Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France
CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC):
CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in
adults who have previously been treated with sorafenib.
Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products.
CABOMETYX (cabozantinib) tablets and COMETRIQ (cabozantinib) capsules are not bioequivalent and should not be used interchangeably (see section 5.2). If a patient must switch from cabozantinib capsules to cabozantinib tablets, the patient should continue at a CABOMETYX dose not to exceed 60 mg or the current COMETRIQ dose (whichever is lower).
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 treatment interruption and/or dose reduction of CABOMETYX therapy (see Table 1). 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.
Table 1. Recommended CABOMETYX dose modifications for adverse reactions:
| Adverse reaction and severity | Treatment Modification |
|---|---|
| Grade 1 and Grade 2 adverse reactions which are tolerable and easily managed | Dose adjustment is usually not required. Add supportive care as indicated. |
| Grade 2 adverse reactions which are intolerable and cannot be managed with a dose reduction or supportive care | Interrupt treatment until the adverse reaction resolves to Grade ≤1. Add supportive care as indicated. Consider re-initiating at a reduced dose. |
| Grade 3 adverse reactions (except clinically nonrelevant laboratory abnormalities) | Interrupt treatment until the adverse reaction resolves to Grade ≤1. Add supportive care as indicated. Re-initiate at a reduced dose. |
| Grade 4 adverse reactions (except clinically nonrelevant laboratory abnormalities) | Interrupt treatment. Institute appropriate medical care. If adverse reaction resolves to Grade ≤1, re-initiate at a reduced dose. If adverse reaction does not resolve, permanently discontinue CABOMETYX. |
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
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).
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
No dose adjustment is necessary based on ethnicity (see section 5.2)
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.
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).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).
There are limited data in patients with cardiac impairment. No specific dosing recommendations can be made.
The safety and efficacy of cabozantinib in children and adolescents aged <18 years have not yet been established. No data are available.
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.
There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
In the event of suspected overdose, cabozantinib should be withheld and supportive care instituted. Metabolic clinical laboratory parameters should be monitored at least weekly or as deemed clinically appropriate to assess any possible changing trends. Adverse reactions associated with overdose are to be treated symptomatically.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets. Each carton contains 4 blisters with 28 film-coated tablets.
HDPE bottle with a polypropylene child-resistant closure and three silica gel dessicant canisters. Each bottle contains 30 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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