INDICATIONS AND USAGE（适应症）

Metastatic Merkel Cell Carcinoma

BAVENCIO (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Locally Advanced or Metastatic Urothelial Carcinoma

First-Line Maintenance Treatment of Urothelial Carcinoma

BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

Previously-Treated Urothelial Carcinoma

BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who:

Have disease progression during or following platinum-containing chemotherapy

Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Advanced Renal Cell Carcinoma

BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

DOSAGE（服用剂量）

Premedication

Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of BAVENCIO. Premedication should be administered for subsequent BAVENCIO doses based upon clinical judgment and presence/severity of prior infusion reactions.

Recommended Dosage for MCC

The recommended dose of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Recommended Dosage for UC

The recommended dose of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Recommended Dosage for RCC

The recommended dose of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks in combination with axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.

When axitinib is used in combination with BAVENCIO, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of two weeks or longer. Review the Full Prescribing Information for axitinib prior to initiation.

ADVERSE REACTIONS（不良反应）

Severe and fatal immune-mediated adverse reactions

Infusion-related reactions

Complications of allogeneic HSCT

Major adverse cardiovascular events

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5cd725a1-2fa4-408a-a651-57a7b84b2118/spl-doc?hl=avelumab

BAVENCIOinformation