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Key Considerations for Initiating a Chronic Lymphocytic Leukemia Therapy

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Key Considerations for Initiating a Chronic Lymphocytic Leukemia Therapy

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Key Considerations for Initiating a Chronic Lymphocytic Leukemia Therapy
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How can you reduce the risk of tumor lysis syndrome when starting patients on a therapy for chronic lymphocytic leukemia? 

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  • Overview

    No matter whether you’re using venetoclax for chronic lymphocytic leukemia in the first-line or
    relapsed/refractory setting, there are some important considerations to keep in mind, like its dose ramp-up as well as the importance of hydration and tumor lysis syndrome prophylaxis. Tune in as Dr. Lisa Nodzon, advanced oncology certified nurse practitioner in the Department of Malignant Hematology at Moffitt Cancer Center, reviews those key considerations and more.

  • Important Safety Information

    Indication and Usage

    • Venetoclax is a BCL-2 inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

    Dosage and Administration

    • Venetoclax dosing begins with a 5-week ramp-up: Administer the venetoclax dose according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg – Venetoclax Daily Dose: 20 mg (Week 1), 50 mg (Week 2), 100 mg (Week 3), 200 mg (Week 4), and 400 mg (Week 5 and beyond).
    • VEN+R: For venetoclax in combination with rituximab, administer rituximab after the 5-week ramp-up schedule with venetoclax. Continue venetoclax for 24 months from Cycle 1 Day 1 of rituximab.
    • VEN+G: For venetoclax in combination with obinutuzumab, begin obinutuzumab administration on Cycle 1 Day 1. Administer obinutuzumab for a total of 6 cycles. On Cycle 1 Day 22, start venetoclax according to the 5-week ramp-up schedule. Administer venetoclax until the last day of cycle 12.
    • Oral, Once Daily Dosing: Venetoclax tablets should be taken orally once daily with a meal and water. Do not chew, crush, or break tablets.
    • Perform prophylaxis for tumor lysis syndrome (TLS).

    Contraindications

    • Strong CYP3A Inhibitors: Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with CLL/SLL is contraindicated.

    Warnings and Precautions

    • TLS: Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients with high tumor burden when 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 and for signs of infection; manage as medically appropriate.
    • Infections: Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated
      with venetoclax. Monitor patients closely for signs and symptoms of infection and treat promptly.
      Withhold venetoclax for ≥Grade 3 infection.
    • Immunization: Do not administer live vaccines prior to, during, or after venetoclax treatment.
    • 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 during treatment.
    • 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 CLL/SLL, the most common adverse reactions (≥20%) for venetoclax when given in combination with obinutuzumab or rituximab or as monotherapy were neutropenia, thrombocytopenia, anemia, diarrhea, nausea, upper respiratory tract infection, cough, musculoskeletal pain, fatigue, and edema.

    Review VENCLEXTA 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-00023-MC
    Version 1.0, Approved August 2020

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Programs 12/3/20