PMID- 32124273 OWN - NLM STAT- MEDLINE DCOM- 20201207 LR - 20220408 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 37 IP - 4 DP - 2020 Apr TI - Clinical Practice Experience with HyQvia in Adults Using Alternative Dosing Regimens and Pediatric Patients: A Retrospective Study. PG - 1536-1549 LID - 10.1007/s12325-020-01264-7 [doi] AB - 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 ramp-up. 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 well-suited to children. FAU - Wasserman, Richard L AU - Wasserman RL AD - Allergy Partners of North Texas, Dallas, TX, USA. drrichwasserman@gmail.com. CN - HyQvia Experience Study Group LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200302 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 0 (Immunoglobulin G) RN - 0 (Immunoglobulins, Intravenous) MH - Administration, Intravenous MH - Adolescent MH - Adult MH - Child MH - Child, Preschool MH - Clinical Protocols MH - Drug Tolerance MH - Female MH - Humans MH - Immunoglobulin G/adverse effects/*therapeutic use MH - Immunoglobulins, Intravenous/adverse effects/*therapeutic use MH - Infusions, Subcutaneous MH - Male MH - Medical Records MH - Primary Immunodeficiency Diseases/*drug therapy MH - Retrospective Studies MH - Treatment Outcome PMC - PMC7140738 OTO - NOTNLM OT - Enzyme-facilitated subcutaneous IgG replacement OT - HyQvia, subcutaneous immunoglobulin OT - Pediatrics OT - Primary immunodeficiency (PID) OT - Recombinant human hyaluronidase OT - SCIG OT - Subcutaneous IgG replacement OT - fSCIG EDAT- 2020/03/04 06:00 MHDA- 2020/12/15 06:00 PMCR- 2020/03/02 CRDT- 2020/03/04 06:00 PHST- 2019/12/12 00:00 [received] PHST- 2020/03/04 06:00 [pubmed] PHST- 2020/12/15 06:00 [medline] PHST- 2020/03/04 06:00 [entrez] PHST- 2020/03/02 00:00 [pmc-release] AID - 10.1007/s12325-020-01264-7 [pii] AID - 1264 [pii] AID - 10.1007/s12325-020-01264-7 [doi] PST - ppublish SO - Adv Ther. 2020 Apr;37(4):1536-1549. doi: 10.1007/s12325-020-01264-7. Epub 2020 Mar 2.