MYLOTARG™ Description

(gemtuzumab ozogamicin)

11. DESCRIPTION

Chemical Structure

Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.

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).

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Description

11. DESCRIPTION

Chemical Structure

Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.

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).

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