4 Things Pharmacists Should Know About Eculizumab and Meningococcal Disease

Eculizumab (Soliris) is an injection that is associated with an increased risk of meningococcal disease. In fact, the risk is 1,000-fold to 2,000-fold among patients taking Soliris.¹ Soliris is approved to treat 2 rare conditions: paroxysmal nocturnal hemoglobinuria (type of anemia) and atypical hemolytic uremic syndrome (genetic disease with blood clots affecting vital organs). Read below for 4 things pharmacists should know about Soliris and meningococcal disease.

Soliris contains a boxed warning for the risk of meningococcal infections.

The Soliris prescribing information contains a boxed warning that serious meningococcal infections have occurred in patients taking this medication.² Patients should be immunized with meningococcal vaccines at least 2 weeks prior to receiving the first dose of Soliris.² Patients should be monitored for the following signs and symptoms of meningococcal infections:

• Headache with nausea or vomiting,
• Headache with a fever,
• Headache with a stiff neck or stiff back,
• Fever,
• Fever and a rash,
• Confusion,
• Muscle aches with flu-like symptoms,
• Eyes sensitive to light.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) to educate health care professionals and patients regarding early signs of meningococcal infection. As part of the REMS requirements, Soliris is available through a restricted program and health care practitioners prescribing the medication must be certified.

Two vaccines are recommended for patients taking Soliris.

The Advisory Committee on Immunization Practices recommends that Soliris recipients receive both quadrivalent meningococcal conjugate (MenACWY) and serogroup B (MenB) meningococcal vaccines.³ Patients taking Soliris should receive a 2-dose primary series with MenACWY at least 2 months apart and be revaccinated every 5 years. They should also receive MenB with either a 2-dose series of MenB-4C (Bexsero) at least 1 month apart or a 3-dose series of MenB-FHbp (Trumenba) at 0,1-2, and 6 months. The MenB and MenACWY vaccines may be administered at the same time but at different injection sites.³

Recent report of meningococcal disease in vaccinated patients.

Officials with the CDC note that 16 cases of meningococcal disease were identified in Soliris recipients in the United States.¹ The majority of cases occurred in patients that received at least 1 dose of meningococcal vaccine before disease onset. Pharmacists should continue to recommend that patients receive both meningococcal vaccines.

Antimicrobial prophylaxis should be considered.

Since Soliris patients remain at risk for meningococcal disease even after receiving vaccines, some health care professionals in the United States and public health agencies in the United Kingdom and France recommend antimicrobial prophylaxis with penicillin for the duration of therapy.¹ Long-term penicillin prophylaxis is generally considered safe, but more studies are needed to demonstrate the effectiveness.¹ Macrolides may be used for penicillin-allergic patients. Soliris patients who have received both meningococcal vaccines and antimicrobial prophylaxis should still be monitored closely for signs of meningococcal disease.

References

• McNamara LA, Topaz N, Wang X, Hariri S, Fox L, MacNeil JR. High risk for invasive meningococcal disease among patients receiving eculizumab (Soliris) despite receipt of meningococcal vaccine. MMWR Morb Mortal Wkly Rep. ePub: 7 July 2017. DOI: http://dx.doi.org/10.15585/mmwr.mm6627e1.
• Soliris [prescribing information]. New Haven, CT: Alexion Pharmaceuticals; 2017.
• Recommended immunization schedule for adults. CDC website. https://www.cdc.gov/vaccines/schedules/hcp/adult.html. Accessed July 9, 2017.