Inotuzumab Ozogamicin
Pronunciation: (in-oh-TOO-zoo-mab oh-zoe-GAM-i-sin).
- Generic name
- Inotuzumab ozogamicin
- Brand names
- Inotuzumab, Inozumab, Besponsa
- Drug class
- Antineoplastic agent; Anti-CD22 monoclonal antibody-drug conjugate
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Inotuzumab ozogamicin is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Inotuzumab ozogamicin works
Inotuzumab ozogamicin is a humanized monoclonal antibody-drug conjugate that targets CD22, a cell surface antigen expressed on B-cell malignancies. The antibody portion binds to CD22, facilitating internalization of the conjugate into the cell. Once inside, the cytotoxic agent calicheamicin is released, causing double-stranded DNA breaks and subsequent apoptosis of the malignant B-cell. FDA-approved for adults and, since March 6, 2024, for pediatric patients aged 1 year and older with relapsed/refractory CD22-positive B-cell precursor ALL. (1) (2)
What Inotuzumab ozogamicin is used for
Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)
FDA-approved for adults and pediatric patients aged 1 year and older. The pediatric indication (age 1+) was approved March 6, 2024, based on a 53-patient trial showing a 42% complete-remission rate. (2)
Acute lymphoblastic leukemia (ALL) in adults
Acute lymphoblastic leukemia (ALL) in adults (2)
Acute lymphoblastic leukemia (ALL) in pediatric patients aged 1 year and older
CORRECTED: this is now an FDA-APPROVED indication (since March 2024), not an off-label use as older product information described it. (2)
Before taking Inotuzumab ozogamicin
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to inotuzumab ozogamicin or its excipients. (Contraindication) (2)
Tell your clinician about
(2)How to take Inotuzumab ozogamicin
- General Instructions: Inotuzumab ozogamicin is administered by a healthcare professional as an intravenous infusion. Do not self-administer.. Adult and Pediatric (age 1+) Dosing: dosed by body surface area, split across Days 1, 8, and 15 of each treatment cycle — NOT the same amount on each day. Cycle 1 is 21 days: Day 1 = 0.8 mg/m², Day 8 = 0.5 mg/m², Day 15 = 0.5 mg/m² (totaling 1.8 mg/m² for the cycle); Cycle 1 may be extended to 28 days for patients achieving remission or to manage toxicity. Subsequent cycles are generally 28 days: patients in complete remission receive 0.5 mg/m² on Days 1, 8, and 15; patients not yet in remission receive 0.8 mg/m² on Day 1 and 0.5 mg/m² on Days 8 and 15. Dose adjustments may be needed based on response and side effects.. Pediatric Dosing: FDA-approved since March 2024 for ages 1 year and older; dosing is individualized by the treating oncologist using the same body-surface-area-based structure as adults.. Administration: Given as an IV infusion over 1 hour in a hospital or clinic. Pre-medications may be given to reduce infusion reactions.. When To Stop: Treatment may be discontinued if there is disease progression, unacceptable toxicity, or as directed by your healthcare provider — this is a clinical decision made by the treating oncology team, not something to decide alone.. Storage: This medication is stored and prepared by healthcare professionals. Patients do not need to store it at home.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If a dose is missed, contact your healthcare provider immediately to reschedule. Do not attempt to make up the dose on your own.
