BNF for Children (BNFC) 2018-2019

(singke) #1

Factor VIII fraction, dried


(Human coagulation factor VIII, dried)


lINDICATIONS AND DOSE
Treatment and prophylaxis of haemorrhage in congenital
factor VIII deficiency (haemophilia A), acquired factor
VIII deficiency|Von Willebrand’s disease
▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION,
OR BY CONTINUOUS INTRAVENOUS INFUSION
▶Child:(consult haematologist)

lCAUTIONSIntravascular haemolysis after large or
frequently repeated doses in patients with blood groups A,
B, or AB—less likely with high potency concentrates.
vaccination against hepatitis A and hepatitis B may be
required (not necessary with recombinant preparation)
lSIDE-EFFECTS
▶UncommonAngioedema.cardiac discomfort.chills.
flushing.headache.hypersensitivity.hypotension.
lethargy.nausea.paraesthesia.restlessness.skin
reactions.tachycardia.vomiting.wheezing
▶Rare or very rareFever


lMONITORING REQUIREMENTSMonitor for development of
factor VIII inhibitors.


lPRESCRIBING AND DISPENSING INFORMATIONDried factor
VIII fraction is prepared from human plasma by a suitable
fractionation technique; it may also contain varying
amounts of von Willebrand factor.Optivate®,Fanhdi®,
andOctanate®are not indicated for use in von
Willebrand’s disease.
Recombinant human coagulation factor VIII including
octocog alfa, moroctocog alfa, and simoctocog alfa are not
indicated for use in von Willebrand’s disease.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder and solvent for solution for injection
▶Advate(Baxalta UK Ltd)
Octocog alfa 250 unitAdvate 250 unit powder and solvent for
solution for injection vials| 1 vialP£ 177. 50
Octocog alfa 500 unitAdvate 500 unit powder and solvent for
solution for injection vials| 1 vialP£ 355. 00
Octocog alfa 1000 unitAdvate 1 , 000 unit powder and solvent for
solution for injection vials| 1 vialP£ 710. 00
Octocog alfa 2000 unitAdvate 2 , 000 unit powder and solvent for
solution for injection vials| 1 vialP£ 1 , 420. 00
▶Elocta(Swedish Orphan Biovitrum Ltd)A
Efmoroctocog alfa 250 unitElocta 250 unit powder and solvent for
solution for injection vials| 1 vialPs(Hospital only)
Efmoroctocog alfa 500 unitElocta 500 unit powder and solvent for
solution for injection vials| 1 vialPs(Hospital only)
Efmoroctocog alfa 1000 unitElocta 1 , 000 unit powder and solvent
for solution for injection vials| 1 vialPs(Hospital only)
Efmoroctocog alfa 1500 unitElocta 1 , 500 unit powder and solvent
for solution for injection vials| 1 vialPs(Hospital only)
Efmoroctocog alfa 2000 unitElocta 2 , 000 unit powder and solvent
for solution for injection vials| 1 vialPs(Hospital only)
Efmoroctocog alfa 3000 unitElocta 3 , 000 unit powder and solvent
for solution for injection vials| 1 vialPs(Hospital only)
▶Fanhdi(Grifols UK Ltd)
Factor VIII high purity 500 unitFanhdi 500 unit powder and solvent
for solution for injection vials| 1 vialP£ 165. 00 (Hospital only)
Factor VIII high purity 1000 unitFanhdi 1 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 330. 00 (Hospital
only)
Factor VIII high purity 1500 unitFanhdi 1 , 500 unit powder and
solvent for solution for injection vials| 1 vialP£ 495. 00
▶Haemoctin(Biotest (UK) Ltd)
Factor VIII high purity 250 unitHaemoctin 250 unit powder and
solvent for solution for injection vials| 1 vialP£ 150. 00 (Hospital
only)
Factor VIII high purity 500 unitHaemoctin 500 unit powder and
solvent for solution for injection vials| 1 vialP£ 300. 00 (Hospital
only)


