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Patients with hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment (and B). Nexavar (sorafenib) has not been studied in patients with severe hepatic impairment.
[Adverse Reactions] The key safety data of clinical studies in Europe and the United States supporting the marketing of this product: from 40 patients (mainly Caucasian, including a few) treated with Nexavar (sorafenib) as a single drug African Americans, Asians, Hispanics and other races). The most common drug-related adverse events were diarrhea, rash, alopecia, and hand-foot syndrome. Laboratory Abnormalities Elevated lipase and amylase are commonly seen after taking Nexavar (sorafenib). In the study, % of patients in the Nexavar (sorafenib) group had or increased lipase, and % of patients in the placebo group had elevated lipase levels. % of patients in the Nexavar (sorafenib) group experienced or graded amylase elevations, compared with % of patients in the placebo group. Pancreatitis (Grade) occurred in 3 patients taking Nexavar (sorafenib) and 9 patients in the placebo group (Grade).
Asian safety data results: The trial is a non-randomized, non-controlled, open-label phase II clinical study of Nexavar (sorafenib) in the treatment of advanced renal cancer conducted in Japan, which is consistent with key clinical trials in Europe and the United States. Comparing studies, drug-related adverse events reported in trials were similar, with the most common being: elevated lipase, hand-foot syndrome, alopecia, elevated amylase, rash/scaling, and diarrhea. The trial is a multi-center, non-randomized Phase III clinical study of Nexavar (sorafenib) in the treatment of advanced renal cancer conducted in Asia, including mainland China and Taiwan, and the study is ongoing.
Among all patients who have received Nexavar (sorafenib) at least once, 2 patients (.%) have experienced drug-related adverse events, the most common of which is hand-foot syndrome (.%) ), rash (.%), high blood pressure (.%), diarrhea (.%), fatigue (.%), etc. In trials, Nexavar (sorafenib) demonstrated good safety, with most adverse events occurring being mild and tolerable.
[Notes] There is still a lack of sufficient clinical research data on the Chinese population, so it must be used under the guidance of a doctor who has experience in using this product.
Skin Toxicity: Hand-foot skin reactions and rash are the most common adverse reactions of taking Nexavar (sorafenib). Rashes and hand-foot skin reactions usually occur in grades (International Common Toxicity Criteria for Oncology) to grade and more often than not within a few weeks of starting Nexavar (sorafenib). Management of cutaneous toxic reactions includes topical application to reduce symptoms, temporary discontinuation of the drug, and/or dose adjustment of Nexavar (sorafenib). Permanent discontinuation of Nexavar (sorafenib) may be required in patients with severe skin toxicity and prolonged reactions. In severe cases, the drug should be discontinued permanently.
Hypertension: The incidence of hypertension is increased in patients taking Nexavar (sorafenib). Drug-related hypertension is mostly mild to moderate, often appears in the early stages after starting to take medication, and can be controlled with conventional antihypertensive drugs. Blood pressure should be monitored routinely and treated according to standard treatment regimens if necessary. Permanent discontinuation of Nexavar (sorafenib) should be considered in patients with severe or persistent hypertension or hypertensive crisis despite the use of antihypertensive drugs.
Bleeding: Taking Nexavar (sorafenib) treatment may increase the chance of bleeding. Severe bleeding disorders are uncommon. Once treatment is required, it is recommended to consider permanently discontinuing Nexavar (sorafenib).
Warfarin: Some patients taking Nexavar (sorafenib) and warfarin at the same time may occasionally experience bleeding or an increase in the international normalized ratio (R) of coagulation time. For patients taking warfarin together, prothrombin time and R value should be measured routinely and clinical signs of bleeding should be noted.
Wound Healing Complications: The effects of taking Nexavar (sorafenib) on wound healing have not been specifically studied. Patients who require major surgery are advised to suspend Nexavar (sorafenib). There is limited clinical experience in when patients should use Nexavar (sorafenib) again after surgery. Therefore, clinical considerations should be made before deciding to take it again. wound healing. Myocardial ischemia and/or myocardial infarction: In the trial, treatment-related myocardial ischemia/myocardial infarction occurred more frequently in the NEXAVAR (sorafenib) group (.%) than in the placebo group (.%). Patients with unstable coronary artery disease and patients with recent myocardial infarction were not enrolled in the trial. Temporary or long-term discontinuation of Nexavar (sorafenib) therapy should be considered in patients who develop myocardial ischemia and/or myocardial infarction.
Gastrointestinal perforation: Gastrointestinal perforation is relatively rare. Gastrointestinal perforation has been reported in less than % of patients taking Nexavar (sorafenib). In some cases, gastrointestinal perforation is not accompanied by the development of overt intra-abdominal tumors, and treatment with this product should be discontinued.
Liver damage: There are no study data on patients with liver damage levels. Because Nexavar (sorafenib) is primarily eliminated by the liver, exposure may be elevated in patients with severely impaired hepatic function.
Drug-Drug Interactions: Route: Caution is recommended when Nexavar (sorafenib) is used concomitantly with drugs that are metabolized through the route (such as irinotecan).
