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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In the PROTECT VIII main study

Effective bleed protection with Jivi®1

In the PROTECT VIII main study

Effective bleed protection with Jivi®1

Study Design Chart
Study Design Chart

Treatment success in the every-7-day arm was not established

Total ABR in all patients on every-7-day dosing arm (n=43); median (Q1;Q3) ABR for total bleeds of 3.9 (0.0;6.5) and a mean (±SD) of 6.43 (±10.04)2,3

Total ABR in patients who completed every-7-day dosing treatment (n=32); median (Q1;Q3) ABR of 1.0 (0.0;4.3) and a mean (±SD) of 2.67 (±3.82)2,3

Spontaneous ABR in all patients on every-7-day arm (n=43); median (Q1;Q3) of 1.9 (0.0,6.3) and mean (±SD) of 5.42 (±9.79)2,3

Spontaneous ABR in patients who completed every-7-day dosing treatment (n=32); median (Q1;Q3) of 0.0 (0.0;2.1) and mean (±SD) of 1.65 (±2.89)2,3

Patients with 0 or 1 spontaneous bleed (defined as a joint or muscle bleed and no identified trauma) during weeks 1-10 of the main study.2

Patients with 2 or more spontaneous bleeds (defined as joint or muscle bleeds and no identified trauma) during weeks 1-10 of the main study.2

n=9/13 of these patients were on prior prophylaxis and had a mean number total ABR of 17.4 before entering the main study.1

 

ABR, annualized bleed rate

In the PROTECT VIII long-term extension study

ABRs assessed with Jivi®4

While there were no predetermined efficacy objectives in the extension study, bleeding episodes were documented during the routine course of treatment

Study Design Chart
Study Design Chart

Treatment success in the every-7-day was not established

Total ABR in all patients on every-7-day dosing arm in the extension study (n=23); median (Q1;Q3) ABR for total bleeds of 0.7 (0;1.6) and a mean (±SD) of 2.0 (±4.1)4

Spontaneous ABR in all patients on every-7-day dosing arm in the extension study (n=23); median (Q1;Q3) ABR for spontaneous bleeds of 0.2 (0.0;0.8) and a mean (±SD) of 1.5 (±4.0)4

As of 1/31/2018 cutoff.4

Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate, variable-frequency group.5

 

ABR, annualized bleed rate

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. August 2018. Bayer. 2. Reding MT et al. J Thromb Haemost 2017;15:411-419. 3. Data on file. CSR 13024-A. Bayer; 2018.
4. Data on file. Jivi PROTECT VIII Extension JAN 2018 CSR ABR data. 5. Lalezari S et al. Haemophilia 2019;25:1011-1019.

References: 1. Jivi Prescribing Information. August 2018. Bayer. 2. Reding MT et al. J Thromb Haemost 2017;15:411-419. 3. Data on file. CSR 13024-A. Bayer; 2018. 4. Data on file. Jivi PROTECT VIII Extension JAN 2018 CSR ABR data. 5. Lalezari S et al. Haemophilia 2019;25:1011-1019.