For patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after 2 prior systemic treatments did not work.

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For US Residents Only

Use in Chronic GVHD

For US Residents Only

REZUROCK (belumosudil) tablets logo

Prescribing
Information

People with chronic GVHD face a number of challenges. REZUROCK was shown to help

REZUROCK was evaluated in 2 clinical studies that included a total of 186 people with chronic GVHD. One study, called the ROCKstar study, had 132 people. The other study, called the KD025-208 study, had 54 people.

75

%

(that's 3 out of
every 4 people)

of people in the ROCKstar study saw improvement in their chronic GVHD.

 

People who saw results in the REZUROCK clinical trials included

  • People who tried immunosuppressants, such as steroids, and other medicines for chronic GVHD that failed to control their symptoms
  • People with mild, moderate and severe chronic GVHD
  • People with chronic GVHD in 1 or more organs

75%

(that's 3 out of every 4 people)

of people in the ROCKstar study saw improvement in their chronic GVHD.

 

People who saw results in the REZUROCK clinical trials included

  • People who tried immunosuppressants, such as steroids, and other medicines for chronic GVHD that failed to control their symptoms
  • People with mild, moderate and severe chronic GVHD
  • People with chronic GVHD in 1 or more organs

Response was seen in various organs

purple and pink circular icon of an arm

Skin

purple and pink circular icon of an eye

Eyes

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Mouth

purple and pink circular icon of a bent knee joint

Joints and
muscles

purple and pink circular icon of the intestinal tract

GI tract

purple and pink circular icon of the liver

Liver

purple and pink circular icon of the lungs

Lungs

purple and pink circular icon of the esophagus

Esophagus

Response was seen in various organs

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Skin

pink circular icon of an eye

Eyes

pink circular icon of the intestinal tract

GI tract

pink circular icon of the liver

Liver

pink circular icon of an open mouth with teeth

Mouth

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Joints and
muscles

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Lungs

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Esophagus

  • More than half of people who saw improvement did so between WEEKS 4 AND 8
  • Almost everyone who saw improvement did so by WEEK 24
  • Medicine(s) may affect everyone differently. Some people may take longer to respond, especially if they have severe disease caused by fibrosis

Some people taking REZUROCK also had

  • A REDUCED USE OF STEROIDS and other immunosuppressants
  • QUALITY OF LIFE IMPROVEMENTS, reported in an exploratory analysisa

aAn exploratory analysis provides a better understanding of a problem but is not proof. It is difficult to measure quality of life because every person is different and will have a unique experience with treatment.

What are the side effects of REZUROCK?

The most common side effects reported by people taking REZUROCK in 2 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

REZUROCK may affect fertility in males and females. Talk with your health care provider if this is a concern for you.

These are not all of the side effects of REZUROCK.


Additional information from the clinical studies

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In the clinical studies, there were NO NEW CASES of cytomegalovirus (CMV) infection and only 1 case of recurring CMV infection.

CMV is a common serious infection that can happen in people who have had a blood stem cell transplant.

 
purple and pink circuar icon with white 4% in the center

About 4% OF PEOPLE (that’s 1 out of every 25 people) in clinical studies had serious cytopenia (site-oh-pee-nia), a condition that causes a drop in levels of certain blood cells.

GVHD, graft-versus-host disease.

© 2022 Kadmon Pharmaceuticals, LLC.
All Rights Reserved.
This site is intended for use by US Residents only.

 

MAT-US-2201639-v2.0-08/2022   Last updated: August 2022

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