2024 Humate p

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:. Gel

HUMATE-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia). 1.2 Von Willebrand Disease (VWD) HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for: (1) (2)HUMATE-P; Safety; Patient Stories; Support & Resources; About von Willebrand Disease. What Is VWD? Diagnosis & Treatment Options; Home; Why HUMATE-P; Taking HUMATE-P ...Jun 4, 2023 · Some dosage forms listed on this page may not apply to the brand name Humate-P. Applies to antihemophilic factor/von willebrand factor: intravenous powder for solution. Serious side effects of Humate-P. Along with its needed effects, antihemophilic factor/von willebrand factor may cause some unwanted effects. Although not all of these side ... 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 : MedicationsHow to mix HumateMay 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. See full list on drugs.com 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 provides bleed control across all VWD types, including Type 3—the most severe. “Excellent” or “Good” overall clinical response demonstrated across the majority of treatment events in a retrospective study (N=97) *2. 424/437. treatment events. 332/344 nonsurgical.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 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 ... Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate III 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 ...Jan 8, 2019 · 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 ... 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 ...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.Jun 4, 2023 · Some dosage forms listed on this page may not apply to the brand name Humate-P. Applies to antihemophilic factor/von willebrand factor: intravenous powder for solution. Serious side effects of Humate-P. Along with its needed effects, antihemophilic factor/von willebrand factor may cause some unwanted effects. Although not all of these side ... 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.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.1. Humate-P** Humate P is a factor VIII and von Willebrand factor concentrate product made from the purified cold insoluble fraction of pooled human fresh frozen plasma It is used to treat and prevent bleeding in patients with a history of hemophilia A; and treatment of trauma induced bleeding andHumate 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 ... 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 ... 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.Possible side effects of Human Factor VIII with von Willebrand factor. Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Pain, itching, swelling, burning, or a lump under your skin where the needle was placed.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 ...Humate-P Alternatives Compared. Humate-P (antihemophilic factor/von willebrand factor) Desmopressin. DDAVP (desmopressin) Prescription only. Prescribed for von Willebrand Disease, Hemophilia A. Humate-P may also be used for purposes not listed in this medication guide. Prescription only.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 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.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 therapy 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.The generic name of Humate-p is antihemophilic factor/von willebrand factor complex (human). The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 63833-617-02 1 kit in 1 carton * 15 ml in 1 vial (63833-627-01) * 15 ml in 1 vial, single-dose (63833-765-55). This page includes all the important ... Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate IIIHUMATE-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.Jul 3, 2023 · 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. Jan 17, 2012 · 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: 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 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 reportedHUMATE-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 ... 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 ... 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. 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 … Additionally, Humate-P has a potency that is a higher factor than cryoprecipitate preparations. Humate-P can also be used for pediatric patients with VWD in the treatment of spontaneous and trauma-induced bleeding episodes, and the prevention of excessive bleeding during and after surgery.Humate P/Haemate P Plasma derived North America/internationally CSL Behring, Germany 2.4 Pasteurization (60°C for 10 h) Voncento Plasma derived Europe CSL Behring, Germany 2.4 SD, dry heat (80°C, 72 h) Biostate Plasma derived Australia/Asia CSL Behring, Australia 2 SD, dry heat (80°C,72 h) Wilstart Plasma derived FranceHumate-P® has a high degree of purity with a low amount of non-factor proteins. Fibrinogen is less than or equal to 0.2 mg/mL. Humate-P ® has a higher Factor potency thanIn 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.Possible side effects of Human Factor VIII with von Willebrand factor. Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Pain, itching, swelling, burning, or a lump under your skin where the needle was placed. 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.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® 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.Find patient medical information for Humate-P intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. 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® 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 Jul 3, 2023 · 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. 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.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 ...HUMATE-P; Safety; Patient Stories; Support & Resources; About von Willebrand Disease. What Is VWD? Diagnosis & Treatment Options; Home; Why HUMATE-P; Taking HUMATE-P ...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: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 ...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 ... 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 treatmentAlthough 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.1. Humate-P** Humate P is a factor VIII and von Willebrand factor concentrate product made from the purified cold insoluble fraction of pooled human fresh frozen plasma It is used to treat and prevent bleeding in patients with a history of hemophilia A; and treatment of trauma induced bleeding andLillicrap 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.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 ...CSL Behring: Humate-P and Helixate using the Mix2Vial™ Grifols: Alphanate® and AlphaNine® S/D using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) Novo Nordisk: NovoSeven® RT ; Octapharma: Wilate using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) 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 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. Possible side effects of Human Factor VIII with von Willebrand factor. Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing. Pain, itching, swelling, burning, or a lump under your skin where the needle was placed. HUMATE-P is a made in a multi-step process that provides purity and safety every step of the way. Plasma collection, processing, and packaging procedures are designed to retain the properties of the VWF and FVIII proteins. CSL Behring’s Integrated Safety System includes 3 steps specifically designed to identify and remove live viruses.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) VWD – control and prevention of bleeding episodes Type 1 VWD, mild disease Minor or major episodes: 40-60 IU/kg IV loading dose followed by 40- 50 IU/kg IV every 8-12 hours : Type 1 VWD, moderate or severe disease Minor episodes: 40-50 IU/kg IV as one or two doses . Major episodes: 50-75 IU/kg loading doseAmong 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 ...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.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 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.Jan 17, 2012 · 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: How to mix HumateHumate-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 : MedicationsHUMATE-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 • 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 therapyCSL Behring: Humate-P and Helixate using the Mix2Vial™ Grifols: Alphanate® and AlphaNine® S/D using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) Novo Nordisk: NovoSeven® RT ; Octapharma: Wilate using the Mix2Vial™ (see the CSL Behring instructions for Humate-P) 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. 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 …Find patient medical information for Humate-P intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. 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, Antihemophilic Factor/von Willebrand Factor Complex (Human), is a purified, sterile, lyophilized concentrate of Factor VIII (FVIII) and von Willebrand Factor (VWF) (Human) for intravenous administration in the treatment of patients with classical hemophilia (hemophilia A) and VWD [see Clinical Pharmacology (12)].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. HUMATE-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia). 1.2 Von Willebrand Disease (VWD) HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for:Humate-P Alternatives Compared. Humate-P (antihemophilic factor/von willebrand factor) Desmopressin. DDAVP (desmopressin) Prescription only. Prescribed for von Willebrand Disease, Hemophilia A. Humate-P may also be used for purposes not listed in this medication guide. Prescription only.

