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Mylotarg gemtuzumab ozogamicin 5 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 00008-4510-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mylotarg gemtuzumab ozogamicin 5 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 0008-4510-01 (Billing 00008-4510-01)

by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

This is a package of Mylotarg gemtuzumab ozogamicin 5 mg/5mL Injection, Powder, Lyophilized, For Solution from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., marketed since Sep 2017 and currently FDA-listed. It is this product's only package size.

NDC 00008-4510-01
🏷️ FDA NDC (as labeled) 0008-4510-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0008-4510-01
Product NDC 0008-4510
11-digit billing NDC 00008451001
NCPDP billing unit EA — each (per item)
RxCUI 1944701, 1944704
UNII 8GZG754X6M
Application # BLA761060
SPL Set ID 32fd2bb2-1cfa-4250-feb8-d7956c794e05
Established class (EPC) CD33-directed Immunoconjugate
Mechanism of action CD33-directed Antibody Interactions
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-07
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance GEMTUZUMAB OZOGAMICIN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21353630202117
GPI class Mylotarg
GCN Seq No 077700
GCN 43806
HICL code 021218
Ingredient (HICL) Gemtuzumab Ozogamicin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V36
Therapeutic class — specific (HIC3) Antineoplastic- Cd33 Antibody-Cytotoxic Antibiotic
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name MYLOTARG 4.5 MG VIAL
FDB brand name Mylotarg
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077700
  • GCN: 43806
  • GPI-14 (Medi-Span): 21353630202117
  • HICL (First Databank): 021218
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1944701
Why two NDCs? The FDA registers this code as 0008-4510-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00008-4510-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the CD33-directed Immunoconjugate class.

Pharmacologic class CD33-directed Immunoconjugate
Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
How it works CD33-directed Antibody Interactions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MYLOTARG 4.5 MG VIAL Ingredient Gemtuzumab Ozogamicin
📖 What it is MedlinePlus · NLM

Gemtuzumab ozogamicin injection is used alone or in combination with other chemotherapy medications to treat a certain type of acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) in adults and children 1 month of age and older who were recently found to have this cancer. It is also used alone to treat a certain type of AML in adults and children 2 years of age and older whose cancer worsened during or after treatment with other chemotherapy medications. Gemtuzumab ozogamicin injection is in a class of medications called monoclonal antibodies. It works by helping...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats CD33-positive acute myeloid leukemia (AML). That includes newly diagnosed AML in adults and children 1 month and older. It also includes AML that has come back or not res...
  • It is given through a vein (IV infusion) by your healthcare team. Beforehand, you will get a steroid, an antihistamine, and acetaminophen to lower the chance of a reaction. Your te...
  • Common ones include bleeding, infection, fever, nausea, vomiting, constipation, headache, rash, mouth sores, and low appetite. Your team will watch your blood counts and liver test...
  • Call for fever or chills, trouble breathing, or dizziness during or after an infusion. Also call for unusual bleeding, painful belly swelling, rapid weight gain, or yellow skin or...
📖 Read our full Gemtuzumab Ozogamicin Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9203 $247.370 / J9203 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0008-4510-01
11-digit billing NDC00008-4510-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ9203
DescriptorINJECTION, GEMTUZUMAB OZOGAMICIN, 0.1 MG
Billing units / pkg45 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 0.1 MG, so one package = 45 billing units.
Medicare Part B spend (2026 (Q1))$570,923 · 45 claims · $12,687.17 per claim (all NDCs under J9203)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00008-4510-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2017-09-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mylotarg 5 mg/5mLthis 00008-4510-01 Wyeth 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2017
First FDA approval
Sep 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2029. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 1, 2017 ⏳ ~2.9 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Mylotarggemtuzumab ozogamicin
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2017 2019 2021 2023 2025 2027 2029
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateSep 1, 2029
Common questions
Is there a biosimilar for MYLOTARG 4.5 MG VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII K3R6ZDH4DU
    Dextran 40 is a sugar-based polymer derived from bacteria. It acts as a thickener and volume expander in liquid medicines, helping achieve proper consistency and stability.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
FDA applicationBLA761060 (BLA)
Labeler code00008
First marketedSep 2017
Product typeHuman Prescription Drug
Portfolio31 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 98 words ▾

WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. ( 5.1 and 6.1 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning.

Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. ( 5.1 , 6.1 )

🎯 Indications and Usage 113 words ▾

1 INDICATIONS AND USAGE MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ). • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older ( 1.2 ).

1.1Newly-Diagnosed CD33-positive Acute Myeloid Leukemia (AML) MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.

1.2Relapsed or Refractory CD33-positive AML MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.

⏱️ Dosage and Administration ~3 min read ▾

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 ).

2.1Premedication 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. • For patients with hyperleukocytosis (leukocyte count greater than or equal to 30 Gi/L), cytoreduction is recommended prior to administration of MYLOTARG.

