Siltuximab Disease Interactions

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.

The use of siltuximab 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.

Based on a population pharmacokinetic analysis using data from clinical trials in patients, no significant difference in siltuximab clearance was observed in patients with preexisting mild to moderate hepatic impairment (Child-Pugh Class A and B, respectively) compared to patients with baseline normal hepatic function. No initial dosage adjustment is necessary for patients with mild to moderate hepatic impairment. Care should be taken when using this agent in patients with baseline severe hepatic impairment (Child-Pugh Class C) as the potential effect on siltuximab pharmacokinetics cannot be determined as clinical and pharmacokinetic data are not available.

Based on a population pharmacokinetic analysis using data from clinical trials in patients, no significant difference in siltuximab clearance was observed in patients with preexisting renal impairment (creatinine clearance (CrCl) >=15 mL/min) compared to patients with baseline normal renal function (CrCl)>= 90 mL/min). No initial dosage adjustment is necessary for patients with CrCl >= 15 mL/min. Care should be taken when using this agent in patients with end-stage renal disease as the potential effect on siltuximab pharmacokinetics cannot be determined. Clinical monitoring of renal function is recommended.