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: 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; 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 ...Humate-P. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ...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.Feb 1, 2023 · Humate-P; Wilate; Descriptions. 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. 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.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 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® 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 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.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.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 ... 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 ... Obtain your Humate-P prescription for the set monthly price of $50.00 per month. Every year, thousands of Americans are prescribed Humate-P by their doctors to treat hemophilia A. However, filling a Humate-P prescription without coverage can force Americans to make difficult decisions about their care. As the nation’s fastest-growing pharmacy ...None of the reported suspected virus transmission cases were confirmed to be associated with Humate-P. Reported results of company-sponsored studies showed a low incidence of adverse events possibly or probably related to Humate-P. Conclusions: More than 33 years of pharmacovigilance data continue to support the safety of 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.Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate IIIFeb 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; 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 … 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.Antihemophilic factor/VWF complex (Alphanate ®, Humate-P ®, Wilate ®) Full length with VWF: Pooled human plasma: 12.2–17.9 hours: 1978 (Alphanate), 1986 (Humate-P), August 2009 (Wilate) Recombinant: first generation: Antihemophilic factor recombinant (Recombinate ®) Full length: BSA in culture and human albumin as stabilizer: 14.6 ± 4.9 ...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 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 reported 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 ...Adjust dose based on clinical response. Intravenous dosage (Humate-P): Adults: 15 International Units/kg/dose IV to achieve a peak postinfusion factor VIII activity concentration of 30% of normal; most minor bleeds can be treated with 1 dose. If needed, half of the dose may be given 1 to 2 times daily for 1 to 2 days.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.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. 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 ...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. 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 ...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-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 NHP None of the reported suspected virus transmission cases were confirmed to be associated with Humate-P. Reported results of company-sponsored studies showed a low incidence of adverse events possibly or probably related to Humate-P. Conclusions: More than 33 years of pharmacovigilance data continue to support the safety of Humate-P.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 ...Antihemophilic factor/VWF complex (Alphanate ®, Humate-P ®, Wilate ®) Full length with VWF: Pooled human plasma: 12.2–17.9 hours: 1978 (Alphanate), 1986 (Humate-P), August 2009 (Wilate) Recombinant: first generation: Antihemophilic factor recombinant (Recombinate ®) Full length: BSA in culture and human albumin as stabilizer: 14.6 ± 4.9 ...Jan 20, 2023 · Humate-P is a combination medicine used to treat or prevent bleeding episodes in people with von Willebrand disease. Humate-P is also used to treat or prevent bleeding episodes in people with hemophilia A. Humate-P may also be used for purposes not listed in this medication guide. 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 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® 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 reportedAug 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 Feb 1, 2023 · Humate-P; Wilate; Descriptions. 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. Find patient medical information for Humate-P intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Obtain your Humate-P prescription for the set monthly price of $50.00 per month. Every year, thousands of Americans are prescribed Humate-P by their doctors to treat hemophilia A. However, filling a Humate-P prescription without coverage can force Americans to make difficult decisions about their care. As the nation’s fastest-growing pharmacy ...See full list on drugs.com 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.Humate-P Medicare Coverage and Co-Pay Details - GoodRx. ANTIHEMOPHILIC FACTOR 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. This helps your blood clot normally, which reduces bleeding.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. 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, 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 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.See full list on drugs.com 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: 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 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 …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. 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. 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 ... Adjust dose based on clinical response. Intravenous dosage (Humate-P): Adults: 15 International Units/kg/dose IV to achieve a peak postinfusion factor VIII activity concentration of 30% of normal; most minor bleeds can be treated with 1 dose. If needed, half of the dose may be given 1 to 2 times daily for 1 to 2 days. 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; 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 ...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 ...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 ...How to take HUMATE-P Multiple vial sizes to meet your individual needs. HUMATE-P is available in a variety of vial sizes. Multiple vial sizes may help reduce waste and make vials easier to store and carry. Before reconstitution, HUMATE-P can be safely stored at room temperature (up to 25°C [77°F]) for up to 36 months.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 ... 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. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ...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 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: 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 treatmentAug 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. 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-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 thanHumate-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 : MedicationsFactor 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: Humate-P Medicare Coverage and Co-Pay Details - GoodRx. ANTIHEMOPHILIC FACTOR 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. This helps your blood clot normally, which reduces bleeding.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. Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate III 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.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. 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. 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.HUMATE-P loading dose Make individualized HUMATE-P dosing fast, easy, and convenient. This 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.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 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. Adjust dose based on clinical response. Intravenous dosage (Humate-P): Adults: 15 International Units/kg/dose IV to achieve a peak postinfusion factor VIII activity concentration of 30% of normal; most minor bleeds can be treated with 1 dose. If needed, half of the dose may be given 1 to 2 times daily for 1 to 2 days. Berirab® P | Rabies Immunoglobulin. Evogam® | Human Normal Immunoglobulin 16% (16g/100mL) – Subcutaneous Infusion. HAEGARDA® | C1-Esterase Inhibitor Subcutaneous, (Human) Hepatitis B Immunoglobulin P | Human Hepatitis B Immunoglobulin. Hizentra® | Immune Globulin Subcutaneous (Human) 20% Liquid. Intragam® P | Human Normal Immunoglobulin.Humate p
