|
KANJINTI(trastuzumab-anns)for injection, for intravenous useInitial U.S.(五)
5.1)]
Assess left ventricular ejection fraction (LVEF) prior to initiation of KANJINTI and at regular intervalsduring treatment. Withhold KANJINTI dosing for at least 4 weeks for either of the following:≥ 16% absolute decrease in LVEF from pre-treatment valuesLVEF below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pre-treatmentvalues.
KANJINTI may be resumed if, within 4–8 weeks, the LVEF returns to normal limits and the absolutedecrease from baseline is ≤ 15%.
Permanently discontinue KANJINTI for a persistent (> 8 weeks) LVEF decline or for suspension ofKANJINTI 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 preparedand administered is KANJINTI (trastuzumab-anns) and not ado-trastuzumab emtansine.
Reconstitution
Reconstitute each 420 mg vial of KANJINTI with 20 mL of Bacteriostatic Water for Injection (BWFI), USP,containing 0.9% to 1.1% benzyl alcohol as a preservative to yield a multiple-dose solution containing21 mg/mL trastuzumab-anns that delivers 20 mL (420 mg trastuzumab-anns). In patients with knownhypersensitivity to benzyl alcohol, reconstitute with 20 mL of Sterile Water for Injection (SWFI) withoutpreservative 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 lyophilizedpowder of KANJINTI, which has a cake-like appearance. The stream of diluent should be directed intothe cake. The reconstituted vial yields a solution for multiple-dose use, containing 21 mg/mLtrastuzumab-anns.
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 colorlessto pale yellow.
Store reconstituted KANJINTI in the refrigerator at 2°C to 8°C (36°F to 46°F); discard unused KANJINTIafter 28 days. If KANJINTI is reconstituted with SWFI without preservative, use immediately and discardany unused portion. Do not freeze.
Dilution
Determine the dose (mg) of KANJINTI [see Dosage and Administration (2.2)]. Calculate the volume ofthe 21 mg/mL reconstituted KANJINTI solution needed, withdraw this amount from the vial and add itto an 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 KANJINTI for infusion diluted in polyvinylchloride or polyethylene bags 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 4 hoursprior to use. Do not freeze.
3 DOSAGE FORMS AND STRENGTHS
For injection: 420 mg of KANJINTI as a white to pale yellow lyophilized powder in a multiple-dose vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
Trastuzumab products can cause left ventricular cardiac dysfunction, arrhyth |
|
