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Drug overview for VYLOY (zolbetuximab-clzb):
Generic name: ZOLBETUXIMAB-CLZB
Drug class: Antineoplastic Monoclonal Antibodies
Therapeutic class: Antineoplastics
Zolbetuximab-clzb, a claudin 18.2-directed cytolytic antibody, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: ZOLBETUXIMAB-CLZB
Drug class: Antineoplastic Monoclonal Antibodies
Therapeutic class: Antineoplastics
Zolbetuximab-clzb, a claudin 18.2-directed cytolytic antibody, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
VYLOY 100 MG VIAL
The following indications for VYLOY (zolbetuximab-clzb) have been approved by the FDA:
Indications:
HER2-neg and CLDN 18.2 pos gastric or gastroesophageal junction adenocarcinoma
Professional Synonyms:
None.
Indications:
HER2-neg and CLDN 18.2 pos gastric or gastroesophageal junction adenocarcinoma
Professional Synonyms:
None.
The following dosing information is available for VYLOY (zolbetuximab-clzb):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
*Administer by IV infusion only. Do not administer as an IV push or bolus.
*Prior to each infusion, premedicate patients with a combination of antiemetics for the prevention of nausea and vomiting.
*The recommended first dose of zolbetuximab-clzb is 800 mg/m2 followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks. To minimize the risk of adverse reactions, begin each infusion at a slower rate for 30 to 60 minutes; if tolerated, gradually increase the rate as described in the prescribing information.
*See Full Prescribing Information for additional administration and infusion rate recommendations.
*Administer by IV infusion only. Do not administer as an IV push or bolus.
*Prior to each infusion, premedicate patients with a combination of antiemetics for the prevention of nausea and vomiting.
*The recommended first dose of zolbetuximab-clzb is 800 mg/m2 followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks. To minimize the risk of adverse reactions, begin each infusion at a slower rate for 30 to 60 minutes; if tolerated, gradually increase the rate as described in the prescribing information.
*See Full Prescribing Information for additional administration and infusion rate recommendations.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for VYLOY (zolbetuximab-clzb):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for VYLOY (zolbetuximab-clzb):
Drug contraindication overview.
None.
None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for VYLOY (zolbetuximab-clzb):
Adverse reaction overview.
The most common adverse reactions (>=15%) for zolbetuximab-clzb 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 zolbetuximab-clzb 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, increased phosphate, decreased potassium, and decreased magnesium.
The most common adverse reactions (>=15%) for zolbetuximab-clzb 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 zolbetuximab-clzb 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, increased phosphate, decreased potassium, and decreased magnesium.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Nausea Vomiting |
Acute respiratory failure Anaphylaxis Gastrointestinal obstruction Pneumonia Pulmonary thromboembolism Sepsis |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Disseminated intravascular coagulation Encephalopathy Gastrointestinal hemorrhage Hepatic failure Intracerebral hemorrhage |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Acute abdominal pain Anemia Anorexia Constipation Diarrhea Fatigue Fever Hyperglycemia Hyperphosphatemia Hypersensitivity drug reaction Hypoalbuminemia Hypoglycemic disorder Hypokalemia Hypomagnesemia Hyponatremia Leukopenia Lymphopenia Neutropenic disorder Peripheral edema Peripheral neuropathy Thrombocytopenic disorder Weight loss |
None. |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for VYLOY (zolbetuximab-clzb):
The safety and effectiveness of zolbetuximab-clzb in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no data with zolbetuximab use in pregnant women to inform any drug-associated risks. Embryo-fetal toxicity was not observed in pregnant mice intravenously administered zolbetuximab-clzb. Zolbetuximab 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.
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.
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 zolbetuximab and for 8 months after the last dose.
Of the 533 patients in clinical studies of zolbetuximab-clzb in combination with mFOLFOX6 or CAPOX, 34% (n=179) were over 65 years of age, and 5% were over 75 years of age (n=28). No overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients.
The following prioritized warning is available for VYLOY (zolbetuximab-clzb):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VYLOY (zolbetuximab-clzb)'s list of indications:
| HEr2-neg and CLDN 18.2 pos gastric or GE junct adenocarc | |
| C16.0 | Malignant neoplasm of cardia |
| C16.1 | Malignant neoplasm of fundus of stomach |
| C16.2 | Malignant neoplasm of body of stomach |
| C16.3 | Malignant neoplasm of pyloric antrum |
| C16.4 | Malignant neoplasm of pylorus |
| C16.5 | Malignant neoplasm of lesser curvature of stomach, unspecified |
| C16.6 | Malignant neoplasm of greater curvature of stomach, unspecified |
| C16.8 | Malignant neoplasm of overlapping sites of stomach |
| C16.9 | Malignant neoplasm of stomach, unspecified |
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