Wilate 1000 IU FvW/1000 IU FVIII, powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

WILATE, 500 IU VWF and 500 IU FVIII, powder and solvent for solution for injection.

WILATE, 1000 IU VWF and 1000 IU FVIII, powder and solvent for solution for injection.

Human von Willebrand factor and 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. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Wilate is and what it is used for

2. What you need to know before using Wilate

3. How to use Wilate

4. Possible adverse effects

5. How to store Wilate

6. Contents of the container and other information

1. What Wilate is and what it is used for

Wilate belongs to the pharmacotherapeutic group of medicines called coagulation factors, and contains human von Willebrand factor (VWF) and human coagulation factor VIII.

These two proteins together play a role in blood coagulation.

Von Willebrand disease

Wilate is used to treat and prevent bleeding in patients with von Willebrand disease (VWD), which is a group of related disorders. VWD is a blood coagulation disorder in which bleeding may last longer than expected. This may be due to a deficiency of VWF in the blood or to the VWF not functioning properly.

Haemophilia A

Wilate is used to treat and prevent bleeding in patients with haemophilia A. This is a condition in which bleeding may last longer than expected. It is caused by a congenital deficiency of factor VIII in the blood.

2. What you need to know before using Wilate

Do not use Wilate

• If you are allergic (hypersensitive) to human von Willebrand factor, human coagulation factor VIII, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Wilate

• Any medicine, such as Wilate, prepared from human blood (containing proteins) and injected into a vein (administered intravenously) may cause allergic reactions. Pay attention to early signs of allergic reactions (hypersensitivity), such as hives, skin rash, tightness in the chest, difficulty breathing, low blood pressure, or anaphylaxis (when one or more of the above symptoms develop rapidly and are severe).

If you experience these symptoms, you must stop the infusion immediately and contact your doctor.

• When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent transmission of infections to patients. These measures include careful selection of blood and plasma donors to ensure exclusion of those at risk of carrying infections, testing of individual donations and plasma pools for signs of viruses/infections, and inclusion of steps in the processing of blood or plasma capable of inactivating or removing viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infection cannot be completely ruled out. This also applies to all unknown or emerging viruses or other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, and against the non-enveloped hepatitis A virus. However, the measures may have limited effectiveness against non-enveloped viruses such as parvovirus B19.

Parvovirus B19 infection may be serious for a pregnant woman (infection in the baby) and for individuals with weakened immune systems or certain types of anemia (e.g., sickle cell disease or abnormal destruction of red blood cells).

• It is strongly recommended that each time you receive a dose of Wilate, the name and batch number of the product be recorded to maintain a record of the batches used.

Your doctor may recommend vaccination against hepatitis A and B if you are regularly or repeatedly administered human plasma-derived von Willebrand factor/factor VIII products.

Von Willebrand disease (vWD)

• See section 4. (Von Willebrand disease (vWD)) for side effects related to the treatment of vWD.

Haemophilia A

The development of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII-containing medicines. These inhibitors, especially when present in large amounts, may prevent the treatment from working properly, so you and your child will be closely monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled with Wilate, consult your doctor immediately.

• See section 4. (Haemophilia A) for side effects related to the treatment of haemophilia A.

Use of Wilate with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Although no interactions of Wilate with other medicines are known, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Do not mix Wilate with other medicines during infusion.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Wilate contains sodium

This medicine contains up to 58.7 mg of sodium (main component of table/cooking salt) in each 500 IU vial of FvW and FVIII and up to 117.3 mg in each 1000 IU vial of FvW and FVIII. This corresponds to 2.94% and 5.87%, respectively, of the maximum daily recommended intake of sodium for an adult.

3. How to use Wilate

Wilate must be injected into a vein (administered intravenously) after reconstitution with the solvent provided. Treatment should be initiated under medical supervision.

Dosage

Your doctor will advise you of your individual dose and how often you should use Wilate. Follow exactly the instructions for administering Wilate as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

If you use more Wilate than you should

Symptoms of overdose with von Willebrand factor (FvW) or human factor VIII have not been reported. However, the recommended dose should not be exceeded.

