Vyloy

In combination w/ fluoropyrimidine- & platinum-containing chemotherapy, for 1st-line treatment of adults w/ locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) -ve gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 +ve as determined by FDA-approved test.

IV Infuse over min of 2 hr. Administer 1st when given in combination w/ fluoropyrimidine- & platinum-containing chemotherapy on the same day. Pretreatment: Premedicate w/ antiemetics prior to each infusion. Consider systemic corticosteroids particularly before 1st infusion of zolbetuximab. Single loading dose 800 mg/m² on cycle 1, day 1. Infusion rate: 75 mg/m²/hr for the 1st 30-60 min, then 150-300 mg/m²/hr for the remaining infusion time. Maintenance dose 600 mg/m² every 3 wk beginning 3 wk after single loading dose (infusion rate: 75 mg/m²/hr for the 1st 30-60 min, then 150-300 mg/m²/hr for the remaining infusion time) or 400 mg/m² every 2 wk beginning 2 wk after single dose (infusion rate: 50 mg/m²/hr for the 1st 30-60 min, then 100-200 mg/m²/hr for the remaining infusion time). May increase infusion rate as tolerated after 30-60 min in the absence of adverse reactions. Treatment duration: Until disease progression or unacceptable toxicity.

Hypersensitivity.

Hypersensitivity reactions, including anaphylactic reaction & drug hypersensitivity. Not to be administered as IV push or bolus inj. Stop infusion immediately & permanently discontinue treatment if grade 3 or 4 hypersensitivity reactions, anaphylactic reaction, suspected anaphylaxis; grade 3 or 4 infusion-related reaction occur. Permanently discontinue treatment if grade 4 vomiting occurs. Interrupt infusion until grade ≤1, then resume at reduced infusion rate for the remaining infusion in case of grade 2 hypersensitivity & infusion-related reactions; grade 2 or 3 nausea & vomiting. Interrupt infusion, reduce rate or discontinue treatment early in case of GI toxicities. Monitor patients for hypersensitivity reactions w/ symptoms & signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze & throat tightness/voice change) during & after infusion (at least 2 hr, or longer if clinically indicated); signs & symptoms of infusion-related reaction including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough & HTN; nausea & vomiting during & after infusion & manage using standard of care including antiemetics or fluid replacement. Start each infusion at slower rate for 30-60 min to minimize adverse reactions. Evaluate individual patient's risk of GI toxicities. Proactively manage nausea & vomiting to mitigate potential risk of reduced exposure to zolbetuximab &/or chemotherapy. Patients w/ complete or partial gastric outlet syndrome, +ve test for human HIV infection or known active hepatitis B or C infection, significant CV disease (eg, CHF NYHA class III or IV, history of significant ventricular arrhythmias, QTc interval >450 msec for males; >470 msec for females) or history of CNS metastases. Contains polysorbates which may cause allergic reactions. Severe renal impairment (CrCl ≥15 to <30 mL/min). Moderate (total bilirubin >1.5-3x ULN & any AST) or severe (total bilirubin >3-10x ULN & any AST) hepatic impairment. Women of childbearing potential must use effective contraception during treatment. Pregnancy. Not recommended to breastfeed during treatment. Elderly ≥75 yr.

Neutropenia, decreased neutrophil count; hypoalbuminaemia, decreased appetite; nausea, vomiting; peripheral oedema, pyrexia; decreased wt. Drug hypersensitivity; HTN; dyspepsia, salivary hypersecretion; chills; infusion-related reaction.

Targeted Cancer Therapy

L01FX31 - zolbetuximab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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