| Leukemia, Myelocytic, Acute
Mylotarg vs Onureg
Side-by-side clinical, coverage, and cost comparison for leukemia, myelocytic, acute.Deep comparison between: Mylotarg vs Onureg with Prescriber.AI
AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.Safety signalsOnureg has a higher rate of injection site reactions vs Mylotarg based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Onureg but not Mylotarg, including UnitedHealthcare
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Category
Mylotarg
Onureg
At A Glance
IV infusion
CD33-directed antibody-drug conjugate (ADC)
Oral
Once daily, Days 1-14 of 28-day cycle
DNA methyltransferase inhibitor
Indications
- Leukemia, Myelocytic, Acute
- Leukemia, Myelocytic, Acute
Dosing
Leukemia, Myelocytic, Acute - newly-diagnosed, combination regimen Adults: Induction 3 mg/m2 (up to one 4.5 mg vial) IV on Days 1, 4, and 7 with daunorubicin and cytarabine; Consolidation 3 mg/m2 IV on Day 1 with daunorubicin and cytarabine. Pediatric patients 1 month and older: 3 mg/m2 (BSA >=0.6 m2) or 0.1 mg/kg (BSA <0.6 m2) IV.
Leukemia, Myelocytic, Acute - newly-diagnosed, single-agent Adults: Induction 6 mg/m2 IV on Day 1 and 3 mg/m2 on Day 8; Continuation 2 mg/m2 IV on Day 1 every 4 weeks for up to 8 cycles.
Leukemia, Myelocytic, Acute - relapsed or refractory Adults and pediatric patients 2 years and older: 3 mg/m2 (up to one 4.5 mg vial) IV on Days 1, 4, and 7 as a single course.
Leukemia, Myelocytic, Acute 300 mg orally once daily on Days 1 through 14 of each 28-day cycle; continue until disease progression or unacceptable toxicity.
Contraindications
- Known hypersensitivity to gemtuzumab ozogamicin, its components, or any excipient (reactions have included anaphylaxis)
- Known severe hypersensitivity to azacitidine or its components
Adverse Reactions
Most common Infection, febrile neutropenia, hemorrhage, thrombocytopenia, neutropenia, decreased appetite, hyperglycemia, mucositis, transaminase increased, fatigue, nausea
Serious Hepatotoxicity including veno-occlusive disease (VOD), infusion-related reactions, hemorrhage, prolonged thrombocytopenia, prolonged neutropenia
Postmarketing Neutropenic colitis (including fatal events), fungal lung infections (Pulmonary mycosis, Pneumocystis jirovecii pneumonia), Stenotrophomonas bacterial infection, hemorrhagic cystitis, interstitial pneumonia
Most common (>=10%) Nausea, vomiting, diarrhea, fatigue/asthenia, constipation, upper respiratory tract infection, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, skin infection, pain in extremity
Serious Pneumonia, febrile neutropenia, sepsis (including 1 fatal case)
Postmarketing Hypersensitivity reaction, interstitial lung disease, tumor lysis syndrome, Sweet's syndrome (acute febrile neutrophilic dermatosis), necrotizing fasciitis (including fatal cases), differentiation syndrome
Pharmacology
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC) that binds CD33-expressing tumor cells, undergoes internalization of the ADC-CD33 complex, and releases N-acetyl gamma calicheamicin dimethyl hydrazide intracellularly via hydrolytic linker cleavage; the activated calicheamicin derivative induces double-strand DNA breaks, leading to cell cycle arrest and apoptotic cell death.
Azacitidine is a pyrimidine nucleoside analog of cytidine that inhibits DNA/RNA methyltransferases; incorporation into DNA reduces methylation and alters gene expression, while incorporation into RNA reduces RNA methylation and protein synthesis, inducing apoptosis in AML cells.
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Most Common Insurance
Anthem BCBS
Mylotarg
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (4/12) · Qty limit (0/12)
Onureg
- Covered on 5 commercial plans
- PA (11/12) · Step Therapy (0/12) · Qty limit (12/12)
UnitedHealthcare
Mylotarg
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
Onureg
- Covered on 4 commercial plans
- PA (6/8) · Step Therapy (0/8) · Qty limit (2/8)
Humana
Mylotarg
- Covered on 0 commercial plans
- PA (2/3) · Step Therapy (0/3) · Qty limit (0/3)
Onureg
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (0/3) · Qty limit (2/3)
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableAssistance Fund: Acute Myeloid Leukemia
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
Cost estimate not availableAccessia Health: Myelodysplastic Syndromes - Private Insurance: Waitlist
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.