Wilate, 500 IU VWF/500 IU FVIII, powder and liquid for solution for injection, Wilate, 1000 IU VWF/1000 IU FVIII, powder and liquid for solution for injection.
Human von Willebrand factor/human coagulation factor VIII.
What Wilate is and what it is used for
Wilate belongs to the pharmacotherapeutic group of drugs called coagulation factors and contains human von Willebrand factor (VWF) and coagulation factor VIII. Both of these proteins are important for the blood’s ability to clot ( coagulation ability ).
von Willebrand disease
Wilate is used to treat and prevent bleeding in patients with von Willebrand disease (VWS), which is a group of related diseases. VWS ( von Willebrand disease ) is a disorder of blood coagulation, which means that bleeding can last longer than expected. It is either due to a lack of VWF or to VWF not working properly.
Hemophilia A
Wilate is used to treat and prevent bleeding in patients with hemophilia A. This is a disease that means that you bleed for longer than normal. It is due to a congenital deficiency of factor VIII in the blood.
What you need to know before using Wilate
Do not use Wilate
- If you are allergic to human von Willebrand factor, coagulation factor VIII, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Wilate.
- All medicines of the same type as Wilate which are made from human blood (containing proteins ) and are injected into a vessel ( intravenous administration ) can cause allergic reactions. Be aware of early signs of allergic reactions ( hypersensitivity reaction ), such as hives- skin rash- pressure over the chest- wheezing- low blood pressure (may appear as dizziness)- anaphylaxis (when any or all of the above symptoms appear quickly and are intense)
If such symptoms occur, discontinue use immediately and contact your physician.
- When medicines are made from human plasma or blood, special measures are taken to prevent infection from being passed on to patients. This includes careful selection of blood and plasma donors to ensure that people at risk of infection are excluded, testing of individual donations and plasma pools for signs of virus/infection, and also steps in the processing of blood or plasma that may inactivate or shed viruses. Despite this, the risk of transmission of infection cannot be completely excluded when medicines made from human blood or plasma are given. This also applies to new, so far unknown viruses as well as other types of infection. The measures taken are considered to be effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C viruses, and for non-enveloped viruses and hepatitis A virus. The measures may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be serious for pregnant women ( infection of the fetus), individuals with compromised immune systems, or patients with certain types of anemia (eg, sickle cell disease or hemolytic anemia ).
When you are given Wilate, it is recommended that the product name and batch number be recorded to enable tracking of the product used.
Your doctor may suggest vaccination against hepatitis A and B if you are regularly/repeatedly treated with plasma-derived VWF/factor VIII concentrates.
von Willebrand disease (VWS)
- See section 4 ( von Willebrand’s disease (VWS)) for side effects of VWS treatment.
Hemophilia A
The development of inhibitors ( antibodies ) is a known complication that can occur with treatment with all factor VIII drugs. The inhibitors prevent, especially at high levels, the treatment from working as it should. You or your child will be closely monitored for the development of such inhibitors. Tell your doctor immediately if you or your child develop bleeding that cannot be controlled with Wilate.
- See section 4 ( Haemophilia A) for side effects in the treatment of hemophilia A.
Other medicines and Wilate
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Although there is no known effect of other medicines on Wilate, tell your doctor or pharmacist if you are taking or have recently taken any other medicines (including medicines obtained without a prescription).
Wilate must not be mixed with any other medicine during the injection.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Wilate contains sodium
This medicine contains up to 58.7 mg of sodium (the main ingredient in common/table salt) per bottle of 500 IU VWF and FVIII and up to 117.3 mg per bottle of 1000 IU VWF and FVIII. This corresponds to 2.94% and 5.87% respectively of the maximum recommended daily intake of sodium for adults.
How to use Wilate
Wilate should be injected into a blood vessel ( intravenous administration ) after being dissolved in the supplied diluent. Treatment must be started under the supervision of a doctor.
Dosage
Your doctor will decide what dose you should have and how often you should take Wilate. Always use Wilate as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
If you have taken too much Wilate
No symptoms of overdose with human VWF or factor VIII have been reported. However, you should not take more than the prescribed dose.
If you have ingested too much medicine or if, for example, a child has swallowed the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Wilate
Do not take a double to compensate for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Hypersensitivity or allergic reactions have been observed, although this is rare. Such reactions may include:- burning and stinging sensation at the infusion site- shiver- skin redness- headache- hives ( urticaria )- low blood pressure ( hypotension )- fatigue ( lethargy )- nausea- restlessness- palpitations ( tachycardia )- pressure over the chest- tingling sensation (ant crawls)- vomiting- wheezing- sudden swelling in different parts of the body ( angioedema )
If you experience any of the above symptoms, inform your doctor.
You should stop taking Wilate and contact your doctor immediately if you develop symptoms of angioedema, such as:
– Swelling of the tongue, face, or throat (pharynx)
– Difficult to swallow
– Hives and difficulty breathing
- Although less common, fever has also been observed.
- Abdominal pain, back pain, chest pain, cough, and dizziness may also occur, but the frequencies of these side effects are not known.
