jivi may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

Hypersensitivity reactions may also be related to antibodies against polyethylene glycol (PEG).

Neutralizing antibody (inhibitor) formation can occur following administration of Jivi. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained or if bleeding is not controlled as expected with administered dose, suspect the presence of an inhibitor (neutralizing antibody).

A clinical immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed primarily in patients < 6 years of age. The symptoms of the clinical immune response were transient. Anti-PEG IgM titers decreased over time to undetectable levels. No immunoglobulin class switching was observed.

In case of clinical suspicion of loss of drug effect, conduct testing for Factor VIII inhibitors and Factor VIII recovery. A low post-infusion Factor VIII level in the absence of detectable Factor VIII inhibitors indicates that loss of drug effect is likely due to anti-PEG antibodies. Discontinue Jivi and switch patients to a previously effective Factor VIII product.

The most frequently (≥5%) reported adverse reactions in clinical trials in previously treated patients (PTPs) ≥12 years of age were headache, cough, nausea, and fever.

For additional important risk and use information, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References: 1. Jivi® Prescribing Information. Whippany, NJ: Bayer LLC; 2018. 2. Church N, Leong L, Katterle Y, et al. Factor VIII activity of BAY 94‐9027 is accurately measured with most commonly used assays: results from an international laboratory study. Haemophilia. 2018;24(5):823-832.