2.2Recommended Dosage Newly-Diagnosed De Novo CD33-positive AML (Combination Regimen) Adults The recommended dose of MYLOTARG in adults is 3 mg/m 2 . A treatment course including MYLOTARG in combination therapy for adults with newly-diagnosed de novo CD33-positive AML consists of 1 induction cycle and 2 consolidation cycles [see Clinical Studies (14.1) ] . For the induction cycle, the recommended dose of MYLOTARG is 3 mg/m 2 (up to one 4.5 mg vial) on Days 1, 4, and 7 in combination with daunorubicin and cytarabine .

For patients requiring a second induction cycle, do NOT administer MYLOTARG during the second induction cycle. For the consolidation cycles, the recommended dose of MYLOTARG is 3 mg/m 2 on Day 1 (up to one 4.5 mg vial) in combination with daunorubicin and cytarabine. Pediatric Patients 1 Month and Older The recommended dose of MYLOTARG in pediatric patients 1 month and older is: • 3 mg/m 2 for patients with body surface area (BSA) greater than or equal to 0.6 m 2 • 0.1 mg/kg for patients with BSA less than 0.6 m 2 For Induction 1, MYLOTARG is given once in combination with standard chemotherapy.

No MYLOTARG is given in the second induction cycle [see Clinical Studies (14.1) ]. No MYLOTARG is given in the first or third intensification cycles. For Intensification 2, MYLOTARG is given once in combination with standard chemotherapy.

Consider the risks and potential benefits before giving MYLOTARG during Intensification 2 [see Adverse Reactions (6.1) ] . Newly-Diagnosed CD33-positive AML (Single-agent Regimen) A treatment course of MYLOTARG as a singl… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution. For Injection: 4.5 mg as a lyophilized cake or powder in a single-dose vial for reconstitution and dilution ( 3 ).

⛔ Contraindications 55 words ▾

4 CONTRAINDICATIONS MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . Hypersensitivity to MYLOTARG or any of its components ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Infusion-related reactions (including anaphylaxis): Premedicate with a corticosteroid, acetaminophen, and diphenhydramine. Monitor patients during and for at least 1 hour after the end of the infusion. Interrupt the infusion, administer steroids or antihistamines, or permanently discontinue treatment as necessary ( 2.1 , 5.2 , 6 ). • Hemorrhage: Severe, including fatal, hemorrhage may occur when MYLOTARG is used at recommended doses.

Monitor platelet counts frequently ( 5.3 , 6.1 ). • Embryo-fetal toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.6 , 8.1 , 8.3 ).

5.1Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD) Hepatotoxicity, including life-threatening and sometimes fatal hepatic VOD events, have been reported in patients receiving MYLOTARG as a single agent or as part of a combination chemotherapy regimen [see Adverse Reactions (6) ]. In ALFA-0701, VOD events were reported in 6/131 (5%) adult patients during or following treatment with MYLOTARG, or following later hematopoietic stem cell transplantation (HSCT). The median time from the MYLOTARG dose to onset of VOD was 9 days (range: 2–298 days), with 5 events occurring within 28 days of any dose of MYLOTARG and 1 event occurring greater than 28 days after the last dose of MYLOTARG.

Three of the 6 VOD events were fatal. VOD was also reported in 2 patients in the control arm of ALFA-0701 after receiving MYLOTARG as a therapy for relapsed AML. In MyloFrance-1 (MYLOTARG 3 mg/m 2 on Days 1, 4 and 7), VOD events were reported in none of the 57 patients during or following treatment, or following HSCT after completion of MYLOTARG treatment.

In AAML0531, VOD events were reported in 25/520 (5%) pediatric patients in the MYLOTARG arm. VOD was fatal in 2 patients. Among 187 pediatric patients who underwent HSCT in the MYLOTARG arm, VOD occurred within 30 days post-HSCT in 20 (11%) patients.

Based on an analysis across trials, the risk of VOD was higher in adult patients who received higher doses of MYLOTARG as monotherapy, in patients with moderate or severe hepatic impairment prior to receiving MYLOTARG, in patients treated with MYLOTARG after HSCT, and in patients who underwent HSCT after treatment with MYLOTARG. Patients who had moderate/severe hepatic impairment prior to treatment with MYLOTARG were 8.7 times more likely to develop VOD compared to patients without moderate/severe hepatic impairment at baseline.

Patients treated with MYLOTARG for relapse after HSCT were 2.6 times more likely to develop VOD compared to patients without prior HSCT. Patients who underwent HSCT following MYLOTARG treatment were 2.9 times more likely to develop VOD after HSCT compared to patients without HSCT following MYLOTARG treatment. Although no relationship was found between VOD and time of HSCT relative to higher MYLOTARG monotherapy doses, the ALFA-0701 study recommended an interval of 2 months between the last dose of MYLOTARG and HSCT.

