CABOMETYX- cabozantinib tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

cabozantinib s-malate (UNII: DR7ST46X58) (CABOZANTINIB - UNII:1C39JW444G)

제공처:

Exelixis, Inc.

INN (국제 이름):

cabozantinib s-malate

구성:

CABOZANTINIB 60 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced RCC. CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. CABOMETYX is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. None. Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , CABOMETYX can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal developmental and reproductive toxicology studies administration of cabozantinib to pregnant rats and rab

제품 요약:

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: bottle of 30 tablets: NDC 42388-023-26 bottle of 30 tablets packaged in a carton: NDC 42388-023-46 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: bottle of 30 tablets: NDC 42388-025-26 bottle of 30 tablets packaged in a carton: NDC 42388-025-46 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: bottle of 30 tablets: NDC 42388-024-26 bottle of 30 tablets packaged in a carton: NDC 42388-024-46 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].

승인 상태:

New Drug Application

제품 특성 요약

CABOMETYX- CABOZANTINIB TABLET
EXELIXIS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CABOMETYX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CABOMETYX.
CABOMETYX (CABOZANTINIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
CABOMETYX is a kinase inhibitor indicated for the treatment of
patients with advanced renal cell carcinoma (RCC) (1.1)
patients with advanced renal cell carcinoma, as a first-line treatment
in combination with nivolumab
(1.1)
patients with hepatocellular carcinoma (HCC) who have been previously
treated with sorafenib (1.2)
adult and pediatric patients 12 years of age and older with locally
advanced or metastatic differentiated
thyroid cancer (DTC) that has progressed following prior
VEGFR-targeted therapy and who are
radioactive iodine-refractory or ineligible (1.3)
DOSAGE AND ADMINISTRATION
Stop treatment with CABOMETYX at least 3 weeks prior to scheduled
surgery, including dental surgery
(2.1)
Do NOT substitute CABOMETYX tablets with cabozantinib capsules (2.1)
Recommended Dose:
60 mg orally, once daily. (2.2, 2.3)
40 mg orally, once daily, in pediatric patients with BSA less than 1.2
m (2.4)
40 mg orally, once daily, administered in combination with nivolumab
240 mg every 2 weeks or 480
mg every 4 weeks (2.2)
Administer at least 1 hour before or at least 2 hours after eating.
(2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg, and 60 mg. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hemorrhage: Do not administer CABOMETYX if recent history of
hemorrhage. (5.1)
Perforations and Fistulas: Monitor for symptoms. Discontinue CABOMETYX
for Grade 4 fistula or
perforation. (5.2)
Thrombotic Events: Discontinue CABOMETYX for myocardial infarction or
serious venous or arterial
thromboembolic events. (5.3)
Hypertension and Hypertensive Crisis: Monitor blood pressure
regularly. Interrupt for hypertension that
is not adequately controlled with anti-hypertensive therapy.
Discon