Jivi 500 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Jivi 250 IU powder and solvent for solution for injection

Jivi 500 IU powder and solvent for solution for injection

Jivi 1000 IU powder and solvent for solution for injection

Jivi 2000 IU powder and solvent for solution for injection

Jivi 3000 IU powder and solvent for solution for injection

Jivi 4000 IU powder and solvent for solution for injection

recombinant human pegylated coagulation factor VIII with B-domain deleted (damoctocog alfa pegol)

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if the adverse reactions are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Jivi is and what it is used for
2. What you need to know before using Jivi
3. How to use Jivi
4. Possible side effects
5. How to store Jivi
6. Contents of the pack and other information

1. What Jivi is and what it is used for

Jivi contains the active substance damoctocog alfa pegol. It is produced using recombinant technology without the addition of any components of human or animal origin during the manufacturing process. Factor VIII is a protein naturally present in the blood that helps it to clot. The damoctocog alfa pegol protein has been modified (pegylated) to prolong its action in the body.

Jivi is used to treat and prevent bleeding in adults, adolescents, and children aged 7 years and older with haemophilia A (inherited factor VIII deficiency) who have been previously treated. It is not for use in children under 7 years of age.

2. What you need to know before using Jivi

Do not use Jivi if you are:

• allergic to damoctocog alfa pegol or to any of the other ingredients of this medicine (listed in section 6).
• allergic to mouse or hamster proteins.

Warnings and precautions

Consult your doctor or pharmacist if:

• you experience chest tightness, a drop in blood pressure (often manifested by dizziness when standing up quickly), hives with itching, wheezing (whistling sounds when breathing), general malaise, or fainting. These may be signs of a rare, severe, sudden allergic reaction to this medicine. Immediately stop the injection and seek urgent medical attention if this occurs.

• you have bleeding that cannot be controlled with your usual dose of this medicine. Contact your doctor immediately if this happens. You may have developed antibodies against factor VIII (inhibitors) or antibodies against polyethylene glycol (PEG). These antibodies reduce the effectiveness of Jivi in preventing and controlling bleeding. Your doctor may perform blood tests to confirm this possibility and ensure that your dose of Jivi is producing adequate factor VIII levels. If necessary, your doctor may switch you back to the factor VIII treatment you previously used. Once the immune response has resolved, your doctor may consider restarting treatment with Jivi.

• you have previously developed factor VIII inhibitors with another product.

• you have heart disease or are at risk of developing heart disease.

• you need to use a central venous access device for this medicine. You may be at risk of device-related complications at the catheter insertion site, including:

• local infections

• presence of bacteria in the blood

• formation of a blood clot in the blood vessel

Children

Jivi must not be used in children under 7 years of age.

Other medicines and Jivi

It is unknown whether Jivi affects or may be affected by other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Jivi has no influence on the ability to drive and use machines.

Jivi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.

Jivi contains polysorbate 80 (E433)

This medicine contains 0.2 mg of polysorbate 80 in each vial of 250/500/1,000/2,000/3,000 IU and 0.4 mg of polysorbate 80 in each 4,000 IU vial, equivalent to 0.08 mg/ml of injectable solution. Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

3. How to use Jivi

Treatment with Jivi will be initiated by a physician experienced in the care of patients with haemophilia A. After receiving appropriate training, patients or caregivers may be able to administer Jivi at home. Always follow exactly the administration instructions for this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again. The dose of factor VIII units is measured in International Units (IU).

Treatment of bleeding

To treat bleeding, your doctor will calculate and adjust your dose and how often it should be administered, depending on factors such as:

• your weight
• the severity of your haemophilia A
• the location and severity of the bleeding
• whether you have factor VIII inhibitors and how high these levels are
• the required factor VIII level

Prevention of bleeding

To prevent bleeding, your doctor will select an appropriate dose and frequency based on your individual needs. Your doctor may adjust your dose and frequency of administration according to the factor VIII levels achieved and your individual bleeding tendency.

• For adults and adolescents aged 12 years and older

• 45–60 IU per kg body weight every 5 days, or

• 60 IU per kg body weight every 7 days, or

• 30–40 IU per kg body weight twice weekly.

• For children aged 7 to less than 12 years

• 40–60 IU per kg body weight twice weekly.

• Initial dose: 60 IU per kg body weight twice weekly.

Laboratory tests

Regular laboratory testing at appropriate intervals helps ensure that adequate factor VIII levels are maintained. In the specific case of major surgery, your blood coagulation should be closely monitored.

