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Avelumab (Bavencio) is a PD-L1 immune checkpoint inhibitor jointly developed by Pfizer and Merck of 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).
Common name : Avelumab (Avelumab)
Trade name : BAVENCIO®
Dosage form : Intravenous injection
Main ingredient :Anti-PD-L1 monoclonal antibody (humanized IgG1)
Applicable population :Treatment of adult and pediatric patients 12 years old and above with unresectable or metastatic Merkel cell carcinoma (MCC).
Approval status : Based on the accelerated approval process, indications need to be confirmed by FDA-approved testing.
Specifications : 200mg/10mL (20mg/mL) single-dose vial.
Properties : Clear to slightly opalescent, colorless to light yellow solution, which may contain a small amount of translucent to white particles.
Conventional dose of : 10mg/kg, intravenously infused for 60 minutes every 2 weeks until disease progression or intolerable toxicity.
Pretreatment : Acetaminophen and antihistamines should be used before the first 4 infusions to prevent infusion reactions.
Missed infusion treatment : Make up for the infusion as soon as possible, skip it if it is close to the next dose time.
Pneumonia (≥ Grade 2) : Suspend the administration and consider restarting after recovery; permanently discontinue the drug if Grade ≥ 3 or recurrence grade 2.
Hepatitis (ALT/AST>3×ULN) : Suspend administration, permanently discontinue if >5×ULN or bilirubin >3×ULN.
Colitis (≥Grade 2) : Suspend administration, permanently discontinue if Grade ≥4 or Grade 3 recurrence.
Endocrine disease (≥Grade 3) : Suspend administration, and restart hormone replacement therapy after stabilization.
Infusion management :
Use a 0.2 micron filter and flush the pipeline after infusion.
After preparation, store at room temperature for ≤4 hours and refrigerate for ≤24 hours. Avoid freezing or shaking.
Monitoring requirements : Regularly check liver function, thyroid function, kidney function and electrocardiogram.
Pregnant women : may cause fetal damage, contraception is required until 1 month after the last dose.
Lactation : Avoid breastfeeding during treatment and within 1 month of stopping the drug.
Children : Safe and effective for ≥12 years old, but insufficient data for <12 years old.
Hepatic and renal insufficiency : No adjustment is required for mild to moderate, and no recommended dosage for severe.
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 reactions (25%, of which grade ≥3 accounted for 0.7%).
There are no absolute contraindications, but it is prohibited for those who are allergic to the ingredients.
Immunosuppressant : May weaken the efficacy of the drug, avoid combined use.
Strong CYP3A4 inducer : Not clearly studied, so caution is required.
Unopened :Refrigerate at 2-8℃ and avoid light. Do not freeze or shake.
After preparation : Use at room temperature ≤ 4 hours or refrigerated ≤ 24 hours.