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:. E crossstu gmbh

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. 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 provides bleed control across all VWD types, including Type 3—the most severe. “Excellent” or “Good” overall clinical response demonstrated across the majority of treatment events in a retrospective study (N=97) *2. 424/437. treatment events. 332/344 nonsurgical. 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 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.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 ...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 … 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. 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."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. Aug 7, 2023 · 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. 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 ...HUMATE-P Connect SM is here to help with co-pay assistance,* programs to help patients who experience a lapse in insurance or are unable to afford therapy, and peer-to-peer networking events. To get the guidance and support. your patients may need, call 1-800-676-4266. Monday-Friday, 8 AM to 8 PM ET.Humate P: Adequate and well-controlled studies with long-term evaluation of joint damage have not been done. Wilate. Indicated for adolescents with hemophilia A as routine prophylaxis to reduce the frequency of bleeding episodes and for on-demand treatment and control of bleeding episodes; On-demand hemorrhage treatmentHumate-P2 PA Humatrope PA Humira QL LDD Hycamtin , PA Hyrimoz PA Hyqvia IbranceLDD , PA, QL icatibant PA, QL IclusigLDD , PA, QL Idacio Idelvion PA Idhifa PA, QL imatinib PA,QL LDD, PA ImbruvicaLDD , PA, QL Imcivree LDD, PA, QL Impavido , PA Inbrija PA IncrelexLDD , PA Infergen Ingrezza , PA, QL InlytaLDD, PA, QL Inqovi LDD, PA , QL 1 Inrebic ...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-P2 PA Humatrope PA Humira QL LDD Hycamtin , PA Hyrimoz PA Hyqvia IbranceLDD , PA, QL icatibant PA, QL IclusigLDD , PA, QL Idacio Idelvion PA Idhifa PA, QL imatinib PA,QL LDD, PA ImbruvicaLDD , PA, QL Imcivree LDD, PA, QL Impavido , PA Inbrija PA IncrelexLDD , PA Infergen Ingrezza , PA, QL InlytaLDD, PA, QL Inqovi LDD, PA , QL 1 Inrebic ...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 ... 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.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..

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