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[Drug use in pregnant women] Pregnancy
Nexavar does not have sufficient clinical data on pregnant women taking sorafenib. Animal experiments show that the drug has reproductive toxicity including teratogenicity. Sorafenib and its metabolites can pass through the placental barrier in rats, and it is speculated that sorafenib can inhibit fetal angiogenesis. Women of childbearing age should pay attention to contraception during treatment. If 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, fetal death (embryotoxicity). Avoid sorafenib during pregnancy. It should be used in pregnant women only if the benefits of treatment outweigh the possible risks to the fetus. Based on the known multikinase inhibition mechanism of sorafenib and the results of animal studies: multiple adverse reactions occur when the exposure in animals is significantly lower than the clinical dose, it is speculated that sorafenib may harm the fetus when pregnant women take it. Breastfeeding should be discontinued during sorafenib treatment. Animal experiments in women of childbearing age have shown that sorafenib is teratogenic and embryotoxic. Adequate contraception should be used during treatment and for at least 1 week after the end of treatment. Lactation It is not known whether sorafenib is excreted in human breast milk. Animal experiments indicate that sorafenib and/or its metabolites can be excreted in breast milk. Because many drugs are excreted in breast milk and the effects of sorafenib on infants have not been studied, women should stop breastfeeding during treatment with this drug. Reproductive performance Animal test results indicate that sorafenib impairs male and female reproductive performance.
[Pediatric Medication] There is no safety and effectiveness data on the use of 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 sorafenib drug metabolism. 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 sorafenib and therefore decrease sorafenib. Fenib drug concentration. Inhibitors: Ketoconazole is a strong inhibitor. When healthy male volunteers used ketoconazole twice daily for consecutive days, and combined with a single dose of sorafenib, the average plasma concentration of sorafenib did not change. Therefore, there is no drug metabolism interaction between sorafenib and inhibitors. Substrate: Warfarin is a substrate and the effect of sorafenib on warfarin metabolism was assessed by comparing patients taking sorafenib with placebo. The mean -R value did not change in patients receiving sorafenib plus warfarin compared with placebo. However, patients should monitor the R value regularly when taking warfarin together. Isoform-selective substrates: Sorafenib is neither an inhibitor nor an inducer for these cytochrome isoenzymes. Interactions with other antineoplastic drugs: In clinical trials, sorafenib was combined with other antineoplastic drugs at conventional doses, including gemcitabine, oxaliplatin, atoxin, and irinotecan. Sorafenib does not affect the drug metabolism of gemcitabine and oxaliplatin. The combined use of sorafenib and atoxin can cause an average % increase in the level of atoxin in patients with liver cancer. When sorafenib is coadministered with irinotecan, the active metabolite of irinotecan (metabolized by enzymes) increases by %-% and the value of irinotecan increases by -%. The clinical significance of this association is unknown.