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Almonertinib fills the gap in domestic original third-generation EGFR-TKIs, cuts patients' reliance on imported drugs, and offers an accessible, cost-effective full-course domestic targeted therapy for patients with EGFR-mutant NSCLC.
AuthenticGuaranteeFast DeliveryPrivacy Almonertinib Mesilate Tablets is China’s first independently developed third-generation EGFR-TKI and the world’s second one approved for marketing; it was granted approval via priority review and approval by the National Medical Products Administration (NMPA) in March 2020 and holds complete independent intellectual property rights.
Almonertinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after prior treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and have a confirmed positive EGFR T790M mutation.
This product should be administered under the supervision of an oncologist with extensive clinical experience in cancer treatment.
Prior to treatment with this product, the EGFR T790M mutation status must first be confirmed. An approved detection method should be used to verify the presence of the EGFR T790M mutation.
The recommended dose of this product is 110mg orally once daily, continued until disease progression or intolerable toxicity occurs.
This product may be taken on an empty stomach or after meals. It is recommended to take the medication at approximately the same time each day, swallow the tablet whole and administer with a full glass of water; do not chew or crush the tablet. If a dose is missed, the missed dose should be taken if more than 12 hours remain before the next scheduled dose.
Hypersensitivity to Almonertinib Mesilate Tablets or any of its excipients.
At the 110mg dose level, common adverse reactions include diseases of the skin and subcutaneous tissue (rash and pruritus), gastrointestinal disorders (stomatitis and diarrhea), anemia, disorders of the eye and adnexa, musculoskeletal and joint pain, cardiac arrhythmias, cough and proteinuria. Some patients experienced serious adverse reactions, with pulmonary embolism being the identified serious adverse reaction.
Common abnormal laboratory findings include elevated serum creatine phosphokinase, elevated aspartate aminotransferase, elevated alanine aminotransferase, decreased white blood cell count and decreased neutrophil count.
Contraception
Males and females of childbearing potential should avoid conception during treatment with this product and continue to use effective contraceptive measures for 3 months after completion of treatment. The risk of decreased exposure to hormonal contraceptives cannot be excluded when co-administered with this product.
Pregnancy
No data are available on the use of this product in pregnant women, and the potential safety risks to the fetus are currently unknown. Based on its mechanism of action, the use of this product in pregnant women may cause harm to the fetus.
Lactation
It is not known whether this product or its metabolites are excreted in human milk. It is recommended that breastfeeding be discontinued during treatment with this product and for at least 3 months after the last dose.
The efficacy and safety of this product in children or adolescents below 18 years of age have not been established.
In clinical studies of this product, among 283 patients treated at the 110mg dose level, 110 (38.9%) were aged ≥65 years. The incidence of adverse reactions in these patients was 80.9%, with the incidence of grade ≥3 adverse reactions being 18.2%. Current clinical study data indicate that the safety profile of geriatric patients is not significantly different from that of the overall population, and no dose adjustment is required when used under the supervision of a physician.
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