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.

REZUROCK may help treat chronic GVHD in people 12 years and older after failure of at least 2 other types of treatment. REZUROCK works by rebalancing the immune system, helping to improve chronic GVHD.

Many systems in the body work through what are called “PATHWAYS.” These pathways are a series of actions that take place among cells and molecules within the body. One such pathway is called “ROCK2.”

In people with chronic GVHD, this ROCK2 pathway is too active. This leads to a decrease in cells that help keep the immune system in check and an increase in cells that cause inflammation and fibrosis. The result is an immune system that is out of balance.

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.

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 the possible side effects of REZUROCK.

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.

75% of people (that's 3 out of every 4 people) in the ROCKstar study saw improvement in their chronic GVHD. This includes many different types of people with chronic GVHD at different stages of their treatment journeys. For example, 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 and people with chronic GVHD in 1 or more organs.

Some people taking REZUROCK had a reduced need for steroids and other immunosuppressants. And some people reported quality-of-life improvements, in an exploratory analysis.^a

^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.

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 crush or chew the tablet

• Take REZUROCK at approximately the same time each day with a meal. A meal is not a snack. It is about the same amount of calories as you might have for lunch or dinner

• 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.

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.

How long you stay on REZUROCK will depend on multiple things, including how long it takes your body to respond to the medication, how well your body responds to it 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 discussing it first with your health care team. If you experience a side effect, be sure to tell your health care team right away.

Store REZUROCK at room temperature, ranging from 68 °F to 77 °F
(20 °C-25 °C). REZUROCK should be stored in its original container to protect it from moisture. Make sure to close the cap tightly after taking your tablet. Do not discard the drying packet inside the bottle.

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.