ening infusion reactions.
Cardiomyopathy
[See Boxed Warning, Warnings and Precautions (5.1)]
Assess left ventricular ejection fraction (LVEF) prior to initiation of TRAZIMERA and at regular intervalsduring treatment. Withhold TRAZIMERA dosing for at least 4 weeks for either of the following:
• ≥ 16% absolute decrease in LVEF from pre-treatment values
• LVEF below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values.
TRAZIMERA may be resumed if, within 4 to 8 weeks, the LVEF returns to normal limits and the absolutedecrease from baseline is ≤ 15%.
Permanently discontinue TRAZIMERA for a persistent (> 8 weeks) LVEF decline or for suspension ofTRAZIMERA dosing on more than 3 occasions for cardiomyopathy.
2.4 Preparation for Administration
To prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared andadministered is TRAZIMERA (trastuzumab-qyyp) and not ado-trastuzumab emtansine.
420 mg Multiple-Dose Vial
Reconstitution
Reconstitute each 420 mg vial of TRAZIMERA with 20 mL of Bacteriostatic Water for Injection (BWFI)containing 1.1% benzyl alcohol as a preservative to yield a multiple-dose solution containing 21 mg/mL trastuzumab-qyyp that delivers 20 mL (420 mg trastuzumab-qyyp). In patients with known hypersensitivity to
benzyl alcohol, reconstitute with 20 mL of Sterile Water for Injection (SWFI) without preservative to yield a
single use solution.
Use appropriate aseptic technique when performing the following reconstitution steps:
• Using a sterile syringe, slowly inject the 20 mL of diluent into the vial containing the lyophilized powder ofTRAZIMERA, which has a cake-like appearance. The reconstituted vial yields a solution for multiple-doseuse, containing 21 mg/mL trastuzumab-qyyp.
• Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
• Slight foaming of the product may be present upon reconstitution. Allow the vial to stand undisturbed forapproximately 5 minutes.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior toadministration, whenever solution and container permit. Inspect visually for particulates and discoloration.
The solution should be free of visible particulates, clear to slightly opalescent and colorless to paleyellow-brown.
• Store reconstituted TRAZIMERA in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unusedTRAZIMERA after 28 days. If TRAZIMERA is reconstituted with SWFI without preservative, useimmediately and discard any unused portion. Do not freeze.
Dilution
• Determine the dose (mg) of TRAZIMERA [see Dosage and Administration (2.2)]. Calculate the volume ofthe 21 mg/mL reconstituted TRAZIMERA solution needed, withdrawthis amount from the vial and add it toan infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. DO NOT USE DEXTROSE(5%) SOLUTION.
• Gently invert the bag to mix the solution.
• The solution of TRAZIMERA for infusion diluted in polyvinylchloride, polyethylene, polypropylene,
or ethylene vinyl acetate bags or glass IV bottles containing 0.9% Sodium Chloride Injection, USP,should be stored at 2°C to 8°C (36°F to 46°F) for no more than 24 hours prior to use. Do not freeze.
3 DOSAGE FORMS AND STRENGTHS
For injection: 420 mg of TRAZIMERA as a white ly |
