Bold body>>Treatment duration
Treatment should be continued until the patient fails to benefit clinically or develops intolerable toxicity.
Dosage adjustment and special instructions for use
Management of suspected adverse reactions includes suspending or reducing the dosage of sorafenib. If necessary, reduce the dosage of sorafenib to once daily, each time ().
The table lists recommendations for dose adjustments based on skin toxicity.
Skin adverse reaction grade Frequency of adverse reaction Recommended dose adjustment
Grade paralysis, hypoesthesia, paresthesia, numbness, painless swelling, erythema or discomfort in hands and feet but
does not affect daily activities at any time If symptoms occur, continue to use this product and provide local treatment
to eliminate symptoms.
For the first time that grade erythema and swelling of the hands and feet accompanied by pain, and/or discomfort in the hands and feet that affects daily life occurs, continue to use this product, and at the same time give local treatment to eliminate the symptoms. If the symptoms do not improve within days, see the next page
If the symptoms do not improve within days or appear for the second or third time, discontinue treatment with this product until the toxicity is alleviated to grade 1. When reinitiating treatment with this product, reduce to a single dose (daily). Discontinue treatment with this product on the fourth occurrence.
Grade 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 for the first or second occurrence until toxicity is alleviated to grade 1. When reinitiating treatment with this product, reduce to a single dose (daily) and discontinue treatment with this product on the third occurrence.
Bold >> Special Populations
Pediatric Patients
There is no data on the safety and effectiveness of sorafenib in pediatric patients.
Elderly (over 10 years old), gender and weight No dose adjustment is required based on the patient's age (over 10 years old), gender or weight.
Patients with Hepatic Impairment
No dose adjustment is required in patients with mild and moderate hepatic impairment (and). Sorafenib has not been studied in patients with severe hepatic impairment ( ).
Patients with Renal Impairment
No 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.
Monitoring of fluid and electrolyte balance is recommended in patients who may be at risk for renal damage.
Bold >> Adverse reactions
The 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 data from European, American and Asian countries (see [Clinical Trials 】 item).
Because 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 may it reflect the actual observed incidence rate.
The key safety data of clinical studies in Europe and the United States that support the marketing of this product
The most common adverse reactions are diarrhea, rash, hair loss and hand-foot skin reaction (the International Dictionary of Medical Terms corresponds to hand-foot dysesthesia syndrome) .
【Contraindications】
It is contraindicated in patients with severe allergic symptoms to sorafenib or the inactive ingredients of the drug.
Bold body(/)>
Advantages
?Editor
There are some generic drugs of the new molecularly targeted treatment drug Nexavar (sorafenib tablets) active on the market , the trade name is also called Nexavar, but the place of origin and manufacturer are different. 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 March 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. Approved by the Administration for the treatment of primary hepatocellular carcinoma that is inoperable or with distant metastasis, it was officially launched in March. More than a year 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.
News