Gemtuzumab (Mylotarg) is an innovative CD33-directed antibody-drug conjugate (ADC) that plays a crucial role in the treatment of acute myeloid leukemia (AML). As a targeted therapy, it combines the specificity of antibodies with the cytotoxicity of chemotherapeutic agents.

What Are the Indications for Gemtuzumab (Mylotarg)?

Newly Diagnosed CD33-Positive Acute Myeloid Leukemia

Gemtuzumab is indicated for the treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adult patients and pediatric patients aged 1 month and older.

The approval of this indication provides an important treatment option for patients with newly diagnosed AML.

Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

The drug is also indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adult patients and pediatric patients aged 2 years and older.

For patients with disease recurrence, gemtuzumab offers an effective therapeutic alternative.

Specifications and Properties of Gemtuzumab (Mylotarg)

Basic Dosage Form and Specifications

Dosage Form: Injection.

Packaging Form: Single-dose vial.

Specification and Content: Each vial contains 4.5 mg of gemtuzumab ozogamicin.

Physical Characteristics

Lyophilized State: White to off-white lyophilized powder or cake.

Reconstituted State: The reconstituted solution is a clear, colorless to pale tan liquid.

Solubility: It can be reconstituted in sterile water for injection to a concentration of 1 mg/mL.

Drug Composition

Active Ingredient: Gemtuzumab ozogamicin.

Excipients:

Dextran 40: 41.0 mg

Sodium chloride: 26.1 mg

Disodium hydrogen phosphate anhydrous: 2.7 mg

Sodium dihydrogen phosphate monohydrate: 0.45 mg

Sucrose: 69.8 mg

Storage and Handling Methods of Gemtuzumab (Mylotarg)

Storage Requirements

Must be stored in a refrigerated environment at 2°C to 8°C (36°F to 46°F).

Freezing is strictly prohibited.

Prior to reconstitution, it should be kept in the original carton to protect from light.

Reconstitution Operating Specifications

Reconstitution Steps: Using aseptic technique, inject 5 mL of sterile water for injection into each vial.

Gently swirl the vial to facilitate dissolution.

Shaking is strictly prohibited to avoid affecting drug stability.

Reconstitution Time Limit: The reconstituted solution should be used immediately or stored refrigerated at 2-8°C for no more than 1 hour.