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 ... 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 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.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 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: 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 treatmentWhat 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."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 - 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 ...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.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: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. 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.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. 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 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: 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 ...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 • 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 Aug 5, 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 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 ... 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 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. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ... 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.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. The results of both trials revealed that Humate-P was effective in preventing excessive bleeding during and after surgery. 1. The most frequent adverse reactions to Humate-P include allergic reactions such as urticaria, chest tightness, rash, pruritus, edema, injection-site bleeding, and epistaxis. 1. The efficacy of Alphanate in preventing ...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 • 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® 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 (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 doseHUMATE-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)].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. 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. Used for Hemophilia and Von Willebrand Disease. info. Specialty Drug + 1 more alert. MORE expand_more. ANTIHEMOPHILIC FACTOR prevents and treats bleeding ... 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 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. The results of both trials revealed that Humate-P was effective in preventing excessive bleeding during and after surgery. 1. The most frequent adverse reactions to Humate-P include allergic reactions such as urticaria, chest tightness, rash, pruritus, edema, injection-site bleeding, and epistaxis. 1. The efficacy of Alphanate in preventing ...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 NHPMay 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 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.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 andSome 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 - 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 ...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 ...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. 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, 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)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: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-inducedHumate 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 ... 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."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.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 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 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. 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 ...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. 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.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.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)].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; Safety; Patient Stories; Support & Resources; About von Willebrand Disease. What Is VWD? Diagnosis & Treatment Options; Home; Why HUMATE-P; Taking HUMATE-P ...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 Aug 5, 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. The results of both trials revealed that Humate-P was effective in preventing excessive bleeding during and after surgery. 1. The most frequent adverse reactions to Humate-P include allergic reactions such as urticaria, chest tightness, rash, pruritus, edema, injection-site bleeding, and epistaxis. 1. The efficacy of Alphanate in preventing ...Humate-P Coupons, Copay Cards and Rebates. Humate-P offers may take the form of printable coupons, rebates, savings or copay cards, trial offers, or free samples. Certain offers may be printable from a website while others may require registration, completing a questionnaire, or obtaining a sample from a medical professional. 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 ...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: 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 ...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 ...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 …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.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, 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 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. The results of both trials revealed that Humate-P was effective in preventing excessive bleeding during and after surgery. 1. The most frequent adverse reactions to Humate-P include allergic reactions such as urticaria, chest tightness, rash, pruritus, edema, injection-site bleeding, and epistaxis. 1. The efficacy of Alphanate in preventing ...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 ...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-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 ....