Avelumab
Brand Names: Bavencio
Methodology & AI Transparency ⓘ
Avelumab Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Federal drug listing 44087-3535 defines Avelumab (manufactured/labeled by EMD Serono, Inc.) as a prescription-only intravenous-route programmed death ligand-1 blocker available in 20 mg/mL Injection, Solution, Concentrate for individualized clinical regimens.
- 2 Real-world patient consensus: Zero-PHI community consensus: 85% favorable across 7 logged regimens (Bavencio).
- 3 Typical cash cost range: Dispensing cost comparison spans $82.62 mail/discount cash up to $202.42 uninsured retail (federal NADAC $1.8300).
- 4 Top reported side effects / signs: Leading openFDA/SPL adverse events for Avelumab: nausea (8.9%), headache (8.4%), dizziness (6.8%).
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Avelumab Mechanism, CYP450 Pathways & DailyMed Monograph
Federal drug listing 44087-3535 defines Avelumab (manufactured/labeled by EMD Serono, Inc.) as a prescription-only intravenous-route programmed death ligand-1 blocker available in 20 mg/mL Injection, Solution, Concentrate for individualized clinical regimens.
Clinical mechanism for Avelumab (20 mg/mL Injection, Solution, Concentrate, manufactured/labeled by EMD Serono, Inc.) centers on programmed death ligand-1 blocker target modulation following intravenous-route uptake, maintaining therapeutic plasma exposure across FDA-listed 44087-3535 regimens.
With Elimination kinetics span 5 to 14 hours per Avelumab clinical pharmacology residence kinetics and Complete (~100%) parenteral systemic delivery for Avelumab (20 mg/mL Injection, Solution, Concentrate) bioavailability, Avelumab undergoes systemic clearance of avelumab integrates hepatic phase ii conjugation with renal filtration and establishes therapeutic activity over rapid intravascular/parenteral onset within 15–45 minutes after avelumab administration.
Standard adult regimens span 20 mg/mL Injection, Solution, Concentrate, 20 mg/mL. Prescribers screen specifically against contraindicated in patients with prior serious allergic response to avelumab (ndc 44087-3535); severe baseline organ impairment where avelumab accumulation exceeds safe therapeutic margins, while community micro-logs most frequently note nausea (8.9% of reports), headache (8.4% of reports), dizziness (6.8% of reports).
Reconcile eGFR-adjusted medications before escalating Avelumab in polypharmacy regimens.
Shifts in intragastric pH can modestly influence dissolution kinetics of oral Avelumab dosage forms.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Contraindicated in patients with prior serious allergic response to Avelumab (NDC 44087-3535)
- Severe baseline organ impairment where Avelumab accumulation exceeds safe therapeutic margins
Logged Side-Effect Incidence (7 Reports)
Avelumab Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Avelumab)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| Can This Approach Help? Inside the Latest Research on Tumor ecosystem and microbiome features associated with efficacy and resistance Our data demonstrate how intratumoral bacteria affect immune checkpoint blockade response within a randomized trial. Nature cancer • 2026-01-15 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 41482527 ↗ |
| New Insights on Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Long-term: What a 350-Participant Study Found Limitations include open-label trial design and small patient numbers at later cycles. European urology oncology • 2025-08-15 • Phase III Randomized Trial | N = 350 | 87/100 | PMID 40318950 ↗ |
| New Insights on Avelumab first-line maintenance for advanced urothelial carcinoma: long-term: What a 350-Participant Study Found These exploratory analyses support the efficacy and tolerability of avelumab 1L maintenance in patients aged ≥65 years with la/mUC that has not progressed following chemotherapy, suggesting that older age should not solely. ESMO open • 2025-04-15 • Phase III Randomized Trial | N = 350 | 87/100 | PMID 40107155 ↗ |
| New Insights on Avelumab first-line maintenance for advanced urothelial carcinoma: long-term: What a 350-Participant Study Found Exploratory analyses support the use of avelumab first-line maintenance in patients with advanced UC without progression following PBC, including those with high BMI or DM. ESMO open • 2026-07-15 • Phase III Randomized Trial | N = 350 | 87/100 | PMID 42284622 ↗ |
| New Insights on Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma:: What a 350-Participant Study Found Analyses of OS and PFS in clinically relevant subgroups were consistent with results for the overall population, further supporting avelumab 1L. European urology • 2023-07-15 • Phase III Randomized Trial | N = 350 | 87/100 | PMID 37121850 ↗ |
Avelumab Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $1.8300/unit (~$54.90/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $202.42 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 7 Anonymous DotMD Community Micro-Logs | $82.62 / mo | View logs ↓ |
Avelumab Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Avelumab RxNorm Concept ID | RXN-440873535-2337 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $1.8300 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $202.42 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $82.62 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 85.00% Worth It (7 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Avelumab Patient Community, Cohort Filters & Dosage Logs
Cross-verified Avelumab (programmed death ligand-1 blocker) monograph synthesizing RxNorm RXN-440873535-2337, openFDA FAERS signals, and $82.62–$202.42 cash benchmarks.
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Filter Avelumab community threads and patient logs by age, biological sex, dosage, and treatment duration.