Details for: WILATE
Company: OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02286750 | WILATE | ANTIHEMOPHILIC FACTOR (HUMAN); VON WILLEBRAND FACTOR (HUMAN); HUMAN PLASMA PROTEINS | 500 UNIT / 5 ML; 500 UNIT / 5 ML; 7.5 MG / 5 ML | POWDER FOR SOLUTION | INTRAVENOUS |
| 02286769 | WILATE | ANTIHEMOPHILIC FACTOR (HUMAN); VON WILLEBRAND FACTOR (HUMAN); HUMAN PLASMA PROTEINS | 1000 UNIT / 10 ML; 1000 UNIT / 10 ML; 15 MG / 10 ML | POWDER FOR SOLUTION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Hemophilia A
Treatment and prophylaxis of bleeding in patients with
hemophilia A (congenital or acquired FVIII deficiency) and for
the prevention and treatment of bleeding in minor surgical
procedures.
Controlled clinical trials to evaluate the safety and efficacy of wilate® in major surgeries are ongoing in hemophilia A patients. Therefore, limited data are presently available on which to evaluate or to base dosing recommendations. Thus, in the case of major surgical interventions, a precise monitoring of the substitution therapy by means of coagulation analysis (FVIII:C) is indispensable.
Von Willebrand Disease (VWD)
Treatment and prevention of spontaneous and trauma-induced bleeds in all types of VWD in adult and pediatric patients where use of DDAVP (1-deamino-8-D-arginine vasopressin/desmopressin) treatment is ineffective or contra-indicated. Clinical data on controlling severe spontaneous bleeding are limited, and only minimal data exist to support the prophylactic use of wilate®.
Prevention and treatment of bleeding during and after surgical procedures.
What it does
wilate® is a highly purified concentrate of active human von
Willebrand factor (VWF) and coagulation factor VIII (FVIII).
Hemophilia A is a sex-linked hereditary disorder of blood
coagulation due to decreased levels of FVIII and can result in
profuse bleeding into joints, muscles or internal organs, either
spontaneously or as a result of accidental or surgical trauma. With
replacement therapy with wilate®, a complex of human VWF and
FVIII, the plasma levels of FVIII are increased, thereby enabling a
temporary correction of the factor deficiency and correction of the
bleeding tendencies.
Patients suffering from VWD have a deficiency or abnormality of
VWF. A reduction in functional VWF concentration in the bloodstream results in low FVIII activity and abnormal platelet
function. The result is that the platelets cannot adhere to damaged
blood vessel walls to stop bleeding and that the lack of FVIII can
impair the coagulation process. This can result in excessive
bleeding.
Administration of wilate® restores the plasma levels of VWF and
FVIII to normal immediately.
When it should not be used
There are insufficient data to recommend the use of wilate® in children with hemophilia A less than 12 years of age. There is no information on the use of wilate® in patients >65 years old.
What the medicinal ingredient is
Human von Willebrand Factor (VWF) and human Coagulation Factor VIII (FVIII)
What the non-medicinal ingredients are
Calcium chloride, glycine, sodium chloride, sodium citrate and, sucrose. The solvent contains Water for Injections with 0.1% Polysorbate 80.
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage form it comes in
Powder and solvent for solution for injection. One package of wilate® contains:
One powder vial (500 IU VWF/500 IU FVIII or 1000 IU VWF/1000 IU FVIII), a second vial containing the diluent (5 mL or 10 mL) and a Mix2Vial™ transfer set with integrated filter.
Warnings and precautions
Serious Warnings and Precautions
A general risk of all blood products is the risk of transmission of viruses from the blood of the donors to the final recipients of the blood or its products. This risk has been reduced by verifying if the donors of the plasma used to manufacture wilate® had prior exposure to certain viruses and by testing for the presence of certain viral infections. Further, wilate® manufacturing employs two independent steps of viral inactivation/removal and complies with the most rigid norms of viral safety in the European Union and Canada. However, like all blood products, the possibility for transmission of blood-borne viral agents like Parvovirus B19, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent cannot be excluded.
BEFORE you use wilate® talk to your doctor or pharmacist:
- Drugs made from human blood plasma, such as wilate® may transmit infections, including hepatitis. Before starting treatment with wilate®, if you have not been vaccinated against hepatitis A and B, discuss getting vaccinated with your doctor or pharmacist.
- If you are pregnant or nursing. There is no information on wilate® administered to nursing or pregnant women. A pregnancy test is recommended before receiving wilate®.
- If you will be undergoing any scheduled surgical procedures.
- If you are allergic to the active substance or to any of the nonmedicinal ingredients.
Interactions with this medication
There are no known drug interactions with wilate®.
