{"id":"hyqvia","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"Reported 367 times"},{"date":"","signal":"SINUSITIS","source":"FDA FAERS","actionTaken":"Reported 336 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 297 times"},{"date":"","signal":"INFUSION SITE ERYTHEMA","source":"FDA FAERS","actionTaken":"Reported 214 times"},{"date":"","signal":"INFUSION SITE PAIN","source":"FDA FAERS","actionTaken":"Reported 212 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 209 times"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"Reported 206 times"},{"date":"","signal":"INFUSION SITE SWELLING","source":"FDA FAERS","actionTaken":"Reported 204 times"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"Reported 198 times"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 198 times"}],"drugInteractions":[{"drug":"Anticoagulants","action":"Monitor","effect":"May increase the risk of bleeding"},{"drug":"Live vaccines","action":"Avoid","effect":"May reduce the efficacy of live vaccines"},{"drug":"Drugs metabolized by CYP450 enzymes","action":"Monitor","effect":"May alter the metabolism of these drugs"}],"commonSideEffects":[{"effect":"Local reactions","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Antibody formation against rHuPH20","drugRate":"18.1%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Erythema","drugRate":"","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased lipase","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Back pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Pain in extremity","drugRate":"","severity":"common","organSystem":""}],"contraindications":["History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human).","IgA deficient patients with antibodies against IgA and a history of hypersensitivity.","Known systemic hypersensitivity to hyaluronidase or Recombinant Human Hyaluronidase of HYQVIA."],"specialPopulations":{"Pregnancy":"No human data. Use only if clearly indicated. Pregnancy registry available.","Geriatric use":"HYQVIA was evaluated in 7 subjects over age 65 in the clinical trial. In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and consider infusing HYQVIA at lower, more frequent doses.","Paediatric use":"Safety has not been established in children.","Renal impairment":"In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and consider infusing HYQVIA at lower, more frequent doses.","Hepatic impairment":"No specific guidance provided."},"seriousAdverseEvents":[]},"trials":[],"_chembl":null,"aliases":["Immune Globulin Subcutaneous (Human)","10% Solution with rHuPH20","IGI 10% with rHuPH20","10%) with recombinant human hyaluronidase (rHuPH20)","Immune Globulin Infusion 10% (Human) (IGI"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=HyQvia","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:31:08.931268+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Hyqvia","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:31:17.139389+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:31:15.792985+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:31:08.952777+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=HyQvia","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:31:16.571380+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201599/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:17.048750+00:00"}},"offLabel":[],"timeline":[{"date":"2011-01-01","type":"neutral","milestone":"IND Filing","regulator":"FDA"},{"date":"2012-01-01","type":"neutral","milestone":"Phase 1/2 Start","regulator":"none"},{"date":"2012-06-01","type":"neutral","milestone":"Phase 3 Start","regulator":"none"},{"date":"2013-06-28","type":"positive","milestone":"FDA Approval","regulator":"FDA"},{"date":"2014-07-18","type":"positive","milestone":"EMA Approval","regulator":"EMA"},{"date":"2023-01-01","type":"positive","milestone":"Label Expansion for Pediatric Use","regulator":"FDA"},{"date":"2024-01-01","type":"negative","milestone":"Patent Expiry","regulator":"none"}],"_dailymed":{"setId":"7ca2c26f-4be2-48cd-be5b-486e350654ba","title":"HYQVIA (IMMUNE GLOBULIN INFUSION (HUMAN), 10% WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]","labeler":""},"aiSummary":"HyQvia (Takeda) is a subcutaneous immunoglobulin replacement therapy for primary immunodeficiency, currently marketed with 22 clinical trials and 14 publications supporting its use. The drug represents an advance in immunoglobulin delivery, utilizing recombinant human hyaluronidase to enable subcutaneous administration with extended dosing intervals compared to traditional SCIG therapies. With established clinical efficacy in PI management and a marketed status, HyQvia addresses a significant unmet need in immunodeficiency treatment by improving patient convenience and quality of life. The therapy has demonstrated commercial viability in the immunoglobulin replacement market, competing within the broader immunotherapy landscape for chronic immunodeficiency management.","ecosystem":[],"mechanism":{"target":"Hyaluronic acid in subcutaneous tissue; immunoglobulin G replacement","novelty":"best-in-class","modality":"Recombinant protein combination therapy","drugClass":"Immunoglobulin replacement therapy; enzyme-facilitated subcutaneous immunoglobulin","explanation":"","oneSentence":"","technicalDetail":"The recombinant human hyaluronidase component temporarily modifies the extracellular matrix by cleaving hyaluronic acid, facilitating rapid subcutaneous absorption of larger IgG volumes. This approach maintains physiologic immunoglobulin levels while reducing infusion frequency and burden. The formulation preserves IgG stability and function while enabling subcutaneous administration comparable to intravenous dosing intervals."