GEMTUZUMAB 4.5 MG INJECTION
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody. MYLOTARG (gemtuzumab ozogamicin) for Injection is supplied as a sterile, white to off-white,preservative-free lyophilized cake or powder for intravenous administration. Each single-dose vial delivers 4.5 mg gemtuzumab ozogamicin. Inactive ingredients are dextran 40 (41.0 mg), sodium chloride (26.1 mg), sodium phosphate dibasic anhydrous (2.7 mg), sodium phosphate monobasic monohydrate (0.45 mg), and sucrose (69.8 mg). After reconstitution with 5 mL of Sterile Water for Injection USP, the concentration is 1 mg/mL of gemtuzumab ozogamicin with a deliverable volume of 4.5 mL (4.5 mg).
Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution (3)
"As per Recommendation by Company:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf
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MYLOTARG is a CD33-directed antibody-drug conjugate indicated for: *Treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults. *Reatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
