Avelumab: uses, dosing, side effects & brands
Avelumab is a programmed death ligand-1 blocker sold in the U.S. under one brand, for transitional cell carcinoma and merkel cell carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Programmed Death Ligand-1 Blocker
- Treats
- Transitional Cell Carcinoma and Merkel Cell Carcinoma
- Available as
- Injectable
- Sold as
- Bavencio
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How avelumab is dosed
From the FDA label for Bavencio (application BLA761049). Other avelumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Premedicate for the first 4 infusions and subsequently as needed. ( 2.1 ) Merkel Cell Carcinoma : 800 mg every 2 weeks. ( 2.2 ) Urothelial Carcinoma ; 800 mg every 2 weeks. ( 2.3 ) Renal Cell Carcinoma : 800 mg every 2 weeks in combination with axitinib 5 mg orally twice daily. ( 2.4 ) Administer BAVENCIO as an intravenous infusion over 60 minutes. 2.1 Premedication Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of BAVENCIO. Premedication should be administered for subsequent BAVENCIO doses based upon clinical judgment and presence/severity of prior infusion reactions [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ]. 2.2 Recommended Dosage for MCC The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 2.3 Recommended Dosage for UC The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 2.4 Recommended Dosage for RCC The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks in combination with axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity. When…
Avelumab side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of allogeneic HSCT [see Warnings and Precautions (5.3) ] Major adverse cardiovascular events [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥ 20%) in patients were: MCC : Fatigue, musculoskeletal pain, infusion-related reaction, rash, nausea, constipation, cough, and diarrhea. ( 6.1 ) UC : Maintenance treatment: fatigue, musculoskeletal pain, urinary tract infection, and rash. ( 6.1 ) Previously-treated: fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection. ( 6.1 ) RCC (with axitinib) : diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly…
Who shouldn’t take avelumab
None. None. ( 4 )
Every avelumab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Bavencio.
Avelumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for avelumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of avelumab during breastfeeding. Because avelumab is a large protein molecule with a molecular weight of about 147,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, avelumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that mothers not breastfeed during treatment and for at least one month after the last dose of avelumab.
National Institute of Child Health and Human Development, record revised April 14, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about avelumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,211 reports naming avelumab, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- neoplasm progression94 reports
- diarrhoea92 reports
- fatigue80 reports
- nausea78 reports
- pyrexia78 reports
- pneumonitis67 reports
- acute kidney injury66 reports
- general physical health deterioration63 reports
Read these as a signal, not a rate. A report does not mean avelumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is avelumab?
Bavencio (Avelumab) is a programmed death ligand-1 blocker used to treat Transitional Cell Carcinoma, Merkel Cell Carcinoma.
What kind of drug is avelumab?
The FDA classifies avelumab as a programmed death ligand-1 blocker. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take avelumab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run avelumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does avelumab come in?
Across the brands we track, avelumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic avelumab?
We do not currently list a generic-labelled avelumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Avelumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/avelumab
- MLA
- “Avelumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/avelumab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for avelumab on DailyMed (NIH) ↗.