Zolbetuximab-clzb
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Zolbetuximab-clzb is a claudin 18.2 (CLDN18.2)-directed cytolytic antibody that is FDA approved for the treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Common adverse reactions include nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
YLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.
- Administer by intravenous infusion only. Do not administer VYLOY as an intravenous push or bolus.
- The recommended first dose of VYLOY is 800 mg/m2 followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks.
- For injection: 100 mg and 300 mg lyophilized powder in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Zolbetuximab-clzb in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Zolbetuximab-clzb in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Zolbetuximab-clzb FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Zolbetuximab-clzb in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Zolbetuximab-clzb in pediatric patients.
Contraindications
None.
Warnings
- 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.
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.
Manage patients during and after infusion with antiemetics or fluid replacement.
- Interrupt the infusion, or permanently discontinue VYLOY based on severity.
Adverse Reactions
Clinical Trials Experience
- Hypersensitivity Reactions, including anaphylaxis, and infusion related reactions.
- Severe Nausea and Vomiting.
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 the clinical trials of another drug and may not reflect the rates observed in practice.
- The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to VYLOY in 533 patients at an 800 mg/m2 initial dose followed by subsequent doses of 600 mg/m2 every 3 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy in the SPOTLIGHT (279) and GLOW (254) studies. Among 533 patients who received VYLOY in these studies, 47% were exposed for ≥6 months and 20% were exposed for ≥12 months.
- In this pooled population, the most common (≥15%) adverse reactions, were nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. The most common (≥15%) laboratory abnormalities in the pooled population 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, increased phosphate, decreased potassium, and decreased magnesium.
SPOTLIGHT
- The safety of VYLOY was evaluated in SPOTLIGHT in patients with locally advanced unresectable or metastatic gastric or GEJ cancer who received at least one dose of VYLOY at an 800 mg/m2 initial dose followed by 600 mg/m2 subsequent doses every 3 weeks in combination with mFOLFOX6.The median duration of exposure to VYLOY in combination with mFOLFOX6 was 6.2 months (range: 1 day to 40.9 months).
Serious adverse reactions occurred in 45% of patients treated with VYLOY in combination with mFOLFOX6; the most common serious adverse reactions (≥2%) were vomiting (8%), nausea (7%), neutropenia (2.9%), febrile neutropenia (2.9%), diarrhea (2.9%), intestinal obstruction (3.2%), pyrexia (2.5%), pneumonia (2.5%), respiratory failure (2.2%), pulmonary embolism (2.2%), decreased appetite (2.1%) and sepsis (2.0%). Fatal adverse reactions occurred in 5% of patients who received VYLOY in combination with mFOLFOX6 including sepsis (1.4%), pneumonia (1.1%), respiratory failure (1.1%), intestinal obstruction (0.7%), acute hepatic failure (0.4%), acute myocardial infarction (0.4%), death (0.4%), disseminated intravascular coagulation (0.4%), encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%).
- Permanent discontinuation of VYLOY due to an adverse reaction occurred in 20% of patients; the most common adverse reactions leading to discontinuation (≥2%) were nausea and vomiting.
- Dosage interruptions of VYLOY due to an adverse reaction occurred in 75% of patients; the most common adverse reactions leading to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension.
Tables 3 and 4 summarize the most common (≥15%) adverse reactions and laboratory abnormalities with a difference between arms of ≥5%, respectively, compared to placebo in SPOTLIGHT.
GLOW
- The safety of VYLOY was evaluated in GLOW in patients with locally advanced unresectable or metastatic gastric/GEJ cancer who received at least one dose of VYLOY at an 800 mg/m2 initial dose followed by 600 mg/m2 subsequent doses every 3 weeks in combination with CAPOX. The median duration of exposure to VYLOY in combination with CAPOX was 4.4 months (range: 0.03 to 30.7 months).