Overdose
In case of suspected overdose, seek emergency medical attention. Supportive care and monitoring for toxicity are essential, as there is no specific antidote. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Thrombocytopenia
Incidence: Reported in the clinician-authored database; frequency not established
Neutropenia
Incidence: Reported in the clinician-authored database; frequency not established
Hepatotoxicity
Incidence: Reported in the clinician-authored database; frequency not established
Veno-occlusive disease (VOD)
Incidence: Reported in the clinician-authored database; frequency not established
Infusion-related reactions
Incidence: Reported in the clinician-authored database; frequency not established
Hemorrhage
Incidence: Reported in the clinician-authored database; frequency not established
Infections
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
FDA BOXED WARNING (the strongest warning the FDA requires) — two components — serious
Symptoms: FDA BOXED WARNING (the strongest warning the FDA requires) — two components: (1) Hepatotoxicity, including fatal and life-threatening veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome. (2) Increased risk of post-hematopoietic stem cell transplant (HSCT) non-relapse mortality compared with standard chemotherapy. Risk of VOD is greater in patients who go on to have HSCT after treatment; risk factors include prior liver disease, prior HSCT, older age, and a greater number of treatment cycles.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Additional warnings from the clinician database, consistent with the boxed warning above — serious
Symptoms: Additional warnings from the clinician database, consistent with the boxed warning above: increased risk of severe infections due to low blood counts. Potential for infusion-related reactions. Monitor for signs of bleeding or bruising, and for QT prolongation.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
The FDA label does not list a formal contraindications section ("None") — serious
Symptoms: The FDA label does not list a formal contraindications section ("None"); the clinician database's caution against use in known hypersensitivity to inotuzumab ozogamicin or its excipients is a reasonable general safety principle, not a labeled FDA contraindication. Use with caution in patients with pre-existing liver disease, prior history of VOD, or those planning HSCT.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Inotuzumab ozogamicin may interact with other medications that affect liver function or blood counts. Avoid concurrent use with strong CYP3A4 inhibitors or inducers unless directed by your doctor. Inform your healthcare provider about all prescription, over-the-counter, and herbal products you use. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Can cause fetal harm based on its mechanism of action. Females of reproductive potential should use effective contraception during treatment and for 8 months after the last dose. Tell your oncology team if you are or might be pregnant, or are planning a pregnancy. (2)
Breastfeeding
Do not breastfeed during treatment and for 2 months after the last dose, per FDA labeling. (2)
Children
FDA-APPROVED (since March 6, 2024) for pediatric patients aged 1 year and older with relapsed/refractory CD22-positive B-cell precursor ALL — this corrects older product information that described pediatric use as unestablished/off-label. Dosing uses the same body-surface-area-based, cycle-day structure as adults (see how_to_take), individualized by the treating pediatric oncologist. Not established for children under 1 year of age. (2)
Renal_impairment
Use with caution in patients with pre-existing liver disease per the clinician database; hepatotoxicity (including VOD) is a boxed-warning risk that requires liver-function monitoring. Renal-impairment-specific dose adjustment is not established in the sources reviewed; discuss any kidney or liver condition with the treating oncologist. (2)
Hepatic_impairment
Use with caution in patients with pre-existing liver disease per the clinician database; hepatotoxicity (including VOD) is a boxed-warning risk that requires liver-function monitoring. Renal-impairment-specific dose adjustment is not established in the sources reviewed; discuss any kidney or liver condition with the treating oncologist. (2)
Monitoring
(2)Storage
This medication is stored and prepared by healthcare professionals in a hospital or clinic setting. Patients do not need to store it at home.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)
Dose summary: Total 1.8 mg/m² per cycle (NOT 1.8 mg/m² on each day), split as: Cycle 1 (21 days, may extend to 28): Day 1 = 0.8 mg/m², Day 8 = 0.5 mg/m², Day 15 = 0.5 mg/m². Subsequent cycles (28 days): patients in CR/CRi receive 0.5 mg/m² on Days 1, 8, 15; patients not in CR/CRi receive 0.8 mg/m² Day 1 and 0.5 mg/m² Days 8 and 15. Same structure applies to pediatric patients aged 1 year and older (FDA-approved March 2024), individualized by the treating oncologist.
Renal context: Renal-impairment-specific dose adjustment is not established in the clinician-authored database content or the FDA label reviewed; hepatic function (not renal function) is the primary organ-function monitoring concern given the boxed hepatotoxicity/VOD warning. (1) (2)
Frequently asked questions
What is inotuzumab ozogamicin used for?
It is used to treat adults and pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) when other treatments have not worked. The FDA approved use in children aged 1 and older in March 2024.
How does inotuzumab ozogamicin work?
