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Sorafenib tosylate tablets.

Function and indication:
For the treatment of hepatocellular carcinoma that cannot be operated on or has distant metastasis.
Usage and dosage:
The dosage and usage of different dosage forms and specifications of this product may vary. Please read the specific drug instructions for use, or follow the doctor’s advice. Sorafenib Tosylate Tablets: 1. Recommended dose: The recommended dose of sorafenib is 0.4g (2×0.2g) each time, twice a day, on an empty stomach or with a low-fat or medium-fat diet. Dosage Oral, swallow with a cup of warm water. Treatment should continue until the patient can no longer benefit clinically or an intolerable toxic reaction occurs. Dose adjustment and special instructions for use The treatment of suspected adverse reactions includes suspending or reducing the dose of sorafenib. If necessary, the dose of sorafenib is reduced to once a day or every other day, 0.4g (2×0.2g) each time. 2. Special populations Pediatric patients There is no safety and efficacy data on the use of sorafenib in pediatric patients. 3. Elderly (over 65 years old): Gender and weight Dosage does not need to be adjusted according to the patient’s age (over 65 years old), gender or weight. Patients with Hepatic Impairment No dose adjustment is required for patients with mild to moderate hepatic impairment (Child-PμghA and B). No studies have been conducted on the use of sorafenib in patients with severe hepatic impairment (Child-PμghC). Patients with Renal Impairment No dose adjustment is required for patients with mild to moderate renal impairment. No studies have been conducted on the use of sorafenib in patients with severe renal impairment or those undergoing dialysis.
Adverse Reactions:
1. Safety data from key European and American clinical studies supporting the marketing of this product: 1,286 patients (mainly Caucasians, including a small number of African Americans, Asians, Hispanics and other ethnic groups) treated with sorafenib as a single drug. 2. The most common drug-related adverse events are diarrhea, rash, alopecia and hand-foot syndrome. Trial 11213 Drug-related adverse reactions that occurred in at least 5% of patients in any treatment group Table 3 lists drug-related adverse events reported in multiple clinical trials according to different system organs (MedDRA) and frequency of occurrence (in accordance with the CHMP guidelines on drug instructions, EU EMEA). 3. All reported adverse drug reactions in multiple clinical trials (according to MedDRA codes) Laboratory test abnormalities Lipase and amylase usually increase after taking sorafenib. In study 11213, 12% of patients in the sorafenib group had CTCAE3 or 4 lipase increase, and 7% of patients in the placebo group. 1% of patients in the sorafenib group had CTCAE3 or 4 amylase increase, and 3% of patients in the placebo group. Two patients in the 451 patients taking sorafenib developed pancreatitis (CTCAE4), while one of the 451 patients in the placebo group developed pancreatitis (CTCAE2). Asian safety data results trial 11515 is a non-randomized, non-controlled, open-label phase II clinical study of sorafenib for the treatment of advanced renal cancer conducted in Japan. Compared with the key clinical studies in Europe and the United States, the drug-related adverse events reported in the trial are similar, the most common of which are: increased lipase, hand-foot syndrome, alopecia, increased amylase, rash/desquamation and diarrhea. Trial 11559 is a multicenter, non-randomized Phase III clinical study of sorafenib in the treatment of advanced renal cancer in Asia, including mainland China and Taiwan. The study is ongoing. Currently, among all 29 patients who have received at least one sorafenib treatment, 21 patients (72.4%) have experienced drug-related adverse events, the most common of which are hand-foot syndrome (27.6%), rash (20.7%), hypertension (6.9%), diarrhea (6.9%), fatigue (6.9%), etc. In the laboratory, sorafenib has shown good safety, and most of the adverse events are mild and tolerable. Table 4 lists the drug-related adverse events observed by the end of May 2006. 4. Drug-related adverse events in trial 11559 Among all the patients treated, 4 patients had a total of 5 serious adverse events (SAEs), one of which was reported as an SAE due to cerebral hemorrhage in a Taiwanese patient during medication due to trauma. The other 4 SAEs were: hand-foot syndrome, fever, pleural effusion and incomplete intestinal obstruction. Except for hand-foot syndrome, all other SAEs were judged by the researchers and Bayer headquarters to be unrelated to the study drug.
Patients with severe allergic symptoms to sorafenib or the inactive ingredients of the drug are contraindicated.