PMID- 21812863
OWN - NLM
STAT- MEDLINE
DCOM- 20120502
LR  - 20120216
IS  - 1365-2516 (Electronic)
IS  - 1351-8216 (Linking)
VI  - 18
IP  - 2
DP  - 2012 Mar
TI  - Clinical efficacy, safety and pharmacokinetic properties of the plasma-derived 
      factor IX concentrate Haemonine in previously treated patients with severe 
      haemophilia B.
PG  - 175-81
LID - 10.1111/j.1365-2516.2011.02624.x [doi]
AB  - Plasma-derived factor IX (FIX) concentrate remains an important choice for 
      replacement therapy in haemophilia B patients. Haemonine is a high purity 
      double-virus inactivated human plasma-derived coagulation FIX concentrate 
      (pdFIX). Aim was to evaluate the clinical efficacy, safety and pharmacokinetic 
      properties of Haemonine in three prospective, open-label uncontrolled studies and 
      a compassionate use program in previously treated patients with severe 
      haemophilia B. Long-term efficacy and safety were investigated in 29 patients 
      treated prophylactically and, in addition, treatment on-demand (TOD) in the case 
      of acute haemorrhage. Pharmacokinetic properties were assessed in 14 patients at 
      baseline and after 3 months of regular treatment. Pharmacokinetic parameters were 
      in accordance with published data and remained nearly unchanged over time, 
      notably recovery and half-life. Mean terminal elimination half-life was 27.6 h 
      and 25.0 h, mean incremental recovery (IU dL(-1) /IU kg(-1)) was 1.55 and 1.60, 
      at baseline and 3 months, respectively. Haemonine was shown to be effective in 
      preventing and controlling bleeds. 55.2% (16/29) of patients were free of bleeds 
      under prophylaxis. 38 haemorrhages occurred, 42% (16/38) required treatment and 
      87.5% (14/16) resolved after a single infusion, 12.5% after 2 infusions. All 
      responses reported on haemorrhages were rated as 'excellent' or 'good'. Moreover, 
      'excellent' haemostatic efficacy was demonstrated in 12 surgeries with no 
      complications. Few adverse events (AEs) and no thrombogenic complication, nor 
      induction of FIX inhibitory antibodies were observed. Haemonine is effective, 
      safe and well tolerated in long-term prophylaxis, TOD and when applied after 
      minor and major surgeries.
CI  - (c) 2011 Blackwell Publishing Ltd.
FAU - Serban, M
AU  - Serban M
AD  - Louis Turcanu', Timisoara, Romania.
FAU - Skotnicki, A B
AU  - Skotnicki AB
FAU - Colovic, M
AU  - Colovic M
FAU - Jinca, C
AU  - Jinca C
FAU - Klukowska, A
AU  - Klukowska A
FAU - Laguna, P
AU  - Laguna P
FAU - Wolf, D M
AU  - Wolf DM
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110803
PL  - England
TA  - Haemophilia
JT  - Haemophilia : the official journal of the World Federation of Hemophilia
JID - 9442916
RN  - 0 (Blood Coagulation Factors)
RN  - 37224-63-8 (prothrombin complex concentrates)
RN  - 9001-28-9 (Factor IX)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Blood Coagulation Factors
MH  - Child
MH  - Factor IX/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Half-Life
MH  - Hemophilia B/*drug therapy/surgery
MH  - Hemorrhage/epidemiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Young Adult
EDAT- 2011/08/05 06:00
MHDA- 2012/05/04 06:00
CRDT- 2011/08/05 06:00
PHST- 2011/08/05 06:00 [entrez]
PHST- 2011/08/05 06:00 [pubmed]
PHST- 2012/05/04 06:00 [medline]
AID - 10.1111/j.1365-2516.2011.02624.x [doi]
PST - ppublish
SO  - Haemophilia. 2012 Mar;18(2):175-81. doi: 10.1111/j.1365-2516.2011.02624.x. Epub 
      2011 Aug 3.