Rx Item-BAVENCIO 200MG/10ML INJ VIAL BY EMD by Serono Labs

or: Merkel Cell Carcinoma, Urothelial Carcinoma, Renal Cell Carcinoma

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.BAVENCIO- avelumab injection, solution, concentrate
EMD Serono, Inc.

1 INDICATIONS AND USAGE

1.1 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 [see Clinical Studies (14.1)].

1.2 Locally Advanced or Metastatic 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
​ 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 [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 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 [see Dosage and Administration (2.3) and Warnings and Precautions (5.7)].

2.2 Recommended Dosage
The recommended dose of BAVENCIO is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

BAVENCIO 200MG/10ML INJ VIAL BY EMD by S
NDC No. 44087-3535-01 44087-3535-1 4408735351 44087353501 UPC/GTIN No. 3-44087-35351-3 344087-353513 344087353513 MPN 353501

BAVENCIO 200MG/10ML INJ VIAL B
BAVENCIO 200MG/10ML INJ VIAL BY EMD by Serono Labs

Serono Labs, Inc.
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BAVENCIO 200MG/10ML INJ VIAL B
BAVENCIO 200MG/10ML INJ VIAL BY EMD by Serono Labs