In MyloFrance-1, no patients underwent HSCT within 3.5 months of MYLOTARG therapy. Assess ALT, AST, total bilirubin, and alkaline phosphatase prior to each dose of MYLOTARG. After treatment with MYLOTARG, monitor frequently for signs and symptoms of VOD; these may include elevations in ALT, AST, total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites.

Monitoring only total bilirubin may not identify all patients at risk of VOD. For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended. For patients who proceed to HSCT, monitor liver tests frequently during the post-HSCT period, as appropriate.

Manage signs or symptoms of hepatic toxicity by dose interruption or discontinuation of MYLOTARG [see Dosage and Administration (2.3) ] . In patients who experience VOD, discontinue MYLOTARG and treat according to… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hepatotoxicity, including VOD [see Warnings and Precautions (5.1) ] • Infusion-related reactions [see Warnings and Precautions (5.2) ] • Hemorrhage [see Warnings and Precautions (5.3) ] The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, mucositis, febrile neutropenia, and decreased appetite ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Combination Therapy in Newly-Diagnosed De Novo CD33-positive AML The safety of MYLOTARG in first-line combination therapy was evaluated in two prospective clinical trials, Study ALFA-0701 in adults and Study AAML0531 in pediatric patients.

Study ALFA-0701 The safety evaluation of MYLOTARG (3 mg/m 2 Day 1, 4 and 7 in combination with daunorubicin and cytarabine [DA]) in adults is based on data from ALFA-0701 for 131 patients treated with MYLOTARG plus DA and in 137 patients treated with DA alone [see Clinical Studies (14.1) ]. In this study, 123 patients received all 3 fractionated doses of MYLOTARG and 7 patients missed at least 1 dose, with a mean total dose administered during induction of 14.51 mg (range: 4.6–18.0). MYLOTARG was received by 91 (70%) patients in the MYLOTARG arm during Consolidation 1 and 64 (49%) patients in the MYLOTARG arm during Consolidation 2.

Safety data consisting of selected TEAEs considered most important for understanding the safety profile of MYLOTARG as well as all adverse events (AEs) that led to the permanent discontinuation of treatment were retrospectively collected. The selected TEAEs consisted of all grades hemorrhages, all grades VOD, and severe infections. Discontinuation due to any adverse reaction occurred in 31% of patients in the MYLOTARG arm versus 7% in the DA arm.

The most frequent (greater than or equal to 1%) adverse reactions for patients treated with MYLOTARG that led to permanent discontinuation were thrombocytopenia (15%), VOD (3%), and septic shock (2%). Fatal adverse reactions occurred in 8 patients (6%) in the MYLOTARG arm versus 3 patients (2%) in the DA arm. In the MYLOTARG arm, 3 patients died of VOD, 4 patients died of hemorrhage-related events (CNS hemorrhage, hemorrhagic shock), and 1 patient died of suspected cardiac cause.

In the DA arm, 3 patients died of sepsis. Table 2. Selected Grade 3 and Higher Adverse Reactions in Patients with Newly-Diagnosed De Novo AML in ALFA-0701 MYLOTARG + Daunorubicin + Cytarabine (n, %) Daunorubicin + Cytarabine (n, %) Abbreviations: AML=acute myeloid leukemia; N=number of patients; PT=preferred term.

Induction N = 131 N = 137 Infection Infection is a grouped term consisting of multiple preferred terms. 61 (47%) 53 (39%) Hemorrhage Hemorrhage is a grouped term consisting of multiple preferred terms. 24 (18%) 12 (9%) Veno-occlusive liver disease Veno-occlusive liver disease includes the following reported PTs: Veno-occlusive liver disease, veno-occlusive disease.

3 (2%) 0 Consolidation 1 N = 91 N = 103 Infection 50 (55%) 43 (42%) Hemorrhage 5 (5%) 0 Veno-occlusive liver disease 0 0 Consolidation 2 N = 64 N = 107 Infection 32 (50%) 54 (50%) Hemorrhage 4 (6%) 0 Veno-occlusive liver disease 0 0 All patients in ALFA-0701 developed severe neutropenia, thrombocytopenia and anemia. The incidence of Grade 3–4 thrombocytopenia that was prolonged in the absence of active leukemia was higher in patients treated with MYLOTARG (Table 3). Table 3.

Prolonged Cytopenias Platelets less than 50 Gi/L or neutrophils… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 ).

8.1Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] , MYLOTARG can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on MYLOTARG use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alterations to growth, at maternal systemic exposures that were greater than or equal to 0.4 times the exposure in patients at the maximum recommended dose based on AUC (see Data ) .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data In an embryo-fetal development study in rats, pregnant animals received daily intravenous doses up to 1.2 mg/m 2 /day gemtuzumab ozogamicin during the period of organogenesis. Embryo-fetal toxicities including fetal growth retardation as evidenced by decreased live fetal weights, incidence of fetal wavy ribs and delayed skeletal ossification were observed at greater than or equal to 0.15 mg/m 2 /day.

