Vyloy (zolbetuximab-clzb)

If adverse events occur during zolbetuximab-clzb therapy, reduction of the infusion rate, temporary interruption of the infusion, withholding the drug, and/or discontinuance of the drug may be necessary. Dosage reduction is not recommended.

Adverse event severity is graded per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Administer zolbetuximab-clzb via IV infusion in a dedicated line with a low protein-binding 0.2-micron in-line filter.

If administered on the same day as fluoropyrimidine- and platinum-containing chemotherapy, administer zolbetuximab-clzb first.

Zolbetuximab-clzb is available as 100 and 300 mg single-dose vials of white to off-white lyophilized powder that must be reconstituted and diluted prior to IV infusion. Do not administer via rapid IV bolus injection.

Do not administer zolbetuximab-clzb in the same IV line with other medications.

Store vials of zolbetuximab-clzb refrigerated at 2-8degreesC in original carton. Do not freeze.

Zolbetuximab-clzb is compatible with 0.9% sodium chloride injection.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted to date with zolbetuximab-clzb.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

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)

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)

Moderate Interaction: Assess the risk to the patient and take action as needed.

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)

*None.

• Lactation

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (incidence >=15%) reported with zolbetuximab-clzb in combination with mFOLFOX6 or CAPOX in clinical studies were nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.

The most common laboratory abnormalities (incidence >=15%) reported with zolbetuximab-clzb in combination with mFOLFOX6 or CAPOX in clinical studies were decreased neutrophil count, decreased leukocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased AST, decreased platelets, increased alkaline phosphatase, increased ALT, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.

More Frequent

• Nausea
• Vomiting

Less Frequent

• Acute respiratory failure
• Anaphylaxis
• Gastrointestinal obstruction
• Pneumonia
• Pulmonary thromboembolism
• Sepsis

Rare or Very Rare

• Acute myocardial infarction
• Disseminated intravascular coagulation
• Encephalopathy
• Gastrointestinal hemorrhage
• Hepatic failure
• Intracerebral hemorrhage

More Frequent

• Abnormal hepatic function tests
• Acute abdominal pain
• Anemia
• Anorexia
• Constipation
• Diarrhea
• Fatigue
• Fever
• Hyperglycemia
• Hypersensitivity drug reaction
• Hypoalbuminemia
• Hypoglycemic disorder
• Hypokalemia
• Hypomagnesemia
• Hyponatremia
• Hypophosphatemia
• Leukopenia
• Lymphopenia
• Neutropenic disorder
• Peripheral edema
• Peripheral neuropathy
• Thrombocytopenic disorder
• Weight loss

No enhanced messaging available.

Safety and efficacy of zolbetuximab-clzb have not been established in pediatric patients <18 years of age.

There are no human data on zolbetuximab-clzb use in pregnant women to inform any drug-associated risk. In animal studies, embryo-fetal toxicity was not observed in pregnant mice following administration of zolbetuximab-clzb at doses <=300 mg/kg (approximately 1.9 times the recommended clinical dose). Zolbetuximab-clzb crosses the placental barrier; in mice, higher fetal serum concentrations were observed on Day 18 of gestation than maternal serum concentrations on Day 16 of gestation.

It is not known whether zolbetuximab-clzb is distributed into human milk. Effects of the drug on breastfed infants or milk production are also not known. However, antibodies may be excreted in human milk, leading to potential adverse reactions in a breastfed child.

Advise lactating women not to breastfeed during zolbetuximab-clzb treatment and for 8 months after the last dose.

The manufacturer makes no specific recommendations for geriatric patients.

In clinical studies, 34% of patients were >65 years of age; 5% were >75 years of age. No overall differences in safety or efficacy were observed between geriatric patients (>=65 years of age) and younger adults (<65 years of age).