Eculizumab Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria

Initial dose: 600 mg via 35 minute IV infusion every 7 days for the first 4 weeks, followed by 900 mg for the fifth dose 7 days later.
Maintenance dose: 900 mg via 35 minute IV infusion every 14 days.

Usual Adult Dose for Hemolytic Uremic Syndrome

Atypical Hemolytic Uremic Syndrome:
Initial dose: 900 mg via 35 minute IV infusion every 7 days for the first 4 weeks, followed by 1200 mg for the fifth dose 7 days later.
Maintenance dose: 1200 mg via 35 minute IV infusion every 14 days.

Usual Pediatric Dose for Hemolytic Uremic Syndrome

Patient body weight 40 kg or more: Initial dose: 900 mg via 35 minute IV infusion every 7 days for the first 4 weeks, followed by 1200 mg for the fifth dose 7 days later.
Maintenance dose: 1200 mg via 35 minute IV infusion every 14 days.

Patient body weight 30 kg to less than 40 kg: Initial dose: 600 mg via 35 minute IV infusion every 7 days for the first 2 weeks, followed by 900 mg for the third dose 7 days later.
Maintenance dose: 900 mg via 35 minute IV infusion every 14 days.

Patient body weight 20 kg to less than 30 kg: Initial dose: 600 mg via 35 minute IV infusion every 7 days for the first 2 weeks, followed by 600 mg for the third dose 7 days later.
Maintenance dose: 600 mg via 35 minute IV infusion every 14 days.

Patient body weight 10 kg to less than 20 kg: Initial dose: 600 mg via 35 minute IV infusion once, followed by 300 mg for the second dose 7 days later.
Maintenance dose: 300 mg via 35 minute IV infusion every 14 days.

Patient body weight 5 kg to less than 10 kg: Initial dose: 300 mg via 35 minute IV infusion once, followed by 300 mg for the second dose 7 days later.
Maintenance dose: 300 mg via 35 minute IV infusion every 21 days.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Supplemental dosing of eculizumab is required in the setting of concomitant support with plasmapheresis or plasma exchange (PE); or fresh frozen plasma infusion (PI). Each supplemental dose should be administered within 60 minutes after each PE, or 60 minutes prior to each unit of PI.

For plasmapheresis or plasma exchange, if the most recent eculizumab dose is 300 mg then the supplemental dose will be 300 mg for each PE session. If the most recent eculizumab dose is 600 mg or more, then the supplemental dose will be 600 mg for each PE session.

For fresh frozen plasma infusion, and a most recent dose of 300 mg or more, 300 mg of eculizumab should be administered for each unit of fresh frozen plasma infused.

Precautions

Eculizumab should not be administered as an IV push or bolus injection.

Eculizumab should be diluted to a final concentration of 5 mg/mL prior to administration and administered via intravenous infusion over 35 minutes.

All patients who have not been previously vaccinated must receive the meningococcal vaccine at least 2 weeks prior to receiving the first dose of eculizumab and revaccinated according to current guidelines for vaccine use.

Eculizumab therapy should not be initiated in patients with unresolved serious Neisseria meningitidis infection or who are not currently vaccinated against N meningitidis.

All patients should be monitored for early signs and symptoms of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics if necessary. Discontinuation of eculizumab should be considered during treatment of serious meningococcal infections.

Caution is advised when administering eculizumab to patients with any systemic infection.

Eculizumab should be administered at the recommended dosage regimen time points, or within two days of these time points.

If an adverse reaction occurs during administration, the infusion may be slowed or stopped. If the infusion is slowed, the total infusion time should not exceed two hours.

Patients should be monitored for at least one hour following completion of the infusion for signs or symptoms of an infusion reaction.

Since eculizumab increases the number of PNH red blood cells, all PNH patients who discontinue therapy should be monitored for at least 8 weeks to detect hemolysis. Evaluations should include monitoring for any of the following: greater than 25 percent decrease in PNH clone size in one week or less, changes in serum lactate dehydrogenase (LDH), hemoglobin, and serum creatinine levels, thrombosis, angina, and mental status changes.

Monitor patients with atypical hemolytic uremic syndrome (aHUS) for signs and symptoms of thrombotic microangiopathy (TMA). Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. Early signs of TMA include a decrease in platelet count and increases in serum LDH and creatinine levels. Monitor serial platelet counts, serum LDH, and creatinine during eculizumab therapy and for at least 12 weeks following discontinuation of eculizumab.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age) for the treatment of PNH.

Eculizumab is not indicated for the treatment of patients with Shiga toxin Escherichia coli related hemolytic uremic syndrome (STEC-HUS).

Dialysis

Data not available

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for eculizumab. It includes a Medication Guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

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