Belumosudil (bel-ue-MOE-soo-dil)

Treats chronic graft-versus-host disease (cGHVD).

Brand Name(s):

Rezurock

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole with a glass of water. Do not cut, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Take the missed dose only if it is the same day as the scheduled dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how belumosudil works. Tell your doctor if you are using dabigatran, efavirenz, midazolam, omeprazole, rabeprazole, raltegravir, rifampin, or rosuvastatin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, headache, slow or fast heartbeat, lightheadedness, dizziness
• Chest pain, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Muscle or bone pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, loss of appetite, stomach pain, trouble swallowing
• Joint pain, muscle spasms

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088