eculizumab

Contraindicated in:

Unresolved serious Neisseria meninigitidis infection;
Patients not vaccinated against Neisseria meninigitidis (unless risk of delaying treatment outweighs risks of developing a meningococcal infection) (vaccinate at least 2 wk prior to first dose).

Use Cautiously in:

Systemic infection;
Discontinuation requires monitoring for intravascular hemolysis;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established for treatment of PNH or generalized myasthenia gravis in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, tachycardia, peripheral edema

EENT: nasopharyngitis, sinusitis, vertigo

GI: diarrhea, nausea, vomiting, constipation

Hemat: anemia, leukopenia

MS: back pain , extremity pain, myalgia

Neuro: headache, insomnia, fatigue

Resp: cough

Misc: Haemophilus influenzae infection, Neisseria gonorrhoeae infection, Streptococcus pneumoniae infection, fever, herpes simplex infection, influenza-like illness, MENINGOCOCCAL INFECTIONS

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for injection: 10 mg/mL

Route/Dosage ⬆ ⬇

Paroxysmal Nocturnal Hemoglobinuria

IV (Adults ): 600 mg every 7 days for 4 doses, then 900 mg 7 days later, then 900 mg every 14 days.

Atypical Hemolytic Uremic Syndrome

IV (Adults ): 900 mg every 7 days for 4 doses, then 1200 mg 7 days later, then 1200 mg every 14 days; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 600 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.
IV (Children <18 yr and ≥40 kg): 900 mg every 7 days for 4 doses, then 1200 mg 7 days later, then 1200 mg every 14 days; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 600 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.
IV (Children <18 yr and 30–<40 kg): 600 mg every 7 days for 2 doses, then 900 mg 7 days later, then 900 mg every 14 days; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 600 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.
IV (Children <18 yr and 20–<30 kg): 600 mg every 7 days for 2 doses, then 600 mg 7 days later, then 600 mg every 14 days; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 600 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.
IV (Children <18 yr and 10–<20 kg): 600 mg, then 300 mg 7 days later, then 300 mg every 14 days; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 300 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.
IV (Children <18 yr and 5–<10 kg): 300 mg, then 300 mg 7 days later, then 300 mg every 21 days; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 600 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.

Generalized Myasthenia Gravis

IV (Adults ): 900 mg once weekly for Week 1 through Week 4 (total of 4 doses), then 1200 mg 1 wk later during Week 5, then 1200 mg every 2 wk; Supplemental dose if patient receiving plasmapheresis or plasma exchange: 600 mg per each plasmapheresis or plasma exchange session; Supplemental dose if patient receiving fresh frozen plasma infusion: 300 mg per infusion of fresh frozen plasma.

Neuromyelitis Optica Spectrum Disorder

IV (Adults ): 900 mg once weekly for Week 1 through Week 4 (total of 4 doses), then 1200 mg 1 wk later during Week 5, then 1200 mg every 2 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Eculizumab is a monoclonal antibody that binds to complement protein C5. This binding inhibits complement activation, a necessary step in the initiation of hemolysis due to PNH and the development of thrombotic microangiopathy in aHUS.

Therapeutic effects:

Decreased hemolysis associated with PNH.
Reduced complement-mediated thrombotic microangiopathy in aHUS.
Improved ability to perform activities of daily living in generalized myasthenia gravis.
Decreased relapse rates in NMOSD.

Classifications ⬆ ⬇

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: complement.inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Crosses placenta; enters breast milk.

Metabolism/Excretion: Unknown.

Half-Life: 272 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	1–2 wk

Patient/Family Teaching ⬆ ⬇

Explain the risks and benefits of eculizumab to patient. Instruct patient to read the Medication Guide before starting therapy and with each dose in case of changes.
Instruct patient to obtain required meningococcal vaccination at least 2 wks prior to therapy and revaccination according to guidelines. Caution patient to report symptoms of meningococcal infection (moderate to severe headache with nausea or vomiting, headache, fever, or stiff neck or stiff back; fever of 103°F or 39.4°C or higher; fever and a rash; confusion; or severe muscle aches with flu-like symptoms; and eyes sensitive to light).
Inform patients that eculizumab may increase risk of other infections (pneumonia, influenza, gonorrhea, fungal infections). Encourage patient and parents to maintain current vaccinations.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Inform patient to carry the Soliris Patient Safety Card at all times during and for 3 mo following therapy due to increased risk of meningococcal infection.
Advise patient with PNH of potential for serious hemolysis when eculizumab is discontinued and of need for monitoring by health care professional for at least 8 wks following discontinuation. Caution patient to notify health care professional immediately if a large drop in red blood cell count causing anemia, confusion, chest pain, kidney problems, and blood clots occur.
Advise patient with aHUS of potential for serious thrombotic microangiopathy when eculizumab is discontinued and of need for monitoring by health care professional for at least 12 wks following discontinuation. Caution patient to notify health care professional immediately if changes in mental status, seizures, angina, dyspnea, or thrombosis occur.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