KOVALTRY 250 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Kovaltry 250 UI powder and solvent for solution for injection

Kovaltry 500 UI powder and solvent for solution for injection

Kovaltry 1000 UI powder and solvent for solution for injection

Kovaltry 2000 UI powder and solvent for solution for injection

Kovaltry 3000 UI powder and solvent for solution for injection

octocog alfa (recombinant human coagulation factor VIII)

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Kovaltry is and what it is used for

1. What you need to know before you use Kovaltry

1. How to use Kovaltry

1. Possible side effects

1. Storage of Kovaltry

1. Contents of the pack and other information

1. What Kovaltry is and what it is used for

Kovaltry contains the active substance recombinant human coagulation factor VIII, also known as octocog alfa. Kovaltry is prepared using recombinant technology without the addition of any human or animal component in the manufacturing process. Factor VIII is a protein that occurs naturally in the blood and helps it to clot.

Kovaltry is used to treat and prevent bleedingin adults, adolescents, and children of all ages with haemophilia A (hereditary factor VIII deficiency).

2. What you need to know before you use Kovaltry

Do not use Kovaltryif you are

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

Warnings and precautions

Tell your doctor or pharmacist if youhave:

• chest tightness, dizziness (even when getting up from sitting or lying down), skin rash with itching, wheezing (whistling when breathing), feeling of dizziness or fainting. These can be signs of a severe allergic reaction to Kovaltry. Stopthe administration of the medicineand seek medical attention if this occurs.
• bleeding that does not stop with your usual dose of Kovaltry. The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially in large quantities, can prevent the treatment from working properly, so patients being treated with Kovaltry will be carefully monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled with Kovaltry, consult your doctor immediately.
• or have previously developed factor VIII inhibitors to a different product. If you switch to another factor VIII medicine, you may be at risk of developing inhibitors again.
• a confirmed heart disease or are at risk of heart disease.
• using a central venous access device for the administration of Kovaltry. You may be at risk of complications related to the device, where the catheter has been inserted, such as:
• • local infections
  • bacteria in the blood
  • a blood clot in the blood vessel

Children and adolescents

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

Using Kovaltry with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

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

Driving and using machines

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

Kovaltry contains sodium

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

3. How to use Kovaltry

Treatment with Kovaltry will be started by a doctor who is experienced in the care of patients with haemophilia A. Follow the instructions for administration of this medicine exactly as your doctor has told you. If you are unsure, ask your doctor again.

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

Treatment of bleeding

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

• the required level of factor VIII.

Prevention of bleeding

If you are using Kovaltry to prevent bleeding, your doctor will calculate the dose that is right for you. This dose will normally be 20 to 40 IU 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.

Lab tests

Lab tests at appropriate intervals help to ensure that you always have adequate levels of factor VIII. In the case of major surgical procedures, your blood clotting must be strictly monitored.

Use in children and adolescents

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

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 it, your doctor may consider using another medicine.

If you want more information, talk to your doctor.

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

Duration of treatment

Generally, treatment for haemophilia with Kovaltry will be needed for life.

How Kovaltry is administered

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

How to prepare Kovaltry for administration

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

The reconstituted medicine must be filtered using the vial adapterbefore administration to remove any particles that may be present in the solution.

Do not use the venipuncture equipment provided for blood withdrawal, as it contains an in-line filter.

This medicine must notbe mixed with other infusion solutions. Do not use solutions if you notice particles or if the solution is cloudy. Follow the administration instructions given by your doctor and recorded at the end of this leaflet.

If you use more Kovaltry than you should

Tell your doctor if this happens. No cases of overdose have been reported.

If you forget to use Kovaltry

Administer the next dose immediately and continue at regular intervals, following the instructions of your doctor.

Do not use a double dose to make up for forgotten doses.

If you stop using Kovaltry

Do not stop using this medicine without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most seriousside effects are allergic reactionsthat can include a severe allergic reaction. Stopthe injection of Kovaltry and talk to your doctor immediately if this occurs.The following symptoms couldbe an early sign of these reactions:

• chest tightness or general feeling of discomfort
• dizziness
• feeling of dizziness when standing up, indicating a drop in blood pressure
• feeling of discomfort (nausea)

In previously untreated children with factor VIII deficiency, inhibitors(see section 2) can occur very frequently (more than 1 in 10 patients). In patients who have received previous treatment with factor VIII (more than 150 days of treatment), inhibitor antibodies(see section 2) can occur infrequently (less than 1 in 100 patients). If this happens, the medicine you are taking may stop working 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):

• stomach pain or discomfort
• indigestion
• fever
• local reactions at the injection site (e.g. bleeding under the skin, severe itching, swelling, burning sensation, temporary redness)
• headache
• difficulty sleeping
• hives
• rash 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 (feeling that the heart is beating too hard, too fast, or irregularly)
• rapid heartbeat
• distorted taste (dysgeusia)
• flushing (redness of the face)

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kovaltry

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

Do notuse this medicine after the expiry date which is stated on the label and carton.

The expiry date is the last day of the month stated.

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

Keep this medicine in the original pack to protect it from light.

This medicine can be stored at room temperature (up to 25 °C) for a maximum of 12 months, if kept in its original pack. If you store the medicine at room temperature, it will expire after 12 months or on the expiry date stated, whichever is earlier.

You must write the new expiry date on the outer packaging when the medicine is removed from the refrigerator.

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

Do notuse this medicine if you notice particles in the solution or if the solution is cloudy.

Medicines must notbe disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and additional information

Kovaltry composition

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

The othercomponents 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 injectable preparations.

Appearance and pack contents of the product

Kovaltry is presented as a powder and solvent for solution for injection. The powder is dry and white to slightly yellow 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
• a separate plunger
• a vial adapter
• a venipuncture set (for injection into a vein).

Kovaltry is available in:

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Youcan request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this prospectus:

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

--------------------------------------------------------------------------------------------------------------------Instructions for reconstitution and administration of Kovaltry

You will need sterile alcohol-impregnated swabs, sterile swabs, adhesive strips, and a tourniquet. These items are not included in the Kovaltry pack.