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    Vykat XR for Hyperphagia in Prader-Willi Syndrome

    Prescribing Information

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    Expert Guidance

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    VYKAT™ XR (diazoxide choline extended-release tablets) is the first FDA-approved medication to treat hyperphagia—the overwhelming, persistent hunger that is the hallmark symptom of PWS.

    Clinical studies showed that VYKAT XR can reduce food-related behaviors and improve quality of life for many people with PWS. While it is not a cure and does not eliminate the need for food security, it represents an important milestone in PWS research and care.

    What is Vykat XR?

    VYKAT XR is a prescription oral medication for individuals living with Prader-Willi syndrome (PWS) ages 4 and older with hyperphagia. VYKAT XR is an extended-release tablet that must be swallowed whole at the same time every day, with or without food. Crushing, splitting, or chewing the extended-release tablet may compromise the characteristics of the safety and efficacy of the medication.

    How Does Vykat XR Work?

    Vykat works by activating ATP-sensitive potassium (KATP) channels in the hypothalamus, an area of the brain that plays a central role in regulating hunger, fullness, and energy balance. By helping normalize this signaling, VYKAT XR may reduce hyperphagia in people with PWS.

    Like many medications, VYKAT XR does not work immediately. Improvements often develop gradually over weeks to months as the medication is adjusted to the appropriate dose.

    Benefits Seen in Clinical Trials

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    Data from the phase 3 clinical trial showed statistically significant improvement in hyperphagia, as well as these other benefits:

    • Improved behavior
    • Fewer outbursts related to food
    • Improved metabolism
    • Less worrying or talking about food

    Some families also reported meaningful improvements in quality of life as food became less dominant in everyday routines.

    Every individual responds differently. Some people experience noticeable improvements, while others may have more modest changes.

    Importantly, VYKAT XR is not a cure for Prader-Willi syndrome and does not replace food security. Even individuals who respond well to treatment must continue environmental controls that prevent unrestricted access to food.

    Starting Vykat XR: What to Expect

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    VYKAT XR is not an "instant" treatment. While some people notice changes within the first several weeks, many experience gradual improvements over time as their healthcare provider adjusts the dose and monitors their response. The goal is to find the dose that provides meaningful improvement in hyperphagia while minimizing side effects.

    VYKAT XR is started at a dose based on body weight.  Rather than beginning at the full target dose, your provider will gradually increase the dose over time.

    Dosage is determined based on the patient’s body weight and titrated (increased) on a biweekly basis under a clinician’s supervision until the target dose has been met. Clinicians will use a titration schedule based on VYKAT XR prescribing information.

    Prior to receiving treatment, patients must go through laboratory testing to establish a baseline. The bloodwork will test for fasting plasma glucose and HbA1c to ensure the patient is safe to begin treatment and establish safe levels to continue during treatment.

    Common Side Effects

    Like all prescription medications, VYKAT XR can cause side effects.  Your healthcare provider will work with you to determine whether treatment should be adjusted if side effects occur.

    The most commonly reported side effects include:

    • Fluid Overload (swelling, also called edema)
    • Elevated blood sugar
    • Increased hair growth (hypertrichosis)
    • Rash

    Swelling (Edema)

    Swelling, also called edema, is one of the more common side effects of VYKAT XR.  Your healthcare provider will monitor for signs of swelling during treatment.  If edema develops, your provider may recommend continued monitoring, adjusting the medication dose, and/or treating the swelling if appropriate.

    Elevated Blood Sugar

    Because VYKAT XR can increase blood sugar levels, your healthcare provider will monitor glucose throughout treatment.  The VYKAT XR Medication Guide recommends checking blood sugar levels before you start VYKAT XR, at least 1 time every week for the first 2 weeks of treatment, then at least 1 time every 4 weeks and as needed during treatment. This is especially important for individuals who have diabetes, prediabetes, or a history of elevated blood sugar.

    If blood sugar increases, your healthcare provider may recommend additional monitoring, changes to diabetes medications, or adjustments to your treatment plan.

    Who may be at higher risk for problems?

    Certain factors may increase the chance of serious side effects. These include:

    • Obesity
    • Heart or breathing problems (now or in the past)
    • Swelling or fluid buildup in the body
    • Sleep apnea that is not being treated or not well controlled
    • Other breathing issues, such as shallow breathing (hypoventilation)
    • History of severe respiratory infections or pneumonia

    Prescribing doctors should closely monitor, and potentially slow the titration process, for patients who are at higher risk of serious side effects. Additional safety testing (such as an echocardiogram or specific assessment of fluid retention) may be needed before and during Vykat use in individuals with risk factors. 

    If your doctor is not highly experienced in caring for an individual with PWS, they may wish to consult with a more experienced provider prior to starting therapy. 

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    Expert Guidance for Vykat Use

    A group of clinicians with expertise in treating people with PWS have published guidance for the use of Vykat. This important publication can be downloaded and shared with your medical provider. 

    Learn More

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    More Information

    Before starting any medication, it’s essential to talk with your doctor about all relevant factors. Proper nutritional management remains a mainstay during VYKAT XR treatment.

    For more information about VYKAT XR to treat hyperphagia for those living with PWS, download this VYKAT XR fact sheet from the manufacturer.  Additional resources include: