1. Indications and Usage
\nAdvanced Gastric Cancer:
\nTreatment of patients with advanced gastric cancer who have progressed during or after fluoropyrimidine- or platinum-containing chemotherapy.
\nSignificance: This approval marks the first oral formulation of paclitaxel, offering a non-invasive alternative to intravenous (IV) infusion for gastric cancer patients.
\n2. Dosage and Administration
\nRoute of Administration:
\nOral administration.
\nRecommended Dosage:
\nStandard Dose: 200 mg\/m\u00b2 (based on body surface area).
\nFrequency: Administered twice daily (BID).
\nSchedule: Treatment is given on Days 1, 8, and 15 of a 28-day cycle.
\nCritical Administration Instructions:
\nFood Intake: The drug should be taken under conditions that ensure consistent absorption (typically fasting or with specific dietary instructions as per physician guidance). Food can significantly impact bioavailability.
\nAdherence: Strict adherence to the dosing schedule is required to maintain therapeutic plasma concentrations.
\n3. Mechanism of Action
\nMicrotubule Stabilization:
\nPaclitaxel is a microtubule stabilizing agent. It binds to the beta-subunit of tubulin, promoting microtubule polymerization and preventing depolymerization.
\nTherapeutic Result: This arrests cell division at the G2\/M phase, inducing apoptosis in cancer cells.
\nBioavailability Enhancement (DH-LASED):
\nOvercoming Barriers: Unlike traditional IV paclitaxel (which uses the toxic solvent Cremophor EL), this oral solution utilizes lipid-based self-emulsifying drug delivery.
\nMechanism: This technology enhances solubility and absorption in the gastrointestinal tract while minimizing efflux by P-glycoprotein (P-gp) and degradation by intestinal CYP3A4 enzymes, achieving systemic exposure comparable to IV infusion.
\n4. Safety and Warnings
\nMyelosuppression:
\nLike IV paclitaxel, this drug can cause severe neutropenia and anemia. Regular monitoring of blood counts is required.
\nHypersensitivity Reactions:
\nAlthough the incidence is significantly lower than with IV paclitaxel due to the absence of Cremophor EL, hypersensitivity reactions (e.g., anaphylaxis, rash) can still occur.
\nReproductive Toxicity:
\nCan cause fetal harm. Patients of reproductive potential should use effective contraception.
\nContraindications:
\nHistory of serious hypersensitivity to paclitaxel or any excipients.
\nPatients with baseline neutrophil count < 1,500\/mm\u00b3.
\n5.Adverse Reactions and Clinical Research
\nMost Common Adverse Reactions:
\nNeutropenia, anemia, alopecia (hair loss), peripheral neuropathy, nausea, vomiting, diarrhea, and fatigue.
\nClinical Research Highlights:
\nEfficacy (Gastric Cancer): In the pivotal Phase 3 trial, the oral solution demonstrated a statistically significant improvement in Overall Survival (OS) compared to IV paclitaxel (9.13 months vs 6.54 months; HR 0.770).
\nSafety Advantage: The oral formulation showed a lower incidence of alopecia, peripheral neuropathy, and hypersensitivity reactions compared to the IV formulation, likely due to the avoidance of the Cremophor EL vehicle and first-pass metabolism.
\n6.Drug Interactions
\nCYP3A4 Substrates\/Inhibitors:
\nSince intestinal CYP3A4 plays a role in metabolism, caution is advised when co-administering with strong CYP3A4 inhibitors or inducers.
\nP-gp Inhibitors:
\nDrugs that inhibit P-glycoprotein may increase the bioavailability of paclitaxel.
\n7.Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Paclitaxel (in lipid-based self-emulsifying formulation).
\nAppearance: Liquid solution (filled in capsules or bottles depending on market).
\nPackaging: Blister packs.
\nStorage: Store at controlled room temperature.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name:\u67cf\u7ef4\u5e0c \u00ae\uff08Liporaxel\u00ae\uff09
\nGeneric Name: Paclitaxel
\nStrength: 30 mL : 300 mg per bottle
\nManufacturer: Zhejiang Hisun Haihe Pharmaceutical Co., Ltd. \/ Sansheng Pharmaceutical Co., Ltd.
\nMarketing Authorization Holder: Sansheng Pharmaceutical Co., Ltd.
\nApproval Date in China: April 18, 2024
\nRegistration Number: \u56fd\u836f\u51c6\u5b57H20240012
\nStorage: Store at 2\u00b0C\u20138\u00b0C, protected from light; avoid freezing. After opening, use within the specified period. Refer to the full package insert for detailed storage requirements.<\/p>\n
Price&Cost:Contact Us now for the best price of Paclitaxel\uff08Liporaxel\uff09<\/p>\n","protected":false},"featured_media":4367,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[73,70],"product_tag":[],"class_list":["post-4366","product","type-product","status-publish","has-post-thumbnail","product_cat-chinese-innovative-drug","product_cat-oral-solution","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n