Trade Names:Soliris- Solution for injection; preservative-free 300 mg (10 mg/mL)
Inhibits terminal complement-mediated intravascular hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) patients.
C max and C min by wk 26 are 194 and 97 mcg/mL, respectively.
Vd is 7.7 L.
The t ½ is 272 h.
Treatment of PNH to reduce hemolysis.
Unresolved Neisseria meningitidis infection; current vaccination against N. meningitidis .
IV Administer a meningococcal vaccine at least 2 wk prior to starting eculizumab therapy and revaccinate according to current medical guidelines. Infuse eculizumab 600 mg every 7 days for the first 4 wk, then 900 mg 7 days later for the fifth dose, then 900 mg every 14 days thereafter.
Store in original container, under refrigeration between 36° and 46°F, until time of use. Protect from light. Do not freeze or shake. Admixed solution is stable for 2 h at 36° to 46°F and at room temperature.
None well documented.
Headache (44%); fatigue (12%).
Nausea (16%); constipation (7%).
Back pain (19%); myalgia (7%).
Cough (12%); respiratory tract infection, sinusitis (7%).
Herpes simplex infections, pain in extremities (7%); flu-like illness (5%); pyrexia, viral infection (2%).
Eculizumab increases the risk of meningococcal infections. Vaccinate patients according to current medical guidelines at least 2 wk prior to administering the first dose of eculizumab. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected; treat with antibiotics if necessary.
Monitor for serious hemolysis and other reactions for at least 8 wk after discontinuing treatment.
Category C .
Safety and efficacy not established.
Risk of infection, especially with encapsulated bacteria, is increased. Use with caution in patients with systemic infection.
As with any protein product, anaphylaxis or other hypersensitivity reactions may occur. Interrupt treatment and administer medical therapy if a severe infusion reaction occurs.
No cases reported.
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