Wilate 1000

Wilate 500, 500 IU VWF / 500 IU FVIII, powder and solvent for solution for injection
Wilate 1000 , 1000 IU VWF / 1000 IU FVIII, powder and solvent for solution for injection
Human von Willebrand factor / human coagulation factor VIII
Please read this leaflet carefully before using this medicine, as it contains important
information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

1. What Wilate is and what it is used for
2. Important information before using Wilate
3. How to use Wilate
4. Possible side effects
5. How to store Wilate
6. Contents of the pack and other information

1. What Wilate is and what it is used for

Wilate belongs to a group of medicines called coagulation factors and contains human von Willebrand factor (VWF) and coagulation factor VIII. These two proteins are involved in blood clotting.

von Willebrand Disease
Wilate is used to treat and prevent bleeding episodes in patients with von Willebrand disease (VWD), which is essentially a group of related disorders. VWD is a bleeding disorder in which bleeding lasts longer than expected. This condition is due either to a deficiency of von Willebrand factor in the blood or to its impaired function.

Haemophilia A
Wilate is used to treat and prevent bleeding episodes in patients with haemophilia A. This is a condition characterized by prolonged bleeding due to an inherited deficiency of factor VIII in the blood.

2. Important information before using Wilate

When not to use Wilate

• if the patient is allergic (hypersensitive) to human von Willebrand factor, coagulation factor VIII, or any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Wilate, discuss this with your doctor or pharmacist.

• Like any medicine derived from human blood (containing proteins) and administered intravenously (injected into a vein), Wilate may cause allergic reactions. Early signs of allergic (hypersensitivity) reactions such as hives, skin rash, tightness in the chest, wheezing, drop in blood pressure, or anaphylaxis (when one or all of these symptoms occur suddenly and are severe) should be carefully monitored. If any of these symptoms occur, administration of the medicine must be stopped immediately and medical advice sought.
• Medicines derived from human blood or plasma use appropriate methods to prevent transmission of infections to patients. These include strict selection of blood and plasma donors to exclude carriers of infections, testing of individual donations and plasma pools for specific viral/infection markers, and inclusion of viral inactivation or removal steps during manufacturing. Despite these measures, transmission of infectious agents cannot be completely ruled out when administering medicines derived from human blood or plasma. This also applies to unknown or newly emerging viruses and other types of infections. The methods used are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, and non-enveloped hepatitis A virus. However, the methods may have limited effectiveness against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be dangerous for pregnant women (fetal infection) and for patients with immune disorders or certain types of anemia (e.g. sickle cell anemia or conditions involving abnormal breakdown of red blood cells). It is strongly recommended that the name and batch number of the Wilate product be recorded each time it is administered, to maintain a record of batches used. Vaccination against hepatitis A and B may be recommended by the doctor in cases of regular or repeated administration of von Willebrand factor and factor VIII derived from plasma. von Willebrand disease (VWD)
• See section 4 (von Willebrand disease (VWD)) for information on adverse reactions associated with treatment of von Willebrand disease. Hemophilia A

Inhibitor (antibody) formation is a known complication that may occur during treatment with any factor VIII-containing medicine. These inhibitors, especially at high levels, interfere with proper treatment, and the patient will be closely monitored for inhibitor development. If bleeding in the patient is not properly controlled with Wilate, inform your doctor immediately.

• See section 4 (Hemophilia A) for information on adverse reactions associated with treatment of hemophilia A. Wilate and other medicines Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. No interactions between Wilate and other medicines have been reported. Nevertheless, inform your doctor about any other medicines being taken or recently used (including over-the-counter medicines). Do not mix Wilate with other medicines during injection.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Wilate contains sodium
This medicine contains up to 58.7 mg of sodium (the main component of table salt) per 500 IU vial of von Willebrand factor and factor VIII, and up to 117.3 mg of sodium per 1000 IU vial of von Willebrand factor and factor VIII. This corresponds to 2.94% and 5.87%, respectively, of the maximum recommended daily dietary sodium intake for adults.

