For patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after 2 prior systemic treatments did not work.
Read full Important Safety Information
REZUROCK has been shown to help many different types of people with chronic GVHD after failure of any 2 other types of treatment
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.
(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
Skin
Eyes
Mouth
Joints and
muscles
GI tract
Liver
Lungs
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 exploratoryanalysisa
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
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.
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.
If you have chronic GVHD, talk with your health care provider about staying on REZUROCK as long as needed. THIS IS VERY IMPORTANT.
Be sure to tell your health care provider about any side effects you may have. They may be able to help you find ways to manage them.
GI, gastrointestinal; GVHD, graft-versus-host disease.
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.
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
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 at least 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 at least 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 at least 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.
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.
IMPORTANT SAFETY INFORMATION
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 at least 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 at least 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 at least 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.
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.