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. 2 positive tumour status defined as ≥75% of tumour cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed by a CE-marked IVD with the corresponding intended purpose.
If the CE-marked IVD is not available, an alternative validated test should be used. 3 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.
, NK-1 receptor blockers and 5-HT3 receptor blockers, as well as other medicinal products as indicated). 4). 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 1. Table 1. b Until disease progression or unacceptable toxicity.
a. 1). b. Refer to the fluoropyrimidine- or platinum-containing chemotherapy prescribing information regarding the dosing information for chemotherapy. 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 2.
4 Table 2. Dose modifications for zolbetuximab Adverse reaction Severitya Dose modification Hypersensitivity reactions Anaphylactic reaction, suspected anaphylaxis, Grade 3 or 4 Immediately stop the infusion and permanently discontinue.
Grade 2 Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rateb for the remaining infusion. For the next infusion, premedicate with antihistamines and administer per the infusion rates in Table 3. Infusion related reaction Grade 3 or 4 Immediately stop the infusion and permanently discontinue.
Grade 2 Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rateb for the remaining infusion. For the next infusion, premedicate with antihistamines and administer per the infusion rates in Table 3. Nausea Grade 2 or 3 Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rateb for the remaining infusion.
For the next infusion, administer per the infusion rates in Table 3. Vomiting Grade 4 Permanently discontinue. Grade 2 or 3 Interrupt the infusion until Grade ≤1, then resume at a reduced infusion rateb for the remaining infusion. For the next infusion, administer per the infusion rates in Table 3.
a. 03) where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. b. 4 for patient monitoring recommendations). 2). 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.
2). 5 × ULN and any AST). 2). Paediatric 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 minimise potential adverse reactions, it is recommended that each infusion is started at a slower rate for 30-60 minutes, and gradually increased as tolerated during the course of the infusion (see Table 3). If the infusion time exceeds the recommended storage time at […]