Kovaltry 3000 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Kovaltry 250 IU powder and solvent for solution for injection

Kovaltry 500 IU powder and solvent for solution for injection

Kovaltry 1000 IU powder and solvent for solution for injection

Kovaltry 2000 IU powder and solvent for solution for injection

Kovaltry 3000 IU powder and solvent for solution for injection

octocog alfa (recombinant human coagulation factor VIII)

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

• Keep this leaflet, as 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Kovaltry is and what it is used for

2. What you need to know before using Kovaltry

3. How to use Kovaltry

4. Possible side effects

5. How to store Kovaltry

6. 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 produced using recombinant technology, with no addition of any human- or animal-derived components during 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 bleeding in adults, adolescents, and children of any age with haemophilia A (inherited factor VIII deficiency).

2. What you need to know before using Kovaltry

Do not use Kovaltry if you are

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

Warnings and precautions

Consult your doctor or pharmacist if you have:

• chest tightness, dizziness (even when rising from sitting or lying down), skin rash with itching, wheezing (whistling sounds when breathing), or feeling faint or dizzy. These may be signs of a rare, sudden, severe allergic reaction to Kovaltry. Immediately stop administering the medicine and seek medical assistance if this occurs.
• bleeding that cannot be controlled with your usual dose of Kovaltry. The development of inhibitors (antibodies) is a known complication that may occur during treatment with any factor VIII-containing medicine. These inhibitors, especially when present in high amounts, can prevent the treatment from working properly; therefore, patients receiving Kovaltry will be closely monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled by Kovaltry, consult your doctor immediately.
• previously developed factor VIII inhibitors to another product. If switching to another factor VIII medicine, you may be at risk of re-developing inhibitors.
• confirmed heart disease or are at risk of developing heart disease.
• using a central venous access device for administration of Kovaltry. You may be at risk of device-related complications at the site where the catheter has been inserted, such as:
  • local infections
  • bacteria in the blood
  • blood clot in the blood vessel

Children and adolescents

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

Use of Kovaltry with 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.

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

Driving and use of machinery

If you experience dizziness or other symptoms affecting your ability to concentrate and react, you are advised not to drive or operate machinery until these effects have 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 initiated by a physician experienced in the care of patients with haemophilia A. Always follow your doctor's instructions for administering this medicine exactly. 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 their level

• the required level of factor VIII.

Prevention of bleeding

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

Laboratory tests

Regular laboratory testing at appropriate intervals helps ensure that adequate levels of factor VIII are maintained. In the specific case of major surgical procedures, your blood coagulation 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 than those prescribed for adults may be necessary.

Patients with inhibitors

If your doctor informs you that you have developed factor VIII inhibitors, you may require a higher dose of Kovaltry to control bleeding. If this higher dose does not control the bleeding, your doctor may consider using another medicine.

If you would like more information, speak with your doctor.

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

Duration of treatment

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

How Kovaltry is administered

Kovaltry is injected into a vein over 2 to 5 minutes, depending on the total volume and your comfort level, 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 venous access device) supplied in the package for this medicine. Please contact your doctor if you are unable to use these components. Do not use the medicine if any of the package components are open or damaged.

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

Do not use the supplied venous access device to draw blood, as it contains an in-line filter.

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

If you use more Kovaltry than you should

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

If you forget to use Kovaltry

Take 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 treatment with Kovaltry

Do not stop using this medicine without consulting your doctor.

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

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, which may include a severe allergic reaction. Stop the Kovaltry 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 general feeling of discomfort
• dizziness
• feeling dizzy upon standing, indicating a drop in blood pressure
• feeling unwell (nausea)

In previously untreated children receiving factor VIII medications, inhibitors may develop very frequently (in more than 1 out of 10 patients) (see section 2). In patients who have previously received factor VIII treatment (more than 150 days of treatment), inhibitory antibodies (see section 2) may develop rarely (in less than 1 out of 100 patients). If this occurs, the medicine you are taking may no longer work properly and you may experience persistent bleeding. In this case, please contact your doctor immediately.

Other possible adverse effects:

Frequent (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, intense itching, swelling, burning sensation, transient redness)
• headache
• difficulty sleeping
• hives
• rash with or without itching

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

• enlarged lymph nodes (swelling under the skin in the neck, armpit, or groin)
• palpitations (sensation of strong, rapid, or irregular heartbeat)
• increased heart rate
• dysgeusia (altered taste)
• hot flush (facial redness)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse 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 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 (2 °C – 8 °C). Do not freeze.

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

This medicine may be stored at room temperature (up to 25 °C) for a maximum of 12 months, provided it is kept in the original packaging. If stored at room temperature, the medicine expires after 12 months or on the expiry date indicated, whichever comes first.

When removing the medicine from the refrigerator, you must record the new expiry date on the outer packaging.

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within a maximum of 3 hours. Use the contents once only. Discard any unused solution.

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

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

6. Contents of the pack and other information

Composition of Kovaltry

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

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.

Presentation of the product and contents of the pack

Kovaltry is presented as a powder and solvent for injectable solution. The powder is dry and white to slightly yellow in colour. The solvent is a clear liquid.

Each individual pack of Kovaltry contains:

• one glass vial with powder
• one pre-filled syringe with solvent
• separate plunger
• one vial adapter
• one venous access device (for intravenous injection).

Kovaltry is available in pack sizes of:

• 1 individual pack
• 1 multiple pack containing 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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

--------------------------------------------------------------------------------------------------------------------Detailed reconstitution and administration instructions for Kovaltry

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