Gemtuzumab Ozogamicin Injection
Gemtuzumab ozogamicin injection (Mylotarg) is an intravenous cancer medicine used to treat CD33-positive acute myeloid leukemia (AML), both newly diagnosed and relapsed or refractory.
🧬 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 →
How we combine label and product data →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Mylotarg can cause serious, sometimes fatal liver damage, including veno-occlusive disease (VOD). VOD means the small veins in the liver become blocked. It has occurred when Mylotarg is used alone or with other chemotherapy.
Warning signs include painful liver enlargement, rapid weight gain, belly swelling, and abnormal liver blood tests. Your care team should monitor you often after treatment. Tell them right away if you notice any of these signs.
Patient information guide — a plain-language walkthrough of Gemtuzumab Ozogamicin Injection, written from its FDA label.
What Gemtuzumab Ozogamicin Injection is used for
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Gemtuzumab ozogamicin injection treats CD33-positive acute myeloid leukemia (AML).
- Mylotarg (intravenous): newly diagnosed CD33-positive AML in adults and children 1 month and older.
- Mylotarg (intravenous): relapsed or refractory CD33-positive AML in adults and children 2 years and older.
How Gemtuzumab Ozogamicin Injection works
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Gemtuzumab ozogamicin is an antibody-drug conjugate. The antibody part recognizes CD33, a protein on the surface of leukemia cells.
Once attached, the cell takes in the drug and releases a cell-killing agent called calicheamicin. It causes breaks in the cell's DNA, which stops the cell from dividing and leads to its death.
Gemtuzumab Ozogamicin Injection dosage
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Mylotarg is given by IV infusion in a clinic or hospital. The schedule depends on the type of AML, your age, and whether it is combined with other chemotherapy.
- Some regimens give several doses across the first week of a cycle. Others give one dose per cycle.
- You will get a corticosteroid, an antihistamine, and acetaminophen beforehand.
- Your team will also take steps to prevent tumor lysis syndrome and may lower very high white blood cell counts first.
- Your team may delay or stop treatment based on liver tests, blood counts, or reactions.
Follow your prescriber's plan. Your care team handles scheduling, so ask them if you miss an appointment.
Dosing details from the FDA-approved label
From the Gemtuzumab Ozogamicin Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Newly-diagnosed de novo CD33-positive AML (combination regimen) - Adults, induction
- 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine
- Maximum: up to one 4.5 mg vial
- Do NOT administer MYLOTARG during a second induction cycle
- Newly-diagnosed de novo CD33-positive AML (combination regimen) - Adults, consolidation
- 3 mg/m2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine
- Maximum: up to one 4.5 mg vial
- 2 consolidation cycles; discontinue if platelets do not recover to 100 Gi/L or neutrophils to 0.5 Gi/L within 14 days of planned start
- Newly-diagnosed de novo CD33-positive AML (combination regimen) - Pediatric patients 1 month and older with BSA 0.6 m2 or greater
- 3 mg/m2
- Given once in Induction 1 and once in Intensification 2 with standard chemotherapy
- No MYLOTARG in second induction or in first or third intensification cycles
- Newly-diagnosed de novo CD33-positive AML (combination regimen) - Pediatric patients 1 month and older with BSA less than 0.6 m2
- 0.1 mg/kg
- Given once in Induction 1 and once in Intensification 2 with standard chemotherapy
- No MYLOTARG in second induction or in first or third intensification cycles
- Newly-diagnosed CD33-positive AML (single-agent regimen) - Adults, induction
- 6 mg/m2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8
- Newly-diagnosed CD33-positive AML (single-agent regimen) - Adults, continuation
- 2 mg/m2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks, up to 8 continuation courses
- Maximum: up to 8 continuation courses
- For patients without evidence of disease progression following induction
- Relapsed or refractory CD33-positive AML (single-agent regimen) - Adults and pediatric patients 2 years and older
- 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4, and 7
- Maximum: up to one 4.5 mg vial
- Single course of MYLOTARG
