Trastuzumab deruxtecan 德曲妥珠单抗注射液

Effects and efficacy:
HER2-positive breast cancer: Single-agent treatment for unresectable or metastatic HER2-positive adult breast cancer patients who have received one or more anti-HER2 drugs; HER2-positive tumor status is defined as an immunohistochemistry (IHC) score of 3+, or a ratio of 2.0 determined by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) method. HER2-low-expressing breast cancer: Single-agent treatment for unresectable or metastatic HER2-low-expressing (IHC 1+ or IHC 2+/ISH-) adult breast cancer patients who have received at least one systemic treatment in the metastatic disease stage, or who have relapsed during adjuvant chemotherapy or within 6 months after completion of adjuvant chemotherapy. After binding to the HER2 receptor on tumor cells, trastuzumab is internalized into tumor cells, and then its linker is cleaved by lysosomal enzymes in tumor cells, releasing membrane-permeable DXd, which leads to DNA damage and cell apoptosis.
Usage and Dosage:
This product is for intravenous administration. It must be reconstituted and diluted by medical professionals and administered by intravenous infusion. This product should not be administered as an IV push or rapid IV injection. Reconstitution: Dilute immediately after reconstitution; more than one vial may be required for a full dose. Calculate the required dose (mg) and total volume of reconstituted solution for this product, as well as the number of vials of this product required; reconstitute by slowly injecting 5 mL of Sterile Water for Injection into a 100 mg vial using a sterile syringe to make a final concentration of 20 mg/mL; gently swirl the vial until completely dissolved. Do not shake; if not used immediately, reconstituted vials of this product may be stored in a refrigerator at 2-8°C, protected from light, for no more than 24 hours. Do not freeze; the reconstituted formulation does not contain a preservative and is for single use only. Dilution: Remove the calculated amount from the vial using a sterile syringe. Inspect the reconstituted solution for particles and discoloration. The solution should be clear and colorless to light yellow. Do not use if visible particles are observed or if the solution is turbid or discolored; dilute by adding the calculated volume of the reconstituted product to an infusion bag containing 100 mL of 5% glucose solution. Do not use sodium chloride solution. It is recommended to use infusion bags made of polyvinyl chloride or polyolefins (copolymers of ethylene and polypropylene); gently invert the infusion bag to thoroughly mix the solution. Do not shake; wrap the infusion bag to protect from light; if not used immediately, store at room temperature for up to 4 hours (including preparation and infusion) or in a refrigerator at 2-8°C for up to 24 hours, please protect from light. Do not freeze; the reconstituted product does not contain a preservative and is for single use only. Discard any unused portion of the vial. Administration: If the prepared infusion solution is stored in a refrigerator (2~8 ℃), it is recommended to remove the infusion solution before administration and equilibrate to room temperature under light-proof conditions; only 0.20 μm or 0.22 μm in-line polyethersulfone (PES) or polysulfone (PS) filters can be used for intravenous infusion of this product. Do not administer by intravenous push or rapid intravenous injection; the infusion bag needs to be kept away from light; do not mix this product with other drugs, or administer other drugs through the same intravenous infusion line. Dosing regimen: The recommended dose of this product is 5.4 mg/kg, administered by intravenous infusion once every 3 weeks (21 days per cycle) until disease progression or intolerable toxicity occurs. The initial dose should be a 90-minute intravenous infusion. If the previous infusion was well tolerated, the subsequent dose of this product can be administered by 30-minute infusion. Dose adjustment: The management of adverse reactions may require temporary interruption of administration, dose reduction, or termination of treatment with this product; after the dose is reduced, the dose of this product should not be increased. The same medicine produced by different manufacturers may have inconsistent instructions. If you find inconsistencies in the instructions before taking the medicine, please consult a doctor or pharmacist in time.
Drug contraindications:
Allergic to this product is prohibited. Use with caution during pregnancy. Use with caution during liver and kidney dysfunction. Use with caution during lactation.
Related dosage forms:
Injection
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