KBTN-20 CABOZANTINIB 20MG 90 TABLETS Approval No. 03 L 0957/23 Expiration Date 04-4-2026

Cabozantinib Instructions
Product Name: Cabozan
Manufacturer: Alliance Pharmaceuticals
Chinese name: Cabozantinib
English Name: Cabozantinib
Drug approval number: 03 L 0957/23
 
 
【Summary】
Cabozantinib was developed by Exelixis Biopharmaceuticals of the United States and produced and sold by Lucius (Laos) Pharmaceuticals. It is a multi-target broad-spectrum anticancer drug that can inhibit at least 9 targets including MET, VEGFR1/2/3, ROS1, RET, AXL, NTRK, KIT, etc.
At present, cabozantinib has been proven to have good therapeutic effects in a variety of solid tumors, including renal cancer, thyroid cancer, liver cancer, soft tissue sarcoma, non-small cell lung cancer, prostate cancer, breast cancer, ovarian cancer, and intestinal cancer, and its control effect on bone metastasis is particularly outstanding. Due to its wide effectiveness in treating a variety of cancers, cabozantinib is known as the "panacea" among targeted drugs. The targets include: KIT, PDGFR, FGFR, BRAF, BRAFV600, RAF-1, VEGFR1/2/3, TIE-1/-2, RET.
 
【Indications】
1. Treatment of progressive, unresectable locally advanced or metastatic medullary thyroid cancer;
2. Advanced renal cancer that has failed to respond to Sutent;
3. Patients with advanced non-small cell lung cancer with C-met amplification;
4. Liver cancer patients with resistance to Nexavar;
5. Patients with advanced prostate cancer and bone metastasis.
 
【Specification】
20mg/pill, 90 pills/box.
 
【Storage】
Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).
 
【Usage and Dosage】
Dosage:
Take orally on an empty stomach, avoid taking with food, i.e. do not eat within 2 hours before or 1 hour after taking the medicine.
Swallow the cabozantinib tablet whole; do not crush it.
Do not consume foods (such as grapefruit, grapefruit juice) or nutritional supplements known to inhibit cytochrome P450 enzymes while taking this medicine.
 
Recommended dose:
Medullary thyroid carcinoma: 140 mg once a day. The starting dose for patients with mild to moderate hepatic impairment is 80 mg.
Kidney cancer, liver cancer: 60 mg each time, once a day.
Prostate cancer bone metastasis: 40 mg each time, once a day.
 
【 Side effects and adverse reactions 】
The most common side effects and adverse reactions of cabozantinib (incidence > 20%) are:
Diarrhea, stomatitis, hand-foot-skin syndrome (PPES), weight loss, loss of appetite, nausea, fatigue, mouth pain, hair discoloration, taste disturbance, hypertension, abdominal pain, constipation.
The most common (incidence > 25%) laboratory abnormalities caused by cabozantinib are:
AST increased, ALT increased, lymphocytopenia, ALP increased, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, hyperbilirubinemia.
The most common (incidence > 5%) grade 3-4 side effects and adverse reactions of cabozantinib are:
Diarrhea, hand-foot-skin syndrome (PPES), lymphocytopenia, hypocalcemia, fatigue, hypertension, asthenia, ALT elevation, weight loss, stomatitis, loss of appetite.
The most common side effects and adverse reactions leading to permanent discontinuation of cabozantinib are:
Hypocalcemia, elevated lipase, hand-foot skin reaction (PPES), diarrhea, fatigue, hypertension, nausea, pancreatitis, tracheal fistula formation, and vomiting.
 
【Warnings and Precautions】
1. Cardiotoxicity
Cabozantinib also has certain cardiotoxicity, which manifests as chest tightness, palpitations, and difficulty breathing. It can be prevented by taking cardioprotectants, such as coenzyme Q10.
Recommended dosage of Coenzyme Q10: The health care dosage for the general population is 30-60 mg per day; for people at high risk of cardiovascular disease, including patients with hypertension, 60-120 mg per day; for patients with heart failure or ischemic (oxygen) heart disease, the dosage can be increased to 200-400 mg per day. When taking more than 60 mg per day, it can be taken in 2-3 times.
2. Indications for permanent discontinuation of medication
If severe bleeding, myocardial infarction, cerebral infarction, thromboembolism, hypertensive crisis, nephrotic syndrome, severe hepatitis, jaw osteonecrosis, gastrointestinal perforation and fistula occur during treatment, the drug needs to be permanently discontinued.
 
【Drug Interactions】
The following medicines should be avoided while taking cabozantinib:
1. Strong CYP3A4 inhibitors
Including but not limited to: ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole.
2. Strong CYP3A4 inducers
These include, but are not limited to: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St. John's wort.
 
[Special Populations]
Elderly people:
In the Phase 3 studies, 41% of patients treated with cabozantinib were aged 65 years and older, and 8% were aged 75 and older. No differences in safety or efficacy were observed between elderly and younger patients.
 
Patients with hepatic impairment:
Increased exposure to cabozantinib has been observed in patients with mild to moderate hepatic impairment. Reduce the cabozantinib dose in patients with mild (Child-Pugh score (CP) A) or moderate (CP B) hepatic impairment. It is recommended that cabozantinib not be used in patients with severe hepatic impairment.
Patients with renal impairment:
No dose adjustment is required in patients with mild or moderate renal impairment; there is no experience with the use of cabozantinib in patients with severe renal impairment.
 
【Use during pregnancy and lactation】
Pregnancy Risks:
Physicians should inform pregnant women or women of childbearing age of the potential risk of cabozantinib to the fetus.
Breastfeeding Risks:
Breastfeeding women should not breastfeed during treatment with cabozantinib and for 4 months after stopping treatment.
contraception:
Males and females of reproductive potential should use effective contraception during treatment with cabozantinib and for 4 months after stopping treatment.