PORTRAZZA
Generic Name/API: necitumumab
Manufacturer: Eli Lilly
Dosage Forms & Strength & Pack Size:
Injection: 800 mg/50 mL (16 mg/mL) solution in a single-dose vial.
Storage:
Store vials in a refrigerator at 2° to 8°C (36° to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light. DO NOT FREEZE OR SHAKE the vial.
Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
WARNINGS AND PRECAUTIONS
Cardiopulmonary Arrest: Closely monitor serum electrolytes during and after PORTRAZZA. (5.1) Hypomagnesemia: Monitor prior to each infusion and for at least 8 weeks following the completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities; subsequent cycles of PORTRAZZA may be administered in these patients once electrolyte abnormalities have improved to Grade ≤2. Replete electrolytes as necessary. (5.2) Venous and Arterial Thromboembolic Events (VTE and ATE): Discontinue PORTRAZZA for severe VTE or ATE. (5.3) Dermatologic Toxicities: Monitor for dermatologic toxicities and withhold or discontinue PORTRAZZA for severe toxicity. Limit sun exposure. (2.3, 5.4) Infusion-Related Reactions: Monitor for signs and symptoms during and following infusion. Discontinue PORTRAZZA for severe reactions. (2.3, 5.5)
Increased Toxicity: Non-Squamous NSCLC – Increased toxicity and increased mortality. (5.6) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.7, 8.1, 8.3)
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