Eculizumab Disease Interactions

Eculizumab is contraindicated in patients with unresolved serious Neisseria meningitidis infection, in those who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying treatment outweigh the risks of developing a meningococcal infection. Life-threatening and fatal meningococcal infections have occurred in patients treated with eculizumab. The use of eculizumab increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis). Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if an infection is suspected. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. It is recommended to discontinue eculizumab in patients who are undergoing treatment for serious meningococcal infections.

Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents. Patients receiving immunosuppressants are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections including opportunistic infections. Caution should be exercised when considering their use in patients with severe or chronic infections. It is recommended to interrupt therapy in patients who develop a new infection while undergoing treatment and to monitor these patients closely for any sign or symptom indicative of infection.

Immunosuppressive agents may increase the risk of progressive multifocal leukoencephalopathy (PML). Certain agents are contraindicated in patients who have or have had PML. Patients receiving chronic immunosuppressant or immunomodulatory therapy or who have systemic medical conditions resulting in significantly compromised immune system function should not be treated with these agents. Health care professionals should monitor patients for any new sign or symptom suggestive of PML. Therapy dosing should be withheld immediately and an appropriate diagnostic evaluation should be performed at the first sign or symptom suggestive of PML.

Thrombotic microangiopathy (TMA) complications have occurred after treatment discontinuation or after a missed dose of eculizumab. It is recommended to monitor patients with atypical hemolytic uremic syndrome for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. If TMA complications occur after eculizumab discontinuation, consider reinstitution of treatment, plasma therapy or appropriate organ-specific supportive measures.

Eculizumab blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria. Caution is advised when using this agent in immunocompromised and neutropenic patients as Aspergillus infections may occur. It is recommended to administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenza type b (Hib) infections according to the Advisory Committee on Immunization Practices (ACIP) guidelines and to use caution when administering to patients with any systemic infection.