Cabozantinib

MONOTHERAPY: 60 mg once daily is the SPC dose for RCC, HCC, DTC and NET. IN COMBINATION WITH NIVOLUMAB (first-line advanced RCC): the recommended dose of cabozantinib is 40 mg once daily, given with nivolumab solution for infusion intravenously at either 240 mg every 2 weeks or 480 mg every 4 weeks, or with nivolumab solution for injection subcutaneously at either 600 mg every 2 weeks or 1200 mg every 4 weeks; treatment continues until disease progression or unacceptable toxicity, and nivolumab is continued until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression (refer to the nivolumab SmPC). FORMULATION WARNING: cabozantinib tablets and cabozantinib capsules are not bioequivalent and should not be used interchangeably. DOSE REDUCTION: in monotherapy reduce to 40 mg daily, then to 20 mg daily; in combination with nivolumab reduce to 20 mg once daily, then to 20 mg every other day. Dose interruptions are recommended for CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities. MISSED DOSE: the missed dose should not be taken if it is less than 12 hours before the next dose. HEPATIC IMPAIRMENT: mild — no dose adjustment required; moderate (Child-Pugh B) — only limited data, no dosing recommendation can be provided, close safety monitoring recommended; severe (Child-Pugh C) — not recommended. ELDERLY: no specific dose adjustment for patients aged 65 years and over. PAEDIATRIC: safety and efficacy in children and adolescents aged under 18 years have not yet been established and no recommendation on a posology can be made. SOURCE NOTE: eMC §4.4 and §4.8 are truncated at the source-fetch limit and no eMC §4.5 interactions section was retrieved; interaction entries below come from eMC §4.2 and, where tagged, the US prescribing information in the same bundle (US COMETRIQ capsules carry a different 140 mg once-daily regimen for a different indication and formulation — do not apply it to these tablets).