▶UncommonCavernous sinus thrombosis.skin necrosis.
thrombophlebitis
lCONCEPTION AND CONTRACEPTIONManufacturer advises
effective contraception during and for 6 months after
treatment in women of childbearing potential.
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk—no information available.
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lEFFECT ON LABORATORY TESTSManufacturer advises to
avoid intrinsic pathway clotting-based laboratory tests or
use with caution as results may be misinterpreted—consult
product literature.
lDIRECTIONS FOR ADMINISTRATIONManufacturer advises
max. 2 mL per injection site; rotate injection site and avoid
skin that is tender, damaged or scarred. Patients or their
caregivers may self-administerHemlibra®after
appropriate training.
lPRESCRIBING AND DISPENSING INFORMATIONEmicizumab
is a biological medicine. Biological medicines must be
prescribed and dispensed by brand name, seeBiological
medicinesandBiosimilar medicines, under Guidance on
prescribing p. 1 ; manufacturer advises to record the brand
name and batch number after each administration.
lPATIENT AND CARER ADVICE
Missed dosesManufacturer advises if a dose is missed by
more than 5 days, the missed dose should not be taken and
the next dose administered at the normal time.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
▶Hemlibra(Roche Products Ltd)A
Emicizumab 30 mg per 1 mlHemlibra 30 mg/ 1 ml solution for
injection vials| 1 vialP£ 2 , 415. 30
Emicizumab 150 mg per 1 mlHemlibra 150 mg/ 1 ml solution for
injection vials| 1 vialP£ 12 , 076. 50
Hemlibra 105 mg/ 0. 7 ml solution for injection vials| 1 vialP
£ 8 , 453. 55
Hemlibra 60 mg/ 0. 4 ml solution for injection vials| 1 vialP
£ 4 , 830. 602.1 Coagulation factor
deficiencies
BLOOD AND RELATED PRODUCTS›
COAGULATION PROTEINSDried prothrombin complex
(Human prothrombin complex)
lINDICATIONS AND DOSE
Treatment and peri-operative prophylaxis of
haemorrhage in patients with congenital deficiency of
factors II, VII, IX, or X if purified specific coagulation
factors not available|Treatment and peri-operative
prophylaxis of haemorrhage in patients with acquired
deficiency of factors II, VII, IX, or X (e.g. during warfarin
treatment)
▶BY INTRAVENOUS INFUSION
▶Child:(consult haematologist)lCONTRA-INDICATIONSAngina.history of heparin induced
thrombocytopenia.recent myocardial infarction (except
in life-threatening haemorrhage following overdosage of
oral anticoagulants, and before induction offibrinolytic
therapy)lCAUTIONSDisseminated intravascular coagulation.
history of myocardial infarction or coronary heart disease.
postoperative use.risk of thrombosis.vaccination against
hepatitis A and hepatitis B may be required
lSIDE-EFFECTS
▶Rare or very rareFever.headache.hypersensitivity
▶Frequency not knownDisseminated intravascular
coagulation.nephrotic syndrome.thromboembolism
lHEPATIC IMPAIRMENT
MonitoringMonitor closely in hepatic impairment (risk of
thromboembolic complications).
lPRESCRIBING AND DISPENSING INFORMATIONDried
prothrombin complex is prepared from human plasma by a
suitable fractionation technique, and contains factor IX,
together with variable amounts of factors II, VII, and X.
Available from CSL Behring (Beriplex®P/N),
Octapharma (Octaplex®).lMEDICINAL FORMS
No licensed medicines listed.Factor VIIa (recombinant)
(Eptacog alfa (activated))
lINDICATIONS AND DOSE
Treatment and prophylaxis of haemorrhage in patients
with haemophilia A or B with inhibitors to factors VIII or
IX, acquired haemophilia, factor VII deficiency, or
Glanzmann’s thrombasthenia
▶BY INTRAVENOUS INJECTION
▶Child:(consult haematologist)lCAUTIONSDisseminated intravascular coagulation.risk of
thrombosis
lSIDE-EFFECTS
▶UncommonEmbolism and thrombosis.fever.hepatic
disorders.intestinal ischaemia.skin reactions.
therapeutic response decreased
▶Rare or very rareAngina pectoris.cerebrovascular
insufficiency.coagulation disorders.headache.
myocardial infarction.nausea.peripheral ischaemia
▶Frequency not knownAngioedema.flushinglMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder and solvent for solution for injection
▶NovoSeven(Novo Nordisk Ltd)
Eptacog alfa activated 50000 unitNovoSeven 1 mg ( 50 , 000 units)
powder and solvent for solution for injection pre-filled syringes|
1 pre-filled disposable injectionP£ 525. 20 (Hospital only)
NovoSeven 1 mg ( 50 , 000 units) powder and solvent for solution for
injection vials| 1 vialP£ 525. 20 (Hospital only)
Eptacog alfa activated 100000 unitNovoSeven 2 mg ( 100 , 000 units)
powder and solvent for solution for injection vials| 1 vialP
£ 1 , 050. 40 (Hospital only)
NovoSeven 2 mg ( 100 , 000 units) powder and solvent for solution for
injection pre-filled syringes| 1 pre-filled disposable injectionP
£ 1 , 050. 40 (Hospital only)
Eptacog alfa activated 250000 unitNovoSeven 5 mg ( 250 , 000 units)
powder and solvent for solution for injection pre-filled syringes|
1 pre-filled disposable injectionP£ 2 , 626. 00 (Hospital only)
NovoSeven 5 mg ( 250 , 000 units) powder and solvent for solution for
injection vials| 1 vialP£ 2 , 626. 00 (Hospital only)
Eptacog alfa activated 400000 unitNovoSeven 8 mg
( 400 , 000 units) powder and solvent for solution for injection vials|
1 vialP£ 4 , 201. 60 (Hospital only)
NovoSeven 8 mg ( 400 , 000 units) powder and solvent for solution for
injection pre-filled syringes| 1 pre-filled disposable injectionP
£ 4 , 201. 60 (Hospital only)84 Bleeding disorders BNFC 2018 – 2019
Cardiovascular system2