Criteria for selecting an IGIV preparation: The infusion nurses' perspective

Davis, Janet Haggerty; Duff, Kim; Ganio, S.; Garrow-Harris, L.; Gómez, Jocelyn; MacPherson, Phyllis A.; Nolet, Barbara; Scarlet, Cora; Underhill, Craig; Will, Markus

doi:10.1016/s0091-6749(03)80369-x

Cited by 3 publications

(2 citation statements)

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“…The increasing use of high-dose regimens and the more convenient handling have been driving factors for the development of concentrated liquid IVIG products such as IVIG-F10 [3,4,20]. This new 12% IgG solution differs from other IVIG products in various ways.…”

Section: Discussionmentioning

confidence: 99%

Clinical Properties of a Novel Liquid Intravenous Immunoglobulin: Studies in Patients with Immune Thrombocytopenic Purpura and Primary Immunodeficiencies

Borte¹,

Davies²,

Touraine³

et al. 2004

Transfus Med Hemother

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Background: We have developed a novel liquid intravenous immunoglobulin (IVIG-F10). It consists of a nanofiltered 12% immunoglobulin G (IgG) solution, stabilized with nicotinamide, L-proline and L-isoleucine. The efficacy, tolerability, safety, and pharmacokinetics of this product were assessed in patients with chronic immune thrombocytopenic purpura (ITP) and primary humoral immunodeficiencies (PID). Patients and Methods: 33 chronic ITP patients with platelet counts of < 20 × 10⁹/l were treated with IVIG-F10 or Sandoglobulin at doses of 0.4 g/kg body weight on 5 consecutive days. The primary efficacy endpoint was an increase in platelet counts to ≧50 × 10⁹/l. Secondary endpoints were time to and duration of platelet response and regression of bleeding. 34 PID patients with X-linked agammaglobulinemia, common variable immunodeficiency or IgG subclass deficiency were treated for 6 months with IVIG-F10 or Sandoglobulin at doses of 0.3–0.8 g/kg, infused at 3- or 4-week intervals. The primary efficacy endpoint was the number of days absent from school/work. Secondary endpoints were feeling of well-being, days of hospitalization, and use of antibiotics. Results: In ITP patients, the primary endpoint was met by 12/16 patients on IVIG-F10 and by 12/17 patients on Sandoglobulin (p = 1.000). Results of the secondary endpoints were comparable in the two study groups. In the PID study, 10/17 patients on IVIG-F10 and 9/17 patients on Sandoglobulin missed days at school/work, with monthly mean absences of 0.7 and 0.6 days (p = 0.746), respectively. There were no significant differences in the outcome of the secondary endpoints. Pharmacokinetics showed constant peak and trough serum IgG levels in PID patients. The median half-life (t_1/2) of IgG was 33 days in the IVIG-F10 group and 41 days in the Sandoglobulin group. For anti-HBsAg, median t_1/2 values were shorter, i.e. 17 and 19 days for IVIG-F10 and Sandoglobulin, respectively. In the ITP study, adverse events related to study drug were suspected in 9 and 14 patients treated with IVIG-F10 and Sandoglobulin, respectively; in the PID study adverse events occurred in 8 and 9 patients, respectively. Viral safety was ascertained in both studies by serology supplemented with nucleic acid amplification testing. Serum levels of the stabilizers transiently increased after infusion of IVIG-F10, but were back to baseline at the following day. Conclusions: The clinical studies in patients with chronic ITP and PID showed that the efficacy, tolerability, safety, and pharmacokinetics of IVIG-F10 were comparable to the properties of Sandoglobulin.

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Section: Discussionmentioning

confidence: 99%

Clinical Properties of a Novel Liquid Intravenous Immunoglobulin: Studies in Patients with Immune Thrombocytopenic Purpura and Primary Immunodeficiencies

Borte¹,

Davies²,

Touraine³

et al. 2004

Transfus Med Hemother

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“…A self-administered questionnaire completed by 59 infusion nurses found that an overwhelming 87% preferred liquid to lyophilized formulations. 24 Shorter preparation time, safety, fewer adverse effects, and shorter infusion times were perceived as the most important product features both for patient quality of life and for infusion nurses' job performance.…”

Section: Convenience Factorsmentioning

confidence: 99%

The Product: All Intravenous Immunoglobulins Are Not Equivalent

Siegel

2005

Pharmacotherapy

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The first intravenous formulation of intravenous immunoglobulin (IGIV) was introduced in the United States in the early 1980s. At that time, the only indication was for treatment of primary immunodeficiency. By the mid-1990s, IGIV was mainly used for indications approved by the United States Food and Drug Administration, but as new indications are found, use of IGIVs is increasing. In fact, today, IGIV is mostly used for off-label indications. The specific characteristics of individual IGIV products must be directly addressed in the manufacturing process, as clinical efficacy may be affected. In addition, the safety profile of the ideal IGIV should be maximized by ensuring inactivation of the widest spectrum of viruses and prions. Some IGIV products are more suitable than others for certain patients; the challenge is to understand the different characteristics among products and select the most appropriate IGIV product for each patient. Convenience factors must be considered, for both the health care provider and the patient, without jeopardizing the more important features of the IGIV, such as tolerability and safety.

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