vyloy
Pharmaranks rates Vyloy 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Vyloy (Zolbetuximab-Clzb) is a medication used to treat Adenocarcinoma, Esophageal Neoplasms.
Zolbetuximab-Clzb · by Astellas
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Zolbetuximab-Clzb
- Form
- Injectable
- Strength
- ZOLBETUXIMAB-CLZB 100MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- adenocarcinoma, esophageal neoplasms
- Manufacturer
- Astellas
- FDA application
- BLA761365
What is Vyloy?
From the FDA label:Zolbetuximab-clzb is a chimeric (mouse/human) antibody composed of variable regions derived from mouse anti-human claudin-18 isoform 2 monoclonal antibody and constant regions derived from human IgG1. The molecular weight is approximately 147 kDa. VYLOY (zolbetuximab-clzb) for injection is provided as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials for intravenous use. VYLOY is supplied as 100 mg or 300 mg per vial and requires reconstitution with Sterile Water for Injection, USP, (5 mL or 15 mL) resulting in a clear to slightly opalescent, colorless to slightly yellow solution with a final concentration of 20 mg/mL . Each mL of reconstituted solution contains 20 mg of zolbetuximab-clzb, arginine (23.24 mg), polysorbate 80 (0.21 mg), sucrose (51.30 mg), and phosphoric acid to adjust pH to 6.0.
How to use
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…
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…
Warnings
Important safety information
Hypersensitivity reactions including serious anaphylaxis reactions and serious and fatal infusion-related reactions have occurred. Monitor patients during and for at least 2 hours after infusion with VYLOY. Interrupt, slow the rate of infusion or permanently discontinue VYLOY based on severity and type of reaction. Premedicate with antihistamines for subsequent infusions after a hypersensitivity reaction. ( 2.4 , 5.1 ) • Severe nausea and vomiting: Premedicate patients with antiemetics prior to each infusion. Interrupt or permanently discontinue VYLOY based on the severity of the nausea and/or vomiting. Manage patients during and after infusion with antiemetics or fluid replacement. ( 2.4 , 5.2 ) 5.1 Hypersensitivity reactions, including anaphylaxis reactions, and infusion related reactions Hypersensitivity reactions, including serious anaphylaxis reactions, and serious and fatal infusion-related reactions (IRR) have been reported in clinical studies when VYLOY has been administered. Any grade hypersensitivity reactions, including anaphylactic reactions, occurring with VYLOY in combination with mFOLFOX6 or CAPOX was 18%. Severe (Grade 3 or 4) hypersensitivity reactions, including anaphylactic reactions, occurred in 2% of patients. Seven patients (1.3%) permanently discontinued VYLOY for hypersensitivity reactions, including two patients (0.4%) who permanently discontinued VYLOY due to anaphylactic reactions. Seventeen (3.2%) patients required dose interruption, and three patients (0.6%) required infusion rate reduction due to hypersensitivity reactions. All grade IRRs occurred in 3.2% in patients administered VYLOY in combination with mFOLFOX6 or CAPOX. Severe (Grade 3) IRRs occurred in 2 (0.4%) patients who received VYLOY. An IRR led to permanent discontinuation of VYLOY in 2 (0.4%) patients and dose interruption in 7 (1.3%) patients. The infusion rate was reduced for VYLOY for 2 (0.4%) patients due to an IRR. Monitor patients during infusion with VYLOY and for 2 hours after completion of infusion or longer if clinically indicated, for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice). Monitor patients for signs and symptoms of IRRs including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. If a severe or life-threatening hypersensitivity or IRR reaction occurs, discontinue VYLOY permanently, treat symptoms according to standard medical care, and monitor until symptoms resolve. For any Grade 2 hypersensitivity or IRR, interrupt the VYLOY infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. Premedicate the patient with antihistamines for the subsequent infusions, administer per the infusion rates in Table 2 and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated [see Dosage and Administration ( 2.4 )] . 5.2 Severe Nausea and Vomiting VYLOY is emetogenic. Nausea and vomiting occurred more often during the first cycle of treatment. All grade nausea and vomiting occurred in 82% and 67%, respectively, of patients treated with VYLOY in combination with mFOLFOX6 and 69% and 66% in combination with CAPOX, respectively. Severe (Grade 3) nausea occurred in 16% and 9% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX respectively. Severe (Grade 3) vomiting occurred in 16% and 12% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX. Nausea led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 18 (3.4%) patients and dose interruption in 147 (28%) patients. Vomiting led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 20 (3.8%) patients and dose interruption in 150 (28%) patients. Pretreat with antiemetics prior to each infusion of VYLOY [see Dosage and Administration ( 2.2 )] . Manage patients during and after infusion with antiemetics or fluid replacement. Interrupt the infusion, or permanently discontinue VYLOY based on severity [see Dosage and Administration ( 2.4 )] .
Who should not take Vyloy
None. None. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Vyloy treat?
- Vyloy (Zolbetuximab-Clzb) may be used to treat adenocarcinoma, esophageal neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Vyloy rated?
- pharmaranks gives Vyloy a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Vyloy?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vyloy. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vyloy?
- Vyloy is marketed by Astellas. You can see Astellas's full profile, rating, and other products on pharmaranks.
- Is Vyloy a brand-name or generic drug?
- Vyloy is a brand-name product with the active ingredient Zolbetuximab-Clzb.
- Is Vyloy available over the counter?
- No. Vyloy is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vyloy come in?
- Vyloy is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Vyloy FDA-registered?
- Vyloy is on record with the U.S. FDA under application number BLA761365. You can verify this on its official FDA label.
- Has Vyloy been recalled by the FDA?
- Vyloy has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Vyloy safe?
- There's no single safe-or-not verdict. pharmaranks gives Vyloy a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Vyloy?
- Vyloy's side effects are taken directly from its FDA label. From the label: 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 )] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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vyloy
72/100