- Serious adverse reactions occurred in 47% of patients treated with VYLOY in combination with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%), nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%), upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%), pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred in 8% of patients who received VYLOY in combination with CAPOX including sepsis (1.2%), pneumonia (0.4%), death (0.8%), upper gastrointestinal hemorrhage (0.8%), cerebral hemorrhage (0.8%), abdominal infection (0.4%), acute respiratory distress syndrome (0.4%), cardio respiratory arrest (0.4%), decreased platelet count (0.4%), disseminated intravascular coagulation (0.4%), dyspnea (0.4%), gastric perforation (0.4%), hemorrhagic ascites (0.4%), procedural complication (0.4%), sudden death (0.4%), and syncope (0.4%).
- Permanent discontinuation of VYLOY due to an adverse reaction occurred in 19% of patients; the most common adverse reaction leading to discontinuation (≥2%) was vomiting.
- Dosage interruption of VYLOY due to an adverse reaction occurred in 55% of patients; the most common adverse reactions leading to dose interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion-related reaction, and abdominal pain.
Tables 5 and 6 summarize the most common (≥15%) adverse reactions and laboratory abnormalities with a difference between arms of ≥5%, respectively compared to placebo in GLOW.
Postmarketing Experience
There is limited information regarding Zolbetuximab-clzb Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Zolbetuximab-clzb Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Risk Summary
- There are no data with VYLOY use in pregnant women to inform any drug-associated risks. Embryo-fetal toxicity was not observed in pregnant mice intravenously administered zolbetuximab-clzb [see Data]. VYLOY should only be given to a pregnant woman if the benefit outweighs the potential risk.
- The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Data
Animal Data
- In an embryo-fetal development toxicity study, zolbetuximab-clzb was intravenously administered to pregnant mice during the period of organogenesis and did not result in embryo-fetal toxicity at doses up to 300 mg/kg (approximately 1.9 times the recommended clinical dose based on AUC). Zolbetuximab-clzb crossed the placental barrier resulting in higher fetal serum concentrations on Day 18 of gestation than maternal serum concentrations on Day 16 of gestation.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zolbetuximab-clzb in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Zolbetuximab-clzb during labor and delivery.
Nursing Mothers
Risk Summary
- There are no data on the presence of zolbetuximab-clzb in human milk, the effects on the breastfed child, or the effects on milk production. Because antibodies may be excreted in human milk and because of the potential for adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during treatment with VYLOY and for 8 months after the last dose.
Pediatric Use
The safety and effectiveness of VYLOY in pediatric patients have not been established.
Geriatic Use
- Of the 533 patients in clinical studies of VYLOY in combination with mFOLFOX6 or CAPOX, 34% (n=179) were over 65 years, and 5% were over 75 years (n=28).
- No overall differences in safety or effectiveness were observed between patients aged 65 years or older and younger patients.
Gender
There is no FDA guidance on the use of Zolbetuximab-clzb with respect to specific gender populations.
Race
There is no FDA guidance on the use of Zolbetuximab-clzb with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Zolbetuximab-clzb in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Zolbetuximab-clzb in patients with hepatic impairment.
Females of Reproductive Potential and Males
VYLOY is used in combination with fluoropyrimidine- or platinum-containing chemotherapy. Refer to the Full Prescribing Information of fluoropyrimidine- and platinum-containing chemotherapy products for pregnancy testing, contraception, and infertility information.
Immunocompromised Patients
There is no FDA guidance one the use of Zolbetuximab-clzb in patients who are immunocompromised.
Immunogenicity
There is insufficient information to characterize the anti-drug antibody response to zolbetuximab-clzb and the effects of anti-drug antibodies on pharmacokinetics, pharmacodynamics, safety or efficacy of zolbetuximab products.
Administration and Monitoring
Administration
There is limited information regarding Zolbetuximab-clzb Administration in the drug label.
Monitoring
There is limited information regarding Zolbetuximab-clzb Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Zolbetuximab-clzb and IV administrations.
Overdosage
There is limited information regarding Zolbetuximab-clzb overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Zolbetuximab-clzb Pharmacology in the drug label.
Mechanism of Action
- Zolbetuximab-clzb is a claudin 18.2 (CLDN18.2)-directed cytolytic antibody that depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Zolbetuximab-clzb in combination with chemotherapy had increased antitumor activity in CLDN18.2-expressing mouse tumor models compared to zolbetuximab-clzb or chemotherapy alone.
Structure
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.
