Generic Name

Eculizumab

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Classification

FDA Approved Indications

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)
• Generalized myasthenia gravis (gMG) in adults with anti-acetylcholine receptor antibodies
• Complement-mediated complement inhibitor in pediatric patients with aHUS

Mechanism of Action

Eculizumab is a monoclonal antibody that binds to the complement protein C5, preventing its cleavage into C5a and C5b, thereby inhibiting the formation of the membrane attack complex (MAC) and reducing complement-mediated cell destruction.

Dosage and Administration

Adult: Initial dose of 900 mg IV weekly for 4 weeks, followed by 1200 mg at week 5, then 1200 mg every 2 weeks.

Pediatric: Dosing varies based on weight and condition; specific protocols are provided in FDA labeling.

Geriatric: No specific adjustments required; use caution and monitor therapy.

Renal Impairment: No dosage adjustment needed.

Hepatic Impairment: No specific dosage adjustments established.

Pharmacokinetics

Absorption: Administered via intravenous infusion; bioavailability unknown.

Distribution: Widely distributed in body tissues and fluids.

Metabolism: Metabolized via proteolytic degradation into small peptides and amino acids.

Excretion: Excreted primarily through proteolytic catabolism.

Half Life: Approximately 11 days.

Contraindications

• Hypersensitivity to eculizumab or excipients.

Precautions

• Increased risk of meningococcal infections; vaccination against Neisseria meningitidis required prior to treatment. Risk of infections, especially meningococcal, should be carefully managed. Monitor for signs of infection; consider prophylactic antibiotics in some cases.

Adverse Reactions - Common

• Headache (Common)
• Hair thinning or alopecia (Uncommon)
• Nausea (Common)
• Back pain (Uncommon)
• Infusion reactions (Uncommon)

Adverse Reactions - Serious

• Meningococcal meningitis (Serious and potentially life-threatening, very rare without vaccination)
• Severe allergic reactions including anaphylaxis (Rare)
• Serious infections from encapsulated bacteria (Serious, depends on vaccination status.)

Drug-Drug Interactions

• No significant interactions identified with other drugs.

Drug-Food Interactions

• No specific interactions reported.

Drug-Herb Interactions

• Limited data; standard precautions advised.

Nursing Implications

Patient/Family Teaching

• Ensure meningococcal vaccination prior to therapy.
• Report any signs of infection such as fever, headache, or neck stiffness.
• Understand infusion schedule and importance of adherence.
• Be aware of potential allergic reactions during infusions.

Special Considerations

Black Box Warnings:

• Serious infections, including meningococcal infections, which can be fatal. Vaccination is mandatory before initiation of therapy.
• Increased risk of infections due to complement inhibition.

Genetic Factors: Eculizumab may be less effective in individuals with certain complement gene variants but generally used across populations without genetic screening.

Lab Test Interference: Potential for suppressed complement activity; may affect diagnostic tests involving complement.

Overdose Management

Signs/Symptoms: Potential infusion-related reactions, increased risk of infection.

Treatment: Supportive care; no specific antidote. Discontinue infusion and provide supportive treatment as needed.

Storage and Handling

Storage: Store refrigerated at 2-8°C. Do not freeze.

Stability: Stable until the expiration date on the label when stored properly. Protect from light.