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

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

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Skin

purple and pink circular icon of an eye

Eyes

purple and pink circular icon of an open mouth with teeth

Mouth

purple and pink circular icon of a bent knee joint

Joints and
muscles

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GI tract

purple and pink circular icon of the liver

Liver

purple and pink circular icon of the lungs

Lungs

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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

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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.

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