Rezurock 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 this medicine is safe and effective in children less than 12 years old.

• Take Rezurock exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop treatment without first talking to your healthcare provider.
• Take Rezurock tablets one time a day with a meal.
• Take your dose at about the same time each day.
• Swallow the tablets whole with a glass of water.
• Do not cut, crush, or chew the tablets.
• Your healthcare provider will do blood tests to check your liver at least one time a month during treatment.
• If you miss a dose, take it as soon as you remember on the same day. Take your next dose at your regular time on the next day. Do not take extra doses to make up for a missed dose.
• If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Before you start treatment, 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. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment.
  • Females who can become pregnant should use effective birth control during treatment, and for at least one week after the last dose.
  • Males with female partners who can become pregnant should use effective birth control during treatment, and for at least one 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, and for at least one 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.

The most common side effects 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, temporarily stop treatment, or permanently stop treatment 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Kadmon Pharmaceuticals, LLC at 1-877-377-7862.

Strong CYP3A Inducers (rifampin, carbamazepine, phenobarbital, phenytoin and others) and proton pump inhibitors (lansoprazole, omeprazole, esomeprazole, and others) may reduce the effectiveness of belumosudil treatment. Your Rezurock dosage may need to be increased.

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 this medicine works.