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The Ramp-Up & Dosing of an Acute Myeloid Leukemia Therapy

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The Ramp-Up & Dosing of an Acute Myeloid Leukemia Therapy 

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The Ramp-Up & Dosing of an Acute Myeloid Leukemia Therapy
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What’s the appropriate way to start a therapy in patients who are newly diagnosed with acute myeloid leukemia?

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  • Overview

    Here to review the ramp-up and dosing for venetoclax therapy in patients with newly diagnosed acute myeloid leukemia is Ilene Galinsky, Senior Program Research Nurse Practitioner for the Leukemia Program at Dana Farber Cancer Institute.

  • Venetoclax Indication and Safety Overview

    Indication
    Venetoclax is a BCL-2 inhibitor indicated:

    • In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults:
      • who are age 75 years or older, or
      • who have comorbidities that preclude use of intensive induction chemotherapy.

    Warnings and Precautions

    • TLS: Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients treated with venetoclax. Anticipate TLS; assess risk in all patients. Premedicate with anti-hyperuricemics and ensure adequate hydration. Employ more intensive measures (intravenous hydration, frequent monitoring, hospitalization) as overall risk increases.
    • Neutropenia: Monitor blood counts. Interrupt dosing and resume at same or reduced dose. Consider supportive care measures.
    • Infections: Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated with venetoclax. Monitor for signs and symptoms of infection and treat promptly. Withhold venetoclax for Grade 3 and 4 infection until resolution and resume at same or reduced dose.
    • Immunization: Do not administer live attenuated vaccines prior to, during, or after venetoclax treatment until B-cell recovery.
    • Embryo-Fetal Toxicity: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
    • Increased mortality in patients with multiple myeloma (MM) when venetoclax is added to bortezomib and dexamethasone. In a randomized trial in patients with relapsed or refractory MM, the addition of venetoclax to bortezomib plus dexamethasone, a use for which venetoclax is not indicated, resulted in increased mortality. Treatment of patients with MM with venetoclax in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.

    Adverse Reactions

    • In AML, the most common adverse reactions (≥30%) in combination with azacitidine, or decitabine, or low-dose cytarabine were nausea, diarrhea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, edema, pyrexia, pneumonia, dyspnea, hemorrhage, anemia, rash, abdominal pain, sepsis, musculoskeletal pain, dizziness, cough, oropharyngeal pain, and hypotension.

     Review full prescribing information for additional information at www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110 or go to abbviemedinfo.com.

    BCL2-US-00030-MC
    Version 1.0, Approved December 2020
Programs 5/13/21