Applies to belumosudil: oral tablet.

Serious side effects of Belumosudil

Along with its needed effects, belumosudil 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 while taking belumosudil:

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

Other side effects of Belumosudil

Some side effects of belumosudil 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

For Healthcare Professionals

Applies to belumosudil: oral tablet.

Hematologic

Very common (10% or more): Neutrophil count decreased (83%), platelets decreased (82%), hemoglobin decreased (79%), lymphocytes decreased (62%)^[Ref]

Immunologic

Very common (10% or more): Infection (unspecified pathogen) (e.g., acute sinusitis, device related infection, ear infection, folliculitis, gastroenteritis, GI infection, hordeolum, infectious colitis, lung infection, skin infection, tooth infection, urinary tract infection, wound infection, upper respiratory tract infection, pneumonia, conjunctivitis, sinusitis, respiratory tract infection, bronchitis, sepsis, septic shock) (53%), viral infection (e.g., influenza, rhinovirus infection, gastroenteritis viral, viral upper respiratory tract infection, bronchitis viral, Epstein-Barr viremia, Epstein-Barr virus infection, parainfluenzae virus infection, Varicella zoster virus infection, viral infection) (19%), bacterial infection (e.g., cellulitis, Helicobacter infection, Staphylococcal bacteremia, catheter site cellulitis, Clostridium difficile colitis, Escherichia urinary tract infection, gastroenteritis Escherichia coli, Pseudomonas infection, urinary tract infection bacterial) (16%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal (e.g., pain in extremity, back pain, flank pain, limb discomfort, musculoskeletal chest pain, neck pain, musculoskeletal pain) (22%), muscle spasm (17%), arthralgia (15%)^[Ref]

Metabolic

Very common (10% or more): Anorexia (17%)^[Ref]

Hepatic

Very common (10% or more): Gamma glutamyl transferase increased (47%)^[Ref]

Respiratory

Very common (10% or more): Dyspnea (e.g., dyspnea exertional, apnea, orthopnea, sleep apnea syndrome) (33%), cough/productive cough (30%), nasal congestion (12%)^[Ref]

Other

Very common (10% or more): Alkaline aminotransferase increased (83%), calcium decreased (82%), potassium increased (82%), alkaline phosphatase increased (80%), phosphate decreased (76%), asthenia/fatigue/malaise (46%), edema (e.g., edema peripheral, generalized edema, face edema, localized edema, edema) (27%), pyrexia (18%)^[Ref]

General

The most common (20% or greater) adverse reactions, including laboratory abnormalities, were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.

Adverse reactions leading to dose interruption occurred in 29% of patients. The adverse reactions leading to dose interruption in 2% or greater were infections (11%), diarrhea (4%), asthenia (2%), dyspnea (2%), hemorrhage (2%), hypotension (2%), liver function test abnormal (2%), nausea (2%), pyrexia (2%), edema (2%), and renal failure (2%).

Permanent discontinuation of this drug due to adverse reactions occurred in 18% of patients. The adverse reactions requiring discontinuation reported in greater than 3% of patients included nausea (4%).^[Ref]

Nervous system

Very common (10% or more): Headache/migraine (21%)

Renal

Very common (10% or more): Creatinine increased (83%)^[Ref]

Cardiovascular

Very common (10% or more): Hemorrhage (e.g., contusion, hematoma, epistaxis, increased tendency to bruise, conjunctival hemorrhage, hematochezia, mouth hemorrhage, catheter site hemorrhage, hematuria, hemothorax, purpura) (23%), hypertension (21%)^[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., rash, rash maculopapular, rash erythematous, rash generalized, dermatitis exfoliative) (12%), pruritus/pruritus generalized (11%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (42%), diarrhea (35%), abdominal pain upper/lower (22%), dysphasia (16%)^[Ref]