Year1
- 型号：
- 索拉菲尼
- 规格：
- 200mg*120片/盒
- 有效期：
- 24个月
inhibits tumor cell proliferation, including mouse renal cell carcinoma, models and athymic mouse transplantation of various human tumor models, and inhibits tumor angiogenesis.
Toxicological Studies
Carcinogenicity, mutagenicity, impairment of fertility
Preclinical safety of sorafenib
evaluated in mice, rats, dogs and rabbits sex. Repeated dose toxicity studies showed mild to moderate changes (degeneration and regeneration) in different organs.
Effects on bones and teeth may be observed after multiple doses of sorafenib in young and developing dogs, including sorafenib
at doses up to/body surface area (equivalent to clinically recommended doses of . times) irregular thickening of the femoral epiphyseal plate, reduction of bone marrow cells near this growth plate (days) and changes in dentin composition (days). No similar condition has been found in adult dogs.
In vitro chromosomal aberration tests were conducted on mammalian cells (Chinese hamster ovary), sorafenib
is genotoxic when metabolically activated. The in vitro cytogenetic test (test) result of a certain intermediate during the production process is positive, and the limit in the drug is controlled below .%. Experiments and micronucleus tests in mice show that sorafenib is not genotoxic (the content of this intermediate in the tested drug is .%).
Carcinogenicity testing of sorafenib
has not been performed.
No specific animal fertility testing has been performed. Repeated dose toxicity tests have observed organ changes in animals, so damage to male and female fertility is foreseeable.
Application in rats and rabbits) Sorafenib
has embryotoxicity and teratogenicity, including weight loss of the mother and fetus, increased chance of miscarriage, and increased appearance and visceral malformations. Adverse fetal consequences were observed in rats and rabbits at oral doses of 1 and 2 days, respectively.
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, every time.(.).
Adjust the dose accordingly according to skin toxicity
Grade skin adverse reactions such as paralysis, hypoesthesia, paresthesia, numbness, painless swelling, erythema of hands and feet or discomfort that does not affect daily activities may occur at any time. It is recommended that the dose be adjusted to continue using this product and local treatment be given to eliminate symptoms.
Grade skin adverse reactions include painful erythema and swelling of the hands and feet, and/or discomfort in the hands and feet that affects daily life.
When it occurs for the first time, the dose will be adjusted to continue using this product, and local treatment will be given to eliminate the symptoms. If the 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 the lowest level. When reinitiating treatment with this product, reduce to a single dose (daily or every other day). When it occurs for the fourth time, treatment with this product should be terminated.
Grade skin adverse reactions include 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.
When the first or second occurrence occurs, treatment with this product should be interrupted until the toxicity is alleviated to grade 1. When reinitiating treatment with this product, reduce to a single dose (daily or every other day). When it occurs for the third time, treatment with this product should be terminated.
Trade name) Nexavar
Common name) Sorafenib tablets
English namebr/> Chinese Pinyin
[Ingredients]
The main ingredients of this product are) Sorafenib Rafenib
.
【Character】
This product is a red round tablet.
【Indications】
Treatment of inoperable advanced renal cell carcinoma.
, treatment of primary hepatocellular carcinoma that is inoperable or with distant metastasis
There is currently a lack of randomized controlled clinical trial data comparing sorafenib with interventional treatments such as hepatic arterial chemoembolization in patients with advanced hepatocellular carcinoma. , therefore it is not yet clear whether the advantages and disadvantages of this product compared to interventional treatment, nor whether it is beneficial to use sorafenib in patients who have previously received interventional treatment (see the [Clinical Trial] item). It is recommended that doctors choose appropriate treatment methods based on comprehensive consideration of the patient's specific conditions.
[Usage and Dosage]
Recommended dosage
Recommended dosage) Sorafenib
The dosage is each time (.), twice a day, on an empty stomach or with low-fat, Take with a medium-fat diet.
Instructions for use
Take orally, swallow with a glass of warm water.
【Storage】
Store in a sealed container below ℃. Please keep medicines out of the reach of children.
【Packaging】
Tablets/box, aluminum-aluminum packaging.
[Validity period]
Months
[Execution standards]
Imported drug registration standards
[Imported drug registration certificate number]
[Manufacturer]
/>Manufacturer India Pharmaceuticals Corporation
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