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Utidelone Injection is more effective than conventional regimens, with much lower hematological toxicity than same-class chemotherapeutics; its peripheral neurotoxicity is manageable, reversible and rapidly recoverable.
AuthenticGuaranteeFast DeliveryPrivacy Utidelone Injection is an epothilone derivative, and the world’s only approved next-generation microtubule inhibitor with a novel molecular structure in the past decade. It induces tumor cell apoptosis by promoting tubulin polymerization and stabilizing the microtubule structure.
Utidelone Injection, in combination with capecitabine, is indicated for patients with recurrent or metastatic breast cancer who have received at least one prior chemotherapy regimen.
The prior chemotherapy regimen should include an anthracycline or a taxane drug.
The recommended dosage of Utidelone Injection is 30mg/m², administered by intravenous infusion for approximately 1.5 hours, once daily for 5 consecutive days, with a 21-day treatment cycle.
The recommended dosage of capecitabine is 1000mg/m², taken orally twice daily (once in the morning and once in the evening, with a total daily dosage of 2000 mg/m²), within 30 minutes after meals. The administration regimen is 14 consecutive days of taking the drug followed by 7 days of rest, with a 21-day treatment cycle. For detailed information on the administration of capecitabine, please refer to its package insert.
Patients should receive treatment until disease progression or the occurrence of intolerable toxicity.
All patients should receive intramuscular or oral diphenhydramine 40mg, intravenous dexamethasone 10mg, and intravenous cimetidine 300–400mg or ranitidine 50mg 30 to 60 minutes before the first Utidelone Injection treatment. For the next day of administration, the dosage of dexamethasone and diphenhydramine may be halved or discontinued based on the patient's actual condition.
Patients with severe hypersensitivity to polyoxyethylene (35) castor oil are contraindicated.
The most common adverse reactions (≥20%) included peripheral neuropathy, musculoskeletal pain, fatigue and asthenia, nausea, neutropenia, leukopenia, diarrhea, and anorexia.
No Grade 3/4 adverse reactions with an incidence exceeding 20% were reported. Except for peripheral neuropathy (6 cases, 8.57%) and neutropenia (5 cases, 7.14%), the incidence of other Grade 3/4 adverse reactions was below 3%. No Grade 4 adverse reactions occurred.
The most common adverse reactions (≥20%) included peripheral neuropathy, leukopenia, neutropenia, hand-foot syndrome, nausea, diarrhea, asthenia, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), anemia, and alopecia.
Grade 3 and above adverse reactions with an incidence >2% included peripheral neuropathy (no Grade 4 cases reported), neutropenia, diarrhea, hand-foot syndrome, leukopenia, and anemia.
Pregnancy
No relevant data on the use of Utidelone in pregnant women are currently available. Non-clinical studies suggest that this product may have potential reproductive toxicity. Women of childbearing potential are advised to take adequate contraceptive measures during treatment with Utidelone and for at least 8 weeks after the completion of treatment. If this product is used during pregnancy, or if a patient becomes pregnant during treatment, the patient should be informed of the potential hazards to the fetus, including developmental disorders and severe malformations. During pregnancy, this product may only be used when the potential benefits to the mother outweigh the risks.
Lactating Women
Whether Utidelone is excreted in human milk remains undetermined. Since Utidelone may cause severe adverse reactions in nursing infants, lactating women are advised to discontinue breastfeeding during treatment with Utidelone.
No data on the safety and efficacy of Utidelone in patients under 18 years of age are currently available.
Experience with the use of Utidelone in patients aged 65 years and older is limited.
For more detailed drug information, please consult the official package leaflet.
If any issues arise, please contact us immediately.
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