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Eculizumab Dosage

Applies to the following strength(s): 10 mg/mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria

600 mg IV every 7 days for 4 weeks, followed by 900 mg IV for the fifth dose 7 days later, then 900 mg IV every 14 days thereafter

Comments:
-This drug should be administered by IV infusion over 35 minutes in adults.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 2 hours in adults.
-The patient should be monitored for infusion reactions for at least one hour following the infusion.
-This drug should be administered at the recommended dosage regimen time points, or within 2 days of these time points.

Use: For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis

Usual Adult Dose for Hemolytic Uremic Syndrome

900 mg IV every 7 days for the first 4 weeks, followed by 1200 mg IV for the fifth dose 7 days later, then 1200 mg IV every 14 days thereafter

Comments:
-This drug should be administered by IV infusion over 35 minutes in adults.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 2 hours in adults.
-The patient should be monitored for infusion reactions for at least one hour following the infusion
-This drug should be administered at the recommended dosage regimen time points, or within 2 days of these time points.

Use: For the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy

Usual Pediatric Dose for Hemolytic Uremic Syndrome

Patients less than 18 years of age:
-Body weight 40 kg or more: Initial dose: 900 mg IV every 7 days for the first 4 weeks, followed by 1200 mg IV for the fifth dose 7 days later, then 1200 mg IV every 14 days thereafter
-Body weight 30 kg to less than 40 kg: 600 mg IV every 7 days for the first 2 weeks, followed by 900 mg IV for the third dose 7 days later, then 900 mg IV every 14 days
-Body weight 20 kg to less than 30 kg: 600 mg IV every 7 days for the first 2 weeks, followed by 600 mg IV for the third dose 7 days later, then 600 mg IV every 14 days
-Body weight 10 kg to less than 20 kg: 600 mg IV for the first dose, followed by 300 mg IV for the second dose 7 days later, then 300 mg IV every 14 days
Body weight: 5 kg to less than 10 kg: 300 mg IV for the first dose, followed by 300 mg IV for the second dose 7 days later, then 300 mg IV every 21 days

Comments:
-This drug should be administered by IV infusion over 1 to 4 hours in pediatric patients.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 4 hours in children.
-The patient should be monitored for infusion reactions for at least one hour following the infusion
-This drug should be administered at the recommended dosage regimen time points, or within 2 days of these time points.

Use: For the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy

Renal Dose Adjustments

No dose adjustments recommended

Liver Dose Adjustments

Data not available

Dose Adjustments

Supplemental dosing of eculizumab is required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange/fresh frozen plasma infusion):
PLASMAPHERESIS OR PLASMA EXCHANGE (PE):
-If the most recent eculizumab dose is 300 mg, supplement the dose by 300 mg per each PE session within 60 minutes after each PE exchange
-If the most recent eculizumab dose is 600 mg or more, supplement the dose by 600 mg per each PE session within 60 minutes after each PE exchange
FRESH FROZEN PLASMA INFUSION (PI):
-If the most recent eculizumab dose is 300 mg or more, supplement the dose by 300 mg per each PI session 60 minutes prior to each PI infusion

Precautions

US BOXED WARNINGS:
SERIOUS MENINGOCOCCAL INFECTIONS:
-Life-threatening and fatal meningococcal infections have occurred in patients treated with this drug. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consult with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
-Patients should be immunized with a meningococcal vaccine at least 2 weeks prior to administering the first dose of this drug, unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection.
-Patients should be monitored for early signs of meningococcal infections and evaluated immediately if infection is suspected.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for eculizumab. It includes a medication guide and elements to assure safe use. For additional information: www.fda.gov/REMS.

The safety and effectiveness of this drug for the treatment of PNH in pediatric patients below the age of 18 years have not been established.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

General:
-This drug is not indicated for the treatment of patients with Shiga toxin Escherichia coli related hemolytic uremic syndrome (STEC-HUS).
-One of the eligibility requirements for therapy with this drug is meningococcal vaccination. Patients without a history of meningococcal vaccination should be vaccinated with a polyvalent vaccine at least 2 weeks prior to receiving the first dose, and be revaccinated according to national vaccination guidelines.
-This drug should only be administered as an IV infusion via gravity feed, a syringe-type pump, or an infusion pump.
-This drug should not be administered as an IV push or bolus.
-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 2 hours.
-Patients should be monitored for at least one hour following completion of the infusion for signs of an infusion reaction.
-Atypical hemolytic uremic syndrome patients should be monitored for signs of thrombotic microangiopathy (TMA).
-This drug should be given for the duration of the patient's life, unless discontinuation is clinically indicated.

Reconstitution/Preparation advice:
-Consult the manufacturer product information.

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