Product Details
: ) [Indications of NEXAVAR]
Treatment of inoperable advanced renal cell carcinoma.
, treatment of primary hepatocellular carcinoma that is inoperable or distant metastasis.
There is currently a lack of randomized controlled clinical study data comparing sorafenib with interventional treatments such as hepatic arterial chemoembolization (C) in patients with advanced hepatocellular carcinoma. Therefore, the advantages and disadvantages of Nexavar relative to interventional treatments cannot yet be clarified. It is unclear whether sorafenib is beneficial to patients who have previously undergone interventional therapy (see [Clinical Trials]). It is recommended that doctors choose appropriate treatment methods based on comprehensive consideration of the patient's specific conditions.
[Nexavar Usage and Dosage]
Recommended dosage: The recommended dosage of sorafenib is each time, twice a day, on an empty stomach or with a low-fat or medium-fat diet.
Instructions for taking: Orally, swallow with a glass of warm water.
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, reducing the dosage of sorafenib to once daily, each time.(& .).
Make corresponding dose adjustments based on skin toxicity:
Grade skin adverse reactions: paralysis, hypoesthesia, paresthesia, numbness, painless swelling, erythema or discomfort on hands and feet but does not affect daily activities at any time If symptoms occur, it is recommended that the dose be adjusted to continue using NEXAVAR and local treatment be given to eliminate symptoms.
Grade skin adverse reactions: painful erythema and swelling of the hands and feet, and/or discomfort in the hands and feet that affects daily life.
When it first occurs, the dose is adjusted to continue using Nexavar, and local treatment is given to eliminate symptoms. If symptoms do not improve within days or appear for the second or third time, interrupt NEXAVAR treatment until the toxicity is relieved to grade. When reinitiating NEXAVAR treatment, reduce to a single dose (daily or every other day). When it occurs for the fourth time, NEXAVAR treatment should be terminated.
Grade skin adverse reactions: desquamation, ulcers, blistering, 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.
At the first or second occurrence, NEXAVAR treatment should be interrupted until toxicity resolves to grade 1. When reinitiating NEXAVAR treatment, reduce to a single dose (daily or every other day). When symptoms occur for the third time, NEXAVAR treatment should be terminated.
Special Populations
Pediatric Patients
There is no data on the safety and effectiveness of sorafenib in pediatric patients.
Elderly (years and older): Gender and weight
No dosage adjustment is required based on the patient's age (years and older), gender, or weight.
Patients with Hepatic Impairment
No dose adjustment is required in patients with mild to moderate hepatic impairment (C and B). 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.
[Nexavar Precautions]
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 with experience in using NEXAVAR.
Skin toxicity: Hand-foot skin reactions and rash are common adverse reactions of taking sorafenib. Rashes and hand-foot skin reactions are usually grade C (International Common Toxicity Criteria for Oncology) to grade and most often occur within a few weeks of starting sorafenib. Management of cutaneous toxic reactions includes topical administration to reduce symptoms, temporary discontinuation of the drug, and/or dose adjustment of sorafenib. Sorafenib may need to be discontinued in patients with severe skin toxicity and prolonged reactions. In severe cases, the medication should be discontinued.
: ) [NExavar Validity Period]
Months
[Nexavar Approval Number]
Registration Certificate Number
[NEXAVAR Manufacturer]< br/> Original drug manufacturer: Brr & generic manufacturer: Indian Company C
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