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Fuzeresib Tablets is a national Class 1 innovative drug independently developed in China, as well as China's first and the world's third KRAS G12C inhibitor.
AuthenticGuaranteeFast DeliveryPrivacy Fuzeresib tablets are well-tolerated and are the only KRAS G12C inhibitor without grade ≥3 gastrointestinal adverse reactions, which can reduce hepatic toxicity adverse events by 97% compared with similar products.
This product is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy.
The above indication has been granted conditional approval based on a single-arm clinical trial. Full approval of this indication will be contingent upon the clinical benefit established by the planned confirmatory trials.
Fuzeresib Tablets should be administered under the supervision of a physician experienced in the treatment of cancer.
Confirmation of KRAS G12C mutation positivity detected by an approved testing method is mandatory prior to the initiation of treatment with this product.
The recommended dosage of fuzeresib is 600mg orally twice daily (approximately 12 hours apart), with or without food, and administered continuously until disease progression or unacceptable toxicity occurs.
Swallow the tablets whole. Do not chew, crush, or split the tablets.
It is recommended to take this product at approximately the same time each day. In case of a missed dose during treatment, if more than 4 hours have passed since the scheduled administration time, do not make up the missed dose and resume dosing at the next scheduled time.
If vomiting occurs after taking fuzeresib, do not take an additional dose. Resume dosing at the next scheduled time.
This product is contraindicated in patients with hypersensitivity to fuzeresib tablets or any of its excipients.
The most common adverse reactions (≥20%) include: anemia, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, detection of proteinuria, fatigue, hypoalbuminemia, pruritus, edema, increased gamma-glutamyl transferase.
Common grade ≥3 adverse reactions (incidence ≥3%) include: anemia, increased gamma-glutamyl transferase, fatigue, abnormal liver function, increased blood alkaline phosphatase and decreased lymphocyte count.
Serious adverse reactions occurred in patients, and the common serious adverse reactions (incidence ≥2%) include: abnormal liver function, anemia.
Contraception
Males and females of reproductive potential should avoid pregnancy during treatment with this product. It is recommended that effective contraceptive measures be adopted during the course of treatment with this product.
Pregnancy
No clinical data are available on the use of this product in pregnant women.
Based on the animal study findings and the mechanism of action of this product, fetal harm may occur if pregnant women take this product. Women of reproductive potential and pregnant women should be informed of the potential risks of this product to the fetus.
The use of this product is not recommended during pregnancy.
Lactation
It is unknown whether this product or its metabolites are excreted in human milk, and there are no data on the effects of this product on breastfeeding and milk production. Since breastfed infants may be at risk of potential serious adverse reactions, lactating women are advised to avoid breastfeeding during treatment and for 1 week after the last dose.
The safety and effectiveness of this product have not been established in pediatric and adolescent patients under 18 years of age.
Among 301 patients treated with this product, 41.9% (126 patients) were aged 65 years and older. No significant differences in the safety or effectiveness of this product were observed in patients aged 65 years and older.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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