Pharmacodynamics
The exposure-response relationships for efficacy and safety at the recommended dosages of zolbetuximab-clzb in patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive have not been fully characterized.
Pharmacokinetics
- Following a 2-hour intravenous infusion, zolbetuximab-clzb exhibited dose-proportional pharmacokinetics at doses ranging from 33 mg/m2 to 1000 mg/m2 (0.04 times to 1.25 times the recommended first dose). When administered at a first dose of 800 mg/m2 followed by subsequent doses of 600 mg/m2 every 3 weeks, steady state was achieved by 18 weeks with a geometric mean (coefficient of variation [CV]%) Cmax of 415 (22%) mcg/mL and AUCtau of 3149 (37%) day•mcg/mL.
Distribution
- The estimated geometric mean (CV%) of the steady state volume of distribution of zolbetuximab-clzb was 14.0 (59%) L.
Metabolism
Zolbetuximab-clzb is expected to be catabolized into small peptides and amino acids.
Elimination
The estimated geometric mean (CV%) of the clearance (CL) and t1/2 of zolbetuximab-clzb was 0.013 (44%) L/h and 41 (62%) days, respectively.
Specific Populations
- The following factors had no clinically important effect on the clearance of zolbetuximab-clzb: age (range: 22 to 83 years), sex, race including White (50%), Asian (42%), Black (0.8%), mild to moderate (CLcr ≥30 to <90 mL/min) renal impairment and mild hepatic impairment (total bilirubin (TB) ≤upper limit of normal (ULN) and AST >ULN, or TB >1 to 1.5 x ULN and any AST). The effect of severe renal impairment, and moderate to severe hepatic impairment is unknown.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
- No studies in animals have been performed with zolbetuximab-clzb to evaluate carcinogenicity, mutagenicity, or impairment of fertility.
Clinical Studies
SPOTLIGHT
- The efficacy of VYLOY in combination with mFOLFOX6 was evaluated in SPOTLIGHT (NCT03504397), a double blind, randomized, multicenter study that enrolled 565 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. CLDN18.2 positivity (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining) was determined by immunohistochemistry on gastric or GEJ tumor tissue specimens from all patients with the VENTANA CLDN18 (43-14A) RxDx Assay performed in a central laboratory. Patients were excluded from the study if they had a complete or partial gastric outlet syndrome, or history of central nervous system metastases.
- Patients were randomized 1:1 to receive VYLOY in combination with mFOLFOX6 (n=283) or placebo in combination with mFOLFOX6 (n=282). VYLOY was administered intravenously at an initial dose of 800 mg/m2 (Day 1 of cycle 1) followed by subsequent doses of 600 mg/m2 every 3 weeks in combination with up to 12 treatments (4 cycles) of mFOLFOX6 (oxaliplatin 85 mg/m2, folinic acid (leucovorin or local equivalent) 400 mg/m2, fluorouracil 400 mg/m2 given as a bolus and fluorouracil 2400 mg/m2 given as a continuous infusion) administered on Days 1, 15 and 29 of a 42-day cycle. After 12 treatments, patients were allowed to continue treatment with VYLOY, 5-fluorouracil and folinic acid (leucovorin or local equivalent) at the discretion of the investigator, until progression of disease or unacceptable toxicity.
- Treatment with VYLOY continued until RECIST v1.1-defined progression of disease as determined by an independent review committee (IRC) or a subsequent anticancer treatment was initiated. Tumor assessments were performed every 9 weeks up to and including Week 54, then every 12 weeks thereafter.
- The major efficacy outcome measure was progression free survival (PFS) as assessed per RECIST v1.1 by IRC. Additional efficacy outcome measures were overall survival (OS), objective response rate (ORR) and duration of response (DOR) as assessed per RECIST v1.1 by IRC.
- The study population characteristics were median age of 61 (range: 20-86); 62% were male; 48% were White, 34% Asian, 3.0% American Indian or Alaska, 1.2% Black or African American, 4.1% other racial groups, and race in 9% was unknown or missing; 78% non-Hispanic or Latino, 13% Hispanic or Latino, and ethnicity in 10% was missing; 98% had ECOG performance status (PS) of 0 or 1; 76% had gastric cancer, 24% had GEJ cancer; 84% were metastatic, 16% were locally advanced; and 29% had undergone prior gastrectomy. Subsequent anticancer therapy was received by 135 (48%) patients in the VYLOY in combination with mFOLFOX6 arm and 148 (53%) patients in the placebo in combination with mFOLFOX6 arm.
