Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies

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Abstract:

Abstract

Background and aims:  Intragam┬« 10 NF is the next generation 10% intravenous immunoglobulin with three pathogen reduction steps and a noncarbohydrate stabiliser. This open label, cross‐over study in patients with primary immunodeficiency was designed to evaluate whether Intragam 10 NF differed in its pharmacokinetics (PK) compared with Intragam P and to assess Intragam 10 NF safety and tolerability.

Methods:  Nineteen primary immunodeficiency patients were administered one cycle of their existing Intragam P dose (0.2–0.8 g/kg 3–4 weekly), followed by seven cycles of Intragam 10 NF administered at the same dosing schedule as Intragam P. The primary objective was to compare serum immunoglobulin G (IgG) trough levels. Secondary endpoints were PK variables, safety and tolerability.

Results:  There was no significant within‐patient difference in the average trough immunoglobulin G concentration between Intragam P and Intragam 10 NF (8.76 g/L, 8.55 g/L respectively) (geometrical mean ratio 1.034; 95% confidence interval 0.996–1.073; P = 0.079). Mean PK parameters for both products were similar, with all 95% confidence interval encompassing 1.0 except for time to maximum concentration. Time to maximum concentration occurred earlier with Intragam 10 NF compared with Intragam P, with a shorter infusion time (mean 1.75 h vs 2.52 h respectively; P < 0.05). Headache was the most frequent treatment‐related event following both products. There were no study withdrawals, deaths, or notable changes in laboratory values or vital signs.

Conclusion:  Intragam 10 NF was well tolerated and exhibited similar PK to Intragam P, with the advantage of a 45 min shorter infusion time.

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1445-5994.2011.02712.x

Affiliations: 1: Department of Clinical Immunology and Allergy, the Royal Melbourne Hospital 2: Department of Allergy and Immunology, Flinders Medical Centre 3: Department of Clinical Immunology and Allergy, Royal Adelaide Hospital, Adelaide, South Australia, Australia 4: Department of Allergy, Immunology and Respiratory Medicine, the Alfred Hospital, Melbourne 5: Department of Medical and Research Management, CSL Limited, Melbourne, Victoria

Publication date: March 1, 2012

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