Portrazza ® ▼ (necitumumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: 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.

Sodium, 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).

The SQUamous 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).

Progressively 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).

References

Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Portrazza EU Summary of Product Characteristics. Utrecht, The Netherlands: Eli Lilly and Company Limited.

Rosner MH, Dalkin AC. Electrolyte disorders associated with cancer. Adv Chronic Kidney Dis. 2014;21(1):7-17.

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.

This 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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