For: Hemophilia A
Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, Factor VIII concentrate indicated to treat and control bleeding in patients with hemophilia A. How Supplied
Jivi is available as a lyophilized powder in single-use glass vials, one vial per carton. It is supplied with a sterile vial adapter with 15-micrometer filter and a prefilled diluent glass barrel syringe, which together serve as a needleless reconstitution system. The prefilled diluent syringe contains Sterile Water for Injection, USP. An administration set is also provided in the package. Available sizes:
Nominal Strength (IU)
Diluent (mL)
Kit NDC Number
Color Code
500
2.5
0026-3942-25
Green
1000
2.5
0026-3944-25
Red
2000
2.5
0026-3946-25
Yellow
3000
2.5
0026-3948-25
Gray
Actual Factor VIII activity in IU is stated on the label of each Jivi vial.
The product vial and diluent syringe are not made with natural rubber latex.
Storage and Handling
Product as Packaged for Sale
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Store Jivi at +2�C to +8�C (36�F to 46�F) for up to 24 months from the date of manufacture. Do not freeze. Within this period, Jivi may be stored for a single period of up to 6 months at temperatures up to +25�C or 77�F.
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Record the starting date of room temperature storage on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier.
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Do not use Jivi after the expiration date indicated on the vial.
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Protect Jivi from extreme exposure to light and store the vial with the lyophilized powder in the carton prior to use.
Product After Reconstitution
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Administer reconstituted Jivi as soon as possible. If you do not administer the reconstituted Jivi immediately, then store at room temperature for no longer than 3 hours.
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Do not use Jivi if the reconstituted solution is cloudy or has particulate matter.
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Use the administration set provided. hese highlights do not include all the information needed to use JIVI safely and effectively. See full prescribing information for JIVI.
JIVI� [antihemophilic factor (recombinant), PEGylated-aucl]
lyophilized powder for solution, for intravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
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:
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On-demand treatment and control of bleeding episodes
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Perioperative management of bleeding
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Routine prophylaxis to reduce the frequency of bleeding episodes (1)
Limitations of use
Jivi is not indicated for use in children < 12 years of age due to a greater risk for hypersensitivity reactions. (8.4)
Jivi is not indicated for use in previously untreated patients (PUPs).
Jivi is not indicated for the treatment of von Willebrand disease.
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
Control of bleeding episodes and perioperative management (2.1)
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Expected recovery: one unit per kilogram body weight of Jivi will increase the Factor VIII level by 2 international units per deciliter (IU/dL). Each vial of Jivi contains the labeled amount of recombinant Factor VIII in IU (3).
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Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected recovery (or observed recovery, if available).
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Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg).
Routine prophylaxis (2.1)
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The recommended initial regimen is 30�40 IU/kg twice weekly.
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Based on the bleeding episodes:
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The regimen may be adjusted to 45�60 IU/kg every 5 days.
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A regimen may be further individually adjusted to less or more frequent dosing.
DOSAGE FORMS AND STRENGTHS
Jivi is available as lyophilized powder in single-use vials containing nominally 500, 1000, 2000, or 3000 IU (3).
CONTRAINDICATIONS
Do not use 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 (4).
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions, including severe allergic reactions, have occurred. Monitor patients for hypersensitivity symptoms. Should hypersensitivity symptoms occur, discontinue treatment with Jivi and administer appropriate treatment. Hypersensitivity reactions may also be related to antibodies against polyethylene glycol (PEG) (5.1, 5.3).
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Development of Factor VIII neutralizing antibodies can occur. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, then perform an assay that measures Factor VIII inhibitor concentration (5.2, 5.3).
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Immune response to PEG, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed primarily in subjects < 6 years of age. Evaluate patients experiencing symptoms of hypersensitivity reactions in the absence of detectable Factor VIII inhibitors for possible bleeding or reduced recovery (5.3, 6.1) .
ADVERSE REACTIONS
The most frequently reported adverse reactions in clinical trials in previously treated patients (PTPs) ? 12 years of age (? 5%) were headache, cough, nausea and fever (6).
To report SUSPECTED ADVERSE REACTIONS, contact Bayer at 1?888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Jivi is not for use in children < 12 years of age or in previously untreated patients (PUPs) (8.4).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2018