FAQs

When you start a new medicine for chronic graft-versus-host disease (chronic GVHD), you may have many important questions. Below are the answers to some questions you may have about REZUROCK and chronic GVHD.

  • What causes chronic
    GVHD?

    During a blood stem cell transplant, stem cells from a donor (the graft) are added to your body (the host). Donor cells may attack your body’s cells and organs because they see them as a threat.

    When this happens, it can lead to chronic GVHD. Chronic GVHD causes your immune system to become unbalanced, creating too many of some cells and not enough of others. This leads to inflammation (swelling) and fibrosis (scarring), which can damage your organs.

  • How serious is
    chronic GVHD?

    The severity of chronic GVHD depends on the person. Chronic GVHD may affect multiple organs and cause

    Painful skin rashes, along with skin thickening or tightening

    Joint stiffness and trouble moving and using hands

    Eye problems

    Lung damage

    Stomach problems

    General decline in health, including fatigue

  • Does everyone who
    has a blood stem cell
    transplant get
    chronic
    GVHD?

    Not everyone who gets a blood stem cell transplant gets chronic GVHD. Those who do, may have to manage it over a long period of time.

  • What is REZUROCK for?

    REZUROCK may help reduce the symptoms of chronic GVHD in people 12 years and older after failure of at least 2 other types of treatment. REZUROCK works by rebalancing your immune system, and it has been shown to help reduce symptoms in many different types of people with chronic GVHD.

  • How is REZUROCK
    different from other
    medicines for
    chronic
    GVHD?

    Most medicines for chronic GVHD are immunosuppressants. These medicines suppress (reduce the strength of) your immune system. While these medicines can help treat your condition, they can also lower your body’s ability to fight something it recognizes as being an invader, such as an infection.

    REZUROCK is different. It can help rebalance your immune system. REZUROCK is the only approved medicine that blocks the ROCK2 pathway in your body and may reduce the symptoms of inflammation and fibrosis.

  • Does REZUROCK cause
    side effects?

    The most common side effects reported by people taking REZUROCK in clinical studies were

    Infections

    Tiredness or weakness

    Nausea

    Diarrhea

    Shortness of breath

    Cough

    Swelling

    Bleeding

    Stomach (abdominal) pain

    Muscle or bone pain

    Headache

    High blood pressure

  • How long does it take for
    REZUROCK to work?

    Many people who took REZUROCK in the clinical studies found symptom relief within 4 to 8 weeks, although with others it took longer. The time it takes your body to respond to REZUROCK may be different than in someone else.

  • How well does
    REZUROCK work?

    More than 7 out of 10 people who took REZUROCK in the ROCKstar study found symptom relief. This includes many different types of people with chronic GVHD at different stages of their treatment journeys. For example, some people had been treated with other medicines, besides steroids, for chronic GVHD before entering the studies. Some people had chronic GVHD affecting more than 1 organ. People in the REZUROCK studies had mild, moderate or severe GVHD.

  • How do I take
    REZUROCK?

    The REZUROCK 200-mg tablet is taken by mouth once a day with a meal.

    The REZUROCK tablet should be swallowed whole with a glass of water

    Do not cut, crush or chew the REZUROCK tablet

    Take REZUROCK at approximately the same time each day with a meal

    If you miss a dose of REZUROCK, take it as soon as you remember on the same day. Take your next dose of REZUROCK at your regular time on the next day. Do not take extra doses of REZUROCK to make up for a missed dose

  • Can I take REZUROCK
    with other
    medicines?

    Your health care team may choose to prescribe REZUROCK along with other medicines for chronic GVHD. Talk with your health care team to find out if REZUROCK is right for you.

    If you are taking REZUROCK, make sure to tell your health care team about all of the prescription and over-the-counter medicines (including proton pump inhibitors, or PPIs), vitamins and herbal products you are taking because they may affect how REZUROCK works.

  • How long will I stay
    on REZUROCK?

