Cabometyx 20mg、40mg、60mg film-coated tablets
1. Name of the medicinal product
CABOMETYX 20 mg film-coated tablets
CABOMETYX 40 mg film-coated tablets
CABOMETYX 60 mg film-coated tablets
2. Qualitative and quantitative composition
CABOMETYX 20 mg film-coated tablets
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.
Excipients with known effect
Each film-coated tablet contains 15.54 mg lactose.
CABOMETYX 40 mg film-coated tablets
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.
Excipients with known effect
Each film-coated tablet contains 31.07 mg lactose.
CABOMETYX 60 mg film-coated tablets
Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.
Excipients with known effect
Each film-coated tablet contains 46.61 mg lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
CABOMETYX 20 mg film-coated tablets
The tablets are yellow round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet.
CABOMETYX 40 mg film-coated tablets
The tablets are yellow triangle shaped with no score, and debossed with “XL” on one side and “40” on the other side of the tablet.
CABOMETYX 60 mg film-coated tablets
The tablets are yellow oval shaped with no score, and debossed with “XL” on one side and “60” on the other side of the tablet.
4. Clinical particulars
4.1 Therapeutic indications
CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC):
- in treatment-naïve adults with intermediate or poor risk (see section 5.1)
- in adults following prior vascular endothelial growth factor (VEGF)-targeted 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 (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).
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.
Consi