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Newly-diagnosed, de novo AML (combination regimen) Adults : - Induction: 3 mg/m 2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine ( 2.2 ). - Consolidation: 3 mg/m 2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine ( 2.2 ). Pediatric patients 1 month and older : - 3 mg/m 2 for patients with body surface area (BSA) 0.6 m 2 or greater ( 2.2 ). - 0.1 mg/kg for patients with BSA less than 0.6 m 2 ( 2.2 ). - See Full Prescribing Information for complete dosing information ( 2.2 ). • Newly-diagnosed AML (single-agent regimen): Adults : - Induction: 6 mg/m 2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m 2 (not limited to one 4.5 mg vial) on Day 8 ( 2.2 ). - Continuation: For patients without evidence of disease progression following induction, up to 8 continuation courses of MYLOTARG 2 mg/m 2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks ( 2.2 ). • Relapsed or refractory AML (single-agent regimen): Adults and pediatric patients 2 years and older: - 3 mg/m 2 (up to one 4.5 mg vial) on Days 1, 4, and 7 ( 2.2 ). • Premedicate with a corticosteroid, antihistamine, and acetaminophen ( 2.1 ). 2.1 Premedication and Special Considerations • Premedicate adults with acetaminophen 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour prior to MYLOTARG dosing and 1 mg/kg methylprednisolone or an equivalent dose of an alternative corticosteroid within 30 minutes prior to infusion of MYLOTARG. • Premedicate pediatric patients 1 month and older with acetaminophen 15 mg/kg (maximum of 650 mg) and diphenhydramine 1 mg/kg (maximum of 50 mg) 1 hour prior to MYLOTARG dosing, and 1 mg/kg methylprednisolone orally or intravenously within 30 minutes prior to infusion of MYLOTARG; additional doses of acetaminophen and diphenhydramine may be administered every 4 hours after the initial pretreatment dose. Repeat with the same dose of methylprednisolone or an equivalent corticosteroid for any sign of an infusion reaction, such as fever, chills, hypotension, or dyspnea during the infusion or within 4 hours afterwards [see Warnings and Precautions (5.2) ] . • Use appropriate measures to prevent tumor lysis syndrome.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Gemtuzumab Ozogamicin Injection side effects
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Common side effects
- Bleeding (hemorrhage)
- Infection
- Fever
- Nausea and vomiting
- Constipation
- Headache
- Rash
- Mouth sores (mucositis)
When to get medical help
- Tell your care team right away about painful liver swelling, rapid weight gain, belly swelling, or yellowing of the skin or eyes. These can be signs of serious liver damage (VOD).
- Get help right away for fever, chills, dizziness or low blood pressure, fast heartbeat, or trouble breathing during or within 24 hours after the infusion.
- Report any unusual or severe bleeding or easy bruising right away. Bleeding can be life-threatening.
- Report signs of infection, such as fever, promptly. Infections can be severe.
The most common side effects (in more than 15% of people) include:
- Bleeding
- Infection
- Fever
- Nausea and vomiting
- Constipation
- Headache
- Raised liver tests (AST, ALT)
- Rash
- Mouth sores (mucositis)
- Fever with low white blood cells (febrile neutropenia)
- Decreased appetite
Serious reactions include liver damage (VOD), severe infusion reactions, and serious bleeding. Tell your care team right away if you notice warning signs.
Gemtuzumab Ozogamicin Injection warnings and precautions
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- Liver damage (VOD): can be life-threatening or fatal. Risk is higher with moderate or severe liver impairment, a stem cell transplant before or after treatment, and higher single-agent doses. Liver tests are checked before each dose.
- Infusion reactions: can occur during or within 24 hours after the infusion. Signs include fever, chills, low blood pressure, fast heartbeat, low oxygen, and breathing trouble.
- Bleeding: Mylotarg suppresses bone marrow and lowers platelets for a prolonged time. Fatal bleeding has occurred, and platelets are monitored often.
- Low blood counts and infection: blood counts are checked often. Treatment may be delayed or stopped if counts do not recover.
- Pregnancy: can cause fetal harm.
Gemtuzumab Ozogamicin Injection interactions
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No clinical drug interaction studies have been done.
- In lab tests, Mylotarg and its active cell-killing part had a low potential to affect common liver enzymes (CYP450) or drug transporters.
- It is often given with daunorubicin and cytarabine. Your oncology team plans these combinations.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Gemtuzumab Ozogamicin Injection
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- Do not use it if you have had a serious allergic reaction, including anaphylaxis, to Mylotarg or its ingredients.
- Tell your doctor about liver problems or a past or planned stem cell transplant.
- Pregnancy: a pregnancy test is advised first. Use effective contraception during treatment and for at least 6 months after the last dose (females) or 3 months (males with female partners).
