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

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.

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.

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.

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

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.

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.

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

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 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.

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.

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.

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

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

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