Use Humate-P (Antihemophilic And Von Willebrand Factor Complex) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than ...Dec 1, 2009 · Humate-P and Alphanate are currently the only plasma-derived VWF concentrates approved by the U.S. Food and Drug Administration for the treatment of VWD. These products also contain factor VIII ... Oct 27, 2016 · Humate P is the only product available for patients with von Willebrand Disease (VWD). Dose is based on VWF:RCo units only for VWD. VWF units varies in ratio to Factor VIII units with an average of 2.4:1. *Per Pharmacy & Therapeutics committee, Pharmacy can adjust dose within +/- 10% based on current dosage vial sizes in pharmacy to prevent waste. HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses.Feb 20, 2023 · sudden cough, coughing up blood; pain, swelling, warmth, or redness in one or both legs; pale or yellowed skin, dark colored urine, fever, confusion or weakness; bleeding from a wound or where the medicine was injected; or. bleeding that is not controlled. Common Wilate side effects may include: nosebleeds; humate-p Savings, Coupons and Information. | ANTIHEMOPHILIC FACTOR (an tee hee moe FIL ik fak tir) prevents and treats bleeding episodes in people with hemophilia A or von Willebrand disease, conditions caused by low levels of blood clotting factors. It works by increasing these factor levels in your body.Haemate P/Humate-P is an intermediate-purity VWF/FVIII concentrate with extensive clinical experience in VWD. This concentrate has been shown to correct haemostatic defects of VWD, with efficacy ratings of good/excellent in nearly all patients treated for bleeding or surgical events.At CSL Behring, we believe everyone should have access to therapy. For HUMATE-P we provide support services to help you get the treatment you need. Co-pay Assistance: Patients meeting eligibility requirements* may receive up to $12,000 in Co-Pay support. *Patient must have coverage for HUMATE-P under a private, commercial plan.Humate-P® has a high degree of purity with a low amount of non-factor proteins. Each Humate-P® vial contains the labeled amount of Factor VIII and vWF:RCoF activity expressed in international units (IU). Reconstituted solution is clear or slightly opalescent. Available in 1000 RcoF IU, and 2000 RcoF IU single-use vials.Feb 20, 2023 · sudden cough, coughing up blood; pain, swelling, warmth, or redness in one or both legs; pale or yellowed skin, dark colored urine, fever, confusion or weakness; bleeding from a wound or where the medicine was injected; or. bleeding that is not controlled. Common Wilate side effects may include: nosebleeds; J7187. Injection, von willebrand factor complex (humate-p), per iu vwf:rco. Drugs administered other than oral method, chemotherapy drugs. J7187 is a valid 2023 HCPCS code for Injection, von willebrand factor complex (humate-p), per iu vwf:rco or just “ Humate-p, inj ” for short, used in Medical care .Humate-P® Humate-P ®, FDA approved in 1986, is an anti-hemophilic factor/von Willebrand factor complex (human) originally indicated for the treatment and prevention of bleeding in adults with hemo-philia A. In 1999, the FDA approved Humate-P® for adults and pediatric patients with VWD for the treatment of spontaneous and trauma-induced A. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatmentA. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatmentHUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.Important Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...In many cases, HUMATE-P from a single request was used for several treatment courses in one subject. Therefore, there are more reported treatment courses than requests. HUMATE-P was administered to 97 subjects in 530 treatment courses: 73 for surgery, 344 for treatment of bleeding, and 20 for prophylaxis of bleeding. May 25, 2022 · Examples of plasma-derived product brand names include Humate P, Alphanate, Koate, and Wilfactin. An example of a product manufactured in the laboratory is Vonvendi. These treatments are injected into a vein, often in the hospital or in a health care provider's office, but some patients are taught how to self-inject this treatment at home. Aetna considers Alphanate, Humate-P or Koate medically necessary for treatment of VWD when any of the following criteria is met: Member has type 1, 2A, 2M, or 2N VWD and has had an insufficient response to desmopressin or a documented clinical reason for not using desmopressin (see Appendix B ); or In many cases, HUMATE-P from a single request was used for several treatment courses in one subject. Therefore, there are more reported treatment courses than requests. HUMATE-P was administered to 97 subjects in 530 treatment courses: 73 for surgery, 344 for treatment of bleeding, and 20 for prophylaxis of bleeding.Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is approved to treat and prevent bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P also treats spontaneous or trauma-induced bleeding episodes in adults and children with von Willebrand disease (VWD) and prevents excessive bleeding during and ...Lillicrap D, Poon M-C, Walker I, Xie F, Schwartz BA, and members of the Association of Hemophilia Clinic Directors of Canada. Efficacy and safety of the factor VIII/von Willebrand factor concentrate, Haemate-P/HUMATE-P: ristocetin cofactor unit dosing in patients with von Willebrand disease. Thromb Haemost. 2002;87 (2):224-230.Dose: individualize dose IV q8-24h until hemostasis; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100%; 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors.Feb 20, 2023 · sudden cough, coughing up blood; pain, swelling, warmth, or redness in one or both legs; pale or yellowed skin, dark colored urine, fever, confusion or weakness; bleeding from a wound or where the medicine was injected; or. bleeding that is not controlled. Common Wilate side effects may include: nosebleeds; The reported VWF:RCo average and terminal t1/2 of 10.4 and 15.8 hours (h), respectively, for Wilate and 9.3 h and 12.8 h for Humate-P, were not statistically different. Also, the mean VWF:RCo in vivo recoveries (Wilate 1.89, Humate-P 1.99 IU/dl per IU/kg) were similar between the two replacement therapies. Among the 63 VWD subjects who received HUMATE-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and ... What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects."Aetna considers Alphanate, Humate-P or Koate medically necessary for treatment of VWD when any of the following criteria is met: Member has type 1, 2A, 2M, or 2N VWD and has had an insufficient response to desmopressin or a documented clinical reason for not using desmopressin (see Appendix B ); or Factor VIII (plasma -derived)/von Willebrand Factor Complex (plasma -derived) [Alphanate or Humate -P], Factor VIII (plasma -derived) [Hemofil M or Koāte -DVI), and Factor VIII (recombinant) [Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq , or Recombinate ] are proven and medically necessary when both of the following c riteria are met:What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects."Humate-P • If patient needs FEIBA • If patient needs rFVIIa • If patient needs dose of DDAVP! Goal for factor replacement is 30 minutes or less for suspected head bleeds and 60 minutes or less for suspected bleeding in areas other than the head. Pearls: P1: When in doubt, administer clotting factor replacement therapyHumate-P, Wilate) Reference Number: ERX.SPA.185 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are factor VIII/von Willebrand factor complexes (human) requiring prior authorization:Humate-P Prices, Coupons and Patient Assistance Programs. Humate-P (antihemophilic factor/von willebrand factor) is a member of the miscellaneous coagulation modifiers drug class and is commonly used for Hemophilia A, and von Willebrand Disease.HUMATE-P; Safety; Patient Stories; Support & Resources; About von Willebrand Disease. What Is VWD? Diagnosis & Treatment Options; Home; Why HUMATE-P; Taking HUMATE-P ...Haemate P/Humate-P, the first plasma-derived von Willebrand factor (VWF)/factor VIII (FVIII)-containing concentrate that was pasteurized to reduce the risk of virus infection, was developed in the 1970s and approved for use in Germany in 1981. Today, Haemate P is marketed in over 35 countries worldw … Dec 6, 2019 · Surgical procedures represent a serious hemostatic challenge for patients with von Willebrand disease (VWD), and careful perioperative management is required to minimize bleeding risk. Risk stratification includes not only the nature of the surgery to be performed but the baseline plasma von Willebrand factor (VWF) levels, bleeding history, and ... HUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing. viral transmission. The primary viral reduction step of the Humate-P® manufacturing process is the heat treatment of the purified, stabilized aqueous solution at 60.0 +/ - 1°C for 10 hours. In addition, the purification procedure (several precipitation steps) used in the manufacture of Humate-P® also provides viral reduction capacity. Failure to confirm specific third-party payor coding requirements may result in underpayment for Humate-P. Call 1-800-676-4266 for information on insurance matters or assistance with individual case inquiries on a variety of reimbursement services, including: claim processing reviews. appeals. Humate P - J7190 or J7186 or J7187 . Profilate HP- J7190 . AHF M - J7190 . Alphanate - J7190 . Antihemophilic Factor (Porcine) Hyate:C - J7191 . Recombinate (Recombinant) - J7192 . Kogenate - J7192 . Bioclate - J7192 . Helixate - J7192 . Xyntha – J7185 . 