Avelumab (Bavencio) is a programmed death ligand-1 (PD-L1) blocking antibody, first approved for marketing by the U.S. FDA in 2017. As an immune checkpoint inhibitor, it activates the immune system to fight against tumors by blocking the PD-L1/PD-1 signaling pathway.
Indications of Avelumab (Bavencio)
Treatment of Merkel Cell Carcinoma
The core indication of avelumab is for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients 12 years of age and older.
This indication was approved through the accelerated approval pathway based on tumor response rate and duration of response. Its continued approval may be contingent upon the verification and description of clinical benefit in confirmatory trials.
Use Restrictions
Avelumab (Bavencio) is currently only approved for the treatment of metastatic Merkel cell carcinoma and is not applicable to other types of tumors.
Dosage Form, Strength and Properties of Avelumab (Bavencio)
Dosage Form and Strength
Strength: 200 mg/10 mL (20 mg/mL).
Appearance: Clear, colorless to slightly yellow solution.
Packaging: One vial per carton (NDC 44087-3535-1).
Composition
Active Ingredient: 20 mg avelumab.
Excipients: 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 range of the solution is 5.0-5.6. It is important to note that this medicinal product does not contain natural rubber latex.
Storage Method of Avelumab (Bavencio)
Storage Conditions
Store in the original packaging in a refrigerator at 2°C to 8°C (36°F to 46°F).
Store away from light; avoid freezing or vigorous shaking.
After dilution, the solution can be stored at room temperature (≤25°C/77°F) for no more than 4 hours, or at 2°C to 8°C for no more than 24 hours.
Precautions for Use
Visually inspect the medicinal product before use. Discard if the solution is cloudy, discolored, or contains particulate matter.
After removing from the refrigerator, allow the product to equilibrate to room temperature before use.
Freezing or vigorous shaking of the vial is prohibited, as this may affect the stability of the drug.
Any unused product or waste material should be disposed of in accordance with local regulations.
