ECULIZUMAB

ECULIZUMAB
(e-cul-i-zu'mab)
Soliris
Classifications: biologic response modifier; immunoglobulin; monoclonal antibody;
Therapeutic: monoclonal antibody; immunoglobulin
Prototype: Immune globulin
Pregnancy Category: C

Availability

30 mL vials containing 10 mg/mL solution for IV injection

Action

A monoclonal antibody (IgG) immunoglobulin molecule that binds with high affinity to complement C5 inhibiting formation of the terminal complement complex, C5b-9.

Therapeutic Effect

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.

Uses

Reduction of hemolysis in patients with paroxysmal nocturnal hemoglobinuria.

Contraindications

Serious meningococcal infections; pregnancy (category C); children <18 y.

Cautious Use

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

Administration

Intravenous

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 Soliris^TM 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.

Pharmacokinetics

Half-Life: 272 ? 82 h.

Nursing Implications

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 light.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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