Inotuzumab ozogamicin (Besponsa) is an antibody-drug conjugate targeting CD22, indicated for patients with specific types of acute lymphoblastic leukemia.

Indications for Inotuzumab Ozogamicin (Besponsa)

Primary Indications

Inotuzumab ozogamicin is primarily indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia in adult patients and pediatric patients aged 1 year and older.

By targeting the CD22 antigen, the drug delivers cytotoxic agents precisely to leukemia cells, thereby achieving therapeutic effects.

Specifications and Properties of Inotuzumab Ozogamicin (Besponsa)

Specifications

Inotuzumab ozogamicin is a lyophilized powder for injection, with each vial containing 0.9 mg of the active ingredient.

It appears as a white to off-white, sterile, preservative-free, single-dose package.

Properties

Each vial must be reconstituted with 4 mL of sterile water for injection before use. The reconstituted solution has a concentration of 0.25 mg/mL, with a withdrawable volume of 3.6 mL (equivalent to 0.9 mg of the active ingredient).

The reconstituted solution should be clear to opalescent, colorless to slightly yellow, and free of visible particles.

Composition

Excipients of inotuzumab ozogamicin include polysorbate 80, sodium chloride, sucrose, and tromethamine.

The pH of the reconstituted solution is approximately 8.0.

Storage Methods for Inotuzumab Ozogamicin (Besponsa)

Unreconstituted Drug

Should be stored under refrigeration at 2°C to 8°C (36°F to 46°F) and kept in the original packaging to protect from light.

Freezing is not allowed.

Reconstituted Solution

If not used immediately, the reconstituted solution can be stored under refrigeration for a maximum of 4 hours, with protection from light.

The total time from reconstitution to the end of administration must not exceed 8 hours, with the interval between reconstitution and dilution not exceeding 4 hours.

Diluted Solution

The diluted drug solution can be stored at room temperature or under refrigeration for a maximum of 6 hours.

If stored under refrigeration, it should be equilibrated to room temperature for approximately 1 hour before administration. The entire process from reconstitution to the end of infusion must be completed within 8 hours.

Special Precautions

Inotuzumab ozogamicin is classified as a hazardous drug. Handling must comply with relevant protection and waste disposal standards to avoid skin contact or inhalation of aerosols.