Enhertu Caution For Usage


Daiichi Sankyo




Daiichi Sankyo
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Full Prescribing Info
Caution For Usage
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling.
Sodium chloride solution for infusion must not be used for reconstitution or dilution since it may cause particulate formation
Special precautions for disposal and other handling: In order to prevent medicinal product errors, it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Enhertu (trastuzumab deruxtecan) and not trastuzumab or trastuzumab emtansine.
Appropriate procedures for the preparation of chemotherapeutic medicinal products should be used. Appropriate aseptic technique should be used for the following reconstitution and dilution procedures.
Reconstitution: Reconstitute immediately before dilution.
More than one vial may be needed for a full dose. Calculate the dose (mg), the total volume of reconstituted Enhertu solution required, and the number of vial(s) of Enhertu needed (see Dosage & Administration).
Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of water for injection into each vial to obtain a final concentration of 20 mg/mL.
Swirl the vial gently until completely dissolved. Do not shake.
Inspect the reconstituted solution for particulates and discolouration. The solution should be clear and colourless to light yellow. Do not use if visible particles are observed or if the solution is cloudy or discoloured.
If not used immediately, store the reconstituted Enhertu vials in a refrigerator at 2 °C to 8 °C for up to 24 hours from the time of reconstitution, protected from light. Do not freeze.
The reconstituted product contains no preservative and is intended for single use only.
Dilution: Dilute the calculated volume of reconstituted Enhertu in an infusion bag containing 100 mL of 5% glucose solution. Do not use sodium chloride solution (see Incompatibilities). An infusion bag made of polyvinylchloride or polyolefin (copolymer of ethylene and polypropylene) is recommended.
Gently invert the infusion bag to thoroughly mix the solution. Do not shake.
Cover 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 °C to 8 °C for up to 24 hours, protected from light. Do not freeze.
Discard any unused portion left in the vial.
Administration: If the prepared infusion solution was stored refrigerated (2 °C to 8 °C), it is recommended that the solution be allowed to equilibrate to room temperature prior to administration, protected from light.
Administer Enhertu as an intravenous infusion only with a 0.20 or 0.22 micron in-line polyethersulfone (PES) or polysulfone (PS) filter.
The initial dose should be administered as a 90-minute intravenous infusion. If the prior infusion was well tolerated, subsequent doses of Enhertu may be administered as 30-minute infusions. Do not administer as an intravenous push or bolus (see Dosage & Administration).
Do not mix Enhertu with other medicinal products or administer other medicinal products through the same intravenous line.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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