3. Factor VIII inhibitors . Autoplex T (anti-inhibitor) - J7198 . Feiba VH (anti ... Among the 63 VWD subjects who received HUMATE-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and ...This unique HUMATE-P Surgery Dosing Calculator makes individual dosing fast, easy, and convenient. The calculator determines the correct HUMATE-P loading dose (measured in VWF:RCo units) needed to achieve the desired increase in circulating VWF, as defined in the product prescribing information. (For guidance on loading dose recommendations ...HUMATE-P; Safety; Patient Stories; Support & Resources; About von Willebrand Disease. What Is VWD? Diagnosis & Treatment Options; Home; Why HUMATE-P; Taking HUMATE-P ...HUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing. Oct 27, 2016 · Humate P is the only product available for patients with von Willebrand Disease (VWD). Dose is based on VWF:RCo units only for VWD. VWF units varies in ratio to Factor VIII units with an average of 2.4:1. *Per Pharmacy & Therapeutics committee, Pharmacy can adjust dose within +/- 10% based on current dosage vial sizes in pharmacy to prevent waste. Dose: individualize dose IV q8-24h until hemostasis; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100%; 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors. Surgical procedures represent a serious hemostatic challenge for patients with von Willebrand disease (VWD), and careful perioperative management is required to minimize bleeding risk. Risk stratification includes not only the nature of the surgery to be performed but the baseline plasma von Willebrand factor (VWF) levels, bleeding history, and ...How to mix HumateHumate-P® has a high degree of purity with a low amount of non-factor proteins. Each Humate-P® vial contains the labeled amount of Factor VIII and vWF:RCoF activity expressed in international units (IU). Reconstituted solution is clear or slightly opalescent. Available in 1000 RcoF IU, and 2000 RcoF IU single-use vials. Humate-P® has a high degree of purity with a low amount of non-factor proteins. Each Humate-P® vial contains the labeled amount of Factor VIII and vWF:RCoF activity expressed in international units (IU). Reconstituted solution is clear or slightly opalescent. Available in 1000 RcoF IU, and 2000 RcoF IU single-use vials. What is HUMATE-P HUMATE-P is a VWF/FVIII replacement therapy that delivers results, patient after patient, treatment after treatment, decade after decade, as proven by a US study of the hemostatic efficacy of HUMATE-P. Based on this study, an independent Data Safety Monitoring Board judged hemostatic efficacy as "effective in 94.3% of the perioperative study subjects."Aug 28, 2023 · Humate-P: View Coupon: Humate-P Connect This program provides brand name medications at no or low cost: Provided by: CSL Behring: TEL: 800-676-4266 ALT PHONE: 844-727-2752 FAX: 844-727-2757: Languages Spoken: English. Program Website : Program Applications and Forms: Humate-P Connect Enrollment Form : Medications HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses.Nov 15, 2017 · A. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatment Humate-P: No adequate and well-controlled studies in pediatric patients with hemophilia A. Long-term evaluation of joint damage not available for pediatric patients; joint damage may result from suboptimal treatment of hemarthroses. Safety and efficacy established in infants, children, and adolescents with von Willebrand disease, but not in ...Humate-P and Alphanate are currently the only plasma-derived VWF concentrates approved by the U.S. Food and Drug Administration for the treatment of VWD. These products also contain factor VIII ...Sep 4, 2023 · HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Sep 4, 2023 · HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. Humate is the generic name for soil humic substances. Humic acid is the chemical properties of humate. Humate and Humic acid are basically one in the same. Humate is essentially to life…for humans, animals and all the plants on this earth. Between 65 to 100 million years ago the Earth enjoyed optimum organic growing conditions.May 25, 2022 · Examples of plasma-derived product brand names include Humate P, Alphanate, Koate, and Wilfactin. An example of a product manufactured in the laboratory is