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MYLOTARG™ How Supplied/Storage and Handling (gemtuzumab ozogamicin)

16 HOW SUPPLIED/STORAGE AND HANDLING

MYLOTARG (gemtuzumab ozogamicin) for Injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial [see Dosage and Administration (2)].

Refrigerate (2–8°C; 36–46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE.

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

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