Proper use of this medication
Usual Dose
As dosage and treatment duration depend on your clinical situation, the type and severity of your bleeding, and your VWF and/or FVIII:C levels, your physician will decide on your treatment on an individual basis.
Overdose
No symptoms of overdose with human VWF or FVIII have been reported.
Missed Dose
It is important to take the total daily dose prescribed to ensure you get maximum benefit. If you miss a dose, take the missed dose as soon as possible, and then continue as before. However, if a dose is skipped, do not double the next dose. Continue on with your normal dose on the regular schedule as prescribed by your doctor.
Administration
wilate® is administered via intravenous infusion.
Instructions for Reconstitution:
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1. Warm the wilate® powder and solvent in the closed vials up to room temperature (maximum +37°C). This temperature should be maintained during reconstitution. |
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2. Remove the flip caps from both the wilate® vial and the solvent vial and clean the rubber stoppers with an alcohol swab. |
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3. Peel away the lid of the outer package of the Mix2Vial™ transfer set. Place the solvent vial on an even surface and hold the vial firmly. Take the Mix2Vial™ together with its outer package and invert it over the solvent vial. Push the blue plastic cannula of the Mix2Vial™ firmly through the rubber stopper of the solvent vial (Fig. 1). While holding onto the solvent vial, carefully remove the outer package from the Mix2Vial™, being careful to leave the Mix2Vial™ attached firmly to the solvent vial (Fig. 2). |
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4. With the wilate® vial held firmly on an even surface, quickly invert the solvent vial (with the Mix2Vial™ attached) and push the transparent plastic cannula end of the Mix2Vial™ firmly through the stopper of the wilate® vial (Fig. 3). The solvent will be drawn into the wilate® vial by vacuum. |
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5. With both vials still attached, slowly (careful not to introduce bubbles) swirl the wilate® vial to ensure the product is fully dissolved, giving a clear or slightly opalescent, colourless or slightly yellow solution. Once the contents of the wilate® vial are dissolved, firmly hold both the transparent and blue parts of the Mix2Vial™. Unscrew the Mix2Vial™ into two separate pieces with the vials still attached (Fig. 4) and discard the empty solvent vial and the blue part of the Mix2Vial™. |
Instructions for Injection
As a precautionary measure, the patients pulse rate should be measured before and during the injection. If a marked increase in the pulse rate occurs the injection speed must be reduced or the administration must be interrupted.
- Attach a plastic sterile disposable syringe to the transparent part of Mix2Vial™. Invert the system and draw the reconstituted wilate® into the syringe.
- Once the wilate® solution has been transferred into the syringe, firmly hold the barrel of the syringe (keeping it facing down) and detach the Mix2Vial™ from the syringe. Discard the Mix2Vial™ (transparent plastic part) and the empty wilate® vial.
- Clean the intended injection site with an alcohol swab.
- Attach a suitable infusion needle to the syringe.
- Inject the solution intravenously at a slow speed of 2-3 mL/minute.
Side effects and what to do about them
Allergic reactions such as hives, itching, tightness of the chest, wheezing, chills, flushing, headache, feeling unusually tired, drowsy or restless, feeling sick or vomiting, and tingling of the skin, can occur with wilate®. If these symptoms occur contact your doctor or pharmacist for advice before continuing treatment. In rare cases, the allergic reactions are severe, known as shock or anaphylactic shock. This may include extreme difficulty breathing, or loss of consciousness. Urgent treatment is required and the emergency services should be called, for example 911.
Patients with VWD or hemophilia A may develop neutralizing antibodies (inhibitors) to VWF or FVIII. If the expected VWF/FVIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if FVIII inhibitors are present. Sometimes, treatment with wilate® stops working due to the development of inhibitors. If you find that your usual treatment for bleeding is not working, you should contact your doctor as soon as possible. In some cases higher doses of wilate® or another VWF/factor VIII product are required, in other cases, alternative treatments may be prescribed by a doctor specializing in the treatment of Hemophilia and or VWD.
This is not a complete list of side effects. For any unexpected effects while taking wilate®, contact your doctor or pharmacist.
How to store
wilate® and solvent can be stored at between +2°C and +8°C until the indicated expiry date. Within this period wilate® and solvent may be stored for a single block of up to 6 months at room temperature (max. +25°C). If stored at room temperature (max. +25°C) wilate® must either be used within 6 months or discarded. Protect from light. Do not freeze. The reconstituted solution should be used on one occasion only. Any solution remaining should be discarded.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.octapharma.com
or by contacting Octapharma Canada Inc.,
at: 1-888-438-0488
This leaflet was prepared by Octapharma Pharmazeutika
Produktionsges.m.b.H
Last revised: October 16, 2015