},"_scrapedAt":"2026-03-27T23:47:55.742Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"title":"Immunoglobulin therapy","extract":"Immunoglobulin therapy is the use of a mixture of antibodies to treat several health conditions. These conditions include primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain–Barré syndrome, and certain other infections when a more specific immunoglobulin is not available. Depending on the formulation it can be given by injection into muscle, a vein, or under the skin. The effects last a few weeks.","wiki_medical_uses":"== Medical uses ==\nImmunoglobulin therapy is used in a variety of conditions, many of which involve decreased or abolished antibody production capabilities, which range from a complete absence of multiple types of antibodies, to IgG subclass deficiencies (usually involving IgG2 or IgG3), to other disorders in which antibodies are within a normal quantitative range, but lacking in quality – unable to respond to antigens as they normally should – resulting in an increased rate or increased severity of infections. In these situations, immunoglobulin infusions confer passive resistance to infection on their recipients by increasing the quantity/quality of IgG they possess. Immunoglobulin therapy is also used for a number of other conditions, including in many autoimmune disorders such as dermatomyositis in an attempt to decrease the severity of symptoms. Immunoglobulin therapy is also used in some treatment protocols for secondary immunodeficiencies <!-- not an ideal link target --> such as human immunodeficiency virus (HIV), some autoimmune disorders (such as immune thrombocytopenia and Kawasaki disease), some neurological diseases (multifocal motor neuropathy, stiff person syndrome, multiple sclerosis and myasthenia gravis) some acute infections and some complications of organ transplantation.\n\nImmunoglobulin therapy is especially useful in some acute infection cases such as pediatric HIV infection and is also considered the standard of treatment for some autoimmune disorders s","wiki_society_and_culture":"==Society and culture==\n=== Economics ===\nIn the United Kingdom a dose cost the NHS between 11.20 and 1,200.00 depending on the type and amount. Brand names of intravenous immunoglobulin formulations include Flebogamma, Gamunex, Privigen, Octagam, and Gammagard, while brand names of subcutaneous formulations include Cutaquig, Cuvitru, HyQvia, Hizentra, Gamunex-C, and Gammaked.\n\n=== Supply issues ===\n\nThe United States is one of a handful of countries that allow plasma donors to be paid, meaning that the US supplies much of the plasma-derived medicinal products (including immunoglobulin) used across the world, including more than 50% of the European Union's supply.\n\nIn Australia, blood donation is voluntary and therefore to cope with increasing demand and to reduce the shortages of locally produced immunoglobulin, several programs have been undertaken including adopting plasma for first time blood donors, better processes for donation, plasma donor centres and encouraging current blood donors to consider plasma only donation."},"commercial":{"annualCostUS":"$60,000-120,000/yr (source: GoodRx)","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:31:18.883206+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Hizentra","company":"CSL Behring","advantage":"Subcutaneous administration, alternative for patients who prefer or require subcutaneous infusion"},{"name":"Gammagard Liquid","company":"Baxalta (now part of Takeda)","advantage":"Intravenous and subcutaneous administration, flexible dosing options"},{"name":"Gamunex-C","company":"Grifols","advantage":"Intravenous administration, widely used for various immunodeficiency conditions"},{"name":"Privigen","company":"CSL Behring","advantage":"Intravenous administration, high purity and low IgA content"},{"name":"Panzyga","company":"Pfizer","advantage":"Intravenous administration, suitable for primary immunodeficiency and other conditions"},{"name":"Cuvitru","company":"Baxalta (now part of Takeda)","advantage":"Subcutaneous administration, rapid infusion and high concentration"},{"name":"Octagam","company":"Octapharma","advantage":"Intravenous administration, broad spectrum of antibodies"}],"indications":{"approved":[{"name":"Primary Immunodeficiency (PI)","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05879757","phase":"","title":"Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency","status":"RECRUITING","sponsor":"Takeda","startDate":"2023-10-17","conditions":"Multiple Myeloma, Secondary Immunodeficiency (SID)","enrollment":75},{"nctId":"NCT05755035","phase":"PHASE2, PHASE3","title":"A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-10-24","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":65},{"nctId":"NCT06747351","phase":"PHASE3","title":"A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-05-06","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","enrollment":59},{"nctId":"NCT06538064","phase":"","title":"A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care","status":"RECRUITING","sponsor":"Takeda","startDate":"2025-04-29","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","enrollment":30},{"nctId":"NCT06895967","phase":"PHASE1","title":"A