(trastuzumab-qyyp)

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

420 mg Multiple-dose vial

TRAZIMERA (trastuzumab-qyyp) for injection 420 mg/vial is supplied in a multiple-dose vial as a sterile, white lyophilized powder. Each carton contains one multiple-dose vial of TRAZIMERA and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol as a preservative.

NDC 0069-0305-01.

150 mg Single-dose vial

TRAZIMERA (trastuzumab-qyyp) for injection 150 mg/vial is supplied in a single-dose vial as a sterile, white lyophilized powder. Each carton contains one single-dose vial of TRAZIMERA.

NDC 0069-0308-01.

16.2 Storage

Store TRAZIMERA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

If needed, unopened TRAZIMERA vials may be removed from the refrigerator and stored at room temperature up to 30°C (86°F) for a single period of up to 3 months in the original carton to protect from light. Once removed from the refrigerator, do not return to the refrigerator and discard after 3 months or by the expiration date stamped on the vial, whichever occurs first. Write the revised expiration date in the space provided on the carton labeling.

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