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
There is limited information regarding Zolbetuximab-clzb Contraindications in the drug label.
Warnings
There is limited information regarding Zolbetuximab-clzb Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Zolbetuximab-clzb Clinical Trials Experience in the drug label.
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
Pregnancy Category (FDA):
There is no FDA guidance on usage of Zolbetuximab-clzb in women who are pregnant.
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
There is no FDA guidance on the use of Zolbetuximab-clzb in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Zolbetuximab-clzb in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Zolbetuximab-clzb in geriatric settings.
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
There is no FDA guidance on the use of Zolbetuximab-clzb in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Zolbetuximab-clzb in patients who are immunocompromised.
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
There is limited information regarding Zolbetuximab-clzb Mechanism of Action in the drug label.
Structure
There is limited information regarding Zolbetuximab-clzb Structure in the drug label.
Pharmacodynamics
There is limited information regarding Zolbetuximab-clzb Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Zolbetuximab-clzb Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Zolbetuximab-clzb Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Zolbetuximab-clzb Clinical Studies in the drug label.
How Supplied
There is limited information regarding Zolbetuximab-clzb How Supplied in the drug label.
Storage
There is limited information regarding Zolbetuximab-clzb Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Zolbetuximab-clzb Patient Counseling Information in the drug label.
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
There is limited information regarding Zolbetuximab-clzb Brand Names in the drug label.
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.