How it is administered

Inotuzumab ozogamicin is given as an intravenous (IV) infusion. It comes as a sterile, preservative-free, lyophilized powder that is reconstituted and diluted before administration. The medication is administered over one hour, typically in a hospital or clinic setting.

Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended before each dose to reduce the risk of infusion-related reactions. The dosing schedule involves three doses per cycle, with adjustments based on response and tolerability. The exact dose is calculated based on body surface area (mg/m²).

How it works

Inotuzumab ozogamicin is a targeted therapy known as an antibody-drug conjugate (ADC). It consists of a humanized antibody that specifically binds to CD22, a protein found on the surface of most B-cell precursor acute lymphoblastic leukemia (ALL) cells. Attached to this antibody is a potent cytotoxic agent called calicheamicin.

Once inotuzumab ozogamicin binds to CD22 on the leukemia cell, the entire complex is internalized 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 programmed cell death (apoptosis) of the cancerous cell. The targeted nature of this therapy helps to deliver the cytotoxic drug directly to leukemia cells, sparing more of the healthy cells in the body.

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 therapies.

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, previous treatments, and overall health.

Who should not take it

There are no absolute contraindications listed for inotuzumab ozogamicin. However, caution is necessary in certain situations:

• Patients with a history of severe liver disease or previous veno-occlusive disease (VOD) are at increased risk for serious liver complications with this medication.
• Women who are pregnant or may become pregnant should not take inotuzumab ozogamicin, as it can cause harm to the unborn baby. Effective contraception is required during treatment and for several months after the last dose.
• Breastfeeding is not recommended during treatment and for at least 2 months after the last dose.

Always discuss your full medical history with your healthcare provider before starting this medication.

Commonly used with

Inotuzumab ozogamicin is often used as a single agent for relapsed or refractory ALL. However, it may be used as a bridge to hematopoietic stem cell transplantation (HSCT) in eligible patients. Supportive medications such as corticosteroids, antipyretics, and antihistamines are commonly given before infusions to reduce side effects.

In some treatment protocols, it may be combined with other chemotherapy agents or used in sequence with other therapies, depending on individual patient needs and treatment goals.

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 and sometimes in the context of preparing patients for stem cell transplantation.

Ongoing research is evaluating its use in combination with other targeted therapies or immunotherapies for blood cancers.