Drug Action
Eculizumab, a recombinant monoclonal antibody, inhibits terminal complement activation at the Blood and nutrition C5 protein and thereby reduces haemolysis and thrombotic microangiopathy.
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Drug reference
Eculizumab, a recombinant monoclonal antibody, inhibits terminal complement activation at the Blood and nutrition C5 protein and thereby reduces haemolysis and thrombotic microangiopathy.
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Reduce haemolysis in paroxysmal nocturnal haemoglobinuria (PNH), in those with a history of blood transfusions (under expert supervision) ▶BY INTRAVENOUS INFUSION ▶Adult: Initially 600 mg once weekly for 4 weeks, then increased to 900 mg once weekly for 1 week; maintenance 900 mg every 12–16 days Reduce thrombotic microangiopathy in atypical haemolytic uraemic syndrome (aHUS) (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: Initially 900 mg once weekly for 4 weeks, then increased to 1.2 g once weekly for 1 week; maintenance 1.2 g every 12–16 days
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Patients unvaccinated against Neisseria meningitidis. unresolved Neisseria meningitidis infection
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Active systemic infection CAUTIONS, FURTHER INFORMATION ▶Meningococcal infection Manufacturer advises vaccinate against Neisseria meningitidis at least 2 weeks before treatment (vaccines against serotypes A, C, Y, W135 and B where available, are recommended); revaccinate according to current medical guidelines. Patients receiving eculizumab less than 2 weeks after receiving meningococcal vaccine must be given prophylactic antibiotics until 2 weeks after vaccination. Advise patient to report promptly any signs of meningococcal infection. Other immunisations should also be up to date.
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Consult product literature for details of supplemental doses with concomitant plasmapheresis, plasma exchange, or plasma infusion.
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NICE decisions ▶Eculizumab for treating atypical haemolytic uraemic syndrome (January 2015) NICE HST1 Eculizumab, within its marketing authorisation, is recommended for funding for treating atypical haemolytic uraemic syndrome, only if all the following arrangements are in place: . coordination of eculizumab use through an expert centre, and . monitoring systems to record the number of people with a diagnosis of atypical haemolytic uraemic syndrome and the number who have eculizumab, and the dose and duration of treatment, and . a national protocol for starting and stopping eculizumab for clinical reasons, and . a research programme with robust methods to evaluate when stopping treatment or dose adjustment might occur. The long-term budget impact of eculizumab for treating atypical haemolytic uraemic syndrome is uncertain but will be considerable. NHS England and the manufacturer should consider what opportunities might exist to reduce the cost of eculizumab to the NHS. www.nice.org.uk/guidance/HST1
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→Appendix 1: monoclonal antibodies
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▶Common or very common Alopecia. asthenia. chills. cough . decreased leucocytes. diarrhoea. dizziness. fever. gastrointestinal discomfort. headache. hypertension. increased risk of infection. influenza like illness. joint disorders. muscle complaints. nausea. oropharyngeal pain. pain. skin reactions. sleep disorders. taste altered. tremor. vomiting ▶Uncommon Abscess. anxiety. appetite decreased. chest discomfort. constipation. cystitis. depression. dysuria. haemorrhage. hot flush. hyperhidrosis. hypersensitivity. hypotension. meningitis meningococcal. mood swings. nasal complaints. oedema. palpitations. paraesthesia. sepsis. spontaneous penile erection. throat irritation. tinnitus. vascular disorders. vertigo. vision blurred ▶Rare or very rare Abnormal clotting factor. conjunctival irritation. feeling hot. gastrooesophageal reflux disease. gingival discomfort. Grave’s disease. infusion related reaction. jaundice. malignant melanoma. menstrual disorder. syncope. urogenital tract gonococcal infection
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Manufacturer advises effective contraception during and for 5 months after treatment.
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Manufacturer advises use only if potential benefit outweighs risk—limited information available. Eculizumab is an immunoglobulin G (IgG) monoclonal antibody; human IgG antibodies are known to cross the placenta.
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Manufacturer advises use with caution— limited information available; unlikely to be present in milk.
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▶Monitor for 1 hour after infusion. Blood and nutrition ▶For paroxysmal nocturnal haemoglobinuria, monitor for intravascular haemolysis (including serum-lactate dehydrogenase concentration) during treatment and for at least 8 weeks after discontinuation. ▶For atypical haemolytic uraemic syndrome, monitor for thrombotic microangiopathy (measure platelet count, serum-lactate dehydrogenase concentration, and serum creatinine) during treatment and for at least 12 weeks after discontinuation.
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For intravenous infusion (Soliris ®), give intermittently in Glucose 5% or Sodium chloride 0.9%. Dilute requisite dose to a concentration of 5 mg/mL and mix gently; give over 25–45 minutes (infusion time may be increased to 2 hours if infusion- related reactions occur).
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ELECTROLYTES: May contain Sodium ▶Soliris (Alexion Pharma UK Ltd) Eculizumab 10 mg per 1 ml Soliris 300mg/30ml concentrate for solution for infusion vials | 1 vial P £3,150.00 (Hospital only)
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Patients or carers should be advised to report promptly any signs of meningococcal infection. Advice about prevention of gonorrhoea should also be given. A patient information card and a patient safety card should be provided.
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Initially 600 mg once weekly for 4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
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Initially 900 mg once weekly for 4 weeks, then
First-line fragment. Read the complete Indications and Dose section above.
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