Feb 1, 2023 · Humate-P; Wilate; Descriptions. 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. How to take HUMATE-P Multiple vial sizes to meet your individual needs. HUMATE-P is available in a variety of vial sizes. Multiple vial sizes may help reduce waste and make vials easier to store and carry. Before reconstitution, HUMATE-P can be safely stored at room temperature (up to 25°C [77°F]) for up to 36 months.Humate-P is a combination medicine used to treat or prevent bleeding episodes in people with von Willebrand disease. Humate-P is also used to treat or prevent bleeding episodes in people with hemophilia A. Humate-P may also be used for purposes not listed in this medication guide.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.How to take HUMATE-P Multiple vial sizes to meet your individual needs. HUMATE-P is available in a variety of vial sizes. Multiple vial sizes may help reduce waste and make vials easier to store and carry. Before reconstitution, HUMATE-P can be safely stored at room temperature (up to 25°C [77°F]) for up to 36 months.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 treatmentHUMATE-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. 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)].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 ... 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: 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 : MedicationsDosing 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 (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 NHPJan 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: Dec 6, 2019 · 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 France 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.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 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 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.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 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® 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 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. Humate-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 than 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 ...Humate-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 than 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: 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 : MedicationsThe 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 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 ...Humate-P; Wilate; Descriptions. 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.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 (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 NHP 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. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ... Jan 20, 2023 · Humate-P is a combination medicine used to treat or prevent bleeding episodes in people with von Willebrand disease. Humate-P is also used to treat or prevent bleeding episodes in people with hemophilia A. Humate-P may also be used for purposes not listed in this medication guide. Humate-P; Wilate; Descriptions. 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.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. 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.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 loading dose Make individualized HUMATE-P dosing fast, easy, and convenient. This 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. 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 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.Find patient medical information for Humate-P intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.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.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. 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. Jan 20, 2023 · Humate-P is a combination medicine used to treat or prevent bleeding episodes in people with von Willebrand disease. Humate-P is also used to treat or prevent bleeding episodes in people with hemophilia A. Humate-P may also be used for purposes not listed in this medication guide. Jun 15, 2017 · Antihemophilic factor/VWF complex (Alphanate ®, Humate-P ®, Wilate ®) Full length with VWF: Pooled human plasma: 12.2–17.9 hours: 1978 (Alphanate), 1986 (Humate-P), August 2009 (Wilate) Recombinant: first generation: Antihemophilic factor recombinant (Recombinate ®) Full length: BSA in culture and human albumin as stabilizer: 14.6 ± 4.9 ... 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.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 treatmentThe 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.Find patient medical information for Humate-P intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate IIIExamples 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.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. 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.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. 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 loading dose Make individualized HUMATE-P dosing fast, easy, and convenient. This 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.Jul 7, 2023 · Berirab® P | Rabies Immunoglobulin. Evogam® | Human Normal Immunoglobulin 16% (16g/100mL) – Subcutaneous Infusion. HAEGARDA® | C1-Esterase Inhibitor Subcutaneous, (Human) Hepatitis B Immunoglobulin P | Human Hepatitis B Immunoglobulin. Hizentra® | Immune Globulin Subcutaneous (Human) 20% Liquid. Intragam® P | Human Normal Immunoglobulin. 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 ... 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 ... 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.Jan 20, 2023 · Humate-P is a combination medicine used to treat or prevent bleeding episodes in people with von Willebrand disease. Humate-P is also used to treat or prevent bleeding episodes in people with hemophilia A. Humate-P may also be used for purposes not listed in this medication guide. 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.Antihemophilic factor/VWF complex (Alphanate ®, Humate-P ®, Wilate ®) Full length with VWF: Pooled human plasma: 12.2–17.9 hours: 1978 (Alphanate), 1986 (Humate-P), August 2009 (Wilate) Recombinant: first generation: Antihemophilic factor recombinant (Recombinate ®) Full length: BSA in culture and human albumin as stabilizer: 14.6 ± 4.9 ...Humate-P. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ... 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 NHP 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;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; 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 ...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 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® 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 than 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.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. 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 ...Humate-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 than Feb 1, 2023 · Humate-P; Wilate; Descriptions. 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. 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 ... Hemophilia A. Minor hemorrhage: Loading dose 15 IU/kg IV should achieve FVIII:C plasma level ~30% of normal. Moderate hemorrhage: Loading dose 25 IU/kg IV should achieve FVIII:C plasma level ~50% of normal. Life-threatening hemorrhage: 40-50 IU/kg IV initially, followed by 2-25 IU q8-12hr to maintain FVIII:C level at 80-100% of normal. . Gonzalez and sons equipment inc