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
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 CUT, 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.
If you are taking 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.
Take REZUROCK as prescribed by your health care team.
Always talk with your health care team about any changes to your medications
Do not start or stop taking any medicines 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.
Always let your health care team know about all the medicines you are taking.
How to store REZUROCK
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 each time after taking your tablet. Do not discard the drying packet inside the bottle.
Learn more about the
KADMON ASSIST™ SUPPORT PROGRAMS
designed for people who need treatment for chronic GVHD.
Learn more about the
KADMON ASSIST™ SUPPORT PROGRAMS
designed for people who need treatment
for chronic GVHD.
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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.