Avelumab (Bavencio) is a programmed death ligand-1 (PD-L1) blocking antibody, indicated for the treatment of adult and pediatric patients aged 12 years and older with metastatic Merkel cell carcinoma (MCC).

How to Use Avelumab (Bavencio)

Administration Method

The recommended dose of avelumab is 800 mg, administered as an intravenous infusion once every 2 weeks, with each infusion lasting 60 minutes.

Treatment should be continued until disease progression or the occurrence of unacceptable toxicity.

Premedication Regimen

Antihistamines and paracetamol should be administered as premedication before the first 4 infusions.

Based on clinical judgment and the presence/severity of previous infusion reactions, premedication may be continued in subsequent infusions.

Preparation and Storage

Preparation: Withdraw the required volume of avelumab from the vial and inject it into a 250 mL infusion bag containing 0.9% Sodium Chloride Injection or 0.45% Sodium Chloride Injection.

Storage: The diluted solution can be stored at room temperature (≤25°C) for no more than 4 hours, or under refrigerated conditions (2-8°C) for no more than 24 hours.

Freezing or shaking of the diluted solution is prohibited.

Administration Precautions

Administer through an intravenous line equipped with a 0.2 μm sterile, pyrogen-free, low protein-binding in-line filter.

Other medications must not be administered simultaneously through the same intravenous line.

Dose Adjustment of Avelumab (Bavencio)

Dose Adjustment for Immune-Related Adverse Reactions

Pneumonitis: Withhold administration for grade 2 pneumonitis; permanently discontinue treatment for grade 3 or 4 pneumonitis, or recurrent grade 2 pneumonitis.

Hepatitis: Withhold administration if AST/ALT > 3-5 × ULN or total bilirubin > 1.5-3 × ULN; permanently discontinue treatment if AST or ALT > 5 × ULN or total bilirubin > 3 × ULN.

Colitis: Withhold administration for grade 2 or 3 diarrhea or colitis; permanently discontinue treatment for grade 4 diarrhea or colitis, or recurrent grade 3 diarrhea or colitis.

Endocrine Disorders: Withhold administration for grade 3 or 4 endocrine disorders.

Nephritis and Renal Dysfunction: Withhold administration if serum creatinine > 1.5-6 × ULN; permanently discontinue treatment if serum creatinine > 6 × ULN.

Dose Adjustment for Infusion Reactions

Grade 1 or 2 Infusion Reactions: Interrupt the infusion or reduce the infusion rate.

Grade 3 or 4 Infusion Reactions: Discontinue the infusion and permanently discontinue treatment.

Avelumab (Bavencio) Use in Special Populations

Patients with Hepatic Impairment

No dose adjustment is required for patients with moderate hepatic impairment.

Data on the use of avelumab in patients with severe hepatic impairment are limited, and caution should be exercised.

Patients with Renal Impairment

No dose adjustment is required for patients with renal impairment of any degree, including those with end-stage renal disease.

Hemodialysis does not affect the clearance of the drug.

Pregnant Women

Avelumab may cause harm to the fetus.

Animal studies have shown that inhibition of the PD-1/PD-L1 pathway may increase immune-mediated rejection reactions in the fetus, leading to fetal death.

Use during pregnancy should be considered only if the expected benefit to the mother outweighs the potential risk to the fetus.