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 graphic 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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During the PROTECT VIII main and extension studies

Target-joint resolution with Jivi®1

During the PROTECT VIII main and extension studies

Target-joint resolution with Jivi®1

Results from a post hoc analysis of target-joint status in 82 patients in the prophylactic group from baseline through the main study and into the extension period (median time of 1421 days [range: 700-2071]1)

Circle graph

95%
 
of historic target joints* were resolved1†

107 of 113 historic target joints were resolved at time of analysis (data cutoff 8/28/2019)1

The median (IQR) target joint ABR was 0 (0-1.5) at the end of the main study and 0 (0-1.4) at the extension cutoff date (8/28/2019)1

The mean (SD) target joint ABR was 1.28 (2.14) at the end of the main study and 1.06 (2.08) at the extension cutoff date (8/28/2019)2

Analysis consisted of1:

  • • Numbers of historic target joints, as judged by the investigator, recorded at study entry
  • • Numbers of resolved target joints (≤2 spontaneous bleeds during last 12 months)
Circle graph 2

91%

 
of historic or new target joints* were resolved1†

111 of 122 historic or new target joints were resolved at time of analysis (data cutoff 8/28/2019)1

The median (IQR) target joint ABR was 0 (0-1.5) at the end of the main study and 0 (0-1.4) at the extension cutoff date (8/28/2019)1

The mean (SD) target joint ABR was 1.28 (2.14) at the end of the main study and 1.06 (2.08) at the extension cutoff date (8/28/2019)2

Analysis consisted of1:

  • • Numbers of historic target joints, as judged by the investigator, recorded at study entry
  • • Numbers of new target joints that developed on-study (≥3 spontaneous bleeds within 6 months)
  • • Numbers of resolved target joints (≤2 spontaneous bleeds during last 12 months)
Target joint resolution data chart
Target joint resolution data chart
Target joint resolution data chart
Target joint resolution data chart

Patients remaining on the same prophylaxis regimen during the last 90 days of treatment. Median (Q1; Q3) joint ABRs were 0.00 (0.0; 8.1) for twice-weekly and 0.00 (0.0; 4.1) for every-5-day final on-study dosing interval.3

†As defined by the International Society of Thrombosis and Hemostasis (ISTH).1

Patients remaining on the same prophylaxis regimen during the last 90 days of treatment. Median (Q1; Q3) joint ABRs were 0.00 (0.0; 8.1) for twice-weekly and 0.00 (0.0; 4.1) for every-5-day final on-study dosing interval.3

As defined by the International Society of Thrombosis and Hemostasis (ISTH).1

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. Reding MT et al. Haemophilia. 2020;26(4):e201-e204. 2. Data on file. Jivi PROTECT VIII Extension AUG 2019 CSR Target Joint Analysis data; Bayer. 3. Reding MT et al. Poster P29. Presented at the Hemostasis and Thrombosis Research Society 2019 Scientific Symposium. 9-11 May 2019, New Orleans, Louisiana.