Ciltacabtagene autoleucel Disease Interactions

Ciltacabtagene autoleucel should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections have occurred in patients after infusion with this drug. Patients should be monitored for signs/symptoms of infection before and after infusion of this drug and treated appropriately. Prophylactic, preemptive, and/or therapeutic antimicrobials should be administered according to standard institutional guidelines. Patients should be counseled on the importance of prevention measures. Institutional guidelines for vaccination and management of immunocompromised patients with COVID-19 should be followed.

Ciltacabtagene autoleucel has not been formally studied in patients with liver dysfunction. The pharmacokinetics of this drug were not affected by mild liver dysfunction (total bilirubin up to 1 times the upper limit of normal [1 x ULN] and AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN).

Treatment with ciltacabtagene autoleucel may cause hypogammaglobulinemia. Hepatitis B virus (HBV) reactivation (in some cases resulting in fulminant hepatitis, hepatic failure, and death) can occur in patients with hypogammaglobulinemia. Screening for CMV, HBV, hepatitis C virus (HCV), and HIV or any other viral infectious agents should be performed according to clinical guidelines before collection of cells for manufacturing. Antiviral therapy to prevent viral reactivation should be considered according to local institutional guidelines/clinical practice.

Ciltacabtagene autoleucel has not been formally studied in patients with renal dysfunction. The pharmacokinetics of this drug were not affected by mild (CrCl 60 to less than 90 mL/min) or moderate (CrCl 30 to less than 60 mL/min) renal dysfunction.