Treatment of Hemolytic Uremic Syndrome With Eculizumab
Eculizumab (Soliris®, Alexion) is available through a restricted access program. It is supplied in 300 mg single-use vials, with a concentration of 10 mg/mL. It must be refrigerated until use and diluted to a final concentration of 5 mg/mL with 0.45% or 0.9% sodium chloride, 5% dextrose in water, or Ringer's injection. The diluted solution should be administered as an IV infusion over 35 minutes. The duration may be slowed to 2 hours for patients who experience adverse effects.
The recommended induction regimen for eculizumab in patients 18 years of age and older is 900 mg given once weekly for 4 weeks. The first maintenance dose of 1,200 mg is given one week after completion of the induction phase (week 5). A 1,200 mg dose is then administered every 2 weeks. In younger patients, dosing is adjusted according to body weight. For patients between 30 and 40 kg, the induction phase consists of 600 mg given weekly for 2 doses, followed by 900 mg at week 3 and then every 2 weeks afterwards. Patients between 20 and 30 kg should receive 600 mg weekly for 2 doses, followed by 600 mg at week 3 and then every 2 weeks. Patients between 10 and 20 kg should be given 600 mg at week 1, 300 mg at week 2, and then 300 mg every 2 weeks. Infants between 5 and 10 kg should receive 300 mg at weeks 1 and 2, then 300 mg every 3 weeks. Upon discontinuation, patients should be monitored for at least 12 weeks to identify any return of symptoms.
Supplemental doses of eculizumab should be administered within 60 minutes after each plasmapheresis or plasma exchange, using the most recent dosage the patient has received. A supplemental dose should also be administered 60 minutes prior to each unit of fresh frozen plasma infused.
Availability and Dosing Recommendations
Eculizumab (Soliris®, Alexion) is available through a restricted access program. It is supplied in 300 mg single-use vials, with a concentration of 10 mg/mL. It must be refrigerated until use and diluted to a final concentration of 5 mg/mL with 0.45% or 0.9% sodium chloride, 5% dextrose in water, or Ringer's injection. The diluted solution should be administered as an IV infusion over 35 minutes. The duration may be slowed to 2 hours for patients who experience adverse effects.
The recommended induction regimen for eculizumab in patients 18 years of age and older is 900 mg given once weekly for 4 weeks. The first maintenance dose of 1,200 mg is given one week after completion of the induction phase (week 5). A 1,200 mg dose is then administered every 2 weeks. In younger patients, dosing is adjusted according to body weight. For patients between 30 and 40 kg, the induction phase consists of 600 mg given weekly for 2 doses, followed by 900 mg at week 3 and then every 2 weeks afterwards. Patients between 20 and 30 kg should receive 600 mg weekly for 2 doses, followed by 600 mg at week 3 and then every 2 weeks. Patients between 10 and 20 kg should be given 600 mg at week 1, 300 mg at week 2, and then 300 mg every 2 weeks. Infants between 5 and 10 kg should receive 300 mg at weeks 1 and 2, then 300 mg every 3 weeks. Upon discontinuation, patients should be monitored for at least 12 weeks to identify any return of symptoms.
Supplemental doses of eculizumab should be administered within 60 minutes after each plasmapheresis or plasma exchange, using the most recent dosage the patient has received. A supplemental dose should also be administered 60 minutes prior to each unit of fresh frozen plasma infused.