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< - , boldface, treatment time
- . Treatment should be continued until the patient no longer benefits clinically or develops intolerable toxicity.
- rDose adjustment and special instructions for use
- rManagement of suspected adverse reactions includes suspending or reducing the dosage of sorafenib. If necessary, the dosage of sorafenib is reduced to once daily, every Second-rate.(.).
- Table r lists recommendations for dose adjustments based on skin toxicity.
- r Skin Adverse Reaction Grade Adverse Reaction Frequency Suggested Dosage Adjustment
- R Grade: Paralysis, hypoesthesia, paresthesia, numbness, painless swelling, erythema or discomfort in hands and feet
- rContinue to use this product if it does not affect daily activities at any time, and provide local treatment to
- r eliminate symptoms.
- Level R: For the first time when erythema and swelling of the hands and feet accompanied by pain, and/or hand and foot discomfort that affects daily life, continue to use this product, and local treatment is given to eliminate the symptoms. If symptoms do not improve within days, see below
- If symptoms do not improve within days or appear for the second or third time, interrupt treatment with this product until the toxicity is relieved to grade -. When reinitiating treatment with this product, reduce to a single dose (daily.) Discontinue treatment with this product after the fourth occurrence.
- Level r3: Wet peeling, ulcers, blistering and pain on the hands and feet, or severe hand and foot discomfort that causes the patient to be unable to work and live a normal life. Interrupt treatment with this product until the toxicity resolves to grade - for the first or second occurrence. When reinitiating treatment with this product, reduce to a single dose (daily.) Discontinue treatment with this product after the third occurrence.
< -, bold, special populations
- rPediatric patients
- rThere is no data on the safety and effectiveness of sorafenib in pediatric patients.
- rElderly (over 10 years), gender and weight No dosage adjustment is required based on the patient's age (over 10 years), gender or weight.
- rPatients with hepatic impairment
- rNo dose adjustment is required in patients with mild and moderate hepatic impairment (- and B). Sorafenib has not been studied in patients with severe hepatic impairment (-).
- rPatients with renal impairment
- rNo dose adjustment is required in patients with mild, moderate, or severe renal impairment that does not require dialysis. Sorafenib has not been studied in dialysis patients.
- rMonitoring of fluid and electrolyte balance is recommended in patients who may be at risk for renal damage.
< -, bold, adverse reactions
- rThe following data are mainly derived from the safety data obtained in clinical trials of this product in advanced hepatocellular carcinoma and advanced renal cell carcinoma, including Europe, America and Asia. National data (see [Clinical Trials]).
- rBecause clinical trials are conducted under a wide variety of conditions, the incidence of adverse reactions observed in one clinical trial cannot be directly compared with the incidence in other clinical trials, nor does it reflect actual Observed incidence.
- rKey safety data from clinical studies supporting the marketing of this product in Europe and the United States:
- rThe most common adverse reactions are diarrhea, rash, alopecia and hand-foot skin reactions (International Dictionary of Medical Terms (R) Corresponding to hand-foot dysesthesia syndrome).
- r【Contraindications】
- r It is contraindicated in patients with severe allergic symptoms to sorafenib or the inactive ingredients of the drug.
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Superiority
_b::Edit
- rNew molecular targeted therapy drug Nexavar (Sorafenib tablets) There are some generic drugs active in the market, the trade name is also called Nexavar, but they are produced in different places and manufacturers. In fact, the real Nexavar (sorafenib) is produced by Bayer Healthcare of Germany and has been approved for marketing in China since this year. There are many authoritative certifications and clinical data that can prove the efficacy is reliable. Although generic drugs advertise that their product ingredients are the same as those of German Nexavar, in fact, generic drugs have not been clinically verified, and the purchasing channels are confusing and inevitably full of counterfeit drugs. However, German Nexavar has designated pharmacies across the country, and the quality of the drugs is Guaranteed.
- In January 2019, Nexavar from Germany was the first to be approved by the China State Food and Drug Administration for the treatment of patients with inoperable advanced renal cell carcinoma. It was approved by the Food and Drug Administration for the treatment of primary hepatocellular carcinoma that is inoperable or distantly metastasized, and was officially launched in March. More than 3 years after it was launched, the response from patients has been good. Statistics from kidney cancer clinical trials show that patients who use Nexavar achieve clinical benefits, including disease stabilization rate, partial response rate, and some patients achieve complete response.