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The below information is provided in response to your request and may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above.
See important safety information, including boxed warning, in the attached prescribing information.
Baseline Renal Function in SQUIRE Clinical Trial
Inclusion criteria in the PORTRAZZA® (necitumumab) SQUamous NSCLC treatment with the Inhibitor of EGF REceptor (SQUIRE) clinical trial included having adequate renal function, specifically (Thatcher, 2015):
serum creatinine ≤1.2 x the upper limit of normal; or
calculated creatinine clearance (CrCl) >50 mL/minute.
Additionally, prior to each administration of study therapy, renal function must be adequate, as previously defined (Thatcher, 2015).
Therefore, it is not known if necitumumab may be used in patients with renal impairment.
Effects of Renal Impairment on Necitumumab Pharmacokinetics
No formal studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of necitumumab.
Based on the results of the population pharmacokinetic analysis there was no impact of renal function as assessed by estimated CrCl (11-250mL/min) on the pharmacokinetics of necitumumab (Portrazza Package Insert, 2015).
Enclosed Prescribing Information
Portrazza [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015.
Thatcher N, Hirsch FR, Luft AV, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non‑small‑cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015;16(7):763-774. Accompanied by: Supplementary appendix available at http://www.sciencedirect.com/science/MiamiMultiMediaURL/1-s2.0-S1470204515000212/1-s2.0-S1470204515000212-mmc1.pdf/272203/html/S1470204515000212/ecac2bc0482b4ab814f47b61433dbbdc/mmc1.pdf as a pdf file.
Date of Last Review: April 13, 2017