Pronunciation:

bel-ue-MOE-soo-dil

Brand Names:

• Rezurock

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Immune Suppressant

Uses of This Medicine:

Belumosudil is used to treat chronic graft-versus-host disease (cGVHD) in patients who have received at least 2 previous treatments that did not work.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of belumosudil in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of belumosudil in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Carbamazepine
• Clarithromycin
• Dexlansoprazole
• Enzalutamide
• Esomeprazole
• Fedratinib
• Fexinidazole
• Fosphenytoin
• Itraconazole
• Lansoprazole
• Lumacaftor
• Mavacamten
• Mitotane
• Omaveloxolone
• Omeprazole
• Pantoprazole
• Phenobarbital
• Phenytoin
• Primidone
• Rabeprazole
• Rifampin
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease, severe—Use with caution. This medicine has not been studied in patients with these conditions.

• Liver disease, moderate or severe—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine at the same time each day. It is best to take it with food.

Swallow the tablet whole with a glass of water. Do not cut, crush, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For chronic graft-versus-host disease (cGVHD):
    • Adults and children 12 years of age and older—200 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Take the missed dose only if it is the same day as the scheduled dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Women should use an effective form of birth control during treatment and for 1 week after the last dose. Men should use an effective form of birth control during treatment and for 1 week after the last dose to prevent pregnancy in a sexual partner. If you think a pregnancy has occurred with this medicine, tell your doctor right away.

This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bloody nose

bloody or cloudy urine

bluish lips or skin

blurred vision

body aches or pain

burning, dry or itching eyes

chest pain or tightness

chills

collection of blood under the skin

confusion

cough

cough producing mucus

deep, dark purple bruise

diarrhea

difficult, burning, or painful urination

discharge, excessive tearing

dizziness

ear congestion

fainting

fast heartbeat

fever

frequent urge to urinate

headache

itching, pain, redness, or swelling

loss of appetite

loss of voice

lower back or side pain

muscle or bone pain

nausea

nervousness

pain or tenderness around the eyes and cheekbones

pale skin

pounding in the ears

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

sneezing

sore throat

stomach pain

stuffy or runny nose

swelling of the hands, ankles, feet, or lower legs

swelling or puffiness of the face

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

watery and severe diarrhea, which may also be bloody

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Cracks in the skin

difficulty in moving

difficulty swallowing

lack or loss of strength

loss of heat from the body

muscle pain, stiffness, or spasm

pain in the joints

rash with flat lesions or small raised lesions on the skin

red, swollen, or scaly skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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