Inotuzumab Ozogamicin Injection
Inotuzumab ozogamicin injection (Besponsa) is an antibody-drug conjugate used to treat relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 year and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Besponsa carries a serious FDA boxed warning for life-threatening liver damage and higher death rates after stem cell transplant.
A dangerous liver condition called veno-occlusive disease (VOD) — where blood flow through the liver becomes blocked — has occurred in patients receiving Besponsa, including fatal cases. The risk of VOD is especially high in patients who undergo a stem cell transplant (HSCT) after treatment, particularly if the transplant uses two alkylating chemotherapy drugs or if bilirubin levels were already elevated before the transplant. Other factors that raise VOD risk include pre-existing liver disease, a previous HSCT, older age, more prior treatment lines, and more Besponsa cycles. Watch for warning signs: yellowing of the skin or eyes, sudden weight gain, painful abdominal swelling, or abdominal fluid buildup. Additionally, patients who received Besponsa had a higher rate of death from causes other than cancer relapse in the period after stem cell transplant compared to those who received standard chemotherapy.
📖 Inotuzumab Ozogamicin Injection: Patient Information Guide
A plain-language walkthrough of Inotuzumab Ozogamicin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Inotuzumab ozogamicin injection is a targeted cancer therapy approved for a specific type of leukemia.
- Besponsa (intravenous) is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year of age and older — meaning ALL that has come back after treatment or has not responded to prior therapy
⚙️How it works▾
Besponsa is an antibody-drug conjugate (ADC) — a two-part weapon against leukemia. The antibody part locks onto a protein called CD22, which is found on the surface of the leukemia cells being targeted. Once bound, the whole complex is drawn inside the cancer cell. There, the attached cytotoxic (cell-killing) agent — calicheamicin — is released. It causes double-strand breaks in the cancer cell's DNA, which triggers cell cycle arrest (the cell stops dividing) and apoptosis (programmed cell death), ultimately destroying the leukemia cell.
💊How it's taken▾
Besponsa is given by intravenous (IV) infusion at a clinic or hospital — it is not available as a pill or home injection. Treatment is organized into cycles, with infusions given on specific days (typically Day 1, Day 8, and Day 15 of each cycle). The length of each cycle and the number of cycles depend on how your disease responds to treatment. Your dose is calculated based on your body surface area. Always follow your oncologist's exact schedule.
- Pre-medications are given before every infusion to reduce infusion reactions
- Patients with high numbers of circulating leukemia cells may need additional medications before the first dose to bring those counts down
- If you are heading toward a stem cell transplant, your team will plan the number of Besponsa cycles accordingly
🤒Side effects — in detail▾
The most common side effects seen with Besponsa include:
- Low platelet count (thrombocytopenia) — raises risk of bruising and bleeding
- Low neutrophil count (neutropenia) — raises infection risk
- Anemia (low red blood cell count)
- Low white blood cell count (leukopenia)
- Fever (pyrexia)
- Nausea and vomiting
- Fatigue
- Headache
- Elevated liver enzymes and bilirubin on blood tests
- Bleeding (hemorrhage) of various types, most commonly nosebleeds
Serious reactions that need prompt medical attention include signs of liver veno-occlusive disease (jaundice, rapid weight gain, belly swelling), severe infections including febrile neutropenia, significant bleeding, infusion reactions (fever, chills, rash, breathing trouble during or after infusion), and heart rhythm changes (palpitations, feeling faint).
⚠️Warnings & precautions▾
- Hepatic veno-occlusive disease (VOD): This life-threatening liver condition has occurred in Besponsa patients, including fatal cases. Risk is highest after a subsequent stem cell transplant. Signs include jaundice, rapid weight gain, painful liver enlargement, and abdominal fluid buildup. Liver tests must be monitored before and after every dose.
- Higher post-transplant mortality: Patients who received Besponsa had a higher rate of death not related to cancer relapse in the 100 days after stem cell transplant, compared to those who received standard chemotherapy. The main causes were VOD and infections.
- Myelosuppression (bone marrow suppression): Besponsa frequently causes low counts of platelets, neutrophils, and red blood cells, leading to serious infection, bleeding, and febrile neutropenia risks. Blood counts are monitored before each dose.
- QT prolongation: Besponsa can lengthen the heart's electrical cycle (QT interval), potentially causing dangerous arrhythmias. ECGs and electrolyte levels are monitored during treatment.
- Infusion reactions: Reactions can occur during or shortly after infusion — patients are pre-medicated and monitored for at least 1 hour after each infusion.
- Embryo-fetal toxicity: Besponsa can cause serious harm to a developing baby. Effective contraception is required during treatment and for months after the last dose.
🔀What it interacts with▾
Besponsa has one key drug interaction category to be aware of:
- QT-prolonging drugs (medicines that affect heart rhythm, such as certain antibiotics, antifungals, antipsychotics, and antiarrhythmics): Using these at the same time as Besponsa can increase the risk of a potentially dangerous abnormal heart rhythm called Torsades de Pointes. Your doctor should switch you to alternatives when possible, or monitor your heart rhythm and electrolytes more closely if those medications cannot be avoided.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Liver disease: Tell your doctor if you have or have had liver disease, cirrhosis, nodular regenerative hyperplasia, or active hepatitis — you are at much higher risk for VOD
- Prior stem cell transplant: A previous HSCT significantly raises VOD risk with Besponsa
- Pregnancy: Besponsa can harm an unborn baby. Females of reproductive potential must use effective contraception during treatment and for 8 months after the last dose. Males with female partners of reproductive potential should use contraception during treatment and for 5 months after the last dose. A pregnancy test is done before starting treatment.
