Tocilizumab 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.

Clinical studies have reported that tocilizumab may have an effect on demyelinating disorders such as multiple sclerosis and chronic inflammatory demyelinating polyneuropathy. Monitor patients for signs and symptoms potentially indicative of demyelinating disorders. Caution should be exercise when considering the use of tocilizumab in patients with preexisting or recent onset demyelinating disorders.

The use of tocilizumab may cause gastrointestinal (GI) perforation. Use with caution in patients who may be at increased risk for GI perforation. It is recommended to closely monitor patients for symptoms indicative or that may be associated with GI perforation.

The safety and efficacy of tocilizumab have not been studied in patients with hepatic impairment, including patients with positive HBV and HCV serology. Treatment with tocilizumab is not recommended in patients with active hepatic disease or hepatic impairment.

No dose adjustment is required in patients with mild renal impairment. Care should be taken and close monitoring is recommended in patients with moderate to severe renal impairment as tocilizumab has not been studied in these patients. Clinical monitoring of renal function is recommended.