- VYLOY in combination with mFOLFOX6 demonstrated a statistically significant improvement in PFS and OS compared with placebo in combination with mFOLFOX6.
TABLE 7, Figures 1 and 2 summarize the efficacy results for the SPOTLIGHT study.
GLOW
- The efficacy of VYLOY in combination with CAPOX was evaluated in GLOW (NCT03653507), a double-blind, randomized, multicenter study that enrolled 507 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive. CLDN18.2 positivity (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining) was determined by immunohistochemistry on gastric or GEJ tumor tissue specimens from all patients with the VENTANA CLDN18 (43-14A) RxDx Assay performed in a central laboratory. Patients were excluded from the study if they had a complete or partial gastric outlet syndrome, or history of central nervous system metastases.
- Patients were randomized 1:1 to receive VYLOY in combination with CAPOX (n=254) or placebo in combination with CAPOX (n=253). VYLOY was administered intravenously at an initial dose of 800 mg/m2 (Day 1 of cycle 1) followed by a subsequent dose of 600 mg/m2 every 3 weeks in combination with up to 8 treatments (8 cycles) of CAPOX administered on Day 1 (oxaliplatin 130 mg/m2) and on Days 1 to 14 (capecitabine 1000 mg/m2) of a 21-day cycle. After 8 treatments of oxaliplatin, patients were allowed to continue treatment of VYLOY and capecitabine at the discretion of the investigator, until progression of disease or unacceptable toxicity.
- Treatment with VYLOY continued until RECIST v1.1-defined progression of disease as determined by IRC or subsequent anticancer treatment was initiated. Tumor assessments were performed every 9 weeks up to and including Week 54, then every 12 weeks thereafter.
- The major efficacy outcome measure was PFS as assessed per RECIST v1.1 by IRC. Additional efficacy outcome measures were OS, ORR, and DOR as assessed per RECIST v1.1 by IRC.
- The study population characteristics were median age of 60 years (range: 21-83); 62% were male; 62% were Asian, 36% were White and race in 1.4% was missing; 95% non-Hispanic or Latino, 3.4% were Hispanic or Latino and ethnicity in 1.4% was missing; 99% had ECOG performance status (PS) of 0 or 1; 84% had primary gastric cancer, 16% had primary gastroesophageal adenocarcinoma; 88% were metastatic, 12% were locally advanced; and 27% had undergone prior gastrectomy.
VYLOY in combination with CAPOX demonstrated a statistically significant improvement in PFS and OS compared with placebo in combination with CAPOX. TABLE 8, Figures 3 and 4 summarize the efficacy results for the GLOW study.
How Supplied
VYLOY (zolbetuximab-clzb) for injection 100 mg and 300 mg are supplied as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials. VYLOY vials are available in the following packages:
• Carton of one 100 mg single-dose vial (NDC 0469-3425-10) • Carton of one 300 mg single-dose vial (NDC 0469-4425-30)
Storage
Store VYLOY vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton. Do not freeze. Do not shake.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- Advise the patient to read the FDA-approved patient labeling (Patient Information).
- Hypersensitivity reactions, including anaphylaxis and infusion-related reactions
Advise patients of the risk of hypersensitivity reactions including anaphylaxis and infusion-related reactions and to contact their healthcare provider right away if they experience symptoms of a hypersensitivity or infusion-related reaction during or after the administration of VYLOY.
- Severe nausea and vomiting
Advise patients of the risk of severe nausea and vomiting and to immediately contact their healthcare provider if they experience persistent or worsening nausea or vomiting.
Lactation
- Advise women not to breastfeed during treatment with VYLOY and for 8 months after the last dose of VYLOY
Precautions with Alcohol
Alcohol-Zolbetuximab-clzb interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
VYLOY
Look-Alike Drug Names
There is limited information regarding Zolbetuximab-clzb Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.