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BESPONSA™ How Supplied/Storage and Handling (inotuzumab ozogamicin)

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

BESPONSA (inotuzumab ozogamicin) for Injection is supplied as a white to off-white lyophilized powder in a single-dose vial for reconstitution and further dilution. Each vial delivers 0.9 mg inotuzumab ozogamicin. Each carton (NDC 0008-0100-01) contains one single-dose vial.

16.2 Storage and Handling

Refrigerate (2–8°C; 36–46°F) BESPONSA vials and store in the original carton to protect from light. Do not freeze.

BESPONSA is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

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