- Breastfeeding: Do not breastfeed during Besponsa treatment or for 2 months after the last dose
- Fertility: Based on animal studies, Besponsa may affect fertility in both males and females — discuss this with your doctor before starting treatment if this is a concern
- Heart rhythm issues: Tell your doctor if you have a history of QT prolongation, low potassium or magnesium, or take any medications that affect heart rhythm
- Pediatric patients (1 year and older): Besponsa is approved for children 1 year and older. Children tend to have higher drug exposure and higher rates of liver test abnormalities than adults and require close monitoring
- Children under 1 year: Safety and effectiveness have not been established in infants under 1 year old
- Older adults (65+): No meaningful difference in efficacy was seen in older patients; no starting dose adjustment is required based on age alone
- Kidney impairment: Mild to severe kidney impairment does not significantly affect how the body clears Besponsa; the safety in end-stage renal disease or dialysis patients is not established
- Hepatic impairment: Mild hepatic impairment does not require a starting dose adjustment, but dosing interruptions or permanent discontinuation may be needed if liver tests worsen during treatment
📡Pharmacodynamics — effects in the body▾
During treatment, Besponsa works by depleting CD22-positive leukemic blasts — the abnormal cancer cells — in the blood and bone marrow. Besponsa can also affect the heart's electrical activity: it has been shown to prolong the QT interval (the time the heart takes to reset between beats), which is why heart monitoring with ECGs is part of standard care during treatment.
🔬Pharmacokinetics — how your body processes it▾
Besponsa is given intravenously and distributes into a relatively small volume in the body (about 12 liters). It accumulates with repeated dosing, reaching steady-state levels by around the fourth treatment cycle. The drug has a terminal half-life of approximately 12.3 days — meaning it takes roughly that long for levels to fall by half after dosing stops. The active payload (calicheamicin) is broken down primarily through a non-enzyme chemical process, and its levels in the blood are typically too low to detect. The body does not clear Besponsa significantly faster or slower based on age, sex, or race; however, dose is calculated based on body surface area, and pediatric patients tend to have about 30% higher drug exposure than adults at the same body-surface-area-based dose.
📦How to store it▾
How Supplied BESPONSA (inotuzumab ozogamicin) for injection is supplied as a white to off-white lyophilized powder in a single-dose vial for reconstitution and further dilution. Refrigerate (2-8°C; 36-46°F) BESPONSA vials and store in the original carton to protect from light.
📄 Written from Inotuzumab Ozogamicin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Inotuzumab Ozogamicin Injection
13 supplements and herbal products have documented interactions with Inotuzumab Ozogamicin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 7
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Inotuzumab Ozogamicin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Besponsa and why was I prescribed it? ▾
How will I receive Besponsa — is it a pill or an injection? ▾
What are the most important side effects I should watch for at home? ▾
I'm also taking other medications. Is there anything Besponsa can interact with? ▾
Can I become pregnant or breastfeed while on Besponsa? ▾
Will my liver be at risk during treatment? ▾
Is Inotuzumab Ozogamicin Injection available over the counter? ▾
When was Inotuzumab Ozogamicin Injection first available? ▾
💬 Answers drafted from Inotuzumab Ozogamicin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Inotuzumab Ozogamicin Injection comes
Inotuzumab Ozogamicin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Besponsa is used intravenously to treat relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and pediatric patients 1 year of age and older
- Besponsa is given as an intravenous infusion only — never injected any other way
- Before each Besponsa infusion, you will receive pre-medications including a corticosteroid, antipyretic (fever reducer), and antihistamine to reduce the risk of infusion reactions
- Patients are observed during the infusion and for at least 1 hour afterward for any signs of a reaction
- Besponsa is prepared from a lyophilized (freeze-dried) powder that is reconstituted and diluted by trained pharmacy or clinical staff before administration
📊 Inotuzumab Ozogamicin Injection across the U.S. market
How Inotuzumab Ozogamicin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Inotuzumab Ozogamicin Injection is used
A general measure of how commonly Inotuzumab Ozogamicin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Inotuzumab Ozogamicin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Inotuzumab Ozogamicin Injection prescribed? Of the 1,596 medications we measure, Inotuzumab Ozogamicin Injection ranks #1,515 by Medicaid prescriptions — more than 5% of them.
Utilization by Inotuzumab Ozogamicin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
inotuzumab ozogamicin 0.9 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1942954
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Inotuzumab Ozogamicin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Inotuzumab Ozogamicin Injection NDCs with Medicaid activity.
🔍 Compare Inotuzumab Ozogamicin Injection products
A representative set of FDA-listed product records for Inotuzumab Ozogamicin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 0.25 mg/mL | Intravenous | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. × 2 listings | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Inotuzumab Ozogamicin Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Inotuzumab Ozogamicin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Inotuzumab Ozogamicin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Inotuzumab Ozogamicin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1942950 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1942953In current FDA listingsClinical drug / strength (SCD) 0.9 MGRxCUI 1942954
Look up RxCUI 1942950 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Inotuzumab Ozogamicin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Inotuzumab Ozogamicin Injection belongs to the CD22-directed Immunoconjugate class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.