Label: information for theuser

Jivi 250 UI powder and solvent for injectable solutioninjectable solution

Jivi 500 UI powder and solvent for injectable solutioninjectable solution

Jivi 1000 UI powder and solvent for injectable solutioninjectable solution

Jivi 2000 UI powder and solvent for injectable solutioninjectable solution

Jivi 3000 UI powder and solvent for injectable solutioninjectable solution

human recombinant coagulation factor VIII pegylated with B domain suppressed (damoctocog alfapegol)

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

Jivi is used totreat and prevent bleedingin adults and adolescents 12 years of age or older with hemophilia A (hereditary factor VIII deficiency) who have been previously treated. It is not for use in children under 12 years of age.

If you are:

• allergic to damoctocog alfa pegol or to any of the other components of this medication (listed in section6).
• 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 accompanied by dizziness when standing up quickly), hives with itching, wheezing (whistling sound when breathing), general discomfort, or fainting. These may be signs of asevere and rare allergic reactionto this medication.Stopinjecting the medication immediatelyand seek medical help right awayif this occurs.

• experiencing uncontrolled bleeding. Talk to your doctor immediately if this happens. You may have developed antibodies against factor VIII (inhibitors) or antibodies against polyethylene glycol (PEG).These antibodiesreduce the effectiveness of Jivi in preventing and controlling bleeding. Your doctor may perform tests to confirm this possibility and ensure that your Jivi dose generates adequate levels of factor VIII. If necessary, your doctor may switch youbackto your previous factor VIII treatment.
• previously developed inhibitors to factor VIII with another product.
• have a heart condition or are at risk of developing a heart condition.
• need to use a central venous access device for this medication. You may be at risk of complications related to the device in the area where the catheter is inserted, including:

• local infections
• bacteria in the blood
• blood clot formation in the blood vessel

Children

Jivi cannot be used in children under 12 years old.

Other medications and Jivi

It is unknown whether Jivi affects or is affected by other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machines

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

Jivi contains sodium

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

The treatment with Jivi will be initiated by an experienced doctor in the care of patients with hemophilia A. After receiving the relevant training, patients or caregivers may be able to administer Jivi at home. Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The dose of factor VIII units is measured in International Units (IU).

Bleeding Treatment

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 hemophilia A
• The location and severity of the bleeding
• If you have factor VIII inhibitors and how high those levels are
• The required factor VIII level

Bleeding Prevention

To prevent bleeding, your doctor will select an appropriate dose and frequency based on your needs:

• 45-60 IU per kg of body weight every 5 days or
• 60 IU per kg of body weight every 7 days or
• 30-40 IU per kg of body weight twice a week.

Laboratory Tests

Regular laboratory tests help to check that you always have adequate levels of factor VIII. In the case of major surgery, your blood coagulation should be closely monitored.

Treatment Duration

Generally, treatment for hemophilia with Jivi will be necessary for life.

How Jivi is Administered

Jivi is injected into a vein over 2-5 minutes, depending on the total volume and your level of comfort. The maximum speed is 2.5 ml per minute. Jivi should be used within 3 hours of reconstitution.

How to Prepare Jivi for Injection

Use only the components (the vial adapter, the pre-loaded syringe with the solvent, and the venipuncture equipment) included in the package for this medication. Consult your doctor if it is not possible to use these components. If any of the package components are open or damaged, do not use that component.

The reconstituted medication should be filtered using the vial adapter before injection to eliminate any particles present in the solution.

This medication should not be mixed with other injections. Do not use solutions that are turbid or contain visible particles. Follow the usage instructions given by your doctor and those listed at the end of this leaflet.

If You Use More Jivi Than You Should

Inform your doctor if this occurs. No symptoms of overdose have been reported.

If You Forget to Use Jivi

Inject the next dose immediately and continue at regular intervals following your doctor's instructions.

Do not use a double dose to compensate for missed doses.

If You Interrupt Treatment with Jivi

Do not stop using this medication without consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The mostseriousside effects areallergic reactionsor a severe allergic reaction.Stop the Jivi injection immediately and talk to your doctor right away if you experience a reaction of this type.The following symptoms may be an early sign of these reactions:

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

In patients who have received previous treatment with factor VIII (more than 150 days of treatment), antibodies inhibitors (see section 2) may form in rare cases (less than 1 in 100 patients). If this occurs, your medicine may not work well and you may experience persistent bleeding. If this occurs, you should contact your doctor immediately.

The following side 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 hives, generalized urticaria, chest tightness, wheezing, shortness of breath, decreased blood pressure; for initial symptoms, see above)

?local reactions at the injection site, such as bleeding under the skin, intense itching, swelling, burning sensation, transient redness

• dizziness
• difficulty falling asleep
• cough
• pruritus, skin redness

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

• factor VIII inhibition
• alteration of taste
• flushing
• itching

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them

directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do notuse this medication after the expiration date that appears on the labels and in the boxes. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C).Do notfreeze.

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

This medication can be stored at room temperature (below 25 °C) for a maximum of 6 months, if it is kept in the original packaging. If it is stored at room temperature, it expires after 6 months or on the expiration date indicated, whichever occurs first.

You must note the new expiration date on the outer packaging when you remove the medication from the refrigerator.

Do notrefrigerate the solution after reconstitution. The reconstituted solution must be used within a maximum of 3 hours.

Do notuse this medication if you observe particles or if the solution is cloudy.

This medication is for single use only. Dispose of unused solution.

Medicationsshould notbe thrown away through the drains or in the trash. Ask your pharmacist or doctor how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Jivi

• The active principle is human recombinant coagulation factor VIII pegylated with a deleted domain B (damoctocog alfa pegol). Each vial of Jivi contains 250, 500, 1000, 2000, or 3000 UI of damoctocog alfa pegol. After reconstitution with the provided solvent (sterile water for injection), the prepared solutions have the following concentration:

• The other components are sucrose, histidine, glycine, sodium chloride (see section 2 "Jivi contains sodium"), calcium chloride dihydrate, polisorbate 80, glacial acetic acid, and water for injection.

Appearance of the product and contents of the pack

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

Each pack of Jivi contains

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

Jivi is available in packs of:

•1 individual pack

•1 multiple pack with 30 individual packs

Not all pack sizes may be marketed.

Marketing Authorization Holder

Bayer AG

51368 Leverkusen

Germany

Responsible for manufacturing

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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Detailed instructions for reconstitution and administration of Jivi

You will need sterile gauze pads soaked in alcohol, sterile gauze, dressings, and a tourniquet. These items are not included in the Jivi pack.