Increased embryo-fetal lethality and fetal morphological anomalies (digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae) were observed at greater than or equal to 0.36 mg/m 2 /day. All doses with embryo-fetal effects were observed in the presence of maternal toxicity that included decreases in gestational body weight gain, food consumption, and gravid uterine weight. The lowest dose at which embryo-fetal effects were observed in rats (0.15 mg/m 2 /day) was 0.4 times the exposure in patients at the maximum recommended human dose, based on AUC.

8.2Lactation Risk Summary There are no data on the presence of gemtuzumab ozogamicin or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise women not to breastfeed during treatment with MYLOTARG and for at least 1 month after the final dose.

8.3Females and Males of Reproductive Potential MYLOTARG can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating MYLOTARG. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose [see Nonclinical Toxicology (13.1) ] .

Males Advise males with female partners of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose [see Nonclinical Toxicology (13.1) ] . Infertility Females Based on findings in animals, MYLOTARG may impair female fertility [see Nonclinical Toxicology (13.1) ] . Males Based on findings in animals, MYLOTARG may impair male fertility [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of MYLOTARG in combination with standard chemotherapy have been established in pediatric patients 1 month and older with newly-diagnosed de novo AML. The use of MYLOTARG for this indication is supported by evidence of effectiveness from adequate and well-controlled studies in adults with supportive data on safety and effectiveness in Study AAML0531 (NCT00372593) [see Adverse Reactions (6.1) , Cl… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] , MYLOTARG can cause embryo-fetal harm when administered to a pregnant woman. There are no available data on MYLOTARG use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alterations to growth, at maternal systemic exposures that were greater than or equal to 0.4 times the exposure in patients at the maximum recommended dose based on AUC (see Data ) .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data In an embryo-fetal development study in rats, pregnant animals received daily intravenous doses up to 1.2 mg/m 2 /day gemtuzumab ozogamicin during the period of organogenesis. Embryo-fetal toxicities including fetal growth retardation as evidenced by decreased live fetal weights, incidence of fetal wavy ribs and delayed skeletal ossification were observed at greater than or equal to 0.15 mg/m 2 /day.

Increased embryo-fetal lethality and fetal morphological anomalies (digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae) were observed at greater than or equal to 0.36 mg/m 2 /day. All doses with embryo-fetal effects were observed in the presence of maternal toxicity that included decreases in gestational body weight gain, food consumption, and gravid uterine weight. The lowest dose at which embryo-fetal effects were observed in rats (0.15 mg/m 2 /day) was 0.4 times the exposure in patients at the maximum recommended human dose, based on AUC.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of MYLOTARG in combination with standard chemotherapy have been established in pediatric patients 1 month and older with newly-diagnosed de novo AML. The use of MYLOTARG for this indication is supported by evidence of effectiveness from adequate and well-controlled studies in adults with supportive data on safety and effectiveness in Study AAML0531 (NCT00372593) [see Adverse Reactions (6.1) , Clinical Studies (14.1) ]. AAML0531 included patients in the following age groups: 2 patients less than 27 days old, 94 patients 28 days to less than 2 years old, 225 patients 2 years to less than 12 years old, 175 patients 12 years old to less than 18 years old, and 36 patients 18 years or older in the MYLOTARG plus chemotherapy arm.

The safety and effectiveness of MYLOTARG with standard chemotherapy in pediatric patients less than 1 month of age with newly-diagnosed de novo AML have not been established. The safety and effectiveness of MYLOTARG as a single agent in pediatric patients with newly-diagnosed AML have not been established. The safety and effectiveness of MYLOTARG as a single agent in the pediatric patients with relapsed or refractory AML is supported by a single-arm trial in 29 patients in the following age groups: 1 patient 1 month to less than 2 years old, 13 patients 2 years to less than 12 years old, and 15 patients 12 years to 18 years old.

A literature review included an additional 96 patients with ages ranging from 0.2 to 21 years. No differences in efficacy and safety were observed by age. The information on this use is discussed throughout the labeling.

The safety and effectiveness of MYLOTARG as a single agent in pediatric patients less than 2 years of age with relapsed or refractory AML have not been established.

🧓 Geriatric Use 154 words ▾

8.5Geriatric Use Use of MYLOTARG in combination with daunorubicin and cytarabine in newly-diagnosed adult patients with de novo AML is supported by a randomized, controlled trial that included 50 patients greater than or equal to 65 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Use of MYLOTARG monotherapy in newly-diagnosed adult patients with AML is supported by a randomized controlled trial with 118 patients treated with MYLOTARG.

All patients were over the age of 60 years and 65% of patients were above 75 years. No overall differences in effectiveness were observed by age. Use of MYLOTARG as single-agent treatment of relapsed or refractory AML is supported by a single-arm trial that included 27 patients 65 years or older.

No overall differences in effectiveness were observed between these patients and younger patients. Elderly patients experienced a higher rate of fever and severe or greater infections.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes human CD33 antigen. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker.

Nonclinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.