Vonvendi. These treatments are injected into a vein, often in the hospital or in a health care provider's office, but some patients are taught how to self-inject this treatment at home. HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. With the HUMATE-P vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the HUMATE-P vial (Fig. 4). The diluent will automatically transfer into the HUMATE-P vial.Factor VIII ( FVIII) is an essential blood-clotting protein, also known as anti-hemophilic factor (AHF). In humans, factor VIII is encoded by the F8 gene. [5] [6] Defects in this gene result in hemophilia A, an X-linked coagulation disorder. [7] Factor VIII is produced in liver sinusoidal cells and endothelial cells outside the liver throughout ...The densitometric analysis shows that, like normal human plasma, HUMATE-P contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers, and it is capable of correcting the hemostatic defect in patients with VWD. View an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.HUMATE-P; Safety; Patient Stories; Support & Resources; About von Willebrand Disease. What Is VWD? Diagnosis & Treatment Options; Home; Why HUMATE-P; Taking HUMATE-P ...Find patient medical information for Humate-P intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Humate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Although few adverse reactions have been reported in patients receiving Humate-P®, the most commonly reportedThe platelet bridges and VWF form layers, known as the initial hemostatic plug, which stops the bleeding at the injury site. 1. Successful completion of both stages of hemostasis results in the final step of the clotting process, the formation of a stable hemostatic plug. HUMATE-P has 94% homology with normal human plasma (NHP). 2.After adding the solution to the powder, gently swirl the vial to completely dissolve the powder. Do not shake the vial. Before using this product, check it visually for particles or discoloration ...HUMATE-P provides reliable hemostatic control for all VWD types. HUMATE-P is also proven effective across multiple types of bleeds, including: All bleeding episodes, including spontaneous bleeding episodes (bleeding that occurs without an obvious cause) or after an injury, such as nosebleeds4. 97% of patients overall (100% Type 1, 100% Type 2 ...Dosing Overview. HUMATE-P is labeled in VWF:RCo for dosing accuracy in VWD: Treatment of bleeding episodes: Administer 40–80 IU VWF:RCo per kg body weight every 8–12 hours. Prevention of excessive bleeding during and after surgery: Surgical dosing differs by type of surgery (ie, major, minor) and should be customized to patient need ...HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. HUMATE-P (represented in the graph by the blue line) had the highest content of HMW-VWF multimers among VWF products tested, and its multimer pattern was most like that of NHP The multimer patterns of products A, G, H, and E (represented in the densitometric analysis by the red, green, orange, and yellow lines, respectively) differ from that of NHPHumate P - J7190 or J7186 or J7187 . Profilate HP- J7190 . AHF M - J7190 . Alphanate - J7190 . Antihemophilic Factor (Porcine) Hyate:C - J7191 . Recombinate (Recombinant) - J7192 . Kogenate - J7192 . Bioclate - J7192 . Helixate - J7192 . Xyntha – J7185 . 3. Factor VIII inhibitors . Autoplex T (anti-inhibitor) - J7198 . Feiba VH (anti ...In studies, more than 5% of patients reported the following adverse reactions to HUMATE-P: allergic/anaphylactic reactions, including hives, chest tightness, rash, itching, and swelling. The most common adverse reactions after surgery were bleeding at the wound or infusion site, and nosebleeds. Please see full prescribing information. Anti-hemophilic factor/von Willebrand factor complex (Humate-P) is indicated for use in adult patients for treatment and prevention of bleeding in hemophilia A and in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease ...Humate-P Prices, Coupons and Patient Assistance Programs. Humate-P (antihemophilic factor/von willebrand factor) is a member of the miscellaneous coagulation modifiers drug class and is commonly used for Hemophilia A, and von Willebrand Disease.HUMATE-P is made from human blood and could contain infectious agents. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating and/or removing viruses during manufacturing.Failure to confirm specific third-party payor coding requirements may result in underpayment for Humate-P. Call 1-800-676-4266 for information on insurance matters or assistance with individual case inquiries on a variety of reimbursement services, including: claim processing reviews. appeals.Haemate P/Humate-P is an intermediate-purity VWF/FVIII concentrate with extensive clinical experience in VWD. This concentrate has been shown to correct haemostatic defects of VWD, with efficacy ratings of good/excellent in nearly all patients treated for bleeding or surgical events. Humate is the generic name for soil humic substances. Humic acid is the chemical properties of humate. Humate and Humic acid are basically one in the same. Humate is essentially to life…for humans, animals and all the plants on this earth. Between 65 to 100 million years ago the Earth enjoyed optimum organic growing conditions.
