Zolbetuximab-Clzb: uses, dosing, side effects & brands
Zolbetuximab-Clzb is a medicine sold in the U.S. under one brand, for adenocarcinoma and esophageal neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Adenocarcinoma and Esophageal Neoplasms
- Available as
- Injectable
- Sold as
- Vyloy
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How zolbetuximab-clzb is dosed
From the FDA label for Vyloy (application BLA761365). Other zolbetuximab-clzb products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer by intravenous infusion only . Do not administer VYLOY as an intravenous push or bolus. ( 2.6 ) • The recommended first dose of VYLOY is 800 mg/m 2 followed by 600 mg/m 2 every 3 weeks or 400 mg/m 2 every 2 weeks. ( 2.3 ) 2.1 Patient Selection Select adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining) for treatment with VYLOY in combination with fluoropyrimidine- and platinum-containing chemotherapy using an FDA-approved test [see Clinical Studies ( 14 )]. Information on FDA-approved tests for the detection of CLDN18.2 is available at https://www.fda.gov/CompanionDiagnostics . 2.2 Prior to Administration If a patient is experiencing nausea and/or vomiting prior to administration of VYLOY, the symptoms should be resolved to Grade ≤1 before administering the first infusion. Premedication Prior to each infusion of VYLOY, premedicate patients with a combination of antiemetics (e.g., NK-1 receptor blockers and/or 5-HT3 receptor blockers, as well as other drugs as indicated) for the prevention of nausea and vomiting [see Warnings and Precautions ( 5.2 )]. 2.3 Recommended Dosage Administer VYLOY in combination with fluoropyrimidine- and platinum-containing chemotherapy as…
Zolbetuximab-Clzb side effects
The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions, including anaphylaxis, and infusion related reactions [see Warnings and Precautions ( 5.1 )] . • Severe Nausea and Vomiting [see Warnings and Precautions ( 5.2 )] . The most common adverse reactions (≥15%) for VYLOY in combination with mFOLFOX6 or CAPOX were nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. The most common laboratory abnormalities (≥15%) for VYLOY in combination with mFOLFOX6 or CAPOX were decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, decreased phosphate, decreased potassium, and decreased magnesium ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 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 compared to rates in…
Who shouldn’t take zolbetuximab-clzb
None. None. ( 4 )
Every zolbetuximab-clzb 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: Vyloy.
What people report to the FDA about zolbetuximab-clzb
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming zolbetuximab-clzb, and the FDA flagged 100% 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:
- pulmonary embolism1 reports
- therapy cessation1 reports
Read these as a signal, not a rate. A report does not mean zolbetuximab-clzb 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 26, 2026.
Related calculators
Frequently asked questions
What is zolbetuximab-clzb?
Vyloy (Zolbetuximab-Clzb) is a medication used to treat Adenocarcinoma, Esophageal Neoplasms.
Can you take zolbetuximab-clzb 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 zolbetuximab-clzb 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 zolbetuximab-clzb come in?
Across the brands we track, zolbetuximab-clzb 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 zolbetuximab-clzb?
We do not currently list a generic-labelled zolbetuximab-clzb 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). Zolbetuximab-Clzb: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/zolbetuximab-clzb
- MLA
- “Zolbetuximab-Clzb: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/zolbetuximab-clzb.
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 zolbetuximab-clzb on DailyMed (NIH) ↗.