page180
Hepatic impairment
monitor closely (risk of thro-
moembolic complications)
Side-effects
thrombotic events (including dissemi-
nated intravascular coagulation);
rarely
headache;
very rarely
pyrexia,
antibody formation, hypersensi-
tivity reactions (including anaphylaxis);
nephrotic
syndrome also reported
Available from CSL Behring (
Beriplex
c
P/N
), Octapharma
(
Octaplex
c
)
DROTRECOGIN ALFA (ACTIVATED)
Recombinant activated protein C
Indications
adjunctive treatment of severe sepsis with
multiple organ failure—start treatment within 24
hours (and no later than 48 hours) after onset of organ
failure
Cautions
increased risk of bleeding,
concomitant use
of drugs that increase risk of bleeding;
interactions:
Appendix 1 (drotrecogin alfa)
Contra-indications
internal bleeding;
intracranial
neoplasm or cerebral herniation;
thrombocytopenia;
not recommended for use in children under 18 years
or in single organ failure
Hepatic impairment
avoid in chronic severe liver
disease
Pregnancy
manufacturer advises avoid unless benefit
outweighs risk—no information available
Breast-feeding
manufacturer advises avoid—no
information available
Side-effects
bleeding;
headache;
ecchymosis;
pain
Available from Lilly (
Xigris
c
)
NICE guidance
Drotrecogin alfa (activated) for severe sepsis
(September 2004)
Drotrecogin alfa (activated) should be considered for
adults with severe sepsis that has resulted in the failure
of
two or more major organs and who are receiving
optimum intensive
care
support.
Drotrecogin alfa
(activated)
should be initiated and supervised only
by a specialist
consultant
with intensive care skills
and experience in the care of patients with sepsis.
FACTOR VIIa (RECOMBINANT)
Eptacog alfa (activated)
Indications
treatment and prophylaxis of haemorr-
hage in patients with haemophilia A or B with inhi-
bitors to factors VIII or IX,
acquired haemophilia,
factor VII deficiency, or Glanzmann’s thrombasthenia
Cautions
risk of thrombosis or disseminated intravas-
cular coagulation
Side-effects
very rarely
nausea,
thrombotic events
(including myocardial infarction and cerebrovascular
accident),
coagulation disorders,
fever,
pain, and
allergic reactions including rash
Available from Novo Nordisk (
NovoSeven
c
T)
FACTOR VIII FRACTION, DRIED
(Human Coagulation Factor VIII, Dried)
Dried factor VIII fraction is prepared from human
plasma by a suitable fractionation technique
Indications
treatment and prophylaxis of haemorr-
hage in congenital factor VIII deficiency (haemophilia
A),
acquired factor VIII deficiency,
von Willebrand’s
disease
Cautions
monitor for development of factor VIII inhi-
bitors;
intravascular haemolysis after large or fre-
quently repeated doses in patients with blood groups
A,
B,
or AB—less likely with high potency concen-
trates
Side-effects
gastro-intestinal disturbances,
taste dis-
turbances;
flushing,
palpitation;
dyspnoea,
coughing;
headache, dizziness, paraesthesia, drowsiness; blurred
vision; antibody formation; hypersensitivity reactions
including hypotension,
angioedema,
chills,
fever,
urticaria,
and anaphylaxis
Available from Biotest UK (
Haemoctin
c
T),
CSL Behring
(
Haemate
c
P
),
BPL (
Optivate
c
, High Purity Factor VIII and
von Willebrand factor concentrate;
8Y
c
), Grifols (
Alphanate
c
;
Fanhdi
c
),
Octapharma (
Octanate
c
;
Wilate
c
T)
Note
Preparation of
recombinant
human coagulation factor
VIII (octocog alfa) available from CSL Behring (
Helixate
c
NexGen
),
Baxter (
Advate
c
),
Bayer Schering (
Kogenate
c
Bayer
);
preparation of recombinant human coagulation factor
VIII (moroctocog alfa) available from Wyeth (
ReFacto AF
c
T);
octocog alfa and moroctocog alfa are not indicated for use in
von Willebrand’s disease
FACTOR VIII INHIBITOR BYPASSING
FRACTION
Preparations with factor VIII inhibitor bypassing
activity are prepared from human plasma
Indications
treatment and prophylaxis of haemorr-
hage in patients with congenital factor VIII deficiency
(haemophilia A) and factor VIII inhibitors;
treatment
of haemorrhage in non-haemophiliac patients with
acquired factor VIII inhibitors
Contra-indications
disseminated intravascular coa-
gulation
Side-effects
thrombosis,
disseminated intravascular
coagulation,
myocardial infarction;
paraesthesia;
pyrexia; hypersensitivity reactions including hypo-
tension,
flushing,
urticaria, rash,
and anaphylaxis
Available from Baxter (
FEIBA
c
)
FACTOR IX FRACTION, DRIED
Dried factor IX fraction is prepared from human
plasma by a suitable fractionation technique;
it may
also contain clotting factors II,
VII, and X
Indications
treatment and prophylaxis of haemorr-
hage in congenital factor IX deficiency (haemophilia
B)
Cautions
risk of thrombosis—principally with former
low purity products
Contra-indications
disseminated intravascular coa-
gulation
Side-effects
gastro-intestinal disturbances;
headache,
dizziness;
allergic reactions,
including chills,
fever
Available from CSL Behring (
Mononine
c
),
BPL (
Replenine
c
-
VF
,
Dried Factor IX Fraction), Grifols (
AlphaNine
c
)
Note
Preparation of recombinant coagulation factor IX (non-
acog alfa) available from Wyeth (
BeneFIX
c
)
FACTOR XIII FRACTION, DRIED
(Human Fibrin-stabilising Factor, Dried)
Indications
congenital factor XIII deficiency
Side-effects
rarely,
allergic reactions and fever
Available from CSL Behring (
Fibrogammin
c
P
)
160
2.11 Antifibrinolytic drugs and haemostatics
BNF 61
2
Cardiovascular system