SELECTED IMPORTANT SAFETY INFORMATION: You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi. CONTINUE READING BELOW

Jivi vs. Eloctate - PK Comparison

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    Jivi® rFVIII levels remain elevated and sustained over time

    • The pharmacokinetics (PK) of Jivi® were investigated in 29 severe hemophilia A patients (≥12 years of age) following a single 60 IU/kg dose
    • Pharmacokinetics is the activity of drugs in the body over a period of time

    PK was primarily measured by*

    Clearance—the speed at which a drug is removed from the body

    Area under the curve—the total amount of a drug that reaches the bloodstream, measured by plasma concentration, over time

    Half-life—the amount of time that it takes for the concentration of a drug to be reduced by half; used to determine how long a drug remains active in the body

    PK was primarily measured by*

    Clearance—the speed at which a drug is removed from the body

    Area under the curve—the total amount of a drug that reaches the bloodstream, measured by plasma concentration, over time

    Half-life—the amount of time that it takes for the concentration of a drug to be reduced by half; used to determine how long a drug remains active in the body

    Jivi® is a PEGylated rFVIII with an extended half-life§ of 17.9 hours

    Half-life of 17.9 hours
    IU, international units; kg, kilograms; PEG, polyethylene glycol; rFVIII, recombinant Factor VIII.
    Other PK parameters measured were maximum drug concentration in plasma after a single dose, mean residence time after an IV administration, and apparent volume of distribution at steady state.
    Clearance measured 1.63 mL/h/kg.
    Area under the curve measured 4060 IU*h/dL.
    Half-life is defined as the time it takes for the amount of a drug in the blood to decrease by one half.
    With a single, 60 IU/kg dose.

    Hear why Chama knew he wanted an extended half-life factor VIII product.

    Jivi® vs Eloctate® PK comparison

    Jivi® and Eloctate® compared PK parameters in a crossover study of 18 male patients aged 18-65 with severe hemophilia A. Patients were each given a single dose of either Jivi® or Eloctate®, then halfway through the study, following a washout, patients switched to a single dose of the other treatment

    One patient with preexisting anti-PEG antibodies had significantly different PK results. This patient was determined to be an outlier. Including this outlier patient in the analysis (N=18), there were no PK differences observed. The outlier patient was excluded from further analysis

    Jivi® vs Eloctate® PK Comparison

    In the 17 patients (excluding the outlier), there were 3 statistically significant PK differences:

    Compared with Eloctate®

    Jivi® gave patients a HIGHER AMOUNT of medication available for clotting over time*

    Jivi® REMAINED LONGER in the body

    Jivi® had a LONGER HALF-LIFE

    Compared with Eloctate®

    Jivi® gave patients a HIGHER AMOUNT of medication available for clotting over time*

    Jivi® REMAINED LONGER in the body

    Jivi® had a LONGER HALF-LIFE

    Jivi® demonstrated more time before reaching minimum FVIII levels

    Jivi® median time to minimum FVIII levels (compared to Eloctate®) in a population PK analysis (excluding the outlier patient, N=17)®

    Horizontal bar chart illustrating that Jivi demonstrated more time before reaching minimum FVIII levels. The minimum FVIII levels is the factor concentration just above any level that may raise the risk of bleeds. All patients have a different minimum factor level that meets their needs. Ask your doctor which FVIII level is right for you.
      PK, pharmacokinetics; FVIII, factor VIII.
    *Jivi® had a higher mean area under the curve (+25%).
    Jivi® had lower mean clearance (-20%). 
    Jivi® had a longer mean half-life (+7%).
    §Adapted from Shah et al. A population PK model was developed based on data obtained by a one-stage assay to simulate time to reach FVIII thresholds of 1, 3, 5, and 10% FVIII.

    Compared with Eloctate®, Jivi® demonstrated statistically significantly (N=17):

    Image summarizing that Jivi had a higher amount of medication available for clotting over time, remained longer in the body, had a longer half-life and offered more time before reaching minimum factor VIII levels

    For N=18 patients, including the PK outlier patient, Jivi® demonstrated noninferiority to Eloctate® for AUC(0-tlast)*

    Ask your doctor if the pharmacokinetic coverage of Jivi® is right for you.

    Ask your doctor if the pharmacokinetic coverage of Jivi® is right for you.

      PK, pharmacokinetics; FVIII, factor VIII.
    *Jivi® had a higher mean area under the curve (+25%).
    Jivi® had lower mean clearance (-20%). 
    Jivi® had a longer mean half-life (+7%).
    §10%: 63 hours on Jivi® vs 52 hours on Eloctate®; 5%: 79 hours on Jivi® vs 67 hours on Eloctate®;
     3%: 91 hours on Jivi® vs 79 hours on Eloctate®; 1%: 117 hours on Jivi® vs 104 hours on Eloctate®.

    PK, pharmacokinetics.

    INDICATIONS

    Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

    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 below 12 years of age or in previously untreated patients.

    Jivi is not used to treat von Willebrand disease.

    IMPORTANT SAFETY INFORMATION

    You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.

    Tell your healthcare provider about all of your medical conditions that you have or had.

    Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.

    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 “inhibitors,” against Jivi, which may stop Jivi from working properly. Consult 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.

    The common side effects of Jivi are headache, cough, nausea, and fever.

    These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does
    not go away.

    For additional important risk and use information, please see the full Prescribing Information.

    References: Anderson PL. The ABCs of pharmacokinetics. http://www.thebody.com/content/art875.html. Accessed April 2018. • Collins PW, Blanchette VS, Fischer K, et al. Break-through bleeding in relation to predicted factor VIII levels in patients receiving prophylactic treatment for severe hemophilia A. J Thromb Haemost. 2009;7(3):413-420. • Data on file. 2.5 Clinical Overview. Bayer; 2017. • Data on file. Tx Review 1018. Bayer; 2018. • Dhillon S, Gill K. Basic pharmacokinetics. In: Dhillon S, Kostrzewski A, eds. Clinical Pharmacokinetics. London, UK: Pharmaceutical Press; 2006. • Ivens IA, Baumann A, McDonald TA, Humphries TJ, Michaels LA, Mathew P. PEGylated therapeutic proteins for haemophilia treatment: a review for haemophilia caregivers. Haemophilia. 2013;19(1):11-20. • Jivi® Prescribing Information. Whippany, NJ: Bayer LLC; 2018. • Ratain MJ, Plunkett WK Jr. Principles of pharmacokinetics. In: Kufe DW, Pollock RE, Weichselbaum RR, et al, eds. Holland-Frei Cancer Medicine. 6th ed. Hamilton, Ontario: BC Decker, Inc; 2003. • Shah A, Solms A, Wiegmann S, et al. Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A. Ann Hematol. 2019;1-10. https://link.springer.com/article/10.1007%2Fs00277-019-03747-2. Published June 24, 2019. Accessed June 25, 2019. • Veronese FM, Mero A. The impact of PEGylation on biological therapies. BioDrugs. 2008;22(5):315-329. • Webster R, Elliot V, Park BK, Walker D, Hankin M, Taupin P. PEG and PEG conjugates toxicity: towards an understanding of the toxicity of PEG and its relevance to PEGylated biologicals. In: Veronese FM, ed. PEGylated Protein Drugs: Basic Science and Clinical Applications. Basel, Switzerland: Birkhäuser Verlag/Switzerland; 2009:127-146.