    How long you stay on REZUROCK will depend on multiple things, including how long it takes your body to respond to the medication and the amount of improvement you experience.

  • What should I do if I
    want to change my
    REZUROCK therapy?

    Talk with your health care team about the best course of treatment for you. Do not change your dose or stop taking REZUROCK without first talking to your health care team.

  • How should I store
    REZUROCK?

    Store REZUROCK at room temperature, ranging from 68 °F to 77 °F
    (20 °C- 25 °C). REZUROCK should be stored in its original container, with the drying packet in the bottle. Do not throw the drying packet out. Remember to close the bottle tightly after you take your tablet.

  • Is REZUROCK expensive?

    Talk with your health care team about enrolling in Kadmon ASSIST™ to see what support you may be eligible for.

  • Is REZUROCK covered by
    my insurance?

    Talk with your health care team about enrolling in Kadmon ASSIST™ to see what support you may be eligible for.

  • How do I pronounce
    belumosudil?

    The generic name of REZUROCK, belumosudil, is pronounced
    bel-you-mos-oo-dill.

For more information about REZUROCK, please see the Prescribing Information.

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View information about REZUROCK and chronic GVHD

Discussion guide

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How REZUROCK Works

GVHD, graft-versus-host disease.

USE

REZUROCKTM (belumosudil) is a prescription medicine used to treat adults and children 12 years of age and older with chronic graft-versus-host disease (chronic GVHD) after you have received at least 2 prior treatments (systemic therapy) and they did not work. It is not known if REZUROCK is safe and effective in children less than 12 years old.

IMPORTANT SIDE EFFECT INFORMATION

Before taking REZUROCK, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems.
  • are pregnant or plan to become pregnant. REZUROCK can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with REZUROCK. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with REZUROCK.
  • - Females who can become pregnant should use effective birth control during treatment with REZUROCK and for at least 1 week after the last dose.
  • - Males with female partners who can become pregnant should use effective birth control during treatment with REZUROCK and for at least 1 week after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if REZUROCK passes into breast milk. Do not breastfeed during treatment with REZUROCK and for at least 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REZUROCK may affect the way other medicines work, and other medicines may affect the way REZUROCK works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take REZUROCK?

  • Take REZUROCK exactly as your healthcare provider tells you to take it.
  • Do not change your dose or stop taking REZUROCK without first talking to your healthcare provider.
  • Take REZUROCK 1 time a day with a meal.
  • Take REZUROCK at about the same time each day.
  • Swallow REZUROCK tablets whole with a glass of water.
  • Do not cut, crush, or chew REZUROCK tablets.
  • Your healthcare provider will do blood tests to check your liver at least 1 time a month during treatment with REZUROCK.
  • If you miss a dose of REZUROCK, take it as soon as you remember on the same day. Take your next dose of REZUROCK at your regular time on the next day. Do not take extra doses of REZUROCK to make up for a missed dose.
  • If you take too much REZUROCK, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of REZUROCK?

The most common side effects of REZUROCK include:

  • infections
  • tiredness or weakness
  • nausea
  • diarrhea
  • shortness of breath
  • cough
  • swelling
  • bleeding
  • stomach (abdominal) pain
  • muscle or bone pain
  • headache
  • high blood pressure

Your healthcare provider may change your dose of REZUROCK, temporarily stop, or permanently stop treatment with REZUROCK if you have certain side effects.

REZUROCK may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of REZUROCK. Call your doctor for medical advice about side effects.

Please see full Prescribing Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC, at 1-877-377-7862 to report side effects.

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Use

REZUROCKTM (belumosudil) is a prescription medicine used to treat adults and children 12 years of age and older with chronic graft-versus-host disease (chronic GVHD)

IMPORTANT SIDE EFFECT INFORMATION Before taking REZUROCK, tell your healthcare provider about all of your medical conditions, including if you: pink circular icon with plus sign

Use & Important side effect information

REZUROCKTM (belumosudil) is a prescription medicine used to treat adults and children