Classifications: biologic response modifier; immunoglobulin; monoclonal antibody; Therapeutic: monoclonal antibody; immunoglobulin
Prototype: Immune globulin
Pregnancy Category: C
30 mL vials containing 10 mg/mL solution for IV injection
A monoclonal antibody (IgG) immunoglobulin molecule that binds with high affinity to complement C5 inhibiting formation of
the terminal complement complex, C5b-9.
Inhibition of C5b-9 complement complex prevents complement-mediated hemolysis in those with RBC deficiency in patients with
paroxysmal nocturnal hemoglobinuria (PNH), resulting form genetic mutation.
Reduction of hemolysis in patients with paroxysmal nocturnal hemoglobinuria.
Serious meningococcal infections; pregnancy (category C); children <18 y.
History of hypersensitivity to protein components; older adults; systemic infection; lactation.
Route & Dosage
|Paroxysmal Nocturnal Hemoglobinuria
Adult: IV 600 mg IV infusion every 7 d x 4 wk (a total of 4 doses); then 900 mg IV on day 7 after the 4th dose, and then
900 mg IV every 14 d thereafter
- Note: Patients must be vaccinated against Neisseria meningitidis at least 2 wk prior to the first dose of eculizumab. Prior to initiating treatment, patients and prescribers must be enrolled in the SolirisTM Safety Registry.
PREPARE: IV Infusion: Dilute to a final concentration of 5 mg/mL in NS, D5/0.45% NaCl, or RL by adding the required volume of eculizumab to
an EQUAL volume of IV fluid. Invert bag to mix. Final infusion volumes will be 600 mg in 120 mL and 900 mg in 180 mL. Allow
to come to room temperature prior to infusion
ADMINISTER: IV Infusion: Do NOT give direct IV. ??Give over 35 min via infusion pump or syringe pump. If infusion is slowed for an infusion reaction, the total infusion time
should not exceed 2 h.
INCOMPATIBILITIES Solution/additive/Y-site: Do not mix with any other drugs or solutions.
- Store infusion bags for 24 h at 2°8° C (36°46° F).
Adverse Effects (≥1%) Body as a Whole:
Herpes simplex infections, influenza-like illness, pain in extremity. CNS: Fatigue, headache. GI: Constipation
, nausea. Musculoskeletal: Back pain,
myalgia. Respiratory: Cough, nasopharyngitis,
respiratory tract infection, sinusitis
272 ? 82 h.
Assessment & Drug Effects
- Monitor for an hypersensitivity reaction throughout infusion and for at least 1 h after completion of the infusion.
- Monitor for early signs of meningococcal infection. Report immediately if an infection is suspected.
- Lab tests: Baseline and periodic serum LDH and RBC blood studies.
Patient & Family Education
- Vaccination may not prevent meningitis. Report immediately any of the following: moderate to severe headache with nausea or
vomiting, stiff neck or stiff back, fever, rash, confusion, severe muscle aches with flu-like symptoms, and sensitivity to