It targets the CD22 protein on cancerous B-cells, delivering a chemotherapy agent directly to the cancer cells to help destroy them.
What are the most serious side effects?
The most serious risks include liver toxicity (veno-occlusive disease), severe infections, infusion reactions, and low blood counts.
Can I take inotuzumab ozogamicin if I am pregnant?
No, inotuzumab ozogamicin can cause fetal harm. Effective contraception is required during treatment and for 8 months after the last dose. Do not breastfeed during treatment and for 2 months after the last dose.
How is inotuzumab ozogamicin administered?
It is given as an intravenous infusion by a healthcare professional in a hospital or clinic setting.
What should I do if I miss a dose?
Contact your healthcare provider immediately to reschedule the missed dose. Do not try to self-administer or double up doses.
Are there any foods or medicines I should avoid?
Avoid live vaccines, alcohol, and new medications or supplements without consulting your doctor, as these may increase the risk of side effects or interactions.
What happens if I take too much Inotuzumab ozogamicin?
Taking too much Inotuzumab ozogamicin can lead to severe adverse effects, potentially exacerbating common side effects such as myelosuppression, hepatotoxicity, and veno-occlusive disease. If an overdose is suspected, it is crucial to seek immediate emergency medical attention. Healthcare providers will monitor for complications and provide supportive care as needed to manage symptoms.
Can I drink alcohol while taking Inotuzumab ozogamicin?
It is generally advisable to avoid or limit alcohol consumption while taking Inotuzumab ozogamicin. As an antineoplastic agent, this medication can impact liver function, and alcohol can further increase the risk of liver damage or exacerbate existing hepatotoxicity. Always consult your healthcare provider for personalized advice regarding alcohol intake during your treatment.
Is Inotuzumab ozogamicin safe during pregnancy?
Inotuzumab ozogamicin is not recommended for use during pregnancy. Due to its mechanism of action and potential for fetal harm, it is categorized as a medication that requires careful consideration. Women of childbearing potential should use effective contraception during treatment and for 8 months after the last dose. Always consult your doctor to discuss the risks and benefits if you are pregnant or planning to become pregnant.
Can children receive inotuzumab ozogamicin?
Yes — the FDA approved inotuzumab ozogamicin for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor ALL on March 6, 2024, based on a trial in 53 pediatric patients showing a 42% complete-remission rate. This is a formally approved indication, not an off-label use. It is not established for children under 1 year of age.
What is the mechanism of action of Inotuzumab ozogamicin?
Inotuzumab ozogamicin is a humanized monoclonal antibody-drug conjugate that targets CD22, a cell surface antigen expressed on B-cell malignancies. The antibody portion binds to CD22, facilitating internalization of the conjugate into the cell. Once inside, the cytotoxic agent calicheamicin is released, causing double-stranded DNA breaks and subsequent apoptosis of the malignant B-cell. FDA-approved for adults and, since March 6, 2024, for pediatric patients aged 1 year and older with relapsed/refractory CD22-positive B-cell precursor ALL. (1) (2)
What is the generic name of Inotuzumab Ozogamicin?
The generic name is Inotuzumab ozogamicin. It is sold under brand names including Inotuzumab, Inozumab, Besponsa.
What class of drug is Inotuzumab ozogamicin?
Inotuzumab Ozogamicin is classed as: Antineoplastic agent; Anti-CD22 monoclonal antibody-drug conjugate.
References
- Inotuzumab ozogamicin clinician-authored medicine recordMedGuideGlobal · Not applicable · accessed 2026-08-06 · source 1
- BESPONSA (inotuzumab ozogamicin) for injection — prescribing informationU.S. Food and Drug Administration · United States · dated 2024-03-06 · accessed 2026-08-06 · source 2
- Inotuzumab Ozogamicin Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Besponsa — FDA approval record (Drugs@FDA BLA761040)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- Inotuzumab ozogamicin — RxNorm normalized drug concept (RXCUI 1942950)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Inotuzumab ozogamicin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Besponsa.25 mg/mL · wyeth pharmaceuticals llc, a subsidiary of pfizer inc.