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Dalpiciclib Hydroxyethanesulfonate Tablets is China's first independently innovative highly selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, a national Class 1 innovative drug with independent intellectual property rights.
AuthenticGuaranteeFast DeliveryPrivacy Dalpiciclib Hydroxyethanesulfonate Tablets was approved for marketing in 2021, and relevant clinical trials have demonstrated that it can significantly reduce the risk of recurrence in breast cancer patients, providing an excellent domestic innovative anti-tumor treatment option for Chinese breast cancer patients.
This product is indicated for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
in combination with an aromatase inhibitor as the initial endocrine therapy;
in combination with Fulvestrant for patients with disease progression following prior endocrine therapy.
Dalpiciclib Hydroxyethanesulfonate Tablets should be administered under the guidance of a physician experienced in antineoplastic agent therapy.
The recommended dose of Dalpiciclib is 150 mg once daily. It should be taken at approximately the same time each day, with a 1-hour fast before and after administration. Administer continuously for 21 days, followed by a 7-day drug holiday, forming a 28-day treatment cycle. If a patient misses a dose, no make-up dose is required on the same day, and the next dose should be taken as scheduled.
When used in combination with Dalpiciclib, the recommended dose of Fulvestrant is 500 mg per administration, given on Days 1, 15 and 29 respectively, followed by once monthly thereafter. For detailed information on the use of Fulvestrant, please refer to its package insert.
When used in combination with Dalpiciclib, the aromatase inhibitor should be administered in accordance with the dosage regimen specified in its approved package insert.
Treatment should be continued until disease progression or the occurrence of intolerable adverse reactions.
Premenopausal/perimenopausal women receiving Dalpiciclib in combination with endocrine therapy should concurrently receive gonadotropin-releasing hormone agonist (GnRHa) therapy in accordance with current clinical practice standards.
It is contraindicated in patients with known hypersensitivity to Dalpiciclib or any components of this product.
The most common adverse reactions of Dalpiciclib in combination with endocrine therapy for the treatment of recurrent or metastatic breast cancer include: decreased neutrophil count, decreased white blood cell count, anemia, decreased platelet count, rash, nausea, musculoskeletal pain, decreased lymphocyte count, fatigue, urinary tract infection, oral mucositis, elevated serum creatinine and hypokalemia.
Adverse reactions of grade 3 or higher severity with an incidence of ≥2% include: decreased neutrophil count, decreased white blood cell count, anemia, decreased platelet count and decreased lymphocyte count.
Females of Reproductive Potential
Females of reproductive potential receiving Dalpiciclib treatment should adopt effective contraceptive measures during treatment and for 7 months after the end of treatment.
Pregnancy
There is a lack of data on the use of Dalpiciclib in pregnant women. Animal studies have shown that Dalpiciclib has reproductive toxicity. Dalpiciclib is not recommended for pregnant women.
Lactating Women
No relevant studies have been conducted in humans or animals to evaluate the effects of Dalpiciclib on milk production, its presence in breast milk, or its effects on breastfed infants. Whether Dalpiciclib is excreted into human breast milk remains unknown. Lactating women are advised to discontinue breastfeeding during Dalpiciclib treatment.
No data on the safety and efficacy of Dalpiciclib in patients under 18 years of age are currently available.
Among 606 patients receiving Dalpiciclib in combination with endocrine therapy, 101 were patients aged 65 years and above. No significant differences in the safety or efficacy of Dalpiciclib were found between these patients and younger patients. Elderly patients are advised to use this product under the guidance of a physician.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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