- Do not breastfeed during treatment and for at least 1 month after the last dose.
- It may affect fertility in women and men.
- Children: studied in newly diagnosed AML in ages 1 month and older, and relapsed or refractory AML in ages 2 years and older.
- Older adults: more fever and severe infections were seen.
- Effects in severe kidney impairment and moderate or severe liver impairment are not known.
What Gemtuzumab Ozogamicin Injection does in the body
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For the drug to work best, a high share of CD33 sites on leukemia cells must be occupied. Near-maximal CD33 saturation was seen at relatively low dose levels.
The risk of VOD rises as peak drug levels after the first dose increase. The increase is more prominent in people who have had a prior stem cell transplant.
How your body processes Gemtuzumab Ozogamicin Injection
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The antibody part of the drug has a half-life of about 62 hours after the first dose and about 90 hours after the second. It clears more slowly after the second dose.
The cell-killing component is highly bound to proteins in plasma and is broken down mostly by a non-enzyme chemical process. Age, race, sex, mild to moderate kidney impairment, and mild liver impairment did not significantly change how the drug behaved. Its behavior in severe kidney impairment and moderate or severe liver impairment is unknown.
How to store Gemtuzumab Ozogamicin Injection
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Refrigerate (2°C to 8°C; 36°F to 46°F) MYLOTARG vials and store in the original carton to protect from light. DO NOT FREEZE.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Gemtuzumab Ozogamicin Injection
17 supplements and herbal products have documented interactions with Gemtuzumab 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 · 1
- Moderate · 7
- Minor · 9
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.
Gemtuzumab Ozogamicin Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Gemtuzumab Ozogamicin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Mylotarg used for?
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How will I receive it?
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What side effects should I expect?
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Which symptoms mean I should call right away?
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Is it safe in pregnancy or while breastfeeding?
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Will it interact with my other medicines?
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Is Gemtuzumab Ozogamicin Injection available over the counter?
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When was Gemtuzumab Ozogamicin Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Gemtuzumab Ozogamicin Injection on HelloPharmacist
Gemtuzumab Ozogamicin Injection forms and strengths (how it comes)
Gemtuzumab 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
- Mylotarg is used for newly diagnosed CD33-positive AML in adults and children 1 month and older.
- Mylotarg is used for relapsed or refractory CD33-positive AML in adults and children 2 years and older.
- Mylotarg is given as an intravenous infusion by a healthcare professional.
- Mylotarg treatment is preceded by a corticosteroid, an antihistamine, and acetaminophen to help prevent infusion reactions.
- Mylotarg patients are monitored during the infusion and for at least 1 hour afterward.
Gemtuzumab Ozogamicin Injection on the U.S. market: products, makers and brands
How Gemtuzumab 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.
1 company lists 2 Gemtuzumab Ozogamicin Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2017. Brand names on the directory include Mylotarg; the rest are generics.
Compare Gemtuzumab Ozogamicin Injection products
A representative set of FDA-listed product records for Gemtuzumab 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 | ||||
| 5 mg/5 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 Gemtuzumab Ozogamicin Injection NDCs →
Gemtuzumab Ozogamicin Injection side effects reported to the 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 Gemtuzumab 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 Gemtuzumab 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.
Gemtuzumab Ozogamicin Injection FDA approval history
How Gemtuzumab Ozogamicin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Gemtuzumab Ozogamicin Injection 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 1294580 2 dose forms · 2 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 1294583In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 1294584 -
Dose form (SCDF) Injection RxCUI 1944700In current FDA listingsClinical drug / strength (SCD) 4.5 MGRxCUI 1944701
Look up RxCUI 1294580 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.
Gemtuzumab Ozogamicin Injection supply and shortage status
Whether Gemtuzumab 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.
Gemtuzumab Ozogamicin Injection brand names
Gemtuzumab Ozogamicin Injection is sold under one brand name in the FDA directory — Mylotarg. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Gemtuzumab Ozogamicin Injection: manufacturers and labelers
One company lists Gemtuzumab Ozogamicin Injection products with the FDA. By number of product records, the largest are Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Gemtuzumab Ozogamicin Injection drug class (RxNorm)
Gemtuzumab Ozogamicin Injection belongs to the CD33-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.
Sources for this Gemtuzumab Ozogamicin Injection page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →