urgery based on individual pharmacokinetic values. Subsequent therapy with an antifibrinolytic agent is usually administered until adequate healing is achieved.
Major >50 IU/dL >30 IU/dL >50 IU/dL >30 IU/dL 72 hours
Minor ≥30 IU/dL – – >30 IU/dL 48 hours
Oral† ≥30 IU/dL – – >30 IU/dL 8-12 hours‡
Based on individual pharmacokinetic-derived half-lives, the frequency of maintenance doses is generally every 8 or 12 hours; patients with shorter half-lives may require dosing every 6 hours. In the absence of pharmacokinetic data, it is recommended that Humate-P be administered initially every 8 hours with further adjustments determined by monitoring trough coagulation factor levels. When hemostatic levels are judged insufficient or trough levels are outside the recommended range, consider modifying the administration interval and/or the dose.
It is advisable to monitor trough VWF:RCo and FVIII:C levels at least once a day in order to adjust Humate-P dosing as needed to avoid excessive accumulation of coagulation factors. The duration of treatment generally depends on the type of surgery performed, but must be assessed for individual patients based on their hemostatic response (see Clinical Studies [14.2]).
2.4Reconstitution and Administration
Humate-P is for intravenous (IV) use only.
Inspect visually for particulate matter and discoloration prior to administration.
Use either the Mix2Vial™ filter transfer set provided with Humate-P (see How Supplied/Storage and Handling [16]) or a commercially available double-ended needle and vented filter spike.
Plastic disposable syringes are recommended for use with Humate-P. Protein solutions of this type tend to adhere to the ground glass surface of all-glass syringes.
1.
Ensure that the Humate-P and diluent are at room temperature. Using aseptic technique, follow these steps to reconstitute Humate-P.
2.
Place the product vial, diluent vial and Mix2Vial on a flat surface.
3.
Remove product and diluent vial flip caps and treat the stoppers with the alcohol swab provided, and allow to dry prior to opening the Mix2Vial package.
4.
Open the Mix2Vial package by peeling away the lid (Fig. 1). Leave the Mix2Vial in the clear package. Place the diluent vial on a flat surface and hold the vial tight. Grip the Mix2Vial together with the package and snap the blue end onto the diluent stopper (Fig. 2).
Fig. 1
Fig. 2
5.
Carefully remove the clear package from the Mix2Vial set. Make sure that you only pull up the package and not the Mix2Vial set (Fig. 3).
Fig. 3
6.
With the product vial placed firmly on a flat surface, invert the diluent vial with the set attached and snap the transparent adapter onto the product vial stopper (Fig. 4). The diluent will automatically transfer into the product vial.
Fig. 4
7.
With the diluent and product vial still attached, gently swirl the product vial to ensure the product is fully dissolved (Fig. 5). Do not shake vial.
Fig. 5
8.
With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the blue diluent-side of the Mix2Vial set and unscrew the set into two pieces (Fig. 6).
Fig. 6
9.
Draw air into an empty, sterile syringe. While the product vial is upright, screw the syringe to the Mix2Vial set. Inject air into the product vial. While keeping the syringe plunger pressed, i
