Company: Alexion Pharma UK.
Legal category: Prescription. Hospital only. Sport pending.
Active ingredient: Eculizumab 300mg.
Description: Concentrate for solution for infusion.
Presentation: 1 vial, €4557.50.
Indications: Treatment of paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS).
Pharmacology: Eculizumab is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and inhibits terminal complement activation which leads to reduction of complement-mediated intravascular haemolysis and thrombotic microangiopathy.
Dosage: Adult: Administer by 25–45 minute intravenous infusion via gravity feed, a syringe-type pump, or infusion pump. Monitor for 1 hour after infusion (slow or stop infusion if adverse events occur; two hours maximum total infusion time). PNH: Initially 600mg once weekly for 4 weeks, 900mg for 5th week; then 900mg every 14+/- 2 days. aHUS: Initially 900mg once weekly for 4 weeks, 1200mg for 5th week, then 1200mg every 14+/- 2 days. Supplemental dosing required for aHUS patients with concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion): See SPC. Duration: Continue for patient’s lifetime, unless discontinuation clinically indicated. Elderly: As per adults. Limited experience. Children: Administer over 1-4 hours. ≥40kg body weight (BW): As per adults. 30 to <40kg BW, 600mg weekly x 2, 900mg at week 3, then 900mg every 2 weeks; 20 to <30kg BW, 600mg weekly x 2, 600mg at week 3, then 600mg every 2 weeks; 10 to <20kg BW, 600mg weekly x 1, 300mg at week 2, then 300mg every 2 weeks; 5 to <10kg BW, 300mg weekly x 1, 300mg at week 2; then 300mg every 3 weeks. Monitor for 1 hour after infusion (slow or stop infusion if adverse events occur; maximum total infusion time of two hours (≥12 years) and four hours (<12 years).
Contraindications: Hypersensitivity to eculizumab, murine proteins or to any of the excipients. Initiation in patients with unresolved Neisseria meningitidis infection or unvaccinated against Neisseria meningitidis (or aHUS patients who do not receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination). Pregnancy (assess risk/benefit). Women must use contraception and not breastfeed during and for 5 months after treatment.
Special precautions: Do not administer as intravenous push or bolus injection. Caution: Active systemic infection. Monitor PNH patients for intravascular haemolysis (including serum-lactate dehydrogenase levels [LDH] ) during treatment (may require dose adjustment) and for at least 8 weeks after discontinuation. Monitor aHUS patients for thrombotic microangiopathy during treatment (measure platelet count, serum LDH, serum creatinine; may require dose adjustment) and after discontinuation, if discontinuation is medically justified. Patients should be informed to seek immediate medical advice if signs of meningococcal infection (monitor) occur. Vaccinate children against Haemophilus influenzae and pneumococcal infections. Hepatic impairment, safety and efficacy not established. Contains sodium.
Drug interactions: Positive Coombs test.
Adverse drug reactions: Headache, meningococcal sepsis, aspergillus infection, viral infection, upper respiratory tract infection, urinary tract infection, bacterial arthritis, nasopharyngitis, bronchitis, oral herpes, thrombocytopenia, leukopenia, haemolysis, anaphylactic reaction, decreased appetite, dizziness, dysgeusia, hypotension, dyspnoea, cough, nasal congestion, pharyngolaryngeal pain, rhinorrhoea, gastrointestinal upset, rash, alopecia, pruritus, arthralgia, myalgia, muscle spasms, pain (bone, back, neck, in extremity), oedema, chest discomfort, pyrexia, chills, fatigue, influenza like illness.
Full prescribing information and references available from Alexion Pharma UK. Telephone: 1-800 936 537.
E-mail: MedicalInformation.UK@alxn.com