Eculizumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Paroxysmal nocturnal haemoglobinuria Initial: 600 mg once wkly for 4 wk, then increased to 900 mg once wkly for 1 wk and every 12-16 days thereafter, given over 25-45 min. Haemolytic uraemic syndrome, atypical Initial: 900 mg once wkly for 4 wk, then increased to 1,200 mg once wkly for 1 wk and every 12-16 days thereafter, given over 25-45 min. Combination therapy w/ plasmapheresis, plasma exchange or w/ fresh frozen plasma infusion: Give supplemental doses per each session based on the most recent dose.
Dosage Details
Intravenous
Paroxysmal nocturnal haemoglobinuria
Adult: Initially, 600 mg once wkly for 4 wk, then increased to 900 mg once wkly for 1 wk and every 12-16 days thereafter, given via infusion over 25-45 min.
Child: 5-<10 kg: Initially, 300 mg once wkly for 2 wk, then every 3 wk thereafter; 10-<20 kg: Initially, 600 mg once wkly for 1 wk, then 300 mg once wkly for 1 wk, then every 2 wk thereafter; 20-<30 kg: Initially, 600 mg once wkly for 3 wk, then every 2 wk thereafter; 30-<40 kg: Initially, 600 mg once wkly for 2 wk, then increased to 900 mg once wkly for 1 wk, then every 2 wk thereafter; ≥40 kg: Same as adult dose. Doses are given via infusion over 1-4 hr.

Intravenous
Haemolytic uraemic syndrome, atypical
Adult: Initially, 900 mg once wkly for 4 wk, then increased to 1,200 mg once wkly for 1 wk and every 12-16 days thereafter, given via infusion over 25-45 min. Combination therapy w/ plasmapheresis/plasma exchange (PE/PI) or w/ fresh frozen plasma infusion: Give supplemental doses per session based on the most recent dose (PE/PI: 300 mg if recent dose was 300 mg or 600 mg if recent dose was ≥600 mg; fresh frozen plasma: 300 mg if recent dose was ≥300 mg), w/in 1 hr after PE/PI or 1 hr before fresh frozen plasma infusion.
Child: 5-<10 kg: Initially, 300 mg once wkly for 2 wk, then every 3 wk thereafter; 10-<20 kg: Initially, 600 mg once wkly for 1 wk, then 300 mg once wkly for 1 wk, then every 2 wk thereafter; 20-<30 kg: Initially, 600 mg once wkly for 3 wk, then every 2 wk thereafter; 30-<40 kg: Initially, 600 mg once wkly for 2 wk, then increased to 900 mg once wkly for 1 wk, then every 2 wk thereafter; ≥40 kg: Same as adult dose. Doses are given via infusion over 1-4 hr. Combination therapy w/ plasmapheresis/plasma exchange (PE/PI) or w/ fresh frozen plasma infusion: Give supplemental doses per each session based on the most recent dose (PE/PI: 300 mg if recent dose was 300 mg or 600 mg if recent dose was ≥600 mg; fresh frozen plasma: 300 mg if recent dose was ≥300 mg), w/in 1 hr after PE/PI or 1 hr before fresh frozen plasma infusion.
Reconstitution
Dilute w/ appropriate volume of NaCl 0.9% or dextrose 5% in water or Ringer’s soln to prepare a soln containing 5 mg/mL.
Contraindications
Hypersensitivity. Unvaccinated against or unresolved N. meningitidis infection.
Special Precautions
Patient w/ active systemic infections. Not indicated for haemolytic uraemic syndrome associated w/ Shiga toxin producing E. coli. Ensure vaccination against N. meningitidis infections at least 2 wk prior to initiation of therapy. Childn. Pregnancy and lactation.
Adverse Reactions
Significant: Susceptibility to infections (e.g. pneumonia), infusion reactions/immunogenicity (e.g. hypersensitivity reactions, anaphylaxis).
Nervous: Headache, dizziness, dysgeusia, tremor, insomnia, fatigue, influenza-like illness, asthenia.
CV: HTN, peripheral oedema, tachycardia, hypotension.
GI: Diarrhoea, vomiting, nausea, abdominal pain, gastroenteritis, dyspepsia, constipation.
Resp: Cough, oropharyngeal pain, pneumonia, nasopharyngitis, upper resp tract infection, nasal congestion, bronchitis, sinusitis.
Genitourinary: UTI, uropathy, proteinuria, renal insufficiency.
Haematologic: Leucopenia, anaemia.
Musculoskeletal: Arthralgia, myalgia, pain in extremity, back pain, muscle spasm, limb pain.
Ophthalmologic: Eye disorder.
Dermatologic: Rash, pruritus, alopecia.
Immunologic: Herpes simplex infection, neoplasms.
Others: Pyrexia, chills, hypokalaemia.
Potentially Fatal: Meningococcal infection.
MonitoringParameters
Monitor CBC w/ differential, serum lactate dehydrogenase (LDH), serum creatinine, AST, urinalysis. Monitor for signs and symptoms of infections (e.g. meningococcal, influenza), and infusion reactions during and 1 hr after infusion. Monitor for haemolysis in paroxysmal nocturnal haemoglobinuria (PNH) cases for at least 8 wk and for thrombotic microangiopathy in atypical haemolytic uraemic syndrome (aHUS) cases for at least 12 wk after discontinuation of therapy.
Drug Interactions
Concurrent admin of live vaccines may increase the risk of secondary transmission of infection.
Action
Description: Eculizumab is a recombinant monoclonal antibody which binds w/ high affinity to complement protein C5, preventing cleavage into C5a and C5b which subsequently inhibits the formation of terminal complex C5b-9, thereby inhibiting terminal complement-mediated intravascular haemolysis and thrombotic microangiopathy.
Onset: Reduction of haemolysis: ≤1 wk.
Pharmacokinetics:
Distribution: Crosses the placenta. Volume of distribution: 7.7 L (PNH); 6.14 L (aHUS).
Metabolism: Mainly catabolised by lysosomal enzymes into small peptides and amino acids.
Excretion: Elimination half-life: Approx 11-12 days.
Storage
Store between 2-8°C. Do not shake or freeze. Protect from light.
MIMS Class
ATC Classification
L04AA25 - eculizumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Anon. Eculizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/09/2017.

Buckingham R (ed). Eculizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2017.

Joint Formulary Committee. Eculizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Eculizumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 04/09/2017.

Soliris (Alexion Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/09/2017.

Disclaimer: This information is independently developed by MIMS based on Eculizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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