Vyloy Dosage/Direction for Use

Treatment should be prescribed, initiated and supervised by a physician experienced in the use of anti-cancer therapies. Resources for the management of hypersensitivity reactions and/or anaphylactic reactions should be available.
Patient Selection: Eligible patients should have CLDN18.2 positive tumour status defined as ≥75% of tumour cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed by an FDA-approved test.
Posology: Prior to Administration: If a patient is experiencing nausea and/or vomiting prior to administration of zolbetuximab, the symptoms should be resolved to Grade ≤1 before administering the first infusion.
Prior to each infusion of zolbetuximab, patients should be pre-medicated with a combination of antiemetics (e.g., NK-1 receptor blockers and/or 5-HT3 receptor blockers, as well as other medicinal products as indicated).
Pre-medication with a combination of antiemetics is important for the management of nausea and vomiting to prevent early treatment discontinuation of zolbetuximab (see Precautions). Pre-medication with systemic corticosteroids per local treatment guidelines may also be considered particularly before the first infusion of zolbetuximab.
Recommended Dose: The recommended dose should be calculated according to body surface area (BSA) for the zolbetuximab loading dose and maintenance doses as provided in Table 2. (See Table 2.)

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Dose Modifications: No dose reduction for zolbetuximab is recommended. Adverse reactions for zolbetuximab are managed by infusion rate reduction, interruption, and/or discontinuation as presented in Table 3. (See Table 3.)

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Special Populations: Elderly: No dose adjustment is required in patients ≥65 years of age (see Pharmacology: Pharmacokinetics under Actions). Data for patients aged 75 years and older who received zolbetuximab are limited.
Renal impairment: No dose adjustment is required in patients with mild (creatinine clearance [CrCL] ≥60 to <90 mL/min) or moderate (CrCL ≥30 to <60 mL/min) renal impairment. No dose recommendation has been established in patients with severe renal impairment (CrCL ≥15 to <30 mL/min) (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment (total bilirubin [TB] ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN, or TB >1 to 1.5x ULN and any AST). No dose recommendation has been established in patients with moderate (TB >1.5 to 3x ULN and any AST) or severe (TB >3 to 10x ULN and any AST) hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Pediatric population: There is no relevant use of zolbetuximab in the paediatric population in the treatment of gastric or gastro-oesophageal junction adenocarcinoma.
Method of administration: Zolbetuximab is for intravenous use. The recommended dose is administered by intravenous infusion over a minimum of 2 hours. The medicinal product must not be administered as an intravenous push or bolus injection.
If zolbetuximab and fluoropyrimidine- and platinum-containing chemotherapy are administered on the same day, zolbetuximab must be administered first.
To help minimize potential adverse reactions, it is recommended that each infusion should be started at a slower rate for 30-60 minutes, and gradually increased as tolerated during the course of the infusion (see Table 4).
If the infusion time exceeds the recommended storage time at room temperature (≤ 25°C for 6 hours from end of preparation of infusion solution), the infusion bag must be discarded and a new infusion bag prepared to continue the infusion (see Shelf life under Storage for recommended storage times). (See Table 4.)

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For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.