Belumosudil

Belumosudil is used to treat chronic graft-versus-host disease after at least two other treatments did not work.

Belumosudil is for use in adults and children at least 12 years old.

Belumosudil may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Belumosudil is usually taken once per day with a meal. Follow your doctor's dosing instructions very carefully.

Take with a full glass of water, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent blood tests to check your liver function.

Store tightly closed at room temperature, away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tell your doctor if you have ever had liver or kidney problems.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using belumosudil should use effective birth control to prevent pregnancy. Belumosudil can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Belumosudil may cause serious side effects. Call your doctor at once if you have:

• severe ongoing nausea, vomiting, or diarrhea;
• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, bruising or bleeding, painful urination, cough with mucus, chest pain, feeling short of breath.

Common side effects of belumosudil may include:

• stomach pain, nausea, diarrhea;
• infections, bleeding;
• high blood pressure;
• cough, shortness of breath;
• muscle or bone pain;
• swelling;
• headache; or
• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Graft Versus Host Disease:

200 mg orally once a dayDuration of therapy: Until progression of chronic Graft Versus Host Disease (GVHD) that requires new systemic therapyUse: For the treatment of patients with GVHD after failure of at least two prior lines of systemic therapy

Usual Pediatric Dose for Graft Versus Host Disease:

-12 to less than 18 years:200 mg orally once a day-Duration of therapy: Until progression of chronic Graft Versus Host Disease (GVHD) that requires new systemic therapyUse: For the treatment of patients with GVHD after failure of at least two prior lines of systemic therapy

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all your current medicines. Many drugs can affect belumosudil, especially:

• phenobarbital or other barbiturate medicine;
• St. John's wort;
• an antibiotic--rifabutin, rifampin, rifapentine;
• cancer medicine--apalutamide, enzalutamide, mitotane;
• HIV or AIDS medicine--efavirenz, nevirapine;
• a proton pump inhibitor stomach acid medicine--esomeprazole, lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, Protonix, and others;
• seizure medicine--carbamazepine, oxcarbazepine, phenytoin, primidone; or
• steroid medicine--dexamethasone, prednisone.

This list is not complete and many other drugs may affect belumosudil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.