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    Duvyzat™

    Drug - Duvyzat™ (givinostat) [ITF Therapeutics]

    June 2025

    Therapeutic Area - Duchene muscular dystrophy

    Initial approval criteria

    • Patient has a diagnosis of Duchenne Muscular Dystrophy confirmed by genetic analysis (i.e., dystrophin deletion or duplication mutation) (genetic test required) AND 
    • Patient has tried and had an inadequate response after a 6-month duration of therapy with a glucocorticoid used to treat DMD AND
    • Patient will continue to be on a glucocorticoid while taking Duvyzat OR
    • Patient has an intolerance or hypersensitivity to a glucocorticoid used to treat DMD OR
    • Patient has an FDA labeled contraindication to all glucocorticoids used to treat DMD AND
    • Patient’s age is within FDA labeling for the requested indication for Duvyzat AND
    • Patient’s baseline (i.e., prior to therapy with Duvyzat) platelet level has been obtained and is greater than or equal to 150 x 10^9/L AND
    • Patient’s baseline (i.e., prior to therapy with Duvyzat) triglyceride levels have been evaluated AND
    • If patient has underlying cardiac disease or is taking concomitant medications that cause QT prolongation, ECGs have been obtained AND
    • Patient's platelet levels will continue to be monitored during treatment with Duvyzat AND
    • Patient's triglyceride levels will continue to be monitored during treatment with Duvyzat AND
    • If patient has underlying cardiac disease or is taking concomitant medications that cause QT prolongation, ECGs will continue to be monitored as clinically indicated AND
    • Prescriber is a specialist in the area of patient’s diagnosis (e.g., pediatric neurologist), or Prescriber has consulted with a specialist in the area of patient’s diagnosis AND
    • Patient does NOT have any FDA labeled contraindications to Duvyzat

    Renewal criteria

    • Patient has had improvements or stabilization with Duvyzat (e.g., slowed disease progression, improved strength, timed motor function, pulmonary function; reduced need for scoliosis surgery) AND
    • Patient’s platelet level will continue to be monitored during treatment AND
    • Patient’s triglyceride levels will continue to be monitored during treatment AND
    • If patient has underlying cardiac disease or is taking concomitant medications that cause QT prolongation, ECGs will continue to be monitored as clinically indicated AND
    • Prescriber is a specialist in the area of patient’s diagnosis (e.g., pediatric neurologist), or prescriber has consulted with a specialist in the area of patient’s diagnosis AND
    • Patient does NOT have any FDA labeled contraindications to Duvyzat

    Quantity limits

    • 6 mL twice daily
    • Patient’s weight (in kg) must be submitted at time of request
    • Quantity (number of bottles) and corresponding days supplied must be clearly stated on the request form

    Questions?

    Provider Call Center (844) 575-7887

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