Docetaxel: Docetaxel (/or/) is used in combination with this product (.or. administered twice daily). There is a three-day dosing interval between this product and docetaxel. Docetaxel An increase of ~%. Caution is recommended when using this product in combination with docetaxel (see
[Drug Interactions]). Effects on Driving and Using Machines: There are no studies on the effects of Nexavar (sorafenib) on driving and using machines.
[Drugs for Pregnant and Lactating Women] Pregnancy There is no sufficient clinical data on the use of Nexavar (sorafenib) by pregnant women. Animal experiments show that the drug has reproductive toxicity including teratogenicity. Nexavar (Sorafenib) and its metabolites can pass through the placental barrier in rats. It is speculated that Nexavar (Sorafenib) can inhibit fetal angiogenesis.
Women of childbearing age should pay attention to contraception during treatment. If Nexavar (sorafenib) is used during pregnancy, patients should be informed of the possible harm the drug may cause to the fetus, including severe malformations, developmental disorders, and fetal death (embryotoxicity). Avoid using Nexavar (sorafenib) during pregnancy. It should be used in pregnant women only if the benefits of treatment outweigh the possible harm to the fetus. Based on the known multi-kinase inhibition mechanism of Nexavar (Sorafenib) and the results of animal studies: multiple adverse reactions occurred when the exposure in animals was significantly lower than the clinical dose, thus it is speculated that pregnant women taking Nexavar (Sorafenib) Fenil) can harm the fetus. Animal tests on women of childbearing age have shown that Nexavar (sorafenib) is teratogenic and embryotoxic.
Adequate contraceptive measures should be used during treatment and for at least 1 week after the end of treatment. Breastfeeding It is not known whether Nexavar (sorafenib) passes into human breast milk. Animal experiments show that metabolites of Nexavar (sorafenib) can pass into breast milk. Because many drugs are excreted in breast milk and the effects of Nexavar (sorafenib) on infants have not been studied, women should stop breastfeeding during treatment with this drug. Reproductive ability Animal testing results indicate that Nexavar (sorafenib) can impair male and female reproductive ability.
[Pediatric Medication] There is no safety and effectiveness data on the use of Nexavar (sorafenib) in pediatric patients.
[Drug use in the elderly] There is no need to adjust the dose according to the patient’s age (over 10 years old).
[Drug Interactions] Inducers: There is no clinical data on inducers affecting the drug metabolism of Nexavar (sorafenib). Inducers (such as rifampicin, Hypericum perforatum (or Hypericum perforatum, commonly known as St. John's wort), phenytoin, carbamazepine, phenobarbital, and dexamethasone) may increase the metabolism of Nexavar (sorafenib). Therefore, the drug concentration of Nexavar (sorafenib) is reduced.
Inhibitors: Ketoconazole is a strong inhibitor. Healthy male volunteers used ketoconazole once a day for consecutive days, and combined with a single dose of Nexavar (sorafenib). ) did not change. Therefore, drug metabolism interactions between Nexavar (sorafenib) and inhibitors are unlikely.
Substrate: Warfarin is a substrate and the effect of Nexavar (sorafenib) on the metabolism of warfarin was evaluated by comparing patients taking Nexavar (sorafenib) with placebo. The mean -R value did not change in patients taking Nexavar (sorafenib) plus warfarin compared with placebo. However, patients should monitor the R value regularly when taking warfarin together. Isomer-selective substrates: Nexavar (sorafenib) is neither an inhibitor nor an inducer of cytochrome isoenzymes.
Interactions with other anti-tumor drugs: In clinical trials, Nexavar (sorafenib) was combined with other conventional doses of anti-tumor drugs, including gemcitabine, oxaliplatin, doxorubicin and Irinotecan. Nexavar (sorafenib) does not affect the drug metabolism of gemcitabine and oxaliplatin. When paclitaxel (/) and carboplatin () are used together with this product (twice a day, each time or...), before and after using paclitaxel/carboplatin, stop using this product, and the pharmacokinetics of paclitaxel or carboplatin will be affected. There will be no significant impact on learning. The combined use of Nexavar (sorafenib) and doxorubicin can cause an average % increase in the level of doxorubicin in patients with liver cancer. When Nexavar (sorafenib) and irinotecan are co-administered, the active metabolite of irinotecan (metabolized by enzymes) increases by %-% and the value of irinotecan increases by %-%. The clinical significance associated with this is unknown (see
[Precautions] Docetaxel (/or administered twice daily during the daily treatment cycle from day to day or.), this product and docetaxel There is a three-day dosing interval between docetaxel, docetaxel increases by -%, and docetaxel increases by -%. Caution is recommended when this product is used in combination with docetaxel.
[Drug Overdose] There is no known Special treatment measures for overdose of Nexavar (sorafenib). The highest dose of Nexavar (sorafenib) is twice daily. The main adverse reactions observed at this dose are diarrhea and skin toxicity. If you suspect that If overdose occurs, the drug should be discontinued and the patient should be closely observed and provided with corresponding supportive treatment.
[Storage] Store in a sealed container below ℃. Please keep the medicine out of the reach of children.
[Packaging] Tablets/box, aluminum aluminum packaging.
[Validity period] Two and a half years.
[Execution standards] Imported drug registration standards
[Approval number] Registration certificate number
[Manufacturer 】Indian Company
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