VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL [SIN17197P]

Product Info

VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

[SIN17197P]

4.1 Therapeutic indications

Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin (CLDN) 18.2 positive (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Posology

Patient Selection

Select patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining) as determined by a validated test, for treatment with Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Prior to Administration

If a patient is experiencing nausea and/or vomiting prior to administration of Vyloy, the symptoms should be resolved to Grade ≤1 before administering the first infusion.

Recommended Pretreatment
Prior to each infusion of Vyloy, premedicate patients with a combination of antiemetics (e.g., NK-1 receptor blockers and/or 5-HT3 receptor blockers, as well as other drugs as indicated), for the prevention of nausea and vomiting (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pre-medication with a combination of antiemetics is important for the management of nausea and vomiting to prevent early treatment discontinuation of zolbetuximab (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Pre-medication with systemic corticosteroids per local treatment guidelines may also be considered particularly before the first infusion of zolbetuximab.

Recommended Dose

Dose Modifications

No dose reduction for Vyloy is recommended. Adverse reactions for Vyloy are managed by infusion rate reduction, interruption, and/or discontinuation as presented in Table 2.

Special Populations

Elderly
No dose adjustment is required in patients ≥65 years of age. Of the 533 patients in clinical studies of VYLOY in combination with mFOLFOX6 or CAPOX, 34% (n=179) were over 65 years, and 5% were over 75 years (n=28). No overall differences in safety or effectiveness were observed between patients aged 65 years or older and younger patients.

Pediatric population
The safety and efficacy of Vyloy in the pediatric population have not been established.

Renal impairment
No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Vyloy has only been evaluated in a limited number of patients with severe renal impairment.

Hepatic impairment
No dose adjustment is required in patients with mild hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Vyloy has only been evaluated in a limited number of patients with moderate hepatic impairment and has not been evaluated in patients with severe hepatic impairment.

Method of administration

Vyloy is for intravenous use. The recommended dose is administered by intravenous infusion over a minimum of 2 hours. Vyloy must not be administered as an intravenous push or bolus injection.

If Vyloy and fluoropyrimidine- and platinum-containing chemotherapy are administered on the same day, Vyloy must be administered first.

To help minimize potential adverse reactions, it is recommended that each infusion should be started at a slower rate than the initially calculated rate for the entire infusion, and gradually increased as tolerated during the course of the infusion (see Table 3).

If the infusion time exceeds the recommended storage time at room temperature (12 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 section 6.3 for recommended storage times – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.