| Leukemia, Myelocytic, Acute
Onureg vs Mylotarg
Side-by-side clinical, coverage, and cost comparison for leukemia, myelocytic, acute.Deep comparison between: Onureg vs Mylotarg 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 signalsMylotarg has a higher rate of injection site reactions vs Onureg based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Mylotarg but not Onureg, including UnitedHealthcare
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Category
Onureg
Mylotarg
At A Glance
Oral
Once daily, Days 1-14 of 28-day cycle
DNA methyltransferase inhibitor
IV infusion
CD33-directed antibody-drug conjugate (ADC)
Indications
- Leukemia, Myelocytic, Acute
- Leukemia, Myelocytic, Acute
Dosing
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.
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.
Contraindications
- Known severe hypersensitivity to azacitidine or its components
- Known hypersensitivity to gemtuzumab ozogamicin, its components, or any excipient (reactions have included anaphylaxis)
Adverse Reactions
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
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
Pharmacology
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.
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.
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Most Common Insurance
Anthem BCBS
Onureg
- Covered on 5 commercial plans
- PA (11/12) · Step Therapy (0/12) · Qty limit (12/12)
Mylotarg
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (4/12) · Qty limit (0/12)
UnitedHealthcare
Onureg
- Covered on 4 commercial plans
- PA (6/8) · Step Therapy (0/8) · Qty limit (2/8)
Mylotarg
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
Humana
Onureg
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (0/3) · Qty limit (2/3)
Mylotarg
- Covered on 0 commercial plans
- PA (2/3) · Step Therapy (0/3) · Qty limit (0/3)
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableAccessia Health: Myelodysplastic Syndromes - Private Insurance: Waitlist
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
Cost estimate not availableAssistance Fund: Acute Myeloid Leukemia
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.