Adult Dosing
Paroxysmal nocturnal hemoglobinuria
- Start 600 mg IV over at least 35 minutes q7 days x 4 doses; then 900 mg IV 7 days after 4th dose, thereafter 900 mg IV q14 days
- Drug should be administered within the recommended or two days after the recommended dosage regimen time lines
Atypical Hemolytic Uremic Syndrome (aHUS)
- 900 mg IV qwk x 4 weeks, followed by 1200 mg IV qwk x1 week, then 1200 mg IV q2wk thereafter
Note:
- Patients must take meningococcal vaccine at least 2 wks before the initiation of therapy
- Refer package insert for supplemental dose if plasmapheresis, plasma exchange, or plasma infusion
Pediatric Dosing
- Safety and effectiveness in patients <18 yrs have not been established
Atypical Hemolytic Uremic Syndrome (aHUS)
- >40 kg: 900 mg IV qwk x4 weeks, then 1200 mg at week 5, then 1200 mg IV q2wk
- 30-39 kg: 600 mg IV qwk x2 weeks, then 900 mg IV at week 3, then 900 mg IV q2wk
- 20-29 kg: 600 mg IV qwk x 3 weeks, then 600 mg IV at week 3, then 600 mg IV q2wk
- 10-19 kg: 600 mg IV qwk x 1 weeks, then 300 mg IV qwk x1wk, then 300 mg IV q2wk
- Give meningococcal vaccine >2wk before treatment if unvaccinated
- Refer package insert for supplemental dose if plasmapheresis, plasma exchange, or plasma infusion
[Outline]
See Supplemental Patient Information
- Treatment with eculizumab increase susceptibility to serious meningococcal infections
- Vaccinate the patients with quadravalent, conjugated meningococcal vaccines against neisseria meningitidis 2wks prior to first dose and revaccinate accordingly as per the medical guidelines [US Black Box Warning]
- Monitor patients for early signs and symptoms of meningococcal infections and evaluate immediately on suspicion of infection, discontinue the drug during treatment of serious meningococcal infections [US Black Box Warning]
- Infections become life-threatening or fatal if unrecognized/untreated
- Increases susceptibility to infections particularly with encapsulated bacteria
- Rapid discontinuation may result in serious hemolysis
- Monitor patients for at least 8 weeks after discontinuance of treatment and on development of serious hemolysis consider blood transfusion, exchange transfusion (if PNH RBCs are >50% of the total RBCs), anticoagulants, corticosteroids or restarting of treatment
- Discontinuance of anticoagulant therapy during eculizumab treatment has not been established, so do not alter anticoagulant management
- Monitor serum LDH levels as it increases during hemolysis
- Infusion reactions including anaphylaxis or other hypersensitivity reactions may occur, in such case discontinue the drug and consider appropriate medical therapy
- Serious hemolysis may occur after discontinuation
Cautions: Use cautiously in
- Systemic infections
- Infusion reactions
- Upon discontinuation
- Nursing mothers
Supplemental Patient Information
- Instruct patient that there is a potential for serious hemolysis when drug is discontinued; and they will be monitored by their healthcare professional for at least 8wks following eculizumab discontinuation
- Instruct patient to take meningococcal vaccination at least 2 wks prior to therapy and revaccination according to guidelines
- Inform patient to carry Patient Safety Card describing symptoms which, if experienced; patient should seek medical evaluation, at all times
Pregnancy Category:C
Breastfeeding: Excretion through milk is not known. Limited information indicates that maternal doses of eculizumab 900 mg daily produce undetectable levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 October 2010). However manufacturer has advised caution as IgG is excreted in human milk.
