Avelumab (Bavencio) is a programmed death ligand-1 (PD-L1) blocking antibody, belonging to the class of immune checkpoint inhibitors. By blocking the binding of PD-L1 to PD-1 and B7.1 receptors, it restores the human immune system's ability to recognize and attack tumor cells, thereby exerting an anti-tumor effect.

Indications for Avelumab (Bavencio)

Merkel Cell Carcinoma

Indicated for the treatment of metastatic Merkel cell carcinoma in adult and pediatric patients aged 12 years and older.

The approval of this indication is based on a single-arm clinical trial, which showed that patients achieved sustained tumor remission after receiving avelumab treatment.

Urothelial Carcinoma

First-line maintenance therapy: Used for maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed after receiving platinum-containing chemotherapy.

Progression after prior treatment: Indicated for patients who have experienced disease progression during or after platinum-containing chemotherapy, or within 12 months after platinum-containing neoadjuvant or adjuvant therapy.

Renal Cell Carcinoma

Avelumab in combination with axitinib is indicated for the first-line treatment of advanced renal cell carcinoma.

This combination regimen has shown superior progression-free survival benefits compared with sunitinib in clinical trials.

Specifications and Properties of Avelumab (Bavencio)

Drug Specifications

Avelumab is an injection, with each vial containing 10 mL of solution and 200 mg of avelumab, at a concentration of 20 mg/mL.

The drug is supplied in single-dose vials, packaged in cartons.

Description of Properties

Appearance: A sterile, preservative-free, clear, colorless to slightly yellow solution.

Composition: In addition to the active ingredient avelumab, it also contains D-mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, and water for injection.

Acidity and alkalinity: The pH range of the solution is 5.0 to 5.6.

Before use, the solution should be visually inspected for clarity, absence of particles, or discoloration. If the solution is turbid, precipitated, or abnormally colored, its use is prohibited.

Storage Methods for Avelumab (Bavencio)

Unopened Drugs

Should be stored in the original packaging in a refrigerator, with the temperature controlled between 2°C and 8°C.

Must be stored away from light; freezing or violent shaking is not allowed.

Prepared Solution

After withdrawing the required dose from the vial, it should be injected into an infusion bag containing 250 mL of 0.9% sodium chloride injection or 0.45% sodium chloride injection. Gently invert and mix to avoid foaming or violent stirring.

The prepared solution should be stored under the following conditions: At room temperature (≤25°C): no more than 4 hours.

Under refrigeration (2°C–8°C): no more than 24 hours; it needs to be returned to room temperature before use.

Freezing or shaking the prepared solution is not allowed.