| Leukemia, Myelocytic, Acute

Mylotarg vs Idhifa

Side-by-side clinical, coverage, and cost comparison for leukemia, myelocytic, acute.
Deep comparison between: Mylotarg vs Idhifa with Prescriber.AI
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Safety signalsIdhifa has a higher rate of injection site reactions vs Mylotarg based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Idhifa but not Mylotarg, including UnitedHealthcare
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Mylotarg
Idhifa
At A Glance
IV infusion
CD33-directed antibody-drug conjugate (ADC)
Oral
Daily
IDH2 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 100 mg orally once daily until disease progression or unacceptable toxicity; treat for a minimum of 6 months in patients without disease progression or unacceptable toxicity to allow time for clinical response.
Contraindications
  • Known hypersensitivity to gemtuzumab ozogamicin, its components, or any excipient (reactions have included anaphylaxis)
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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 (>=20%) Nausea, diarrhea, vomiting, decreased appetite, elevated bilirubin
Serious Differentiation syndrome, leukocytosis, tumor lysis syndrome, diarrhea, nausea, vomiting, decreased appetite
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.
IDH2 inhibitor; enasidenib is a small molecule that selectively targets mutant IDH2 variants (R140Q, R172S, R172K), decreasing 2-hydroxyglutarate (2-HG) levels and inducing myeloid differentiation in IDH2-mutated AML.
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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)
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Idhifa
  • Covered on 5 commercial plans
  • PA (12/12) · Step Therapy (0/12) · Qty limit (11/12)
View full coverage details ›
UnitedHealthcare
Mylotarg
  • Covered on 4 commercial plans
  • PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
View full coverage details ›
Idhifa
  • Covered on 4 commercial plans
  • PA (6/8) · Step Therapy (0/8) · Qty limit (5/8)
View full coverage details ›
Humana
Mylotarg
  • Covered on 0 commercial plans
  • PA (2/3) · Step Therapy (0/3) · Qty limit (0/3)
View full coverage details ›
Idhifa
  • Covered on 0 commercial plans
  • PA (3/3) · Step Therapy (0/3) · Qty limit (2/3)
View full coverage details ›
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 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.