Duration of treatment

In general, treatment for haemophilia with Jivi will be required for life.

How Jivi is administered

Jivi is injected into a vein over 2–5 minutes, depending on the total volume and your comfort level. The maximum infusion rate is 2.5 ml per minute. Jivi must be used within 3 hours after reconstitution.

How Jivi is prepared for injection

Use only the components provided in the package (the vial adapter, the pre-filled syringe with solvent, and the venous access equipment) for this medicine. Consult your doctor if it is not possible to use these components. Do not use any component if the packaging is open or damaged.

The reconstituted medicine must be filtered using the vial adapter before injection to remove any potential particles present in the solution.

This medicine must not be mixed with other injections. Do not use solutions that are cloudy or contain visible particles. Follow the instructions for use provided by your doctor and those included at the end of this leaflet.

If you use more Jivi than you should

Inform your doctor if this occurs. Symptoms of overdose have not been reported.

If you forget to use Jivi

Inject the next dose as soon as possible and continue at regular intervals as directed by your doctor.

Do not use a double dose to make up for a missed dose.

If you stop using Jivi

Do not discontinue this medicine without consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most serious adverse effects are allergic reactions or a severe allergic reaction. Stop the Jivi infusion immediately and contact your doctor right away if such a reaction occurs. The following symptoms could be early signs of these reactions:

• chest tightness or a general feeling of discomfort
• burning and itching at the infusion site
• hives, flushing
• decreased blood pressure that may cause dizziness upon standing
• nausea

In patients who have received prior treatment with factor VIII (more than 150 exposure days), inhibitor antibodies may develop rarely (less than 1 in 100 patients) (see section 2). If this occurs, your medicine may no longer work effectively and you may experience persistent bleeding. If this happens, you should contact your doctor immediately.

The following adverse effects may occur with this medicine:

Very common (may affect more than 1 in 10 people):

• headache

Common (may affect up to 1 in 10 people):

• stomach pain
• nausea, vomiting
• fever
• allergic reactions (may present as rashes, generalized hives, chest tightness, wheezing, shortness of breath, decreased blood pressure; for early symptoms, see above)
• local reactions at the infusion site, such as bleeding under the skin, intense itching, swelling, burning sensation, transient redness
• dizziness
• difficulty sleeping
• cough
• rash, skin redness

Uncommon (may affect up to 1 in 100 people):

• factor VIII inhibition
• taste disturbance
• flushing
• itching

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them
directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jivi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the labels and cartons. The expiry date refers to the last day of the month indicated.

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

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

This medicine can be stored at room temperature (below 25 °C) for up to 6 months, provided it remains in its original packaging. If stored at room temperature, the medicine will expire after 6 months or on the expiry date indicated, whichever comes first.

You must record the new expiry date on the outer packaging when removing the medicine from the refrigerator.

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within 3 hours.

Do not use this medicine if you observe particles or if the solution is cloudy.

This medicine is for single use only. Discard any unused solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist or doctor how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Jivi

• The active substance is recombinant human coagulation factor VIII with B-domain deleted, pegylated (damoctocog alfa pegol). Each vial of Jivi contains 250, 500, 1,000, 2,000, 3,000, or 4,000 IU of damoctocog alfa pegol. After reconstitution with the provided solvent (sterile water for injections), the prepared solutions have the following concentrations:

• The other components are sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), polysorbate 80 (E 433), glacial acetic acid (E 260), and water for injections. See section 2 “Jivi contains sodium” and “Jivi contains polysorbate 80 (E 433)”.

Appearance of the medicinal product and contents of the container

Jivi is presented as a powder and solvent for injectable solution. The powder is dry and white to slightly yellow. The solvent is a clear liquid. After reconstitution, the solution is clear.

Each individual pack of Jivi contains:

• one glass vial with powder
• one pre-filled syringe with solvent
• one separate plunger rod
• one vial adapter
• one venous puncture set

Jivi is available in pack sizes of:

• 1 individual pack
• 1 multiple pack containing 30 individual packs

Not all pack sizes may be marketed.

Marketing Authorization Holder

Bayer AG
51368 Leverkusen
Germany

Manufacturer

Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

Bayer AG
Müllerstraße 178
13353 Berlin
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.euopa.eu

Detailed reconstitution and administration instructions for Jivi

You will need sterile alcohol-impregnated swabs, sterile gauze, dressings, and a tourniquet. These items are not included in the Jivi package.