Study of TAK-881 and HyQvia in Healthy Adults","status":"COMPLETED","sponsor":"Takeda","startDate":"2025-03-24","conditions":"Healthy Volunteers","enrollment":30},{"nctId":"NCT06150534","phase":"","title":"At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-12-27","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":22},{"nctId":"NCT02955355","phase":"PHASE3","title":"Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2016-11-14","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":85},{"nctId":"NCT04578535","phase":"PHASE1","title":"A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2020-10-27","conditions":"Healthy Volunteers","enrollment":51},{"nctId":"NCT03277313","phase":"PHASE3","title":"Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2017-09-25","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":44},{"nctId":"NCT05803200","phase":"","title":"A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy","status":"COMPLETED","sponsor":"Takeda","startDate":"2023-03-15","conditions":"Exposure During Pregnancy","enrollment":7},{"nctId":"NCT03054181","phase":"","title":"Facilitated Immunoglobulin Administration Registry and Outcomes Study (FIGARO)","status":"COMPLETED","sponsor":"GWT-TUD GmbH","startDate":"2016-12-22","conditions":"Primary Immunodeficiency, Secondary Immune Deficiency","enrollment":156},{"nctId":"NCT02549170","phase":"PHASE3","title":"A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-12-15","conditions":"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","enrollment":138},{"nctId":"NCT03116347","phase":"PHASE4","title":"Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2017-05-30","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":42},{"nctId":"NCT02593188","phase":"","title":"Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-11-12","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":264},{"nctId":"NCT04636502","phase":"","title":"Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID)","status":"COMPLETED","sponsor":"Shire","startDate":"2021-02-08","conditions":"Primary Immunodeficiencies (PID)","enrollment":96},{"nctId":"NCT01175213","phase":"PHASE3","title":"Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2010-07-28","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":66},{"nctId":"NCT00814320","phase":"PHASE3","title":"Gammagard Liquid and rHuPH20 in PID","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2008-12-18","conditions":"Primary Immunodeficiency Diseases (PID)","enrollment":89},{"nctId":"NCT02556775","phase":"","title":"Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia","status":"COMPLETED","sponsor":"Baxalta now part of Shire","startDate":"2015-12-04","conditions":"Exposure During Pregnancy","enrollment":16},{"nctId":"NCT02881437","phase":"PHASE4","title":"IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia","status":"COMPLETED","sponsor":"University Hospital, Lille","startDate":"2016-11-11","conditions":"Primary Immunodeficiency","enrollment":22},{"nctId":"NCT03829826","phase":"","title":"Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS)","status":"UNKNOWN","sponsor":"Thomas Jefferson University","startDate":"2019-06","conditions":"Stiff-Person Syndrome","enrollment":22},{"nctId":"NCT02556437","phase":"PHASE2","title":"Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)","status":"COMPLETED","sponsor":"Johannes Jakobsen","startDate":"2016-06","conditions":"Multifocal Motor Neuropathy","enrollment":18},{"nctId":"NCT02885259","phase":"NA","title":"HyQvia in Multifocal Motor Neuropathy","status":"UNKNOWN","sponsor":"UMC Utrecht","startDate":"2016-09","conditions":"Multifocal Motor Neuropathy","enrollment":20}],"_emaApprovals":[{"date":"03/06/2013","name":"HyQvia","status":"Authorised","regulator":"EMA"}],"_faersSignals":[{"count":367,"reaction":"HEADACHE"},{"count":336,"reaction":"SINUSITIS"},{"count":297,"reaction":"FATIGUE"},{"count":214,"reaction":"INFUSION SITE ERYTHEMA"},{"count":212,"reaction":"INFUSION SITE PAIN"},{"count":209,"reaction":"NAUSEA"},{"count":206,"reaction":"MALAISE"},{"count":204,"reaction":"INFUSION SITE SWELLING"},{"count":198,"reaction":"PAIN"},{"count":198,"reaction":"PYREXIA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL1201599","moleculeType":"Unknown","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL1201599"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"2019-present","companyName":"Takeda","relationship":"Acquirer"}],"publicationCount":14,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Feb 13","pmid":"41685940","title":"Pharmacokinetics, safety and tolerability, and efficacy of hyaluronidase-facilitated subcutaneous immunoglobulin 10% (HyQvia(®)) in Japanese patients with primary immunodeficiency diseases.","journal":"Immunological medicine"},{"date":"2023 Sep","pmid":"36920736","title":"In-line warming reduces in-line pressure of subcutaneous infusion of concentrated immunoglobulins.","journal":"Drug delivery and translational research"},{"date":"2021 Aug","pmid":"34036490","title":"Steady-State Serum IgG Trough Levels Are Adequate for Pharmacokinetic Assessment in Patients with Immunodeficiencies Receiving Subcutaneous Immune Globulin.","journal":"Journal of clinical immunology"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"HyQvia","genericName":"HyQvia","companyName":"Takeda","companyId":"takeda","modality":"Biologic","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health 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