Belumosudil

WHY is this medicine prescribed?

Belumosudil is used to treat graft versus host disease (GVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow]) in adults and children 12 years of age and older who were treated unsuccessfully with at least two other treatments. Belumosudil is in a class of medications called kinase inhibitors. It works to treat GVHD by blocking the signals of the cells that cause GVHD.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Belumosudil comes as a tablet to take by mouth. It is usually taken with a meal once a day. Take belumosudil at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take belumosudil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will order blood tests before and during your treatment to see how you are affected by this medication. Your doctor may increase or decrease your dose of belumosudil during your treatment, or may tell you to stop taking belumosudil for awhile. This depends on how well the medication works for you, your lab test results, and if you experience side effects. Talk to your doctor about how you are feeling during your treatment. Continue to take belumosudil even if you feel well. Do not stop taking belumosudil without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking belumosudil,

• tell your doctor and pharmacist if you are allergic to belumosudil, any other medications, or any of the ingredients in belumosudil tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention phenobarbital; phenytoin (Dilantin, Phenytek); proton pump inhibitors such as dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Yosprala, Zegerid), pantoprazole (Protonix), and rabeprazole (Aciphex); rifampin (Rifadin, Rimactane); and steroids such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos).

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking belumosudil. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your belumosudil treatment and for 1 week after your final dose. If you are male, you and your partner should use birth control to prevent pregnancy during your treatment with belumosudil and for 1 week after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. Belumosudil may decrease fertility in men and women. However, you should not assume that you or your partner cannot become pregnant. If you or your partner become pregnant while taking belumosudil, call your doctor. Belumosudil may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with belumosudil and for at least 1 week after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Belumosudil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness or weakness
• nausea
• difficulty swallowing
• shortness of breath
• diarrhea
• muscle or joint pain
• headache
• swelling of the hands, feet, or face
• rash or itching

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, sore throat, chills, cough, or other signs of infection
• unusual bleeding or bruising

Belumosudil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with medication to absorb moisture).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to belumosudil.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.