3. How to use Wilate

Wilate should be administered intravenously (into a vein) after reconstitution with the solvent provided.
Treatment should be initiated under medical supervision.
Dosage
The dose and frequency of administration should be determined individually for each patient by a physician.
Wilate should always be used exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
Use of a higher than recommended dose of Wilate
Symptoms of overdose with human von Willebrand factor or factor VIII have not been observed.
Nevertheless, the recommended dose should not be exceeded.
Missed dose of 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 medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• Although uncommon, hypersensitivity or allergic reactions have been observed. These may include: burning and stinging at the injection site, chills, flushing, headache, rash (urticaria), drop in blood pressure (hypotension), feeling of fatigue (lethargy), nausea, restlessness, rapid heartbeat (tachycardia), feeling of chest tightness, tingling sensation, vomiting, wheezing, sudden swelling of various body parts (angioedema). Inform your doctor if any of the above symptoms occur. Discontinue use of Wilate and seek immediate medical attention if symptoms of angioedema occur, such as:

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • urticaria and breathing difficulties

• Fever has also been observed, although this occurs uncommonly.

• 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 severe allergic reactions called anaphylaxis (when any or all of the above symptoms appear suddenly or are severe), including shock. In case of anaphylactic shock, appropriate medical management for shock treatment should be initiated.

von Willebrand disease (VWD)

• When using von Willebrand factor-containing products that also contain factor VIII, continuous treatment may lead to excessive increase in factor VIII levels in the blood. This may increase the risk of blood flow disorders (thrombosis). Therefore, patients with elevated clinical or laboratory risk should be monitored for early signs of thrombosis. Prophylactic (preventive) treatment for thrombotic complications should be decided by a physician in accordance with current guidelines.

• In patients with von Willebrand disease (mainly type 3), neutralizing antibodies (inhibitors) against von Willebrand factor may develop during treatment with this factor. In very rare cases, inhibitors may be responsible for the lack of effectiveness of Wilate. If bleeding persists, testing for inhibitors should be performed. Inhibitors may increase the risk of allergic reactions (anaphylactic shock). If allergic reactions occur, testing for inhibitors should be carried out. In case inhibitors are detected, contact a physician experienced in treating coagulation disorders. Consider alternative treatment options, which may be used in cases of high inhibitor titers.

Hemophilia A

• In previously untreated children receiving factor VIII-containing medicines, inhibitory antibodies (see section 2) may develop very frequently (more than 1 in 10 patients). However, in patients who have previously been treated with factor VIII (more than 150 days of exposure), the risk is uncommon (less than 1 in 100 patients). If this occurs, the medicine may stop working properly and prolonged bleeding may occur. In such cases, contact your doctor immediately. Inhibitors may increase the risk of allergic reactions (anaphylactic shock). If allergic reactions occur, testing for inhibitors should be performed.

Uncommon: may affect up to 1 in 100 users
Rare: may affect up to 1 in 1,000 users
Very rare: may affect up to 1 in 10,000 users

There are insufficient data to recommend administration of Wilate in previously untreated patients.
Experience with Wilate in children under 6 years of age is limited.
Information on viral safety, see section 2 (Warnings and precautions).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly (details below). Reporting adverse reactions helps to provide more information on the safety of this medicine.

Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: https://smz.ezdrowie.gov.pl

5. How to store Wilate

Keep the medicine out of the sight and reach of children.
Store the powder and solvent in a refrigerator (2°C - 8°C).
Do not freeze.
Keep vials in the outer packaging to protect from light.
Do not use Wilate after the expiry date stated on the label.
The product may be stored at room temperature (below 25°C) for a period of 2 months. In such a case, the product's expiry date will be the end of the second month after the product was first removed from the refrigerator. The patient should record the new expiry date on the outer packaging.
The powder should be dissolved immediately before injection. The prepared solution has been shown to be stable for 4 hours at room temperature. However, to avoid microbiological contamination, the solution should be used immediately and is intended for single use only.
Medicines must not be 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 other information

What Wilate contains
The active substances are human von Willebrand factor and human coagulation factor VIII.
Other components: Sodium chloride, Glycine, Sucrose, Sodium citrate, and Calcium chloride.
Solvent: Water for injections with 0.1% Polysorbate 80.

