Carla M. Duff

Tolerability of a New 10% Liquid Immunoglobulin for Intravenous Use, Privigen®, at Different Infusion Rates

PurposeThe tolerability of L-proline-stabilized Privigen®, a new 10% liquid immunoglobulin for intravenous administration, was assessed at high infusion rates in a Phase III, open-label, single-arm, multicenter study in 45 patients with primary immune deficiencies.Patients and MethodsMaximum infusion rates were not assigned prospectively. For analysis, patients were grouped according to maximum infusion rate in a low infusion rate group (8 mg/kg/min) and high infusion rate group (12 mg/kg/min).ResultsTwenty-three patients, selected at the investigators’ discretion for the high infusion rate group based on their good tolerability, tolerated Privigen® at 12 mg/kg/min with no increase in temporally associated adverse events (AEs) above the level they had experienced at 8 mg/kg/min. The proportion of infusions with temporally associated AEs in these patients was 0.079 [97.5% confidence interval (CI) 0.114] compared to 0.211 (97.5% CI 0.267) in the low infusion rate group. The most frequent AE was headache. Thus, selected patients tolerate Privigen® at high infusion rates.

Efficacy and tolerability of 16% subcutaneous immunoglobulin compared with 20% subcutaneous immunoglobulin in primary antibody deficiency

Multiple subcutaneous immunoglobulin (SCIG) products are available to treat primary antibody deficiency (PAD). The efficacy and tolerability of 16% SCIG (Vivaglobin®) was compared with 20% SCIG (Hizentra®) in PAD subjects. The study was a prospective, single‐centre, open‐label study of PAD subjects transitioning Vivaglobin to equivalent Hizentra doses, rounded to the nearest vial size. Comparisons included immunoglobulin (Ig)G levels; tetanus, varicella and Streptococcus pneumoniae titres; adverse events (AEs), annual infection rate and quality of life during 8 weeks of Vivaglobin and 24 weeks of Hizentra. Thirty‐two subjects (aged 2–75 years) participated. Rounding to the nearest Hizentra vial size resulted in a 12·8% (± 2·9%) increase in SCIG dose. Median immunoglobulin (Ig)G level following 8 weeks of Vivaglobin was similar to 24 weeks of Hizentra (1050 versus 1035 mg/dl, respectively; P = 0·77). Both products had similar protective titres to tetanus, varicella and serotypes of S. pneumoniae, which were variable but well above protective levels. After 12 weeks of Hizentra, subjects reported fewer local site reactions compared with Vivaglobin. Switching products resulted in increased systemic AEs in some subjects but, overall, not significantly higher than during Vivaglobin treatment. Average infusion time decreased from 104·7 min (3·3 sites) with Vivaglobin to 70·7 min (2·2 sites) with Hizentra (P = 0·0005). Acute serious bacterial infections were similar. Treatment satisfaction was superior with Hizentra. Hizentra and Vivaglobin have similar pharmacokinetics and efficacy. Although transition to a different SCIG product initially increased AEs, Hizentra is well tolerated and can be infused more rapidly and with fewer sites compared to Vivaglobin.

Subcutaneous immunoglobulin replacement therapy: ensuring success.

Subcutaneous immunoglobulin (SCIg) infusions are an option for patients requiring immunoglobulin therapy. Nurses are uniquely positioned to advocate for patients and to teach them how to successfully manage their infusions. The purpose of this review is to describe SCIg therapy and to provide teaching instructions as well as creative tips to ensure treatment success.

Nursing guidelines for administration of immunoglobulin replacement therapy.

Immunoglobulin (Ig) replacement therapy, given as regular infusions of pooled human Ig, is the recognized treatment of humoral immunodeficiencies characterized by hypogammaglobulinemia and impaired antibody responses. It is a safe, effective therapy when delivered by nurses who have been educated to oversee and/or provide these infusions. Guidelines for administration have been developed by the Immune Deficiency Foundation Nurse Advisory Committee to provide a framework and guidance to those nurses administering this therapy.

Importance of ancillary supplies for subcutaneous immunoglobulin infusion: management of the local infusion site.

A number of ancillary supplies are used in the process of administering subcutaneous immunoglobulin. The particular type of ancillary supplies used (needles, tubing, and tape) may contribute to the development of issues at the local infusion site. Patient case studies demonstrate that changes in the choice of ancillary supplies can often alleviate these issues. The use of alternative ancillary supplies should be considered prior to the possibility of changing immunoglobulin replacement products in patients experiencing local infusion-site issues in order to improve outcomes and increase compliance. A treatment progression algorithm of ancillary supply adjustments has been developed.