Pharmacokinetics and safety of fibrinogen concentrate

M. J. Manco-Johnson, D. Dimichele, G. Castaman, S. Fremann, S. Knaub, U. Kalina, F. Peyvandi, G. Piseddu, P. Mannucci

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Although fibrinogen concentrate has been available for the treatment of congenital fibrinogen deficiency for years, knowledge of its pharmacokinetics comes from only two small studies. Objectives: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia. Patients and methods: A multinational, prospective, open-label, uncontrolled study of patients with afibrinogenemia ≥6 years of age was conducted in the USA and Italy. Plasma was collected before and after infusion for PK analyses and evaluation by rotational thromboelastometry of maximum clot firmness (MCF) to assess clot integrity. Safety was assessed on the basis of adverse events and laboratory parameters. Results: After a single dose of 70mgkg -1 body weight (b.w.) FCH in 14 patients, median incremental in vivo recovery was a 1.7mgdL -1 increase per mgkg -1 b.w., and median levels were 1.3gL -1 for fibrinogen activity and antigen 1h after infusion. Median half-life (t 1/2) was 77.1h for fibrinogen activity and 88.0h for antigen. Plasma recovery in children 1/2 and area under the curve were decreased, with an increased steady-state volume and clearance. MCF increased by a mean of 8.9mm from baseline to 1h after infusion of FCH (P

Original languageEnglish
Pages (from-to)2064-2069
Number of pages6
JournalJournal of Thrombosis and Haemostasis
Volume7
Issue number12
DOIs
Publication statusPublished - Dec 2009

Keywords

  • Afibrinogenemia
  • Clot integrity
  • Fibrinogen concentrate
  • Maximum clot firmness
  • Pharmacokinetic
  • Safety

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

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