What Wilate looks like and contents of the pack
Lyophilized powder: white or light yellow powder or cake.
Solution after reconstitution: should be clear or slightly opalescent.
Wilate is supplied as a powder and solvent for solution for injection.
It is available in two pack sizes:

• Wilate 500, 500 IU VWF and 500 IU FVIII, as powder and solvent for solution for injection containing nominally 500 IU of human von Willebrand factor and 500 IU of human factor VIII in a vial. The product contains approximately 100 IU of human von Willebrand factor and 100 IU of human factor VIII per 5 ml after reconstitution with water for injections containing 0.1% Polysorbate 80 (solvent).

• Wilate 1000, 1000 IU VWF and 1000 IU FVIII, as powder and solvent for solution for injection containing nominally 1000 IU of human von Willebrand factor and 1000 IU of human factor VIII in a vial. The product contains approximately 100 IU of human von Willebrand factor and 100 IU of human factor VIII per 10 ml after reconstitution with water for injections containing 0.1% Polysorbate 80 (solvent).

Contents of the pack
1 vial of lyophilized powder
1 vial of solvent
1 package of intravenous administration equipment (1 transfer set, 1 infusion set, 1 single-use syringe)
2 alcohol-impregnated swabs

Marketing Authorisation Holder and Manufacturer
Octapharma (IP) SPRL
Route de Lennik 451
1070 Anderlecht
Belgium
For more detailed information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Octapharma Poland Sp. z o.o.
ul. Domaniewska 39a
02-672 Warsaw
Poland
Tel. +48 22 489 52 28
Fax +48 22 489 52 29

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

This medicinal product is authorised for marketing in the European Economic Area countries 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 home use

• Read all instructions carefully and follow them exactly!
• Do not use Wilate after the expiry date stated on the label.
• Maintain sterile conditions during the procedure described below.
• Visually inspect the prepared solution before administration for the presence of particulate matter or discoloration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain particulate matter.
• Use the prepared solution immediately to prevent microbiological contamination.
• Use only the provided administration set. Using other injection/infusion equipment may cause additional risks and treatment failure.

Instructions for preparing the solution:

1. Do not use the product directly from the refrigerator. Allow the solvent and powder to reach room temperature while still in their sealed vials.
2. Remove the caps from both vials and clean the rubber stoppers with one of the provided alcohol-impregnated swabs.
3. The transfer set is shown in Fig. 1. Place the solvent vial on a flat surface and hold it firmly. Take the transfer set and turn it upside down. Place the blue part of the transfer set onto the top of the solvent vial and press firmly until it clicks into place (Fig. 2 + 3). Do not rotate while attaching.

Fig. 1 Fig. 2 Fig. 3

4. Place the vial with powder on a flat surface and hold it firmly.

Take the solvent vial with the attached transfer set and turn it upside down. Place the white part of the transfer set onto the top of the powder vial and press firmly until it clicks (Fig. 4). Do not rotate while attaching. The solvent will automatically flow into the vial with powder.

5. With both vials still connected, gently rotate the powder vial until the product is completely dissolved. Reconstitution is complete within less than 10 minutes at room temperature. Slight foaming may occur during preparation. Unscrew the transfer set into two parts (Fig. 5). The foam will dissipate.

Discard the empty solvent vial together with the blue part of the transfer set.

Instructions for administering the injection:
As a precaution, monitor the pulse before and during injection. If a significant increase in pulse rate occurs, 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 in the syringe should be clear or slightly opalescent. After transferring the solution, firmly hold the syringe plunger (pushing downward) and remove the syringe from the transfer set (Fig. 7).

Discard the empty solvent vial together with the white part of the transfer set.

2. Clean the selected injection site with one of the provided alcohol-impregnated swabs.
3. Attach the provided infusion set to the syringe.
4. Insert the needle into the selected vein. If a tourniquet was used to visualize the vein, release it before starting the injection of Wilate. Blood must not enter the syringe due to the risk of fibrin clot formation.
5. Inject the solution slowly into the vein, no faster than 2–3 ml per minute. When more than one Wilate powder vial is used in a single treatment cycle, the same needle and syringe may be reused. The transfer set is intended for single use only.

Any unused solution or waste materials must be disposed of in accordance with local regulations.
Do not mix or inject (using the same infusion set) Wilate with other medicinal products.
Administration must be performed only with the provided infusion set. Using other injection or infusion sets may pose additional risks and lead to treatment failure (von Willebrand factor and factor VIII may adsorb to the internal surface of certain infusion sets).