10:00 Antineoplastic Agents
Generic Name
Ado-trastuzumab emtansine is available as a lyophilized powder in single-dose vials containing ado-trastuzumab emtansine 100 or 160 mg.3343 Each 100- or 160-mg vial should be reconstituted with 5 or 8 mL, respectively, of sterile water for injection to yield a solution containing ado-trastuzumab emtansine 20 mg/mL.3343 The vial should swirled gently until the powder is completely dissolved; do not shake.3343 Each mL of solution following reconstitution contains ado-trastuzumab emtansine 20 mg, polysorbate 20 0.2 mg, succinic acid 1.18 mg, sodium hydroxide 0.45 mg, and sucrose 60 mg.3343
The appropriate dose of the reconstituted solution should be diluted in an infusion bag containing 250 mL sodium chloride 0.9%.3343 The bag should be gently inverted to mix the solution.3343
CAUTION: Care should be taken to ensure that the correct drug product is prepared and that no confusion with other products (e.g., trastuzumab) occurs.3343
pH
The reconstituted solution has a pH of 5.3343
Trade Name(s)
Kadcyla
Ado-trastuzumab emtansine is administered only by intravenous infusion following reconstitution and further dilution in 250 mL of sodium chloride 0.9%.3343 The diluted solution for infusion should be administered through a 0.2- or 0.22 µm inline polyethersulfone filter.3343 Do not administer as an intravenous push or bolus injection.3343 The first infusion should be administered over 90 minutes.3343 Subsequent infusions may be administered over 30 minutes if prior infusions were well tolerated.3343
Ado-trastuzumab emtansine should not be mixed or infused with other drugs.3343
Intact vials should be stored at 2 to 8°C until time of reconstitution.3343 Do not freeze or shake.3343
Ado-trastuzumab emtansine is a white to off-white lyophilized powder that forms a clear to slightly opalescent, colorless to pale brown solution upon reconstitution.3343 The reconstituted solution should be free of visible particulates.3343
The reconstituted solution may be stored for up to 24 hours at 2 to 8°C; the reconstituted solution should be discarded if not used after 24 hours.3343 Do not freeze.3343
The diluted solution for infusion may be stored for up to 24 hours at 2 to 8°C (in addition to the storage time allowed for reconstituted vials).3343 Do not freeze or shake diluted solution.3343
Filtration
The diluted solution for infusion should be administered through a 0.2- or 0.22 µm inline polyethersulfone filter.3343
For a list of references cited in the text of this monograph, search the monograph titled References.