See additional questions about general topics, Kovaltry® and insurance below.
Questions about Jivi®
Jivi is an extended half-life (EHL) product that offers previously treated adults and adolescents (12 years of age and older) with hemophilia A the potential for fewer infusions. Jivi has a twice weekly starting dose and the potential (based on bleeding episodes) to step up to every 5 days and fine tune.1 Kogenate FS and Jivi are both manufactured using the same type of cell line. Jivi is not for use in patients under 12 years of age or in previously untreated patients.1
Yes, Jivi clinical trials evaluated efficacy and safety for on-demand treatment, perioperative management of bleeding and routine prophylaxis in 132 previously treated adult and adolescent patients ≥ 12 years during the Protect VIII clinical trial.* A post-hoc subgroup analysis was also completed to evaluate the 48 patients who transitioned from Kogenate FS to Jivi as part of these trials.†1,2 Click here for efficacy and safety data on these patients.
Jivi was approved by the FDA in 2018 based on efficacy and safety data in the treatment and control of bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Jivi is not for use in patients under 12 years of age or in previously untreated patients.1
Jivi is manufactured using the same type of cell line as Kogenate FS.1,3
Yes, both Jivi and Kogenate FS use the same Vial Adapter reconstitution system.1,3
If the dose requires more than one vial, your patient should first reconstitute each vial as described in the Jivi Vial Adapter instructions with the diluent syringe provided. Then, to combine the contents of the vials, a patient should use a larger plastic syringe (not provided) to pool the solution into the syringe and administer as usual.
Yes, Jivi is packaged with a 25-gauge butterfly needle.1
Store Jivi under refrigeration at 36°F to 46°F. Do not freeze. Jivi may be stored for a single period of up to 6 months at temperatures up to 77°F. 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.1 Visit the Jivi HCP website for the full details on storing Jivi.
No, PK testing is not required for patients to transition from Kogenate FS to Jivi; however, eligible patients can receive up to $250 per year to offset out-of-pocket costs for laboratory testing of Jivi.‡§
- Click here to access the Jivi reimbursement for lab testing claim form for your patients.
Pharmacokinetic data for Jivi, including data from two randomized, crossover PK studies comparing Jivi to Eloctate and comparing Jivi to Adynovate, can be found by visiting JiviPK.com.
Yes, Jivi is approved for perioperative management of bleeding.1