Vyloy Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions: Hypersensitivity reactions, including anaphylactic reaction and drug hypersensitivity, occurred in patients treated with zolbetuximab in combination with fluoropyrimidine and platinum-containing chemotherapy during clinical studies (see Adverse Reactions).
Patients should be monitored during and after infusion with zolbetuximab (at least 2 hours, or longer if clinically indicated) for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice).
Hypersensitivity reactions should be managed according to the dose modifications as recommended in Table 3.
Infusion-related reaction: Infusion-related reaction (IRR) has occurred during clinical studies with zolbetuximab in combination with fluoropyrimidine and platinum-containing chemotherapy (see Adverse Reactions).
Patients should be monitored for signs and symptoms of infusion-related reaction including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. These signs and symptoms are usually reversible with the interruption of the infusion.
Infusion-related reactions should be managed according to the dose modifications as recommended in Table 3.
Nausea and Vomiting: During clinical studies, nausea and vomiting were the most frequently observed gastrointestinal adverse reactions with zolbetuximab in combination with fluoropyrimidine and platinum-containing chemotherapy treatment (see Adverse Reactions).
To prevent nausea and vomiting, pretreatment with a combination of antiemetics is recommended prior to each infusion of zolbetuximab (see Dosage & Administration).
During and after infusion, patients should be monitored and managed using standard of care, including antiemetics or fluid replacement, as clinically indicated.
Nausea and vomiting should be managed according to the dose modifications as recommended in Table 3.
Mitigation measures before initiating treatment with zolbetuximab: Prior to treatment with zolbetuximab in combination with fluoropyrimidine- and platinum-containing chemotherapy, prescribers should evaluate the individual patient's risk of gastrointestinal toxicities. It is important to proactively manage nausea and vomiting to mitigate the potential risk of reduced exposure to zolbetuximab and/or chemotherapy.
To prevent nausea and vomiting, pre-treatment with a combination of antiemetics is recommended prior to each infusion of zolbetuximab. During infusion, it is important to closely monitor patients and manage gastrointestinal toxicities by infusion interruption and/or infusion rate reduction to minimize the risk of severe adverse reactions or early treatment discontinuation. During and after infusion, patients should be monitored and managed using standard of care, including antiemetics or fluid replacement, as clinically indicated.
Patients excluded from clinical studies: Patients were excluded from clinical studies if they had a complete or partial gastric outlet syndrome, positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B or C infection, significant cardiovascular disease (e.g., congestive heart failure per New York Heart Association Class III or IV, history of significant ventricular arrhythmias, QTc interval >450 msec for males; >470 msec for females) or history of central nervous system metastases.
Excipient information: This medicinal product contains 1.05 mg of polysorbate 80 in each 100 mg vial. Polysorbates may cause allergic reactions.
This medicinal product does not contain sodium, however, sodium chloride 9 mg/mL (0.9%) solution for infusion is used for the dilution of zolbetuximab prior to administration and this should be taken into consideration in the context of the daily sodium intake of the patient.
Effects on ability to drive and use machines: Zolbetuximab has no or negligible influence on the ability to drive and use machines.