If you forget to use Wilate

Do not administer a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, Wilate may cause adverse effects, although not everyone experiences them.

• Although rare, hypersensitivity or allergic reactions have been observed. These reactions may include:

irritation and burning at the injection site, chills, flushing, headache, skin rashes (urticaria), decreased blood pressure (hypotension), fatigue (lethargy), dizziness (nausea), restlessness, increased heart rate (tachycardia), chest tightness, prickling sensations (tingling), vomiting, breathing difficulties, sudden swelling in various parts of the body (angioedema).

If you experience any of the symptoms listed above, inform your doctor.

You must stop using Wilate and see your doctor immediately if you experience symptoms of angioedema such as:

• swelling of the face, tongue, or throat (pharynx)

• difficulty swallowing

• hives and breathing difficulties

• Although rare, fever has also been reported.

• Abdominal pain, back pain, chest pain, cough, and dizziness may also occur, but the frequency of these adverse reactions is unknown.

• In very rare cases, hypersensitivity may lead to a severe allergic reaction called anaphylaxis (when one or more of the above symptoms develop rapidly and are intense), which may include shock. In the case of anaphylactic shock, treatment according to current medical guidelines for shock is essential.

Von Willebrand Disease (VWD)

• When a VWF product containing factor VIII is used to treat VWD, prolonged treatment may cause excessive increase of factor VIII in the blood. This may increase the risk of altered blood flow (thrombosis).

If you are a patient with known clinical or laboratory risk factors, you should be monitored for early signs of thrombosis. Your doctor should implement thromboprophylaxis according to current recommendations.

• Patients with VWD (especially type 3 patients) may develop inhibitors (neutralizing antibodies) against VWF during treatment with VWF. In these very rare cases, inhibitors may interfere with the effectiveness of Wilate.

If your bleeding continues, the presence of these inhibitors should be tested in your blood.

Inhibitors may increase the risk of severe allergic reactions (anaphylactic shock). If you experience an allergic reaction, testing for inhibitors should be performed.

Once inhibitors are detected in your blood, contact a physician experienced in managing patients with bleeding disorders. Alternative treatment may be beneficial in patients with high inhibitor levels and should be considered.

Hemophilia A

• In children who have not previously been treated with factor VIII-containing medicines, inhibitor antibodies may develop very frequently (more than 1 in 10 patients); however, in patients who have previously received factor VIII treatment (more than 150 days of treatment), the risk is rare (less than 1 in 100 patients). If this occurs, the medicines you or your child are taking may no longer work properly, and you or your child may experience persistent bleeding. In such cases, contact your doctor immediately.

Inhibitors may increase the risk of severe allergic reactions (anaphylactic shock). If you experience an allergic reaction, testing for inhibitors should be performed.

There are insufficient data to recommend the use of Wilate in previously untreated patients.

Experience with Wilate treatment in children under 6 years of age is limited.

For information on viral safety, see section 2 (Warnings and precautions).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Wilate Storage

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

Store the powder and the solvent vial in the refrigerator (2°C - 8°C).

Do not freeze.

Keep the vials in their outer packaging to protect them from light.

Do not use Wilate after the expiry date stated on the packaging after Exp: The expiry date refers to the last day of the month indicated.

Wilate may be stored at a temperature below 25°C for up to 2 months. In this case, the shelf life is 2 months from the first time the product is removed from refrigeration. You should record the new shelf life period on the carton.

The powder should only be reconstituted immediately before injection. The solution has been shown to be stable for 4 hours at a temperature below 25°C. However, to avoid contamination, the solution should be used immediately and only once.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Wilate

• The active substances are human von Willebrand factor and human coagulation factor VIII.
• The other components are sodium chloride, glycine, sucrose, sodium citrate, calcium chloride. Solvent: water for injections with 0.1% polysorbate 80.

Appearance of the product and contents of the pack

Lyophilized powder: white or pale yellow powder or powdered solid.

Reconstituted solution: should be clear or slightly opalescent.

