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Portrazza Summary of Product Characteristics (SmPC)
Portrazza ▼ (necitumumab): Management of electrolyte abnormalities
Serum electrolytes should be carefully monitored prior to and after each necitumumab administration, until within normal limits.
potassium, phosphate, and calcium are all electrolytes that are often
disrupted in patients with cancer. Electrolyte disorders can be a
result of the underlying disease and/or the treatment of the
underlying disease (Rosner, 2014).
non-small cell lung cancer (NSCLC) treatment with the Inhibitor
of EGF REceptor
(SQUIRE) study was a randomized, multicenter, open-label, Phase 3
study of Portrazza (necitumumab) plus gemcitabine‑cisplatin
(NECI+GEM-CIS) chemotherapy versus gemcitabine-cisplatin (GEM-CIS)
chemotherapy alone in the first-line treatment of patients with Stage
IV squamous NSCLC, with the primary endpoint of overall survival
(Thatcher, 2015). Although hypokalemia, hypocalcemia, hyperkalemia,
hyponatremia, and hypophosphatemia occurred in both arms in the
SQUIRE study, only hypocalcemia of any grade was significantly higher
(p=.0010) in the NECI+GEM-CIS arm (Thatcher, 2015; Data on file).
decreasing serum magnesium levels occur frequently (81.3%) and may
lead to severe hypomagnesaemia (18.7%). Hypomagnesaemia may reoccur
at the same grade or worse after a dose delay. Patients should be
carefully monitored for serum electrolytes, including serum
magnesium, potassium, and calcium, prior to each necitumumab
administration and after completion of necitumumab treatment, until
within normal limits. Prompt electrolyte repletion is recommended, as
appropriate (Portrazza Summary of Product Characteristics).
on file, Eli Lilly and Company and/or one of its subsidiaries.
EU Summary of Product Characteristics. Utrecht, The Netherlands: Eli
Lilly and Company Limited.
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.
medicine is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse reactions.
Date of Last Review:September 20, 2017
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