12.2Pharmacodynamics Saturation of a high percentage of CD33 antigenic sites is presumed to be required for maximum delivery of calicheamicin to leukemic blast cells. Near maximal peripheral CD33 saturation was observed across studies after gemtuzumab ozogamicin dosing at dose levels of 2 mg/m 2 and above. At 9 mg/m 2 gemtuzumab ozogamicin (2 doses, 14 days apart), the risk for VOD increases as the C max of the first dose of gemtuzumab ozogamicin increases.

The increase in VOD is more prominent in patients with prior stem cell transplantation.

12.3Pharmacokinetics There are no clinical PK data for the fractionated regimen. When gemtuzumab ozogamicin is administered at 9 mg/m 2 (2 doses, 14 days apart), the C max following the first dose for patients who received 9 mg/m 2 gemtuzumab ozogamicin was 3.0 mg/L and increased to 3.6 mg/L after the second dose. Distribution N-acetyl gamma calicheamicin dimethyl hydrazide is approximately 97% bound to human plasma proteins in vitro.

Population PK analyses found the total volume of distribution of hP67.6 antibody (sum of V1 [6.31 L] and V2 [15.1 L]) to be approximately

21.4L in patients. Elimination The clearance (CL) value of hP67.6 from plasma was

0.35 L/h after the first dose and

0.15L/h after the second dose, a decrease of roughly 60%. The terminal plasma half-life (t ½ ) for hP67.6 was 62 hours after the first dose and 90 hours after the second dose. Metabolism In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolized, primarily via nonenzymatic reduction of the disulfide moiety.

Specific Populations Age, race, sex, mild or moderate renal impairment (creatinine clearance [CLcr] 30–89 mL/min calculated by the Cockcroft-Gault equation) or mild hepatic impairment had no clinically significant effect on the pharmacokinetics of gemtuzumab ozogamicin. The pharmacokinetics of gemtuzumab ozogamicin in patients with severe renal impairment (CLcr 15–29 mL/min) or moderate (total bilirubin greater than 1.5× to 3.0× ULN) and severe hepatic impairment (total bilirubin greater than 3× ULN) is unknown. Drug Interaction Studies No clinical drug interaction studies have been performed.

In Vitro Studies At clinically relevant concentrations, gemtuzumab ozogamicin had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5. At clinically relevant concentrations, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2B6 , CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5. • Induce CYP450 Enzymes : CYP1A2, CYP2B6, and CYP3A4. • Inhibit UGT Enzymes : UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7. • Inhibit Drug Transporters : P-gp (P-glycoprotein), breast cancer resistance protein (BCRP), organic anion transporter (OAT)1 and OAT3, organic cation transporter (OCT)2, and organic anion transporting polypeptide (OATP)1B1 and OATP1B3.

🧬 Mechanism of Action 105 words ▾

12.1Mechanism of Action Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes human CD33 antigen. The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker.

Nonclinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.

📦 How Supplied / Storage and Handling 73 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING MYLOTARG (gemtuzumab ozogamicin) for injection is a white to off-white lyophilized cake or powder supplied in a carton (NDC 0008-4510-01) containing one 4.5 mg single-dose vial [see Dosage and Administration (2) ] . 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.

MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📦 Storage and Handling 35 words ▾

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. MYLOTARG is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📋 Description 181 words ▾

11 DESCRIPTION Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab.

The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab. MYLOTARG (gemtuzumab ozogamicin) for injection is supplied as a sterile, white to off-white, preservative-free lyophilized cake or powder for intravenous administration. Each single-dose vial delivers 4.5 mg gemtuzumab ozogamicin.

Inactive ingredients are dextran 40 (41.0 mg), sodium chloride (26.1 mg), sodium phosphate dibasic anhydrous (2.7 mg), sodium phosphate monobasic monohydrate (0.45 mg), and sucrose (69.8 mg). After reconstitution with 5 mL of Sterile Water for Injection USP, the concentration is 1 mg/mL of gemtuzumab ozogamicin with a deliverable volume of 4.5 mL (4.5 mg). Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD) Inform patients that liver problems, including severe, life-threatening, or fatal VOD may develop during MYLOTARG treatment. Prior to receiving MYLOTARG, inform patients who previously received, or will receive an HSCT that they may be at increased risk for developing VOD. Inform patients that the risk of developing VOD after an allogeneic HSCT is increased after receiving treatment with MYLOTARG.

Inform patients that signs or symptoms of liver toxicity, including rapid weight gain, right upper quadrant pain and tenderness, hepatomegaly, and ascites should be monitored regularly during treatment, but these symptoms may not identify all patients at risk or prevent the complications of liver toxicity. Inform patients that liver problems may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.1) ]. Hemorrhage Inform patients that decreased platelet counts, which may be life-threatening, may develop during MYLOTARG treatment and that complications associated with decreased platelet counts may include bleeding/hemorrhage events, which may be life-threatening or fatal.

