Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products.
Posology: For RCC and HCC, the recommended dose of CABOMETYX is 60 mg once daily. Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of CABOMETYX therapy (see Table 5). When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily. Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities. Dose reductions are recommended for events that, if persistent, could become serious or intolerable.
If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose. (See Table 5.)
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Concomitant medicinal products: Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see Precautions and Interactions).
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
Special populations: Elderly patients: No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
Race: No dose adjustment is necessary based on ethnicity (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: Cabozantinib should be used with caution in patients with mild or moderate renal impairment. Cabozantinib is not recommended for use in patients with severe renal impairment as safety and efficacy have not been established in this population.
Patients with hepatic impairment: In patients with mild hepatic impairment no dose adjustment is required. Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dosing recommendation can be provided. Close monitoring of overall safety is recommended in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions). There is no clinical experience in patients with severe hepatic impairment (Child Pugh C), so cabozantinib is not recommended for use in these patients (see Pharmacology: Pharmacokinetics under Actions).
Patients with cardiac impairment: There is limited data in patients with cardiac impairment. No specific dosing recommendations can be made.
Paediatric population: The safety and efficacy of cabozantinib in children and adolescents aged <18 years have not yet been established. No data are available.
Method of administration: CABOMETYX is for oral use. The tablets should be swallowed whole and not crushed. Patients should be instructed to not eat anything for at least 2 hours before through 1 hour after taking CABOMETYX.