Humate-P® SDS Revision Date: 06/04/2015 Page 3 of 7 administered as directed by a physician. In addition, no adverse health effects are anticipated as a result of incidental contact or exposure to this product by those handling it or administering it in a therapeutic setting. More detailed information is available in the product package insert.. Xcode downloader
Uses for Humate-P. Antihemophilic factor VIII and von Willebrand factor injection is a combination product that is used to treat serious bleeding episodes in patients with a bleeding problem called von Willebrand disease (VWD). The bleeding episode may be related to an injury (trauma) or a surgical procedure.The densitometric analysis shows that, like normal human plasma, HUMATE-P contains a high percentage of high molecular weight von Willebrand factor (HMW-VWF) multimers, and it is capable of correcting the hemostatic defect in patients with VWD. View an animated densitometric analysis comparing various VWF/FVIII concentrates and normal human plasma.Haemate P/Humate-P is an intermediate-purity VWF/FVIII concentrate with extensive clinical experience in VWD. This concentrate has been shown to correct haemostatic defects of VWD, with efficacy ratings of good/excellent in nearly all patients treated for bleeding or surgical events. The NDC Packaged Code 63833-617-02 is assigned to a package of 1 kit in 1 carton * 15 ml in 1 vial (63833-627-01) * 15 ml in 1 vial, single-dose (63833-765-55) of Humate-p, a plasma derivative labeled by Csl Behring Gmbh. The product's dosage form is kit and is administered via form.Although not compared statistically, rVWF appears to have more HMWM VWF and a higher ratio of VWF:GPIbM to VWF:Ag than Humate-P and cryoprecipitate. The estimated acquisition cost for our hospital for treating one major bleeding episode was more than 4-fold higher with Humate-P and 7- to 10-fold higher with rVWF than with cryoprecipitate.This Billing and Coding Article provides coding guidance for Hemophilia Factor Products. This article does not address payment determination for hemophilia factor products. Information on payment for the clotting factor as well as payment for a clotting factor furnishing fee may be found in CMS Internet-Only Manual (IOM) Publication 100-04 ...Tradename: Humate-P. Manufacturer: CSL Behring GmbH, License #1765. Indication: In adult and pediatric patients with von Willebrand disease for (1) treatment of spontaneous and trauma-induced ... Dec 6, 2019 · Surgical procedures represent a serious hemostatic challenge for patients with von Willebrand disease (VWD), and careful perioperative management is required to minimize bleeding risk. Risk stratification includes not only the nature of the surgery to be performed but the baseline plasma von Willebrand factor (VWF) levels, bleeding history, and ... Humate-P, Wilate) Reference Number: ERX.SPA.185 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are factor VIII/von Willebrand factor complexes (human) requiring prior authorization:Humate-P® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Although few adverse reactions have been reported in patients receiving Humate-P®, the most commonly reportedThe reported VWF:RCo average and terminal t1/2 of 10.4 and 15.8 hours (h), respectively, for Wilate and 9.3 h and 12.8 h for Humate-P, were not statistically different. Also, the mean VWF:RCo in vivo recoveries (Wilate 1.89, Humate-P 1.99 IU/dl per IU/kg) were similar between the two replacement therapies. Humate-P® Humate-P ®, FDA approved in 1986, is an anti-hemophilic factor/von Willebrand factor complex (human) originally indicated for the treatment and prevention of bleeding in adults with hemo-philia A. In 1999, the FDA approved Humate-P® for adults and pediatric patients with VWD for the treatment of spontaneous and trauma-inducedDose: individualize dose IV q8-24h until hemostasis; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100%; 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors. .