- Approval Id
- 2301ff6bbc887ff7
- Drug Name
- VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
- Product Name
- VYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
- Approval Number
- SIN17197P
- Approval Date
- 2025-03-06
- Registrant
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Licence Holder
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong><u>Posology</u></strong></p>
<p><strong>Patient Selection</strong></p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Prior to Administration</strong></p>
<p>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.</p>
<p><em>Recommended Pretreatment</em><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Pre-medication with systemic corticosteroids per local treatment guidelines may also be considered particularly before the first infusion of zolbetuximab.</p>
<p><strong>Recommended Dose</strong></p>
<img src="/TGIF/Vyloy-Table1.png" alt="Vyloy Dosage Table 1" /><br><br>
<p><strong>Dose Modifications</strong></p>
<p>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.</p>
<img src="/TGIF/Vyloy-Table2.png" alt="Vyloy Dosage Table 2" /><br><br>
<p><u>Special Populations</u></p>
<p><em>Elderly</em><br>
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.</p>
<p><em>Pediatric population</em><br>
The safety and efficacy of Vyloy in the pediatric population have not been established.</p>
<p><em>Renal impairment</em><br>
No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Vyloy has only been evaluated in a limited number of patients with severe renal impairment.</p>
<p><em>Hepatic impairment</em><br>
No dose adjustment is required in patients with mild hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). 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.</p>
<p><u>Method of administration</u></p>
<p>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.</p>
<p>If Vyloy and fluoropyrimidine- and platinum-containing chemotherapy are administered on the same day, Vyloy must be administered first.</p>
<p>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).</p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<img src="/TGIF/Vyloy-Table3.png" alt="Vyloy Dosage Table 3" /><br><br>
<p>For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- L01FX31
- Pharma Manufacturer Name
- ASTELLAS PHARMA SINGAPORE PTE. LTD.
