How it is administered

Inotuzumab ozogamicin is given as an intravenous (IV) infusion. It comes as a sterile, lyophilized powder that is reconstituted and diluted before administration. The medication is administered in cycles, with the dose based on your body surface area (mg/m²). Each cycle typically involves three infusions on Day 1, Day 8, and Day 15. The first cycle lasts 21 days (can be extended to 28 days if needed), and subsequent cycles are 28 days long. Premedication with a corticosteroid, antipyretic, and antihistamine is recommended before each infusion to reduce the risk of infusion-related reactions.

How it works

Inotuzumab ozogamicin is a type of targeted cancer therapy known as an antibody-drug conjugate (ADC). It works by combining a monoclonal antibody that specifically targets CD22, a protein found on the surface of most B-cell leukemia cells, with a cytotoxic (cell-killing) agent called calicheamicin.

When inotuzumab ozogamicin binds to the CD22 protein on leukemia cells, the entire complex is taken into the cell. Inside the cell, the cytotoxic agent is released, causing double-stranded breaks in the DNA. This leads to cell cycle arrest and ultimately, cell death. By specifically targeting CD22-positive cells, inotuzumab ozogamicin helps to destroy leukemia cells while minimizing effects on normal, healthy cells.

Who Should take it

Inotuzumab ozogamicin is indicated for adults and children (1 year and older) with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). This means it is used when the leukemia has returned after previous treatment or has not responded to other treatments.

It is especially considered for patients whose leukemia cells express the CD22 protein, as the medication specifically targets these cells. The decision to use inotuzumab ozogamicin is made by your healthcare team based on your specific disease characteristics, prior treatments, and overall health.

Who should not take it

There are no absolute contraindications listed for inotuzumab ozogamicin, but it should be used with caution in certain situations. Patients with a history of severe liver disease, including previous veno-occlusive disease (VOD) or ongoing serious liver problems, may be at increased risk for severe side effects and should discuss these risks with their doctor.

Women who are pregnant should not take inotuzumab ozogamicin, as it can cause harm to an unborn baby. Women should use effective contraception during treatment and for 8 months after the last dose. Men with female partners of reproductive potential should use contraception during treatment and for 5 months after the last dose. Breastfeeding is not recommended during treatment and for 2 months after the last dose.

Commonly used with

Inotuzumab ozogamicin is often used alone for relapsed or refractory CD22-positive B-cell precursor ALL. However, it may be used as a bridge to hematopoietic stem cell transplant (HSCT) for eligible patients, and supportive medications such as corticosteroids, antipyretics, and antihistamines are given to reduce side effects. In some treatment protocols, it may be combined with other chemotherapy agents, but this depends on individual treatment plans.

Commonly tested with

In clinical studies, inotuzumab ozogamicin has been compared with standard chemotherapy regimens such as FLAG (fludarabine, cytarabine, and granulocyte colony-stimulating factor), mitoxantrone plus cytarabine, or high-dose cytarabine. It is also tested in combination with supportive care medications to manage side effects. For patients proceeding to stem cell transplant, it is part of a broader treatment plan that may include other chemotherapies and transplant conditioning regimens.