Wilate is supplied as a powder and solvent for injectable solution. It is available in 2 pack sizes:

• Wilate, 500 IU VWF and 500 IU FVIII, powder and solvent for injectable solution, nominally contains 500 IU of human von Willebrand factor and 500 IU of human coagulation factor VIII per vial. The product contains approximately 100 IU/ml of human von Willebrand factor and 100 IU/ml of human coagulation factor VIII when reconstituted with 5 ml of water for injections with 0.1% polysorbate 80 (solvent).
• Wilate, 1000 IU VWF and 1000 IU FVIII, powder and solvent for injectable solution, nominally contains 1000 IU of human von Willebrand factor and 1000 IU of human coagulation factor VIII per vial. The product contains approximately 100 IU/ml of human von Willebrand factor and 100 IU/ml of human coagulation factor VIII when reconstituted with 10 ml of water for injections with 0.1% polysorbate 80 (solvent).

Contents of the pack

1 vial of lyophilized powder
1 vial of solvent
1 box containing intravenous injection equipment (1 transfer device, 1 infusion set, 1 disposable syringe)
2 alcohol swabs

Marketing Authorization Holder and Manufacturer

Octapharma S.A
Avda. Castilla, 2. (P.E. San Fernando)
Ed. Dublin – 2nd Floor, 28830 San Fernando de Henares
Madrid

Manufacturer:

Octapharma Dessau GmbH
Otto-Reuter-Str. 3
D-06847 Dessau-Roßlau
Germany

or

Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaerstr. 235
A-1100 Vienna
Austria

or

Octapharma GmbH
Elisabeth-Selberst-Str. 11
40764 Langenfeld
Germany

Date of the most recent revision of this leaflet: 02/2021

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia, Spain, United Kingdom: Wilate 500/Wilate 1000

Finland, Norway, Sweden: Wilate

Denmark: Wilnativ

France: Eqwilate 500/Eqwilate 1000

Instructions for outpatient treatment

• Read all instructions and follow them carefully.
• Do not use Wilate after the expiry date stated on the packaging.
• Sterility must be maintained throughout the procedure described below.
• The reconstituted solution should be inspected visually for particles or discoloration before administration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain sediment.
• Use the prepared solution immediately to avoid microbial contamination.
• Use only the equipment provided. The use of other injection/infusion equipment may pose additional risks and lead to treatment failure.

Instructions for preparing the solution:

1. Do not use the product directly from the refrigerator. Allow the solvent and powder in their closed vials to reach room temperature.
2. Remove the flip-off caps from the vials and clean the rubber stoppers with one of the alcohol-impregnated swabs provided.
3. The transfer device is shown in Fig. 1. Place the solvent vial on a flat surface and hold it firmly. Take the transfer device and turn it upside down. Place the blue end of the transfer device onto the top of the solvent vial and press firmly until a click is heard (Fig. 2 + 3). Do not twist when attaching.

Instructions for Injection:

As a precaution, measure your pulse rate before and during the injection. If your pulse rate increases significantly, reduce the injection rate or temporarily interrupt administration.

1. Attach the syringe to the white part of the transfer set. Turn the vial upside down and draw the solution into the syringe (Fig. 6). The solution should be clear or slightly opalescent. Once the solution has been transferred, firmly hold the syringe plunger (keeping it depressed) and remove the syringe from the transfer set (Fig. 7). Discard the empty vial together with the white part of the transfer set.

1. Clean the injection site with one of the alcohol swabs provided.

2. Attach the infusion set provided to the syringe.

3. Insert the injection needle into the selected vein. If you used a tourniquet to help visualize the vein, release the tourniquet before starting to inject Wilate.

Blood should not flow into the syringe due to the risk of fibrin clot formation.

1. Inject the solution into the vein slowly, at a rate not exceeding 2–3 mL per minute.

If more than one vial of Wilate powder is used for a treatment, the same injection needle and syringe may be used. The transfer set is for single use only.

Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.

Wilate must not be mixed or administered (using the same infusion set) with other medications. Use only the infusion set provided. The use of other injection/infusion sets may cause additional risks and treatment failure (due to adsorption of VWF/factor VIII onto the internal surfaces of certain infusion sets).

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/