| Leukemia, Myelocytic, Acute
Mylotarg vs Tibsovo
Side-by-side clinical, coverage, and cost comparison for leukemia, myelocytic, acute.Deep comparison between: Mylotarg vs Tibsovo 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 signalsTibsovo has a higher rate of injection site reactions vs Mylotarg based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Tibsovo but not Mylotarg, including UnitedHealthcare
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Category
Mylotarg
Tibsovo
At A Glance
IV infusion
CD33-directed antibody-drug conjugate (ADC)
Oral
Daily
IDH1 inhibitor
Indications
- Leukemia, Myelocytic, Acute
- Leukemia, Myelocytic, Acute
- MYELODYSPLASTIC SYNDROME
- Cholangiocarcinoma
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 500 mg orally once daily; newly diagnosed: in combination with azacitidine 75 mg/m2 SC or IV on Days 1-7 of each 28-day cycle, or as monotherapy, for minimum 6 months; relapsed/refractory: monotherapy until disease progression or unacceptable toxicity.
MYELODYSPLASTIC SYNDROME 500 mg orally once daily as monotherapy until disease progression or unacceptable toxicity; continue for minimum 6 months.
Cholangiocarcinoma 500 mg orally once daily until disease progression or unacceptable toxicity.
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 (>=25%) leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphatase decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, myalgia
Serious differentiation syndrome, electrocardiogram QT prolonged, leukocytosis, Guillain-Barre 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.
Ivosidenib is a small molecule inhibitor of the mutant isocitrate dehydrogenase 1 (IDH1) enzyme that reduces 2-hydroxyglutarate (2-HG) levels and induces myeloid differentiation in IDH1-mutated AML; in IDH1-mutated cholangiocarcinoma, it also reduces 2-HG levels in tumor tissue.
Enter your patient's insuranceCheck specific coverage details for your patient.
Most Common Insurance
Anthem BCBS
Mylotarg
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (4/12) · Qty limit (0/12)
Tibsovo
- Covered on 5 commercial plans
- PA (11/12) · Step Therapy (4/12) · Qty limit (12/12)
UnitedHealthcare
Mylotarg
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
Tibsovo
- 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)
Tibsovo
- 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
No savings programs available for Tibsovo.
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.