The new code, J9295, is defined as "injection, necitumumab, 1 mg." This code is effective January 1, 2017.
Portrazza was approved by the US Food and Drug Administration on November 24, 2015. Portrazza is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for the treatment of nonsquamous NSCLC.
WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA
Please see link for Important Safety Information, including Boxed Warnings for cardiopulmonary arrest and hypomagnesemia, and full Prescribing Information.
- 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.
- Hypomagnesemia occurred in 83% of patients receiving Portrazza in combination with gemcitabine and cisplatin, and was severe in 20% of patients. 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.