KOVALTRY 3000 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

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 may 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 taking this medicine.

Kovaltry is unlikely to affect fertility in male or female patients since the active substance is a natural substance 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 experienced in the care of patients with haemophilia A. Follow the administration instructions for this medicine exactly as prescribed by your doctor. If you are unsure, consult 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 suits you. This dose will usually be 20 to 40 IU of octocog alfa per kilogram 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 ensure that you always have adequate levels of factor VIII. In the case of major surgical procedures, your blood clotting should 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 may be necessary 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 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 necessary 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 possible particles present in the solution.

Do not use the venipuncture equipment provided for blood sampling, 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 those 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 your doctor's instructions.

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) may be formed very frequently (more than 1 in 10 patients). In patients who have received previous treatment with factor VIII (more than 150 days of treatment), inhibitory antibodies (see section 2) may be formed 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 to the Spanish Medicines Agency at 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 its original packaging 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 packaging. 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. Container Contents 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.

Product Appearance and Container Contents

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 Kovaltry container 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 container
• 1 multiple container with 30 individual containers

Not all container sizes may be marketed.

Marketing Authorization Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Youcan request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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

--------------------------------------------------------------------------------------------------------------------Detailed 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 container.