Details for: JIVI

JIVI is given by injection into the bloodstream (intravenously).

JIVI should be injected intravenously over a period of 1 to 15 minutes depending on the total volume. The rate of administration depends on your comfort level. The maximum infusion rate is 2.5 mL/min.

Administer reconstituted JIVI as soon as possible. If not, store at room temperature for no longer than 3 hours.

You must use aseptic conditions (meaning clean and germ free) during reconstitution and administration. Use only the medical devices (Vial Adapter, pre-filled syringe containing diluent and administration set) for reconstitution and administration that are provided with each carton of JIVI. If a device package is opened or damaged, do not use this medical device. If these devices cannot be used, please contact your healthcare provider. If you have any questions about JIVI, contact Bayer at 1-800-265-7382 or canada.medinfo@bayer.com.

JIVI must not be mixed with other medicinal products or solvents. Follow the directions given by your doctor closely and use the instructions below as a guide:

1. Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37°C, 99°F).
2. Remove protective cap from the vial (A). Disinfect the rubber stopper with alcohol, being careful not to handle the rubber stopper.

3. Place product vial on a firm, non-skid surface. Peel off the paper cover on the Vial Adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. Do not remove the adapter housing at this step.

4. Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.

5. Now remove and discard the adapter housing (D).

6. Attach the pre-filled syringe to the threaded Vial Adapter by turning clockwise (E).

7. Grasp the plunger rod by the top plate and remove from carton. Avoid touching the sides and threads of the plunger rod. Immediately attach the plunger rod by turning it firmly clockwise into the threaded syringe rubber stopper (F).

8. Inject the diluent by slowly pushing down on the plunger rod (G).

9. Swirl vial gently until all material is dissolved (H). Do not shake vial. Be sure that the powder is completely dissolved. Do not use solutions containing visible particles or that are cloudy.

10. Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upsidedown (invert) so the vial is now above the syringe (I).

11. Withdraw all the solution into the syringe by pulling the plunger rod back slowly and smoothly (J). Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.

12. Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the administration set provided and inject intravenously (K). NOTE: follow instructions for infusion set provided. The small amount of drug product left in the administration set will not affect your treatment.

If the same patient is to receive more than one bottle, reconstitute each bottle with the diluent syringe provided then combine solutions in a larger syringe (not provided) and administer as usual.

Visually inspect the reconstituted JIVI solution for particulate matter and change in colour before administration. JIVI should be clear and colourless. Do not use JIVI if you see particles or if the solution is cloudy.

Documentation

It is recommended that every time you use JIVI, you note down the name and batch number of the product.

Usual dose:

Prevention of bleeding (prophylaxis)
JIVI can be used to increase Factor VIII levels in your body to help prevent bleeding before it happens, and to protect joints.

The recommended initial regimen is 30-40 IU/kg twice weekly. Based on bleeding episodes, the regimen can be adjusted to 45-60 IU/kg every 5 days. A regimen may be further individually adjusted to more or less frequent dosing.

Because everyone is different, your doctor will individualize your JIVI regimen to meet your specific needs. To get the most out of your treatment, be sure to administer JIVI at the dose and frequency prescribed by your doctor.

Treatment of bleeding
How much JIVI you should use and how often you should use it depends on many factors, including your weight, the severity of your hemophilia, where the bleed is and how serious it is, whether you have inhibitors and the level of inhibitors your blood, and the Factor VIII level that is needed.

Your doctor will calculate the dose of JIVI and how frequently you should use it to get the necessary level of Factor VIII activity in your blood. He/she should always adjust the amount of JIVI to be administered and the frequency of administration according to your individual needs. Under certain circumstances larger amounts than those calculated may be required, especially for the initial dose.

Laboratory Test
After treatment, it is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate Factor VIII levels have been reached and are maintained. For major surgery in particular, close monitoring of the treatment by means of coagulation analysis must be carried out.

If bleeding is not controlled
If the Factor VIII level in your plasma fails to reach expected levels, or if bleeding is not controlled after adequate dose, you may have developed Factor VIII inhibitors. This must be checked by an experienced doctor.

If you feel the effect of JIVI is too strong or too weak, talk to your doctor. Patients with inhibitors
If you have been told by your doctor that you have developed Factor VIII inhibitors, you may need to use a larger amount of JIVI to control bleeding.

Do not increase your dose of JIVI you use to control your bleeding without consulting your doctor.

Duration of treatment
Your doctor will tell you, how often and at what intervals JIVI is to be administered.
Usually, replacement therapy with JIVI is a life-time treatment. Overdose:
No symptoms of overdose with recombinant human coagulation Factor VIII have been reported.


Missed Dose:

Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.

Do not take a double dose to make up for a forgotten dose.