Inform patients to report signs and symptoms of bleeding/hemorrhage during treatment with MYLOTARG. Inform patients that severe bleeding/hemorrhage may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.3) ]. Infusion-Related Reactions Advise patients to contact their health care provider if they experience signs and symptoms of infusion-related reactions, including symptoms such as fever, chills, rash, or breathing problems [see Warnings and Precautions (5.2) ] .

Embryo-Fetal Toxicity Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) , Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose [see Use in Specific Populations (8.3) ] .

Advise males with female partners of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose [see Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment with MYLOTARG and for at least 1 month after the final dose [see Use in Specific Populations (8.2) ]. Infertility Advise males and females of reproductive potential that MYLOTARG may impair fertility [see Use in Specific Populations (8.3) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics There are no clinical PK data for the fractionated regimen. When gemtuzumab ozogamicin is administered at 9 mg/m 2 (2 doses, 14 days apart), the C max following the first dose for patients who received 9 mg/m 2 gemtuzumab ozogamicin was 3.0 mg/L and increased to 3.6 mg/L after the second dose. Distribution N-acetyl gamma calicheamicin dimethyl hydrazide is approximately 97% bound to human plasma proteins in vitro.

Population PK analyses found the total volume of distribution of hP67.6 antibody (sum of V1 [6.31 L] and V2 [15.1 L]) to be approximately

21.4L in patients. Elimination The clearance (CL) value of hP67.6 from plasma was

0.35 L/h after the first dose and

0.15L/h after the second dose, a decrease of roughly 60%. The terminal plasma half-life (t ½ ) for hP67.6 was 62 hours after the first dose and 90 hours after the second dose. Metabolism In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolized, primarily via nonenzymatic reduction of the disulfide moiety.

Specific Populations Age, race, sex, mild or moderate renal impairment (creatinine clearance [CLcr] 30–89 mL/min calculated by the Cockcroft-Gault equation) or mild hepatic impairment had no clinically significant effect on the pharmacokinetics of gemtuzumab ozogamicin. The pharmacokinetics of gemtuzumab ozogamicin in patients with severe renal impairment (CLcr 15–29 mL/min) or moderate (total bilirubin greater than 1.5× to 3.0× ULN) and severe hepatic impairment (total bilirubin greater than 3× ULN) is unknown. Drug Interaction Studies No clinical drug interaction studies have been performed.

In Vitro Studies At clinically relevant concentrations, gemtuzumab ozogamicin had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5. At clinically relevant concentrations, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to: • Inhibit CYP450 Enzymes : CYP1A2, CYP2B6 , CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5. • Induce CYP450 Enzymes : CYP1A2, CYP2B6, and CYP3A4. • Inhibit UGT Enzymes : UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7. • Inhibit Drug Transporters : P-gp (P-glycoprotein), breast cancer resistance protein (BCRP), organic anion transporter (OAT)1 and OAT3, organic cation transporter (OCT)2, and organic anion transporting polypeptide (OATP)1B1 and OATP1B3.

🧬 Pharmacodynamics 89 words ▾

12.2Pharmacodynamics Saturation of a high percentage of CD33 antigenic sites is presumed to be required for maximum delivery of calicheamicin to leukemic blast cells. Near maximal peripheral CD33 saturation was observed across studies after gemtuzumab ozogamicin dosing at dose levels of 2 mg/m 2 and above. At 9 mg/m 2 gemtuzumab ozogamicin (2 doses, 14 days apart), the risk for VOD increases as the C max of the first dose of gemtuzumab ozogamicin increases.

The increase in VOD is more prominent in patients with prior stem cell transplantation.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Newly-Diagnosed CD33-positive AML Study ALFA-0701 MYLOTARG in combination with chemotherapy was evaluated in ALFA-0701 (NCT00927498), a multicenter, randomized, open-label Phase 3 study of 271 patients with newly-diagnosed de novo AML ages 50 to 70 years. Patients were randomized (1:1) to receive induction therapy consisting of daunorubicin (60 mg/m 2 on Days 1 to 3) and cytarabine (200 mg/m 2 on Days 1 to 7) (DA) with (n=135) or without (n=136) MYLOTARG 3 mg/m 2 (up to maximum of one vial) on Days 1, 4, and 7.

Patients who did not achieve a response after first induction could receive a second induction with daunorubicin and cytarabine alone (daunorubicin 35 mg/m 2 /day on Days 1 and 2, and cytarabine 1 g/m 2 every 12 hours, on Day 1 to Day 3 without MYLOTARG). Patients with response received consolidation therapy with 2 courses of treatment including daunorubicin (60 mg/m 2 on Day 1 of consolidation course 1; 60 mg/m 2 on Days 1 and 2 of consolidation course 2) and cytarabine (1 g/m 2 every 12 hours on Days 1 to 4) with or without MYLOTARG 3 mg/m 2 (up to a maximum of one vial) on Day 1 according to their initial randomization.

