2024 Humate p

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. Kidm 1077

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.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. 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. 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 contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses.Sep 4, 2023 · HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. HUMATE-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. 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.Aug 17, 2020 · 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. 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; 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. 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.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. Important Safety Information for Humate-P. Antihemophilic Factor/von Willebrand Factor Complex (Human), HUMATE-P ® is indicated for treatment and prevention of bleeding in adult patients with hemophilia A (classical hemophilia). HUMATE-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of ...In 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.Surgical procedures represent a serious hemostatic challenge for patients with von Willebrand disease (VWD), and careful perioperative management is required to minimize bleeding risk. Risk stratification includes not only the nature of the surgery to be performed but the baseline plasma von Willebrand factor (VWF) levels, bleeding history, and ...Humate-P, Wilate) Reference Number: ERX.SPA.185 Effective Date: 01.11.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are factor VIII/von Willebrand factor complexes (human) requiring prior authorization:Examples of plasma-derived product brand names include Humate P, Alphanate, Koate, and Wilfactin. An example of a product manufactured in the laboratory is Vonvendi. These treatments are injected into a vein, often in the hospital or in a health care provider's office, but some patients are taught how to self-inject this treatment at home.HUMATE-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations. Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses. 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 ...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 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.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 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 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 - 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 ... 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.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. 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 ...How to mix HumateHumate 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 ...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.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.Riastap Tisseel Epoetin alfa (Epogen/Procrit) Albumin Cryoprecipitate Other(s): _____ Others ATryn Thrombate III 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.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 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 • 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 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.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 ...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 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. 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 ... 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 ...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 ...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 andCSL 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® 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 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. 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. 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 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.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.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® 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.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.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.Nov 15, 2017 · A. Alphanate, Humate-P ONLY Coverage is provided in the following conditions: Hemophilia A (congenital factor VIII deficiency) † • Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND Used as treatment for control and prevention of bleeding episodes (episodic treatment HUMATE-P 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 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. 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: 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 ...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. 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." 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.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.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. 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 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 ...Jun 23, 2020 · 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 ... 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 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/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 FranceThe 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.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) 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 dose 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

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 …. Fall women

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