Bavencio is a PD-L1 immune checkpoint inhibitor jointly developed by Pfizer and Merck in Germany. It was approved by the FDA in 2017 and became the world's first immunotherapy for the treatment of metastatic Merkel cell carcinoma (MCC).

1. Drug name and main ingredients

Common name: Avelumab

Product Name: BAVENCIO ®

Dosage form: Intravenous injection

Main ingredients: anti-PD-L1 monoclonal antibody (humanized IgG1)

2. Indications

Applicable population: Adult and pediatric patients aged 12 years and above with unresectable or metastatic Merkel cell carcinoma (MCC).

Approval status: Based on the accelerated approval process, indications need to be confirmed through FDA approved testing.

3. Specifications and characteristics

Specification: 200mg/10mL (20mg/mL) single dose penicillin bottle.

Appearance: Clear to microemulsion light, colorless to light yellow solution, may contain a small amount of semi transparent to white particles.

4. Usage and dosage

Conventional dose: 10mg/kg, intravenous infusion every 2 weeks for 60 minutes until disease progression or intolerable toxicity.

Preparation: Acetaminophen and antihistamines should be used to prevent infusion reactions before the first 4 infusions.

Leakage treatment: Supplement the infusion as soon as possible, and skip if it is close to the next administration time.

5. Dose adjustment (immune related adverse reactions)

Types of adverse reactions

Pneumonia (≥ grade 2): Suspend medication and consider restarting after recovery; Permanent discontinuation of medication for grade ≥ 3 or recurrence grade 2.

Hepatitis (ALT/AST>3 × ULN): Discontinue medication, permanently discontinue medication for ALT/AST>5 × ULN or bilirubin>3 × ULN.

Colitis (grade ≥ 2): Discontinue medication, permanently discontinue medication for grade ≥ 4 or recurrence grade 3.

Endocrine disorders (≥ grade 3): Suspend medication and restart hormone replacement therapy after stabilization.

6. Medication precautions

Infusion management:

Use a 0.2 micron filter and flush the tubing after infusion.

After preparation, store at room temperature for ≤ 4 hours and refrigerate for ≤ 24 hours, avoiding freezing or shaking.

Monitoring requirements: Regular check of liver function, thyroid function, kidney function, and electrocardiogram.

7. Medication for special populations

Pregnant women: May cause fetal damage, contraception should be used until one month after the last dose.

Breastfeeding period: Avoid breastfeeding during treatment and within one month of discontinuing medication.

Children: Safe and effective for ages ≥ 12, insufficient data for ages<12.

Liver and kidney dysfunction: Mild to moderate without adjustment, severe without recommended dosage.

8. Adverse reactions

Common (≥ 20%): fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), rash (22%).

Serious but rare:

Immune pneumonia (3.7%), hepatitis (0.9%), colitis (1.5%).

Infusion reaction (25%, of which ≥ grade 3 accounts for 0.7%).

9. Contraindications

There are no absolute contraindications, but it is contraindicated for those who are allergic to the ingredients.

10. Drug interactions

Immunosuppressants: May weaken the efficacy, avoid combination therapy.

Strong CYP3A4 inducer: Not clearly studied, caution should be exercised.

11. Storage method

Unopened: Keep refrigerated at 2-8 ℃ and avoid light exposure. Do not freeze or shake.

After preparation: use at room temperature ≤ 4 hours or refrigerated ≤ 24 hours.

Bavencioinformation