| Leukemia, Myelocytic, Acute

Mylotarg vs Nivestym

Side-by-side clinical, coverage, and cost comparison for leukemia, myelocytic, acute.

Deep comparison between: Mylotarg vs Nivestym with Prescriber.AI

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Safety signalsNivestym has a higher rate of injection site reactions vs Mylotarg based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Nivestym but not Mylotarg, including UnitedHealthcare

Category

Mylotarg

Nivestym

At A Glance

RouteIV infusion

ClassCD33-directed antibody-drug conjugate (ADC)

RouteSC injection or IV infusion

FrequencyDaily

ClassG-CSF analog

Indications

Leukemia, Myelocytic, Acute

Leukemia, Myelocytic, Acute
Severe congenital neutropenia
Cyclic neutropenia
Idiopathic neutropenia

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.

Cancer receiving myelosuppressive chemotherapy, Leukemia, Myelocytic, Acute 5 mcg/kg/day SC injection, short IV infusion (15-30 min), or continuous IV infusion; administer at least 24 hours after cytotoxic chemotherapy; continue daily for up to 2 weeks or until ANC reaches 10,000/mm3 after the expected nadir.

Cancer undergoing bone marrow transplantation 10 mcg/kg/day IV infusion no longer than 24 hours; administer first dose at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion; titrate against neutrophil response per dosage adjustment table.

Autologous peripheral blood progenitor cell mobilization 10 mcg/kg/day SC injection; administer at least 4 days before first leukapheresis and continue until last leukapheresis; discontinue if WBC rises above 100,000/mm3.

Severe congenital neutropenia 6 mcg/kg SC injection twice daily; individualize based on clinical course and ANC with chronic daily administration.

Cyclic neutropenia, Idiopathic neutropenia 5 mcg/kg SC injection once daily; individualize based on clinical course and ANC with chronic daily administration.

Contraindications

Known hypersensitivity to gemtuzumab ozogamicin, its components, or any excipient (reactions have included anaphylaxis)

History of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products

Drug Interactions

1116View drug interactions

824View drug interactions

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 (>=5% higher incidence vs placebo) Pyrexia, nausea, fatigue, thrombocytopenia, back pain, bone pain, rash, dizziness, dyspnea, cough, chest pain, arthralgia, pain in extremity, increased blood alkaline phosphatase, increased blood lactate dehydrogenase

Serious Splenic rupture, acute respiratory distress syndrome, serious allergic reactions, sickle cell disorders, glomerulonephritis, alveolar hemorrhage and hemoptysis, capillary leak syndrome, myelodysplastic syndrome, acute myeloid leukemia, thrombocytopenia, leukocytosis, cutaneous vasculitis, aortitis

Postmarketing Anaphylaxis, splenomegaly, Sweet's syndrome, decreased bone density and osteoporosis (pediatric chronic use), extramedullary hematopoiesis

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.

Filgrastim-aafi is a recombinant G-CSF analog that binds to specific cell surface receptors on hematopoietic cells, stimulating neutrophil progenitor proliferation, differentiation, and end-cell functional activation; its activity is selective for the neutrophil lineage with minimal effects on other hematopoietic cell types.

View Full FDA Information

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Most Common Insurance

Anthem BCBS

Mylotarg