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FAQs about REZUROCK and useful resources for people with chronic GVHD

 

FAQs

When you start a new medicine for chronic GVHD, you may have many important questions. Below are the answers to some questions you may have about REZUROCK and chronic GVHD.

    Chronic GVHD can occur after a stem cell transplant when the stem cells from your donor (the graft) starts attacking your body (the host) because they see it as foreign. It can affect almost any part of your body lasting from months to a lifetime causing inflammation and fibrosis (scarring and hardening of tissues).

    No, not everyone who undergoes a stem cell transplant develops chronic GVHD. 30%-70% of patients who receive a stem cell transplant from a donor develop chronic GVHD.

    REZUROCK is a prescription medication used to treat adults and adolescents aged 12 years and older with chronic GVHD who have received at least two previous treatments.

    In chronic GVHD a pathway called the ROCK2 pathway has been shown to be too active. REZUROCK works by blocking the ROCK2 pathway which may decrease inflammation and fibrotic symptoms such as scarring.

    Tell your doctor straight away if you experience any of the following rare serious side effects which may affect less than 1 in 10,000 people:

    • Cough, chest pain, difficulty breathing, fever and sweating/chills. These could be symptoms of pneumonia.
    • Painful, hot, swollen or blistering skin.
    • Bloody diarrhoea.

    Other possible side effects include the following listed below. If these side effects become severe, tell your doctor.

    Very common (may affect more than 1 in 10 people):

    • Extreme tiredness.
    • Feeling sick (nausea).

    Common (may affect up to 1 in 10 people):

    • Headache.
    • Increase in aspartate aminotransferase (a liver enzyme).
    • Increase in alanine aminotransferase (a liver enzyme).
    • Diarrhoea.
    • Muscle or joint pain.
    • Being sick (vomiting).
    • Increase in gamma glutamyl transferase (a liver enzyme).
    • Low white blood cell count (cells that fight infection).
    • Swelling.
    • Muscle spasms.
    • Upper respiratory tract infections (such as common cold, sinus infection).
    • Sudden shortness of breath or difficulty breathing (dyspnea).
    • Cough.
    • High blood sugar (hyperglycaemia).
    • Decrease in appetite.
    • Increase in alkaline phosphatase in the blood (a muscle enzyme).
    • Decrease in weight.
    • Low red blood cell count (anaemia).
    • Pain, tingling or numbness in the hands or feet (neuropathy peripheral).
    • High blood pressure.
    • Low platelet count (cells that fight bleeding).
    • Lower respiratory tract infections (such as pneumonia, bronchitis).
    • Pain in the stomach.
    • Constipation.
    • Itching.
    • Dizziness.
    • Increase in creatinine phosphokinase in the blood (a muscle enzyme).
    • Increase in creatinine in the blood (a muscle waste product).
    • Fever.

    REZUROCK may also affect fertility. Talk to your healthcare professional if you are planning on having children.

    The time to response of REZUROCK will be different from other medications you may have taken. It is important that you take REZUROCK as long as your doctor has recommended.

    How long you will stay on REZUROCK will depend on how well your body responds to it. It is important you take REZUROCK for as long as your doctor recommends.

    REZUROCK 200mg tablet is to be taken by mouth once a day with a meal approximately at the same time each day.

    If you miss a dose, take the missed tablet as soon as possible on the same day if it is less than 12 hours since your dose was due. If it is more than 12 hours, do not take it. Take the next dose at your usual time. DO NOT TAKE AN EXTRA DOSE to make up for the missed dose. REZUROCK should be swallowed whole. Do not crush or chew the tablet.

    If you take too much REZUROCK, tell your doctor or go to the nearest hospital right away. Take the medicine pack with you.
    If you are sick (vomit) after taking REZUROCK, do not take another tablet. Take your next dose at your regular time on the next day.

    Your health care team may choose to prescribe REZUROCK along with other medicines for chronic GVHD.

    If you are prescribed 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.

    Do not store REZUROCK above 25⁰C. Store in its original container to protect from moisture. Make sure the cap is tightly closed after taking your tablet and do not discard the drying packet inside the bottle.

GVHD, graft-versus-host disease.

REZUROCK®▼(belumosudil) website for patients - FAQs and helpful resources about REZUROCK

MAT-XU-2305029 (v2.0)
Date of Preparation: February 2025