Drugplain

VYLOY 20 mg/mL

ZOLBETUXIMAB · INJECTION, POWDER, FOR SUSPENSION · Astellas Pharma US, Inc.

No Recall History
Plain English

VYLOY is a injection, powder, for suspension containing zolbetuximab at 20 mg/mL, taken intravenous. Manufactured by Astellas Pharma US, Inc..

Key Facts

Brand Name
VYLOY
Generic Name
ZOLBETUXIMAB
NDC Code (Product)
0469-4425
Manufacturer
Astellas Pharma US, Inc.
Strength
20 mg/mL
Dosage Form
INJECTION, POWDER, FOR SUSPENSION
Route
INTRAVENOUS
Marketing Status
Application #
BLA761365
Drug Class
Claudin 18.2-directed Cytolytic Antibody [EPC]
Marketing Start
04/24/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea428 reports
vomiting202 reports
decreased appetite150 reports
ascites94 reports
hypoalbuminaemia89 reports
malignant neoplasm progression80 reports
blood albumin decreased64 reports
diarrhoea63 reports
oedema peripheral52 reports
malaise48 reports

Frequently Asked Questions

What is VYLOY used for?

VYLOY contains ZOLBETUXIMAB. It is a injection, powder, for suspension taken intravenous. Consult your doctor for specific uses.

Is VYLOY a controlled substance?

VYLOY is not classified as a controlled substance by the DEA.

What is the generic name for VYLOY?

The generic name for VYLOY is ZOLBETUXIMAB. There are no other listed brand versions of ZOLBETUXIMAB.

What is the NDC code for VYLOY 20 mg/mL?

The NDC (National Drug Code) for VYLOY 20 mg/mL is 0469-4425, listed by Astellas Pharma US, Inc..

Product NDC

0469-4425

Package NDC

0469-4425-30

Other VYLOY Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)