Wilate – Von Willebrand Factor/coagulation Factor Viii Complex

Wilate – Von Willebrand Factor/coagulation Factor Viii Complex Manufacturers

• Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
  

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  Wilate – Von Willebrand Factor/coagulation Factor Viii Complex | Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.

  

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  For Intravenous Use after Reconstitution Treatment should be initiated under the supervision of a physician experienced in the treatment of coagulation disorders. Each vial of Wilate contains the labeled amount in International Units (IU) of von Willebrand factor (VWF) activity as measured with the Ristocetin cofactor assay (VWF:RCo), and coagulation factor VIII (FVIII) activity measured with the chromogenic substrate assay. The number of units of VWF:RCo and FVIII activities administered is expressed in IU, which are related to the current WHO standards for VWF and FVIII products. VWF:RCo and FVIII activities in plasma are expressed either as a percentage (relative to normal human plasma) or in IU (relative to the International Standards for VWF:RCo and FVIII activities in plasma). 2.1 Dosage in von Willebrand Disease

  The ratio between VWF:RCo and FVIII activities in Wilate is approximately 1:1.

  The dosage should be adjusted according to the extent and location of the bleeding. In VWD type 3 patients, especially in those with gastro-intestinal (GI) bleedings, higher doses may be required.

  2.2 Dosing Schedule

  Physician supervision of the treatment regimen is required. A guide for dosing in the treatment of major and minor hemorrhages is provided in Table 1 .

  The careful control of replacement therapy is especially important in life-threatening hemorrhages. When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII activity.[ 1 ]

  
  

  Table 1 Guide to Wilate Dosing for Treatment of Minor and Major Hemorrhages

  Type of Hemorrhages Loading Dosage (IU VWF:RCo /kg BW) Maintenance Dosage (IU VWF:RCo /kg BW) Therapeutic Goal

  Minor Hemorrhages

  20-40 IU/kg

  20-30 IU/kg every 12-24 hours*

  VWF:RCo and FVIII activity through levels of >30%

  Major Hemorrhages

  40-60 IU/kg

  20-40 IU/kg every 12-24 hours*

  VWF:RCo and FVIII activity through levels of >50%

  *This may need to be continued for up to 3 days for minor hemorrhages and 5-7 days for major hemorrhages

  
  

  Repeat doses are administered for as long as needed based upon repeat monitoring of appropriate clinical and laboratory measures.

  Although dose can be estimated by the guidelines above, it is highly recommended that whenever possible, appropriate laboratory tests should be performed on the patient’s plasma at suitable intervals to assure that adequate VWF:RCo and FVIII activity levels have been reached and are maintained.

  
  

  In the unlikely event that a patient who is actively bleeding should miss a dose, it may be appropriate to adopt a dosage depending on the level of coagulation factors measured, extent of the bleeding, and patient's clinical condition.

  
  2.3 Administration

  Wilate is administered via intravenous infusion. Wilate is provided with a Mix2Vial TM transfer device for reconstitution of the freeze-dried powder in diluent, a 10-mL syringe, an infusion set and two alcohol swabs.

  
  

  Instructions for Reconstitution:

  1) Warm the Powder and Diluent in the closed vials up to room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers (latex-free) or the caps of the vials. The temperature of the water bath should not exceed +37°C (98°F).

  2) Remove the caps from the concentrate (Wilate) vial and the diluent vial and clean the rubber stoppers with an alcohol swab.

  3) Peel away the lid of the outer package of the Mix2Vial™ transfer set. To maintain sterility, leave the Mix2Vial™ device in the clear outer packaging. Place the diluent vial on a level surface and hold the vial firmly. Take the Mix2Vial™ in its outer package and invert it over the diluent vial. Push the blue plastic cannula of the Mix2Vial™ firmly through the rubber stopper of the diluent vial (Fig. 1). While holding onto the diluent vial, carefully remove the outer package from the Mix2Vial™, being careful to leave the Mix2Vial™ attached firmly to the diluent vial (Fig. 2).

  4) With the concentrate (Wilate) vial held firmly on a level surface, quickly invert the diluent vial with the Mix2Vial™ attached and push the transparent plastic cannula end of the Mix2Vial™ firmly through the stopper of the concentrate (Wilate) vial (Fig. 3). The diluent will be drawn into the concentrate (Wilate) vial by the vacuum.

  5) With both vials still attached, gently swirl the product vial to ensure the product is fully dissolved to a clear solution. Once the contents of the Wilate vial are completely dissolved, firmly hold both the transparent and blue parts of the Mix2Vial™. Unscrew the Mix2Vial™ into two separate pieces (Fig. 4) and discard the empty diluent vial and the blue part of the Mix2Vial™.

  
  The powder should be reconstituted only directly before injection. As Wilate contains no preservatives, the solution should be used immediately after reconstitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The filtered solution is clear or slightly opalescent, colourless or slightly yellow. If the concentrate fails to dissolve completely or an aggregate is formed, the preparation must not be used.

  Instructions for Injection:

  
  With the Wilate vial still upright, attach a plastic disposable syringe to the Mix2Vial™ (transparent plastic part). Invert the system and draw the reconstituted Wilate into the syringe. Once Wilate has been transferred into the syringe, firmly hold the barrel of the syringe (keeping the syringe plunger facing down) and detach the Mix2Vial™ from the syringe. Discard the Mix2Vial™ (transparent plastic part) and 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 2-4 mL/minute. As a precautionary measure, the patient’s 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. Any unused product or waste material should be disposed of in accordance with local requirements.

  Incompatibilities

  Wilate must not be mixed with other medicinal products or administered simultaneously with other intravenous preparation in the same infusion set.

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