Jivi (Bayer, 500 Unit, ..., 3000 Unit): Uses, Side Effects and Dosage

What JIVI is used for:

JIVI is for the treatment of hemophilia A in previously treated patients (PTPs) 7 years of age and older. JIVI can be used to:

• Prevent bleeding before it happens
• Stop a bleeding episode that has already began.

JIVI is not for the treatment of von Willebrand disease.

JIVI is not for use in children less than 7 years of age and in previously untreated patients.

How JIVI works:

• In people without hemophilia A, a protein called Factor VIII is produced naturally by the body to help the blood form clots and stop bleeding.
• People with hemophilia A do not have enough Factor VIII in their bodies. When they are injured, they may bleed internally, which can lead to damage in muscles and joints.
• JIVI is a medicine containing clotting Factor VIII. It is very similar to the Factor VIII that occurs naturally in human blood. JIVI raises the level of Factor VIII in the blood to help prevent bleeding (prophylaxis) or stop it when it happens. JIVI is given directly into the blood through an injection in a vein.
• JIVI is made without addition of any human- or animal-derived components in the manufacturing process.

The ingredients in JIVI are:

Medicinal ingredient: Antihemophilic Factor (Recombinant, B-domain deleted, PEGylated)

Non-medicinal ingredients: Calcium chloride, Histidine, Glycine, Polysorbate 80, Sodium chloride, Sucrose

JIVI comes in the following dosage forms:

JIVI is available in single-use vials that contain nominally 500, 1000, 2000, or 3000 International Units (IU) per vial. After reconstitution with the supplied diluent (sterile water for injection), the prepared solution for injection will have the following concentration:

Do not use JIVI if:

• you are allergic (hypersensitive) to JIVI, or to any of the other ingredients of JIVI
• you have had allergic reactions to mouse or hamster protein

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JIVI. Talk about any health conditions or problems you may have, including if you:

• are allergic to mouse or hamster protein.

Other warnings you should know about:

Allergic reactions to JIVI have occurred.

If you experience tightness in the chest, feel dizzy, sick or faint, or experience dizziness upon standing, you may be experiencing a rare severe sudden allergic reaction (a so-called anaphylactic reaction) to JIVI. If this occurs, stop administration of the product immediately and seek medical advice.

Your doctor may carry out tests to ensure that your current dose of JIVI provides adequate Factor VIII levels.

• If your bleeding is not being controlled with your usual dose of JIVI, consult your doctor immediately. Your body may have formed molecules known as Factor VIII inhibitors and your doctor may carry out tests to confirm this. Factor VIII inhibitors are antibodies in the blood and are a natural part of the body’s defense system. Your doctor may consider other treatment options.
• Antibodies to PEG may block the activity of JIVI, making it less effective to prevent and control bleeding. Your doctor may switch you to your previous Factor VIII treatment without delay.

When frequent injections are required, your healthcare professional may propose to have a device (called a catheter) surgically placed under the skin to facilitate access to the bloodstream. This device may result in an infection. Inform your healthcare provider if you have a catheter-related infection.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with JIVI:

• No interactions with other medicines are known.

How to take JIVI:

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

Treatment with JIVI will be started by your healthcare professional who will monitor your response to treatment.

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. 1. Warm both unopened vial and syringe in your hands to a comfortable temperature (do not exceed 37°C, 99°F).

1. 2.

   Remove protective cap from the vial (A). Disinfect the rubber stopper with alcohol, being careful not to handle the rubber stopper.

1. 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.

1. 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.

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

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

1. 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).

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

1. 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.

1. 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 upside-down (invert) so the vial is now above the syringe (I).

1. 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.

1. 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.

Adults and Adolescents (12 Years of Age and Older)

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.

Children (7 to Below 12 Years of Age)

The recommended initial regimen is 60 IU/kg twice weekly. Based on the bleeding episodes, the dose may be adjusted to 40-60 IU/kg twice weekly.

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 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.

If you think you, or a person you are caring for, have taken too much JIVI, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

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.

Possible side effects from using JIVI:

These are not all the possible side effects you may have when taking JIVI. If you experience any side effects not listed here, tell your healthcare professional.

Very common (may affect 10% of patients or more)

• headache

Common (may affect more than 1% and less than 10% of patients)

• hypersensitivity reactions including tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing. Severe allergic reactions or anaphylactic shock (an uncommon, severe allergic reaction affecting blood pressure and breathing) have not been reported during clinical trials with JIVI.
• stomach pain/discomfort
• vomiting
• fever
• cough
• local reactions where you injected the medication
• dizziness
• trouble falling asleep
• rash/itchy rash

Uncommon (may affect more than 0.1% and less than 1% of patients)

• dysgeusia (odd taste)
• hives
• flushing (redness of the face)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Do not use beyond the expiration date indicated on the labels and cartons.

Store in a refrigerator (2-8°C). Do not freeze.

Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.

You may store the product when kept in its outer carton at room temperature up to 25°C for 6 months or up to 30°C for 3 months. Once the product is removed from refrigeration, it cannot be returned to the refrigerator.

If the product is stored outside the refrigerator, please add the date removed from refrigeration and note a new expiry date on the carton and vial. The new expiry date should be 6 months (25°C) or 3 months (30°C) from the date product is removed from the refrigerator, or the previously stamped expiry date, whichever is shorter.

The reconstituted solution should be used immediately (within 3 hours). This product is for single use only. Any unused solution must be discarded.

Keep out of reach and sight of children.

If you want more information about JIVI:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.bayer.ca or by calling Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.

  Bayer Inc.

  2920 Matheson Blvd East

  Mississauga, Ontario

  L4W 5R6

  Canada

Date of Authorization: October 20, 2025

© 2025, Bayer Inc.

® TM see www.bayer/ca/tm-mc