- In very rare cases, hypersensitivity can lead to a severe allergic reaction called anaphylaxis (when any or all of the above symptoms appear quickly and are intense), which includes shock. If anaphylactic shock occurs, it is of the utmost importance that treatment is given according to current medical recommendations.
von Willebrand disease (VWS)
- When a VWF product containing factor VIII is used to treat VWS, the treatment may lead to an excessive increase in factor VIII in the blood. This can increase the risk of blood flow disturbances (blood clots).
If you are a patient with risk factors identified by a doctor or through laboratory tests, you must be checked for early signs of blood clots. Preventive treatment ( prophylaxis ) against blood clots must be prescribed by your doctor by current recommendations. - Patients with von Willebrand disease (especially type 3 patients) may develop inhibitors (neutralizing antibodies ) against VWF during treatment with VWF. In these very rare cases, the inhibitors may cause Wilate not to work correctly.
If the bleeding does not stop, your blood should be tested for the presence of such inhibitors.
Inhibitors may increase the risk of suffering severe allergic reactions (anaphylactic shock ). If you suffer an allergic reaction, you should be tested for the presence of inhibitors.
If inhibitors are detected in the blood, contact a doctor experienced in treating patients with bleeding disorders. For patients with high levels of inhibitors, other types of treatment may be effective and should be considered.
Hemophilia A
- Among children who have not been treated with factor VIII medicines before, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients). However, for patients who have previously been treated with factor VIII (treatment more than 150 days), the risk is lower and the complication is less common (occurring in fewer than 1 in 100 users). If you or your child develop antibodies, the medicines may stop working as they should, and you or your child may suffer from persistent bleeding. If this happens, contact a doctor immediately.
Inhibitors may increase the risk of suffering severe allergic reactions (anaphylactic shock ). If you suffer an allergic reaction, you should be tested for the presence of inhibitors.
| Uncommon: may occur in up to 1 in 100 patients are: may occur in up to 1 in 1,000 patients very rare: may occur in up to 1 in 10,000 patients |
There are insufficient data to recommend the use of Wilate in previously untreated patients.
There is limited experience in the treatment of children under six years of age.
For infectious agent safety information, see section 2 (Warnings and precautions).
How to store Wilate
Keep this medicine out of the sight and reach of children.
Store the powder and liquid in a refrigerator (2°C-8°C).
Do not freeze.
Store the vials in the outer carton. Light sensitive.
Use before the expiry date stated on the label.
Wilate can be stored at room temperature (max. +25°C) for 2 months. In such a case, the shelf life expires 2 months after the product was first taken out of the refrigerator. You must write down the new expiry date on the outer carton yourself.
The powder should not be dissolved until immediately before injection. The solution is stable for 4 hours at room temperature. However, to prevent contamination of the solution, it should be used immediately and only once.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration:
– The active substances are the human von Willebrand factor and human coagulation factor VIII.
– Other ingredients are sodium chloride, glycine, sucrose, sodium citrate, and calcium chloride. Diluent: water for injections with 0.1% polysorbate 80.
Appearance and package sizes of the medicine
Freeze-dried powder: white or pale yellow powder or crumbly mass.
Reconstituted solution: should be clear or slightly milky.
Wilate is supplied as powder and liquid for solution for injection in two pack sizes:
- Wilate 500 IU VWF and 500 IU FVIII, powder and liquid for solution for injection, has a nominal content of 500 IU human von Willebrand factor and 500 IU human coagulation factor VIII per vial. The product contains approximately 100 IU/ml human von Willebrand factor and 100 IU/ml human coagulation factor VIII after dissolution in 5 ml water for injections with 0.1% polysorbate 80 ( diluent ).
- Wilate 1000 IU VWF and 1000 IU FVIII, powder and liquid for solution for injection, has a nominal content of 1000 IU human von Willebrand factor and 1000 IU human coagulation factor VIII per vial. The product contains approximately 100 IU/ml human von Willebrand factor and 100 IU/ml human coagulation factor VIII after dissolution in 10 ml water for injections with 0.1% polysorbate 80 ( diluent ).
Package contents
1 vial of freeze-dried powder
1 vial with diluent
1 pack of intravenous injection equipment (1 transfer set, 1 infusion set, 1 disposable syringe)
2 disinfection dryers
Marketing Authorization Holder and Manufacturer:
Marketing Authorisation Holder:
Octapharma AB
112 75 Stockholm
Manufacturer:
Octapharma Pharmaceuticals
Produktionsges.mbH
Oberlaaerstr. 235
A-1100 Vienna
Austria
Local representative:
Octapharma Nordic AB
Lars Forssells gata 23
112 75 Stockholm
Phone 08-566 430 00
Customer support: 020-311020
e-mail: fraga@octapharma.se
This medicine is approved in the European Economic Area under the names:
Austria, Belgium, Bulgaria, Cyprus, Croatia, Czech Republic, Estonia, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia, Spain, Great Britain, Hungary: Wilate 500/ Wilate 1000
Finland, Norway, Sweden: Wilate
Denmark: Wilnativ
France: Eqwilate 500/ Eqwilate 1000