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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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
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
In the PROTECT VIII main study
Median Jivi® doses were within recommended label dosing1*
Twice weekly | ||
Bleeding Tendency | Recommended Dose in Label | Median (Range) Prophylaxis Dose/Infusion |
LOW (n=11)1 HIGH* (n=13)1 | 30-40 IU/kg1 | 30.6 IU/kg (29-41 IU/kg)1 39.2 IU/kg (33-42 IU/kg)1 |
Every 5 days | ||
LOW* (n=43)1 | 45-60 IU/kg1 | 45.3 IU/kg (39-58 IU/kg)1 |
Patients received prophylactic therapy for 26 weeks after a 10-week run-in period of twice-weekly 25 IU/kg. Patients that had high bleeding tendency (>1 breakthrough bleeds during the run-in) continued on twice-weekly 30-40 IU/kg. Patients with ≤1 breakthrough bleeds during the run-in were randomized to less frequent dosing of every 5 days (45-60 IU/kg) or every 7 days. After randomization groups were full, remaining eligible patients continued with twice-weekly 30-40 IU/kg.2
In the PROTECT VIII long-term extension study
Median Jivi® doses were within recommended label dosing1,3
|
Twice weekly |
||
|
Bleeding Tendency |
Recommended Dose in Label |
Median (Range) Prophylaxis Dose/Infusion |
|
LOW and HIGH1* (n=23) |
30-40 IU/kg1 |
36.7 IU/kg3 (26.8 - 42.8) |
|
Every 5 days |
||
|
LOW1 (n=33) |
45-60 IU/kg1 |
44.8 IU/kg3 (40.7 - 59.6) |
|
Variable frequency† |
||
|
Varied tendency1(n=28) |
Varied label dose |
50.7 IU/kg3 (29.1 – 63.8) |
Patients received prophylactic therapy for 26 weeks after a 10-week run-in period of twice-weekly 25 IU/kg. Patients that had high bleeding tendency (>1 breakthrough bleeds during the run-in) continued on twice-weekly 30-40 IU/kg. Patients with ≤1 breakthrough bleeds during the run-in were randomized to less frequent dosing of every 5 days (45-60 IU/kg) or every 7 days. After randomization groups were full, remaining eligible patients continued with twice-weekly 30-40 IU/kg.2
Patients who switched at least once after the first week of the extension study were analyzed in a separate variable frequency group.3
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. Reding M, et al. Haemophilia. 2021; 10.1111/hae.14297.
