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Antihemophilic Factor (Recombinant) Pegylated-Aucl (Jivi)

Trade Name : Jivi

Bayer HealthCare LLC

KIT, PLASMA DERIVATIVE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Antihemophilic Factor (Recombinant) Pegylated-Aucl (Jivi) which is also known as Jivi and Manufactured by Bayer HealthCare LLC. It is available in strength of per ml. Read more

Antihemophilic Factor (Recombinant) Pegylated-Aucl (Jivi) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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:
  • Limitations of Use
  • Jivi is not indicated for use in children < 12 years of age due to 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.
  • 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:
  • Limitations of use
  • Jivi is not indicated for use in children < 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.
  • For intravenous use after reconstitution only.
  • For intravenous use after reconstitution only.
  • 2.1
  • 2.1
  • Jivi is available as a white to slightly yellow lyophilized powder in single-use glass vials containing nominally 500, 1000, 2000, or 3000 IU of Factor VIII potency per vial.
  • Each vial of Jivi is labeled with actual Factor VIII potency expressed in IU determined using a chromogenic substrate assay. This potency assignment employs a Factor VIII concentrate standard that is referenced to the current WHO International Standard for Factor VIII concentrate, and is evaluated by appropriate methodology to ensure accuracy of the results.
  • u00a0
  • 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 n
  • 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 ().
  • No data
  • ).
  • 5.2n- 5.3
  • ,
  • The most frequently (u2265 5%) reported adverse reactions in clinical trials in previously treated patients (PTPs) u2265 12 years of age were headache, cough, nausea and fever (see Table 3) .
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • A total of 221 subjects constituted the safety population from three studies. Subjects who received Jivi for perioperative management (n=17) with treatment period of 2 to 3 weeks were excluded from pooled safety analysis but included in analysis for inhibitor development. The median EDs for adults and adolescents (u2265 12 years of age) was 131 EDs (range: 1u2013309) per subject; and the median EDs for subjects < 12 years of age was 53 EDs (range: 1u201368) per subject.
  • The most frequently reported adverse reactions in clinical trials in previously treated patients (PTPs) u2265 12 years of age (u2265 5%) were headache, cough, nausea and fever ().
  • No data
  • u00a0
  • 8.4
  • Jivi [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration. The product is supplied in single-use vials containing dosage strengths of 500, 1000, 2000 and 3000 IU in 2.5 mL fill size. For each dosage strength, the actual assayed potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sWFI, prefilled diluent syringe. Jivi is formulated with the following excipients: 59 mg glycine, 27 mg sucrose, 8.4 mg histidine, 4.7 mg sodium chloride, 0.7 mg calcium chloride, and 0.216 mg polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0.
  • The specific activity of Jivi is approximately 10,000 IU/mg protein.
  • The active protein (or starting molecule), prior to conjugation is a recombinant B-domain deleted human coagulation Factor VIII (BDD-rFVIII) produced by recombinant DNA technology in Baby Hamster Kidney (BHK) cells.
  • Jivi is produced by site-specific conjugation of the BDD-rFVIII variant K1804C at the cysteine amino acid position 1804 (within the A3 domain) with a single maleimide-derivatized, 60 kilodalton (kDa) branched PEG (two 30 kDa PEG) moiety. The A3 domain was selected for conjugation to provide both a consistent coagulation activity and high PEGylation efficiency.
  • The molecular weight of Jivi is approximately 234 kDa based on the calculated average molecular weight of the BDD-rFVIII variant of 165 kDa, plus glycosylation (~4 kDa), and the average molecular weight of the PEG-maleimide of approximately 60 kDa. Functional characterization of Jivi shows comparable mechanism of action to that of rFVIII product with an extended plasma half-life .
  • The manufacturing process of Jivi involves propagation of the recombinant production cell line with the harvest isolation process consisting of continuous filtration of tissue culture fluid and anion exchange chromatography on a membrane adsorber capsule. The process intermediate is purified from process- and product-related impurities using a series of chromatography and filtration steps, including 20 nm viral filtration, prior to conjugation to the 60 kDa maleimide PEG moiety. The mono-PEGylated Jivi active molecule is separated from product-related species by chromatography and then formulated by ultrafiltration. The cell culture, PEGylation, purification process and formulation used in the manufacture of Jivi do not use any additives of human or animal origins.
  • No data
  • No data
  • The efficacy of Jivi for on-demand treatment, perioperative management of bleeding and routine prophylaxis in male subjects with severe hemophilia A were evaluated in one international (including U.S.) clinical study in subjects u2265 12 years. Immunocompetent subjects with severe hemophilia A (Factor VIII activity <1%) and no history of Factor VIII inhibitors were eligible for the trial.
  • Study 1 (NCT01580293): A multinational, open-label, uncontrolled, partially randomized study in adolescent and adult (12 to 65 years of age) previously treated patients (PTPs) (u2265 150 exposure days [EDs]) consisted of three parts: Part A (Weeks 0 u2013 36); an optional extension phase for subjects who completed Part A to accumulate at least 100 EDs; and Part B, a surgical phase.
  • Part A of the study evaluated the PK (single dose of 60 IU/kg), safety and efficacy of Jivi for on-demand treatment and routine prophylaxis (see Table 5). A total of 134 PTPs (12 to 65 years of age) received at least one infusion of Jivi, including 13 subjects ages 12 to 17 years. One hundred thirty two subjects were evaluable for efficacy, of which 126 (94%) subjects (prophylaxis group: n=108; on-demand group: n=18) completed the 36 weeks of treatment in Part A. The primary efficacy variable was annualized bleed rate (ABR).
