Avelumab

NO UK SPC WAS FETCHED FOR THIS PRODUCT — dose taken from the US FDA prescribing information for BAVENCIO, EMD Serono Inc., label date 2025-06-13 (https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e1f3b1c-5aab-408c-930e-619daa6afa8a). VERBATIM (§2.2/§2.3): 'The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.' RCC (§2.4): 'The recommended dosage of BAVENCIO is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks in combination with axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity. When axitinib is used in combination with BAVENCIO, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of two weeks or longer. Review the Full Prescribing Information for axitinib prior to initiation.' PREMEDICATION (§2.1): premedicate with an antihistamine and with paracetamol (US label: acetaminophen) prior to the first 4 infusions; premedication for subsequent doses is based on clinical judgment and the presence/severity of prior infusion reactions. DOSE MODIFICATIONS (§2.5): 'No dose reduction for BAVENCIO is recommended.' In general, withhold for severe (Grade 3) immune-mediated adverse reactions; permanently discontinue for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions requiring systemic immunosuppressive treatment, or an inability to reduce the corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids. Infusion-related reactions: Grade 1 or 2 — interrupt or slow the rate of infusion; Grade 3 or 4 — permanently discontinue. Myocarditis Grade 2, 3 or 4 — permanently discontinue. Organ-specific withhold/discontinue thresholds for pneumonitis, colitis, hepatitis (with and without tumour involvement of the liver), endocrinopathies, nephritis, and exfoliative dermatologic conditions are tabulated in §2.5 of the label. PAEDIATRIC (§8.4): safety and effectiveness have been established in patients aged 12 years and older for metastatic MCC and 'the recommended dose in pediatric patients 12 years of age or greater is the same as that in adults'; safety and effectiveness have not been established below 12 years of age. NOTE: the flat 800 mg dose is current; historical trials referenced in §8.5 used 10 mg/kg — do not use the weight-based dose.