Your Health, We Care
Another NameXL184、LUCICABOZ、Caboxen、Cazanat、卡博替尼片
IndicationsCabozantinib has been approved for the treatment of various cancers.
Reg No.05 L 0971/23
Inspection NO.
Cabozantinib is an oral multi-target small molecule tyrosine kinase inhibitor, originally developed and produced by Exelixis in 2012, and has shown good efficacy in the treatment of various solid tumors.
Cabozantinib has multiple drug specifications for patients to choose from, and the Lucius version of Cabozantinib has a drug specification of 20 mg * 90 tablets.
Cabozantinib has shown significant therapeutic effects in various malignant tumors by inhibiting the activity of multiple receptor tyrosine kinases, blocking signal transduction for tumor growth, metastasis, and angiogenesis.
Cabozantinib
Patients with advanced renal cell carcinoma, differentiated thyroid carcinoma, advanced non-small cell lung cancer, liver cancer, and advanced prostate cancer.
Cabozantinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk.
There is no information regarding the presence of Cabozantinib or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Cabozantinib and for 4 months after the final dose.
Advise females of reproductive potential to use effective contraception during treatment with Cabozantinib and for 4 months after the final dose.
The safety and effectiveness of Cabozantinib in pediatric patients less than 12 years of age have not been established.
No overall difference in safety was reported between elderly patients and younger patients.
Reduce the Cabozantinib dose in patients with moderate hepatic impairment. Avoid Cabozantinib in patients with severe hepatic impairment, since it has not been studied in this population.
No dosage adjustment is recommended in patients with mild or moderate renal impairment. There is no experience with Cabozantinib in patients with severe renal impairment.
One case of overdosage was reported following administration of another formulation of Cabozantinib; a patient inadvertently took twice the intended dose for 9 days. The patient suffered Grade 3 memory impairment, Grade 3 mental status changes, Grade 3 cognitive disturbance, Grade 2 weight loss, and Grade 1 increase in BUN. The extent of recovery was not documented.
Store Cabozantinib 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).
Median time to peak Cabozantinib concentrations (Tmax) ranged from 3 to 4 hours post-dose. A 19% increase in the Cmax of Cabozantinib compared to a Cabozantinib capsule formulation was observed following a single 140 mg dose. A less than 10% difference in the AUC was observed between Cabozantinib and a Cabozantinib capsule formulation.
from FDA，2023.09
