P255 Real-world pediatric experience with hyaluronidase-facilitated subcutaneous immunoglobulin (IGHY) infusion parameters

Gruenemeier, P.; Ernst, Cynthia C.; White, Christopher B.; Duff, Kimberly

doi:10.1016/j.anai.2016.09.268

Cited by 3 publications

(3 citation statements)

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“…The median volume/infusion site was 200 ml (range: 100-300 ml), and doses ranged from 10 to 30 g per infusion every 3 to 4 weeks. The majority (70%) of patients used one infusion site, and 30% used two sites [49]. These data suggest that patient training sessions during dose ramp-up may help determine the ideal needle length and the number of infusion sites for each patient.…”

Section: Anti-ph20 Immunogenic Responsementioning

confidence: 88%

Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Wasserman

2017

Immunotherapy

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Most primary immunodeficiency diseases (PIDDs) resulting in antibody deficiency require intravenous or subcutaneous immunoglobulin G (SCIG) replacement therapy. The flow and distribution of SCIG to the vasculature is impeded by the glycosaminoglycan hyaluronan in the extracellular matrix, which limits the infusion rate and volume per site, necessitating frequent infusions and multiple infusion sites. Hyaluronidase depolymerizes hyaluronan and is a spreading factor for injectable biologics. Recombinant human hyaluronidase (rHuPH20) increases SCIG absorption and dispersion. In patients with PIDD, SCIG facilitated with rHuPH20 (IGHy) has been shown to prevent infections, be well-tolerated and reduce infusion frequency and number of infusion sites as compared with conventional SCIG. This article reviews IGHy clinical studies and real-world practice data in patients with PIDD.

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Section: Anti-ph20 Immunogenic Responsementioning

confidence: 88%

Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Wasserman

2017

Immunotherapy

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“…Of the three pediatric patients with information regarding number of infusion sites, two 10-year-old patients in this study completed all infusions using a single site every 3-4 weeks, while a 15-year-old patient progressed from one to two sites over time. Prior studies have reported use of a single infusion site in 83% and 70% of pediatric patients using HyQvia [22,26].…”

Section: Discussionmentioning

confidence: 99%

“…Recommendations in the USA are also mainly limited to adults, with little information regarding its use in children. To date, there are two retrospective studies addressing the use of HyQvia in adults and pediatric patients in a real-world setting, but these studies included fewer than 20 patients each and provide little detail on tailored HyQvia therapy [25,26]. Thus, a need exists to further examine real-world clinical experience with administration of HyQvia at variance with current guidelines and use in children.…”

Section: Introductionmentioning

confidence: 99%

Clinical Practice Experience with HyQvia in Adults Using Alternative Dosing Regimens and Pediatric Patients: A Retrospective Study

Wasserman

2020

Adv Ther

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Introduction: HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) was developed to combine the advantages of intravenous and subcutaneous immune globulin (SCIG), allowing administration of larger volumes at a single subcutaneous site with less frequent dosing when compared to other SCIG products. Current US prescribing guidelines for HyQvia are limited to adults and do not encompass the flexibility required to achieve success in all patients with primary immunodeficiency (PID). Methods: This retrospective study was designed to evaluate the clinical experience of treating patients with PID with HyQvia regimens outside of package insert recommendations as well as in pediatric patients. Data were abstracted from 38 patient records (317 HyQvia infusions), including five patients less than 16 years of age, from seven US immunology clinics. Results: Among 37 patients receiving HyQvia regimens differing from prescribing guidelines, the most notable variations included shorter ramp-up periods, use of two rather than one infusion site, and slower than maximal infusion rates to mitigate local adverse events (AEs). The medication volume infused for single site doses ranged from 75 to 200 mL and doses split between two sites ranged from 100 to 750 mL. The most common type of regimen variation was a condensed ramp-up phase (shorter schedule, higher doses), and 96% (24/25) of patients managed in this way completed rampup. The most common ramp-up schedule was three infusions (one at 25-45%, another at 50-75%, and the final at 100% of target dose) spread over 2-4 weeks. Conclusions: A shorter ramp-up schedule did not appear to increase the number of AEs compared to standard ramp-up schedules. For patients with AEs, slower infusion rates and the use of two sites may improve medication tolerability. Four of five pediatric patients reported no AEs, and only one discontinued, stating a fear of needles. HyQvia may be tailored to adults requiring alternative rates, ramp-up, and/ or dosing regimens and may be especially wellsuited to children.

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Facilitated Subcutaneous Immunoglobulin Treatment Patterns in Pediatric Patients with Primary Immunodeficiency Diseases

Mach-Tomalska,

Pituch-Noworolska,

Bień

et al. 2024

Immunotherapy

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Aim: This retrospective study investigated real-world hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) treatment patterns in pediatric patients with primary immunodeficiency diseases (PIDs) in Poland. Methods: Clinical and demographic information, fSCIG treatment parameters and clinical outcomes were extracted from medical records of 28 participants (aged ≤18 years) with PIDs who received fSCIG. Results: 18 participants (64.3%) started fSCIG with a ramp-up (median duration: 35.5 days). 27 patients (96.4%) were administered fSCIG every 4 weeks and one patient every 3 weeks. 25 patients (89.3%) used one infusion site. No serious bacterial infections occurred. Conclusion: Data support the feasibility of administering fSCIG to children and adolescents with PIDs every 3–4 weeks using a single infusion site and indicate flexibility in modifying fSCIG infusion parameters. Clinical Trial Registration: NCT04636502 ( ClinicalTrials.gov )

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P255 Real-world pediatric experience with hyaluronidase-facilitated subcutaneous immunoglobulin (IGHY) infusion parameters

Cited by 3 publications

References 0 publications

Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Recombinant Human Hyaluronidase-Facilitated Subcutaneous Immunoglobulin Infusion in Primary Immunodeficiency Diseases

Clinical Practice Experience with HyQvia in Adults Using Alternative Dosing Regimens and Pediatric Patients: A Retrospective Study

Facilitated Subcutaneous Immunoglobulin Treatment Patterns in Pediatric Patients with Primary Immunodeficiency Diseases

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