Factor VIII high purity 1000 unitHaemoctin 1 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 600. 00 (Hospital
only)
▶Helixate NexGen(CSL Behring UK Ltd)
Octocog alfa 250 unitHelixate NexGen 250 unit powder and solvent
for solution for injection vials| 1 vialP£ 139. 50
Octocog alfa 500 unitHelixate NexGen 500 unit powder and solvent
for solution for injection vials| 1 vialP£ 279. 00
Octocog alfa 1000 unitHelixate NexGen 1 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 558. 00
Octocog alfa 2000 unitHelixate NexGen 2 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 1 , 116. 00
▶Kogenate(Bayer Plc)
Octocog alfa 2000 unitKogenate Bayer 2 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 1 , 260. 00
▶Kogenate Bayer(Bayer Plc)
Octocog alfa 250 unitKogenate Bayer 250 unit powder and solvent
for solution for injection vials| 1 vialP£ 157. 50
Octocog alfa 500 unitKogenate Bayer 500 unit powder and solvent
for solution for injection vials| 1 vialP£ 315. 00
Octocog alfa 1000 unitKogenate Bayer 1 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 630. 00
▶Nuwiq(Octapharma Ltd)A
Simoctocog alfa 250 unitNuwiq 250 unit powder and solvent for
solution for injection vials| 1 vialP£ 190. 00 (Hospital only)
Simoctocog alfa 500 unitNuwiq 500 unit powder and solvent for
solution for injection vials| 1 vialP£ 380. 00 (Hospital only)
Simoctocog alfa 1000 unitNuwiq 1 , 000 unit powder and solvent for
solution for injection vials| 1 vialP£ 760. 00 (Hospital only)
Simoctocog alfa 2000 unitNuwiq 2 , 000 unit powder and solvent for
solution for injection vials| 1 vialP£ 1 , 520. 00 (Hospital only)
▶Octanate(Octapharm Ltd)
Factor VIII high purity 500 unitOctanate LV 500 unit powder and
solvent for solution for injection vials| 1 vialP£ 300. 00 (Hospital
only)
Factor VIII high purity 1000 unitOctanate LV 1 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 600. 00 (Hospital
only)
Powder and solvent for solution for infusion
▶Advate(Baxalta UK Ltd)
Octocog alfa 1500 unitAdvate 1 , 500 unit powder and solvent for
solution for infusion vials| 1 vialP£ 1 , 065. 00
Octocog alfa 3000 unitAdvate 3 , 000 unit powder and solvent for
solution for infusion vials| 1 vialP£ 2 , 130. 00
▶Kogenate(Bayer Plc)
Octocog alfa 3000 unitKogenate Bayer 3 , 000 unit powder and
solvent for solution for injection vials| 1 vialP£ 1 , 890. 00

Factor IX fraction, dried


lINDICATIONS AND DOSE
Treatment and prophylaxis of haemorrhage in congenital
factor IX deficiency (haemophilia B)
▶BY INTRAVENOUS INJECTION, OR BY CONTINUOUS
INTRAVENOUS INFUSION
▶Child:(consult haematologist)

lCONTRA-INDICATIONSDisseminated intravascular
coagulation
lCAUTIONSRisk of thrombosis—principally with former low
purity products.vaccination against hepatitis A and
hepatitis B may be required (not necessary with
recombinant preparation)
lSIDE-EFFECTS
▶Common or very commonAnxiety.back pain.dyspnoea.
hypersensitivity.nausea.sensation abnormal.skin
reactions.vasodilation
▶Rare or very rareAngioedema.cardiac discomfort.chills.
disseminated intravascular coagulation.embolism and
thrombosis.headache.hypotension.lethargy.
myocardial infarction.tachycardia.vomiting.wheezing
▶Frequency not knownNephrotic syndrome
lPRESCRIBING AND DISPENSING INFORMATIONDried factor
IX fraction is prepared from human plasma by a suitable

BNFC 2018 – 2019 Coagulation factor deficiencies 85


Cardiovascular system

2

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