INDICATIONS AND USAGE（适应症）

Squamous Non-Small Cell Lung Cancer (NSCLC)

PORTRAZZA™ is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer.

Limitation of Use

PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer.

DOSAGE（服用剂量）

Recommended Dose and Schedule

The recommended dose of PORTRAZZA is 800 mg administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion. Continue PORTRAZZA until disease progression or unacceptable toxicity.

Premedication

For patients who have experienced a previous Grade 1 or 2 infusion-related reaction (IRR), pre-medicate with diphenhydramine hydrochloride (or equivalent) prior to all subsequent PORTRAZZA infusions.

For patients who have experienced a second Grade 1 or 2 occurrence of IRR, pre-medicate for all subsequent infusions, with diphenhydramine hydrochloride (or equivalent), acetaminophen (or equivalent), and dexamethasone (or equivalent) prior to each PORTRAZZA infusion.

ADVERSE REACTIONS（不良反应）

Cardiopulmonary Arrest

Hypomagnesemia

Venous and Arterial Thromboembolic Events

Dermatologic Toxicities

Infusion-Related Reactions

Non-Squamous NSCLC - Increased Toxicity and Increased Mortality

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/89bcf553-669a-40b0-a9d7-67a5c1d2f591/spl-doc?hl=Portrazza

Portrazzainformation