) and MSKCC prognostic criteria for previously treated patients with RCC (0 vs 1 vs 2 or 3) as stratification factors (per IVRS data) † chi-squared test
Median OS (95% CI), months 21.4 (18.7, NE) 16.5 (14.7, 18.8)
HR (95% CI), p-value* 0.66 (0.53, 0.83), p=0.0003
Confirmed ORR (partial responses only)
(95% CI) 17% (13%, 22%) 3% (2%, 6%)
p-value† p<0.0001CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
CABOMETYX tablets are supplied as follows:
60 mg tables are yellow film-coated, oval shaped with no score, debossed with "XL" on one side and "60" on the other side of the tablet; available in bottles of 30 tablets:
NDC 42388-023-26
40 mg tablets are yellow film-coated, triangle shaped with no score, debossed with "XL" on one side and "40" on the other side of the tablet; available in bottles of 30 tablets:
NDC 42388-025-26
20 mg tablets are yellow film-coated, round shaped with no score, debossed with "XL" on one side and "20" on the other side of the tablet; available in bottles of 30 tablets:
NDC 42388-024-26
Store CABOMETYX at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Inform patients of the following:
Hemorrhage: Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual severe bleeding or hemorrhage [see WARNINGS AND PRECAUTIONS (5.1)].
Diarrhea: Advise patients to notify their healthcare provider at the first signs of poorly formed or loose stool or an increased frequency of bowel movements [see WARNINGS AND PRECAUTIONS (5.5)].
Palmar-plantar erythrodysesthesia syndrome: Advise patients to contact their healthcare provider for progressive or intolerable rash [see WARNINGS AND PRECAUTIONS (5.6)].
Wound healing: Patients should be advised to contact their healthcare provider before any planned surgeries, including dental surgery [see DOSAGE AND ADMINISTRATION (2.2)].
Drug interactions: Advise patients to inform their healthcare provider of all prescription or nonprescription medication or herbal products that they are taking.
Weight loss: Advise patients to report significant weight loss.
Embryo-fetal toxicity: Advise females of reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with CABOMETYX [see WARNINGS AND PRECAUTIONS (5.8), USE IN SPECIFIC POPULATIONS (8.1)].
Females of reproductive potential: Advise patients of reproductive potential to use effective contraception during treatment with CABOMETYX and for at least four months after the final dose of CABOMETYX [USE IN SPECIFIC POPULATIONS (8.3)].
Lactation: Advise women not to breastfeed during treatment with CABOMETYX and for 4 months following the last dose [USE IN SPECIFIC POPULATIONS (8.2)].
Important Administration Information
Instruct patients not to eat for at least 2 hours before and at least 1 hour after taking CABOMETYX. Instruct patients to not crush CABOMETYX tablets and to take CABOMETYX tablets with a full glass (at least 8 ounces) of water.
Advise patients not to consume grapefruits or |