Patients who experienced remission were also eligible for allogeneic transplantation. An interval of at least 2 months between the last dose of MYLOTARG and transplantation was recommended. The median age of the patients was 62 years (range, 50–70), 137 female and 134 male, and 88% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at baseline.

Baseline characteristics were balanced between treatment arms with the exception of gender as a higher percentage of males were enrolled in the MYLOTARG arm (55%) than in the DA alone arm (44%). Overall, 59%, 65%, and 70% of patients had documented favorable/intermediate risk and 33%, 27%, and 21% had poor/adverse disease by the National Comprehensive Cancer Network (NCCN), European LeukemiaNet (ELN), and cytogenetic risk classifications, respectively. CD33 expression on AML blasts by flow cytometry harmonized from local laboratory results was determined in 194/271 (72%) patients overall.

Few patients (14%) had low CD33 expression (less than 30% of blasts), and none had no expression of CD33. Efficacy was established on the basis of event-free survival (EFS), measured from the date of randomization until induction failure, relapse, or death by any cause. Per protocol, induction failure was defined as failure to achieve CR or CRp in induction, and date of induction failure was defined as date of marrow evaluation after the last course of induction.

Median EFS was 17.3 months in the MYLOTARG arm versus 9.5 months in the control arm; hazard ratio (HR) 0.56 (95% CI: 0.42–0.76); 2-sided p less than 0.001 by log-rank test. In an exploratory analysis of EFS defined as failure to achieve CR in induction, relapse, or death from any cause and using the date of randomization as the date of induction failure, median EFS was 13.6 months for MYLOTARG + DA and 8.8 months for DA with HR 0.68 (95% CI: 0.51–0.91). The Kaplan-Meier plot for per-protocol EFS is shown in Figure 1.

There was no statistically significant difference between treatment arms in overall survival. Figure 1. Kaplan-Meier Plot of Event-Free Survival (mITT Population) ALFA-0701 Trial Abbreviations: C=cytarabine; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.

Figure 1 Study AAML0531 MYLOTARG in combination with chemotherapy was evaluated in AAML0531 (NCT00372593), a multicenter, randomized study of 1,063 patients with newly-diagnosed AML ages 0 to 29 years. Patients were randomized to 5-cycle chemotherapy alone or with a single dose of MYLOTARG (3 mg/m 2 /dose) administered once on Day 6 in Induction 1 and once on Day 7 in Intensification 2. All patients proceeded to Induction 2 regardless of remission status after Induction 1.

In the absence of active disease, a neutrophil count (ANC) >1 Gi/L and a platelet count >75 Gi/L was rec… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin. In toxicity studies, rats were dosed weekly for 6 weeks with gemtuzumab ozogamicin at doses up to 7.2 mg/m 2 /week. After 6 weeks of dosing, rats developed oval cell hyperplasia in the liver, which is considered a potentially preneoplastic finding, at 7.2 mg/m 2 /week (approximately 16 times the exposure in patients at the maximum recommended dose, based on AUC).

Other preneoplastic or neoplastic changes observed with other antibody-calicheamicin conjugates in rats included basophilic and/or eosinophilic altered cell foci and hepatocellular adenomas. The relevance of these animal findings to humans is uncertain. Gemtuzumab ozogamicin was clastogenic in vivo in the bone marrow of mice that received single doses greater than or equal to 22.1 mg/m 2 .

This is consistent with the known induction of DNA breaks by calicheamicin. N-acetyl gamma calicheamicin dimethyl hydrazide (the released cytotoxic agent) was mutagenic in the bacterial reverse mutation assay and clastogenic in the in vitro micronucleus assay in human TK6 cells. In a female fertility study, female rats were administered daily intravenous doses of gemtuzumab ozogamicin up to 1.08 mg/m 2 for 14 days before mating with untreated male rats.

Significant decreases in the numbers of corpora lutea and implants were observed at 1.08 mg/m 2 , and dose-related decreases and increases in the number of live and dead embryos were observed at doses tested (approximately 0.4 times the exposure in patients at the maximum recommended dose, based on AUC). Increased embryofetal lethality at ≥0.36 mg/m 2 was observed in the presence of maternal toxicity that included decreases in gestational body weight and food consumption. Additional findings in female reproductive organs (ovarian atrophy and decreased numbers of follicles associated with atrophy of the uterus, vagina and mammary glands) occurred in rats and monkeys after dosing with other antibody-calicheamicin conjugates.

Fertility was assessed in male rats administered daily intravenous doses of gemtuzumab ozogamicin from 0.12 to 1.08 mg/m 2 for 28 days, followed by mating with untreated females, either at the end of the dosing period or after a 9-week drug-free period. Male fertility index was decreased at doses ≥0.12 mg/m 2 (approximately 1.2 times the exposure in patients at the maximum recommended dose, based on AUC). Effects on testes and epididymides occurred at ≥0.12 mg/m 2 , including smaller size and lower weights in addition to adverse effects on sperm.