  • A total of 121 subjects received treatment during the extension phase of Study 1 [107u00a0subjects received prophylaxis; 14u00a0subjects continued episodic (onu2011demand) treatment].
  • Safety and efficacy of Jivi in hemostasis during major surgical procedures were evaluated in Part B. Seventeen subjects participated in Part B of Study 1.
  • 1. 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. 2018;00:1-10. n
  • 2. Coyle TE, Reding MT, Lin JC, Michaels LA, Shah A, Powell J. Phase I study of BAY 94-9027, a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A. . 2014;12(4):488-496. doi:10.1111/jth.12506.
  • 3. Reding MT, Ng HJ, Poulsen LH, etu00a0al. Safety and efficacy of BAY 94u20109027, a prolongedu2010halfu2010life factor VIII. . 2017;15:411u2010419.
  • No data
  • No data
  • FDA-Approved Patient Labeling
  • Patient Information
  • Jivi ()
  • antihemophilic factor (recombinant), PEGylated-aucl
  • This leaflet summarizes important information about Jivi with vial adapter. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Jivi. If you have any questions after reading this, ask your healthcare provider.
  • Do not attempt to self-infuse, unless your healthcare provider or hemophilia center has taught you how to self-infuse.
  • What is Jivi?
  • Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (congenital Factor VIII deficiency).
  • Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older ) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
  • Jivi is not for use in children < 12 years of age or in previously untreated patients.
  • Jivi is not used to treat von Willebrand disease.
  • Who should not use Jivi?
  • You should not use Jivi if you
  • What should I tell my healthcare provider before I use Jivi?
  • Tell your healthcare provider about:
  • What are the possible side effects of Jivi?
  • The common side effects of Jivi are headache, cough, nausea and fever.
  • Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea. Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.
  • Your body can also make antibodies, called u201cinhibitorsu201d, against Jivi, which may stop Jivi from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
  • If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.
  • These are not all the possible side effects with Jivi. You can ask your healthcare provider for information that is written for healthcare professionals.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • What are the Jivi dosage strengths?
  • Jivi with 2.5 mL Sterile Water for Injection (SWFI) comes in four different dosage strengths labeled as International Units (IU): 500 IU, 1000 IU, 2000 IU, and 3000 IU. The four different strengths are color-coded as follows:
  • How do I store Jivi?
  • Do not freeze Jivi .
  • Store Jivi at +2u00b0C to +8u00b0C (36u00b0F to 46u00b0F) for up to 24 months from the date of manufacture. Within this period, Jivi may be stored for a period of up to 6 months at temperatures up to +25u00b0C or 77u00b0F.
  • Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.
  • Administer reconstituted Jivi as soon as possible. If not, store at room temperature for no longer than 3 hours.
  • Throw away any unused Jivi after the expiration date.
  • Do not use reconstituted Jivi if it is not clear.
  • What else should I know about Jivi and hemophilia A?
  • Medicines are sometimes prescribed for purposes other than those listed here. Do not use Jivi for a condition for which it is not prescribed. Do not share Jivi with other people, even if they have the same symptoms that you have.
  • This leaflet summarizes the most important information about Jivi that was written for healthcare professionals.
  • Instructions for Use
  • Jivi-antihemophilic factor (recombinant), PEGylated-aucl
  • Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.
  • You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using Jivi. If you are unsure of the procedures, please call your healthcare provider before using.
  • If bleeding is not controlled after using Jivi, then call your healthcare provider right away.
  • Your healthcare provider will prescribe the dose that you should take.
  • Your healthcare provider may need to take blood tests from time to time.
  • Talk to your healthcare provider before traveling. You should plan to bring enough Jivi for your treatment during this time.
  • See the step-by-step instructions below for reconstituting (mixing) Jivi with vial adapter. Follow the specific infusion instruction leaflet included with the infusion set provided.
  • Carefully handle Jivi. Dispose of all materials, including any leftover reconstituted Jivi product, in an appropriate container.
  • Use only the components for reconstitution and administration that are provided with each package of Jivi. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider. Gather all the materials needed for the infusion.
  • Reconstitution
  • Always work on a clean flat surface and wash your hands before performing the following procedures.
  • Rate of Administration
  • The entire dose of Jivi can usually be infused within 1 to 15 minutes. The maximum rate is 2.5 mL per minute. Your healthcare provider will determine the rate of administration that is best for you.
  • Resources at Bayer available to the patient:
  • For Adverse Reaction Reporting, contact Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937)
  • To receive more product information, contact Jivi Customer Service 1-888-606-3780
  • Bayer Reimbursement HELPline 1-800-288-8374
  • For more information, visit n
  • Bayer HealthCare LLCWhippany, NJ 07981 USA
  • U.S. License No. 0008
  • NDC 0026-3942-25
  • Jivi
  • 500 IU Range
  • Antihemophilic Factor (Recombinant)
  • PEGylated-aucl
  • Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3944-25
  • Jivi
  • 1000 IU Range
  • Antihemophilic Factor (Recombinant)
  • PEGylated-aucl
  • Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3946-25
  • Jivi
  • 2000 IU Range
  • Antihemophilic Factor (Recombinant)
  • PEGylated-aucl
  • Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3948-25
  • Jivi
  • 3000 IU Range
  • Antihemophilic Factor (Recombinant)
  • PEGylated-aucl
  • Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set

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