CABOMETYX FILM COATED TABLET 40MG

Patheon Inc. (CANADA)Rottendorf Pharma GmbH (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Jan 3, 2019
Approval ID: d705b0a3437f1b0f
Company: Patheon Inc. (CANADA)Rottendorf Pharma GmbH (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: d705b0a3437f1b0f
Drug Name: CABOMETYX FILM COATED TABLET 40MG
Product Name: CABOMETYX FILM COATED TABLET 40MG
Approval Number: SIN15607P
Approval Date: 2019-01-03
Registrant: IPSEN PHARMA SINGAPORE PTE. LTD.
Licence Holder: IPSEN PHARMA SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: 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, DTC and NET, 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. <img src="/TGIF/Cabometyx-Table1_050123.png" alt="Cabometyx Dosage Table 1" /> 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.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Renal cell carcinoma (RCC) CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma <ul class="dash"> <li>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),</li> <li>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).</li> </ul> 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. Neuroendocrine Tumours (NET) CABOMEYTX is indicated for the treatment of adult patients with locally advanced unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) or extra-pancreatic neuroendocrine tumours (epNET) who have progressed following at least one prior systemic therapy other than somatostatin analogues.
Contraindications: 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.
Atc Code: L01EX07
Atc Item Name: cabozantinib
Pharma Manufacturer Name: IPSEN PHARMA SINGAPORE PTE. LTD.

Active Ingredients

Cabozantinib (S)-malate 50.69mg eqv Cabozantinib

40mg

CABOZANTINIB (S)-MALATE 50.69 MG EQV CABOZANTINIB

40 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jan 3, 2019

Approval ID

d705b0a3437f1b0f

Type

Therapeutic

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