Prescribing Information

Use in Chronic GVHD

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

Learn more about REZUROCK

REZUROCK works differently

REZUROCK can help REBALANCE your immune system. It is the only approved medicine for chronic GVHD that blocks the ROCK2 pathway in your body. This may reduce the INFLAMMATION and FIBROSIS that can happen with chronic GVHD.

GVHD, graft-versus-host disease.

REZUROCK works differently

GVHD, graft-versus-host disease.

People with chronic GVHD face a number of challenges.

REZUROCK was shown to help

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.

Primary end point

(That’s 3 out of every 4 people)

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

Response was seen in various organs

Skin

Eyes

Mouth

Joints and muscles

GI tract

Liver

Lungs

Esophagus

Some people taking REZUROCK had

OBSERVED REDUCTION OF USE OF STEROIDSa
QUALITY-OF-LIFE IMPROVEMENTS reported in an exploratory analysisb

GI, gastrointestinal.

No definitive conclusions about the effect of REZUROCK can be drawn from this data. Also, the ROCKstar study measured overall response across all organs, so improvement in one organ may not mean overall benefit.

^aNo definitive conclusions about the effect of REZUROCK can be drawn from this data.

^bAn 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.

Response was seen in various organs

Skin

Eyes

Mouth

Joints and muscles

GI tract

Liver

Lungs

Esophagus

Some people taking REZUROCK had

OBSERVED REDUCTION OF USE OF STEROIDSa
QUALITY-OF-LIFE IMPROVEMENTS reported in an exploratory analysisb

GI, gastrointestinal.

No definitive conclusions about the effect of REZUROCK can be drawn from this data. Also, the ROCKstar study
measured overall response across all organs, so improvement in one organ may not mean overall benefit.

^aNo definitive conclusions about the effect of REZUROCK can be drawn from this data.

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.

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.

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 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 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 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.

USE

REZUROCK^{^®} (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.

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, a Sanofi Company, at 1-800-633-1610 to report side effects.