Avelumab (Bavencio) is an innovative programmed death-ligand 1 (PD-L1) blocking antibody that activates the human immune system to combat tumor cells. As a key representative of immune checkpoint inhibitors, this medication has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of various advanced malignant tumors.

What are the Indications of Avelumab (Bavencio)?

Merkel Cell Carcinoma

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

Urothelial Carcinoma

Maintenance Treatment: Indicated for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-containing chemotherapy.

Previously Treated Patients: Treats patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy, or progressed within 12 months of platinum-containing neoadjuvant or adjuvant therapy.

Renal Cell Carcinoma

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

Dosage Form, Specification, and Characteristics of Avelumab (Bavencio)

Dosage Form and Specification

Avelumab is an intravenous injection supplied as a clear, colorless to slightly yellow solution at a concentration of 200 mg/10 mL (20 mg/mL), packaged in a single-dose vial.

Active Ingredient

Avelumab, a humanized IgG1λ monoclonal antibody produced by expression in Chinese Hamster Ovary (CHO) cells, with a molecular weight of approximately 147 kDa.

Excipient Composition

Each milliliter of solution contains: D-mannitol (51 mg), glacial acetic acid (0.6 mg), polysorbate 20 (0.5 mg), sodium hydroxide (0.3 mg), and water for injection.

The pH of the solution is strictly controlled within the range of 5.0-5.6 to ensure drug stability.

Storage Conditions for Avelumab (Bavencio)

Storage of Unreconstituted Medication

Store refrigerated at 2°C to 8°C.

Maintain the original packaging intact and protect from direct light.

Freezing or vigorous shaking is strictly prohibited.

Management of Reconstituted Solution

Room temperature storage (≤25°C): Use within 4 hours of reconstitution.

Refrigerated storage (2°C-8°C): Use within 24 hours of reconstitution (allow to warm to room temperature before administration).

Key Reconstitution Instructions

Use a 250 mL infusion bag containing 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection.

Mix gently by inverting the bag; avoid foaming.

Inspect the solution for clarity before injection. Discard if turbidity, discoloration, or particles are observed.