Partial recovery was noted for some effects. Additional effects in male reproductive organs occurred in repeat-dose toxicology studies and included effects on mammary gland, testes, and epididymides in rats at ≥2.4 mg/m 2 /week and effects on testes and epididymides in monkeys at 21.6 mg/m 2 /week. Testicular effects in male monkeys with other antibody-calicheamicin conjugates included degeneration of seminiferous tubules and decreased epididymidal sperm, which did not reverse following a 6-week drug-free period.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin. In toxicity studies, rats were dosed weekly for 6 weeks with gemtuzumab ozogamicin at doses up to 7.2 mg/m 2 /week. After 6 weeks of dosing, rats developed oval cell hyperplasia in the liver, which is considered a potentially preneoplastic finding, at 7.2 mg/m 2 /week (approximately 16 times the exposure in patients at the maximum recommended dose, based on AUC).

Other preneoplastic or neoplastic changes observed with other antibody-calicheamicin conjugates in rats included basophilic and/or eosinophilic altered cell foci and hepatocellular adenomas. The relevance of these animal findings to humans is uncertain. Gemtuzumab ozogamicin was clastogenic in vivo in the bone marrow of mice that received single doses greater than or equal to 22.1 mg/m 2 .

This is consistent with the known induction of DNA breaks by calicheamicin. N-acetyl gamma calicheamicin dimethyl hydrazide (the released cytotoxic agent) was mutagenic in the bacterial reverse mutation assay and clastogenic in the in vitro micronucleus assay in human TK6 cells. In a female fertility study, female rats were administered daily intravenous doses of gemtuzumab ozogamicin up to 1.08 mg/m 2 for 14 days before mating with untreated male rats.

Significant decreases in the numbers of corpora lutea and implants were observed at 1.08 mg/m 2 , and dose-related decreases and increases in the number of live and dead embryos were observed at doses tested (approximately 0.4 times the exposure in patients at the maximum recommended dose, based on AUC). Increased embryofetal lethality at ≥0.36 mg/m 2 was observed in the presence of maternal toxicity that included decreases in gestational body weight and food consumption. Additional findings in female reproductive organs (ovarian atrophy and decreased numbers of follicles associated with atrophy of the uterus, vagina and mammary glands) occurred in rats and monkeys after dosing with other antibody-calicheamicin conjugates.

Fertility was assessed in male rats administered daily intravenous doses of gemtuzumab ozogamicin from 0.12 to 1.08 mg/m 2 for 28 days, followed by mating with untreated females, either at the end of the dosing period or after a 9-week drug-free period. Male fertility index was decreased at doses ≥0.12 mg/m 2 (approximately 1.2 times the exposure in patients at the maximum recommended dose, based on AUC). Effects on testes and epididymides occurred at ≥0.12 mg/m 2 , including smaller size and lower weights in addition to adverse effects on sperm.

Partial recovery was noted for some effects. Additional effects in male reproductive organs occurred in repeat-dose toxicology studies and included effects on mammary gland, testes, and epididymides in rats at ≥2.4 mg/m 2 /week and effects on testes and epididymides in monkeys at 21.6 mg/m 2 /week. Testicular effects in male monkeys with other antibody-calicheamicin conjugates included degeneration of seminiferous tubules and decreased epididymidal sperm, which did not reverse following a 6-week drug-free period.

📚 References 8 words ▾

15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Recent Major Changes 13 words ▾

Dosage and Administration, Instructions for Reconstitution, Dilution, and Administration ( 2.4 ) 08/2021

📄 Package Label / Principal Display Panel 83 words ▾

PRINCIPAL DISPLAY PANEL - 4.5 mg Vial Label Pfizer NDC 0008-4510-01 Rx only MYLOTARG™ (gemtuzumab ozogamicin) for Injection 4.5 mg/vial For Intravenous Infusion Only Single-dose vial. No Preservatives Discard unused portion. Principal Display Panel - 4.5 mg Vial Label

PRINCIPAL DISPLAY PANEL - 4.5 mg Vial Carton Pfizer NDC 0008-4510-01 MYLOTARG™ (gemtuzumab ozogamicin) for Injection 4.5 mg/vial For Intravenous Infusion Only Reconstitution and dilution required No Preservatives One Single-Dose Vial. Discard unused portion. Rx only Principal Display Panel - 4.5 mg Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Mylotarg (this brand).

Top reported reactions

Febrile Neutropenia697
Pyrexia325
Sepsis299
Venoocclusive Liver Disease259
Thrombocytopenia239
Platelet Count Decreased235
Pneumonia197

Age at onset

Neonate2
Infant17
Child40
Adolescent32
Adult119
Elderly37

Reporter sex

3,635 reports
Male · 53%
Female · 47%
Unknown · 0%

Serious outcomes

Hospitalization1,745
Disabling43
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 315 47
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9203 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00008-4001-10 · Wyeth 00008-4990-20 · Wyeth →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.