Portrazza ® (necitumumab) injection

800 mg/50 mL vial

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.

Use of PORTRAZZA® (necitumumab) in Renal Impairment

It is unknown how a patient's renal function affects the pharmacokinetics of PORTRAZZA® (necitumumab) or if it may be used in patients with renal impairment.



WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA

See full prescription information for complete boxed warning

Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration. (5.1, 5.2)

Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20%. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of PORTRAZZA during treatment and for at least 8 weeks following completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate. (5.2)


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

  1. PORTRAZZA® (necitumumab for injection) for Intravenous Use

The published references below are available upon request by contacting 1-800-LillyRx.

References:


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 nonsmallcell 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.

Additional related information

Date of Last Review: April 13, 2017

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