Prospect: information for the user

Kovaltry 250 UI powder and solvent for injectable solution

Kovaltry 500 UI powder and solvent for injectable solution

Kovaltry 1000 UI powder and solvent for injectable solution

Kovaltry 2000 UI powder and solvent for injectable solution

Kovaltry 3000 UI powder and solvent for injectable solution

octocog alfa (human recombinant factor VIII coagulation factor)

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people 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 do not appear in this prospect. See section 4.

1. What you need to know before starting to use Kovaltry

1. How to use Kovaltry

1. Possible adverse effects

1. Storage of Kovaltry

1. Contents of the package and additional information

Kovaltry contains the active ingredient human recombinant factor VIII, also known as octocog alfa. Kovaltry is prepared with 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.

Kovaltry is used totreat and prevent bleedingin adults, adolescents, and children of any age with hemophilia A (hereditary deficiency of factor VIII).

Do not use Kovaltryif you are

• allergic to octocog alfa or any of the other components of this medication (listed in section 6).
• allergic to mouse or hamster proteins.

Warnings and precautions

Consult your doctor or pharmacist ifyou have:

• chest tightness, dizziness (even when standing up from sitting or lying down), skin rash with itching, wheezing (whistling sound when breathing), feeling dizzy or faint. These may be signs of a rare but severe allergic reaction to Kovaltry.Stop administering the medication immediately and seek medical help if this occurs.
• uncontrolled bleeding with your usual dose of Kovaltry. The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII products. These inhibitors, especially in large quantities, prevent the treatment from working properly, so patients on Kovaltry treatment will be closely monitored for the development of these inhibitors. If your bleeding or your child's bleeding is not controlled with Kovaltry, consult your doctor immediately.
• previously developed inhibitors to factor VIII with another product. If you switch to another factor VIII product, you may be at risk of developing inhibitors again.
• confirmed heart disease or are at risk of developing heart disease.
• using a central venous access device for Kovaltry administration. You may be at risk of developing complications related to the device, where the catheter has been inserted, such as:
• • local infections
  • bloodstream infections
  • blood clot in the blood vessel

Children and adolescents

The warnings and precautions listed apply to patients of all ages, adults and children.

Using Kovaltry with 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Kovaltry is unlikely to affect the fertility of male or female patients, as the active ingredient naturally occurs in the body.

Driving and operating machinery

If you experience dizziness or other symptoms that affect your ability to concentrate and react, it is recommended that you do not drive or operate machinery until the effect has subsided.

Kovaltry contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

The treatment with Kovaltry will be initiated by an experienced doctor in the care of patients with hemophilia A. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

The number of factor VIII units is expressed in International Units (UI)

Bleeding treatment

To treat bleeding, your doctor will calculate and adjust the dose and administration frequency, 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 their level

• The required level of factor VIII.

Bleeding prevention

If you are using Kovaltry to prevent bleeding, your doctor will calculate the dose that suits you. This dose will normally be 20 to 40 UI of octocog alfa per kg of body weight, injected two or three times a week. However, in some cases, especially in younger patients, shorter treatment intervals or higher doses may be required.

Laboratory tests

Regular laboratory tests help ensure that you always have the appropriate levels of factor VIII. In the case of major surgical interventions, your blood coagulation must be strictly monitored.

Use in children and adolescents

Kovaltry can be used in children of all ages. In children under 12 years, higher doses or more frequent injections may be required than those prescribed for adults.

Patients with inhibitors

If your doctor tells you that you have developed factor VIII inhibitors, you may need a higher dose of Kovaltry to control bleeding. If this higher dose does not control bleeding, your doctor may consider using another medication.

If you want more information, talk to your doctor.

Do not increase the dose of Kovaltry that your doctor has prescribed to control bleeding without consulting your doctor.

Treatment duration

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

How to administer Kovaltry

Kovaltry is injected into a vein for 2-5 minutes, depending on the total volume and your comfort level, and should be used within 3 hours of reconstitution.

How to prepare Kovaltry for administration

Use only the components (vial adapter, pre-loaded syringe with solvent, and venous puncture equipment) included in the package for this medication. Please contact your doctor if it is not possible to use these components. Do not use it if any of the package components are open or damaged.

The reconstituted medicationmust be filtered using the vial adapterbefore administration to remove any particles present in the solution.

Do not use the venous puncture equipment provided for blood extraction, as it contains an in-line filter.

This medicationshould notbe mixed with other infusion solutions. Do not use solutions if you observe particles or if the solution is cloudy. Follow the administration instructions given by your doctorand collected at the end of this leaflet.

If you use more Kovaltry than you should

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

If you forgot to use Kovaltry

Administer 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 Kovaltry

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.

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

The mostseriousside effects areallergic reactionsthat may include a severe allergic reaction.Stopinjecting Kovaltry immediately and speak with your doctor right away if this reaction occurs.The following symptomsmaybe an early sign of these reactions:

• chest tightness or a general feeling of discomfort
• dizziness
• lightheadedness when standing, indicating a decrease in blood pressure
• nausea

In children not previously treated with factor VIII medications, inhibitors (see section 2) may form very frequently (more than 1 in 10 patients). In patients who have received prior treatment with factor VIII (more than 150 days of treatment), inhibitors (see section 2) may form infrequently (less than 1 in 100 patients). If this happens,the medicine you take may not work properly and you may experience persistent bleeding. In this case, please contact your doctor immediately.

Other possible side effects:

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

• abdominal pain or discomfort
• indigestion
• fever
• local reactions at the injection site (e.g., bleeding under the skin, intense itching, swelling, burning sensation, transient redness)
• headache
• difficulty sleeping
• hives
• urticaria with or without itching

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

• enlargement of lymph nodes (swelling under the skin of the neck, armpit, or groin)
• palpitations (sensation of a strong, rapid, or irregular heartbeat)
• tachycardia (rapid heartbeat)
• disturbance of taste
• flushing (redness of the face)

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 for Pharmacovigilance of Medicinal Products for Human Usewww.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 boxes.

The expiration date is the last day of the month indicated.

Store in the refrigerator (2 °C – 8 °C). Do not freeze.

Store this medication in the original packaging to protect it from light.

This medication can be stored at room temperature (up to 25 °C) for a maximum of 12 months, if it is kept in its original packaging. If you store the medication at room temperature, it expires after 12 months or on the expiration date indicated, whichever is earlier.

You must note the new expiration date on the outer packaging when the medication is removed from the refrigerator.

Do notrefrigerate the solution after reconstitution. The reconstituted solution must be used within a maximum of 3 hours. Use the contents only once. Discard unused solution.

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

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

Composition of Kovaltry

The active principle is octocog alfa (human coagulation factor VIII). Each vial of Kovaltry contains 250, 500, 1000, 2000 or 3000 UI of octocog alfa.

The other components are sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), polisorbate 80 (E 433), glacial acetic acid (E 260) and water for injection.

Appearance of the product and contents of the pack

Kovaltry is presented in the form of a powder and a solvent for injectable solution. The powder is dry and white to slightly yellowish in color. The solvent is a clear liquid.

Each individual pack of Kovaltry contains

• a glass vial with powder
• a pre-filled syringe with solvent
• an independent plunger
• a vial adapter
• a venous puncture device (for injection into a vein).

Kovaltry is available in sizes of:

• 1 individual pack
• 1 multiple pack with 30 individual packs

Not all sizes may be marketed.

Marketing Authorization Holder

Bayer AG

51368 Leverkusen

Germany

Responsible for manufacturing

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu

--------------------------------------------------------------------------------------------------------------------IInstructions for reconstitution and administration of Kovaltry

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