Jivi

Jivi is a prescription medication used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Jivi belongs to a group of drugs called, hematological agents. These help to clot blood and stop bleeding.

This medication is available as an injection form and is to be injected directly into a vein (IV) by a healthcare professional.

Common side effects of Jivi include headache, cough, nausea and fever.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bayer Healthcare Pharmaceuticals Inc.

Jivi may cause serious side effects. See "Drug Precautions" section.

Common side effects include:

• headache
• cough
• nausea
• 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 “inhibitors”, 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.

This is not a complete list of Jivi side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medications to clot your blood.

This is not a complete list of Jivi drug interactions. Ask your doctor of pharmacist for more information.

Serious side effects may occur with Jivi which include:

• Serious allergic reactions

  • Chest or throat tightness
  • Dizziness
  • Mild hypotension
  • Nausea
• If any of these symptoms occur, seek immediate medical attention because these could be the first signs of a severe allergic reaction.
• Your body may develop antibodies to this medication and therefore Jivi may not work as well as it should.

Do not use this medication if you are allergic to:

• polyethylene glycol (PEG)
• mouse or hamster protein
• any ingredient found in Jivi

Medications can interaction with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jivi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Jivi, tell your doctor about all of your medical conditions. Especially tell you doctor if you:

• if you have been told that you have inhibitors to Factor VIII.
• are allergic to rodents (like mice and hamsters).
• are allergic to polyethylene glycol (PEG).
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no studies that have been done in humans with Jivi. It is not known if Jivi may harm your unborn baby.

Talk to your healthcare provider about the risks and benefits of taking Jivi while pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Jivi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jivi.

Receive Jivi exactly as prescribed.

Jivi comes as an injectable form and is given directly into a vein (IV) by a health care professional. The frequency depends on how severe the bleeding is. For bleeding prevention, the initial schedule is twice a week.

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. 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. 
• 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

• Warm the unopened diluent syringe and the concentrate vial to a temperature not to exceed 37°C or 99°F.
• Remove protective cap from the vial. Aseptically cleanse the rubber stopper with a sterile alcohol swab, being careful not to handle the rubber stopper.
• 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. The adapter will snap over the vial cap. Do not remove the adapter housing at this step.
• Holding the syringe by the barrel, snap the syringe cap off the tip. Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
• Now remove and discard the adapter plastic housing.
• Attach the prefilled syringe to the vial adapter thread by turning clockwise.
• Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe.
• Inject the diluent slowly by pushing down on the plunger rod.
• Swirl vial gently until all powder on all sides of the vial is dissolved. Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.
• Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe. Pooling: Pooling is a process of combining the contents of multiple vials into a syringe. If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. To combine the contents of the vials, use a larger plastic syringe (not provided) to pool the solution into the syringe and administer as usual.
• Filter the reconstituted product to remove potential particulate matter in the solution. Filtering is achieved by using the vial adapter. Withdraw all the solution through the vial adapter into the syringe by pulling the plunger rod back slowly and smoothly. 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.
• Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the infusion set provided and inject the reconstituted product intravenously. NOTE: follow instructions for infusion set provided.

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.

The dose you doctor recommends may be based on the following:

• Severity of the bleed

• Body weight

• Lab results

• Condition being treated

The number of doses will be determined by several factors and may be adjusted accordingly.

Control of bleeding episodes and perioperative management 

• 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.
• 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).
• 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 

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

If Jivi is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Do not freeze Jivi.

Store Jivi at +2°C to +8°C (36°F to 46°F) 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 +25°C or 77°F.

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.

This page was written by Christine Borunda, PharmD Candidate 2020 | UT Austin College of Pharmacy