CABOMETYX FILM COATED TABLET 60MG [SIN15608P]

Product Info

CABOMETYX FILM COATED TABLET 60MG

[SIN15608P]

4.1 Therapeutic indications

Renal cell carcinoma (RCC)
CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma

• as first-line treatment of adult patients with intermediate or poor risk (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

• in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatocellular carcinoma (HCC)
CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.

Differentiated thyroid carcinoma (DTC)
CABOMETYX is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

4.2 Posology and method of administration

Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products.

Posology
CABOMETYX as monotherapy
For RCC, HCC and DTC, 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.

CABOMETYX in combination with nivolumab in first-line advanced RCC
The recommended dose of CABOMETYX is 40 mg once daily in combination with nivolumab administered intravenously at either 240 mg every 2 weeks or 480 mg every 4 weeks. The treatment should continue until disease progression or unacceptable toxicity. Nivolumab should be continued until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression (see the Summary of Product Characteristics (SmPC) for posology of nivolumab).

Treatment modification
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction (see Table 1). When dose reduction is necessary in monotherapy, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
When CABOMETYX is administered in combination with nivolumab, it is recommended to reduce the dose to 20 mg of CABOMETYX once daily, and then to 20 mg every other day (refer to the nivolumab SmPC for recommended treatment modification for nivolumab).

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.

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 sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.

Special populations
Elderly
No specific dose adjustment for the use of cabozantinib in elderly patients (≥ 65 years) is recommended.

Race
No dose adjustment is necessary based on ethnicity (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

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 sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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. Currently available data are described in sections 4.8 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information but no recommendation on a posology can be made.

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.