Kevzara (sarilumab) Disease Interactions

Patients requiring non-live vaccination during a course of therapy with interleukin inhibitors may not be protected from the vaccine as the immune response might not be sufficient to prevent the disease. It is recommended to be up-to-date with all required immunizations, as recommended by current immunization guidelines, before initiating therapy with these agents. Patients treated with interleukin inhibitors should not receive live vaccines due to potentially increased risk of infections. Caution is advised when administering live vaccines to household contacts of patients receiving interleukin inhibitors because of the potential risk for shedding from the household contact and transmission to patient.

There have been reports of serious infections, including infections with opportunistic pathogens, and reactivation of latent infections in patients receiving interleukin inhibitors. Treatment with these agents should not be initiated in patients with an active infection until the infection resolves or is adequately treated. Caution is recommended when considering the use of interleukin inhibitors in patients with a history of recurrent infections, underlying conditions which may predispose them to infections, or chronic, latent, or localized infections.

Before initiating certain interleukin inhibitors, patients should be screened for latent tuberculosis infection with a tuberculin skin test. Do not administer these agents to patients with an active tuberculosis infection. Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy. Anti-tuberculosis therapy should be considered prior to initiation of therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.

The use of sarilumab is associate with higher incidence of decrease in absolute neutrophil count (ANC), including neutropenia and thrombocytopenia. It is recommended to assess neutrophil count and platelet count prior to initiation of therapy and monitor these levels 4 to 8 weeks after start of therapy and every 3 months thereafter. Dose modification may be necessary based on the pharmacodynamics of the changes in ANC. Care is recommended when using this agent in patients with blood disorders.

Gastrointestinal (GI) perforations have been reported with the use of sarilumab. GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids. Assess patients for gastrointestinal complications prior to beginning therapy and promptly evaluate patients presenting with new onset abdominal symptoms.

The use of sarilumab is associate with transaminase elevations; therefore, treatment with sarilumab is not recommended in patients with active hepatic disease or hepatic impairment. It is recommended to assess ALT/AST levels prior to initiation of treatment and monitor ALT and AST levels 4 to 8 weeks after start of therapy and every 3 months thereafter. When clinically indicated, consider other liver function tests such as bilirubin. Dose modification based on transaminase elevations might be warranted. The safety and efficacy or sarilumab have not been conducted in patients with hepatic impairment, including patients with positive HBV or HCV serology.

The use of sarilumab is associate with increases in lipid parameters such as LDL cholesterol, HDL cholesterol and/or triglycerides. Care should be exercised when using this agent in patients with lipid abnormalities. It is recommended to assess lipid parameters at baseline and parameters approximately 4 to 8 weeks following initiation of treatment, then at approximately 6 months intervals.

Monoclonal antibodies, including sarilumab, are not eliminated via renal pathway. No dose adjustment is required in patients with mild to moderate renal impairment. The use of sarilumab has not been evaluated in patients with severe renal impairment. Care should be exercised.