Actemra

Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection, or in COVID-19 patients with other concurrent infections. Monitor closely for signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection or sepsis develop. Test for and treat latent TB prior to starting therapy (except for COVID-19 patients). HBV or HCV infection. For RA, GCA, SSc-ILD:  ANC <500mm³, platelets <50000mm³, or ALT/AST >5xULN: not recommended; obtain liver function tests before initiation, every 4–8 weeks after starting for the 1^st 6 months, then every 3 months thereafter; and monitor neutrophils, platelets: 4–8 weeks after initiation, then every 3 months thereafter. Monitor lipids 4–8 weeks after initiation, then subsequently according to clinical guidelines. Monitor neutrophils, platelets, ALT/AST for SJIA: at the time of the 2^nd administration and then every 2–4 weeks; PJIA: at the time of the 2^nd administration and then every 4–8 weeks. Increased risk of GI perforation. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or other hypersensitivity reactions occur. Active hepatic disease or impairment: not recommended. Severe renal impairment. Elderly. Pregnancy. Nursing mothers.

Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection, or in COVID-19 patients with other concurrent infections. Monitor closely for signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection or sepsis develop. Test for and treat latent TB prior to starting therapy (except for COVID-19 patients). HBV or HCV infection. For RA, GCA, SSc-ILD:  ANC <500mm³, platelets <50000mm³, or ALT/AST >5xULN: not recommended; obtain liver function tests before initiation, every 4–8 weeks after starting for the 1^st 6 months, then every 3 months thereafter; and monitor neutrophils, platelets: 4–8 weeks after initiation, then every 3 months thereafter. Monitor lipids 4–8 weeks after initiation, then subsequently according to clinical guidelines. Monitor neutrophils, platelets, ALT/AST for SJIA: at the time of the 2^nd administration and then every 2–4 weeks; PJIA: at the time of the 2^nd administration and then every 4–8 weeks. Increased risk of GI perforation. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or other hypersensitivity reactions occur. Active hepatic disease or impairment: not recommended. Severe renal impairment. Elderly. Pregnancy. Nursing mothers.

Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection, or in COVID-19 patients with other concurrent infections. Monitor closely for signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection or sepsis develop. Test for and treat latent TB prior to starting therapy (except for COVID-19 patients). HBV or HCV infection. For RA, GCA, SSc-ILD:  ANC <500mm³, platelets <50000mm³, or ALT/AST >5xULN: not recommended; obtain liver function tests before initiation, every 4–8 weeks after starting for the 1^st 6 months, then every 3 months thereafter; and monitor neutrophils, platelets: 4–8 weeks after initiation, then every 3 months thereafter. Monitor lipids 4–8 weeks after initiation, then subsequently according to clinical guidelines. Monitor neutrophils, platelets, ALT/AST for SJIA: at the time of the 2^nd administration and then every 2–4 weeks; PJIA: at the time of the 2^nd administration and then every 4–8 weeks. Increased risk of GI perforation. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or other hypersensitivity reactions occur. Active hepatic disease or impairment: not recommended. Severe renal impairment. Elderly. Pregnancy. Nursing mothers.

Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection, or in COVID-19 patients with other concurrent infections. Monitor closely for signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection or sepsis develop. Test for and treat latent TB prior to starting therapy (except for COVID-19 patients). HBV or HCV infection. For RA, GCA, SSc-ILD:  ANC <500mm³, platelets <50000mm³, or ALT/AST >5xULN: not recommended; obtain liver function tests before initiation, every 4–8 weeks after starting for the 1^st 6 months, then every 3 months thereafter; and monitor neutrophils, platelets: 4–8 weeks after initiation, then every 3 months thereafter. Monitor lipids 4–8 weeks after initiation, then subsequently according to clinical guidelines. Monitor neutrophils, platelets, ALT/AST for SJIA: at the time of the 2^nd administration and then every 2–4 weeks; PJIA: at the time of the 2^nd administration and then every 4–8 weeks. Increased risk of GI perforation. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or other hypersensitivity reactions occur. Active hepatic disease or impairment: not recommended. Severe renal impairment. Elderly. Pregnancy. Nursing mothers.