REZUROCK SIDE EFFECTS

  • Generic Name: belumosudil tablets
  • Brand Name: Rezurock
Last updated on MDtodate: 10/03/2022

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely variable conditions, adverse event rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice.

Chronic Graft Versus Host Disease

In two clinical trials (Study KD025-213 and Study KD025-208), 83 adult patients with chronic GVHD were treated with REZUROCK 200 mg once daily. The median duration of treatment was 9.2 months (range 0.5 to 44.7 months).

Fatal adverse reaction was reported in one patient with severe nausea, vomiting, diarrhea and multi-organ failure.

Permanent discontinuation of REZUROCK due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of REZUROCK in > 3% of patients included nausea (4%). Adverse reactions leading to dose interruption occurred in 29% of patients. The adverse reactions leading to dose interruption in ≥ 2% were infections (11%), diarrhea (4%), and asthenia, dyspnea, hemorrhage, hypotension, liver function test abnormal, nausea, pyrexia, edema, and renal failure with (2% each).

The most common (≥ 20%) 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.

Table 1 summarizes the nonlaboratory adverse reactions.

Table 1: Nonlaboratory Adverse Reactions in ≥ 10% Patients with Chronic GVHD Treated with REZUROCK

Adverse Reaction REZUROCK 200 mg once daily
(N=83)
All Grades (%) Grades 3-4 (%)
Infections and infestations
Infection (pathogen not specified)a 53 16
Viral infectionb 19 4
Bacterial infectionc 16 4
General disorders and administration site conditions
Astheniad 46 4
Edemae 27 1
Pyrexia 18 1
Gastrointestinal
Nauseaf 42 4
Diarrhea 35 5
Abdominal paing 22 1
Dysphagia 16 0
Respiratory, thoracic and mediastinal
Dyspneah 33 5
Coughi 30 0
Nasal congestion 12 0
Vascular
Hemorrhagej 23 5
Hypertension 21 7
Musculoskeletal and connective tissue
Musculoskeletal paink 22 4
Muscle spasm 17 0
Arthralgia 15 2
Nervous system
Headache1 21 0
Metabolism and nutrition
Decreased appetite 17 1
Skin and subcutaneous
Rashm 12 0
Pruritusn 11 0
a infection with an unspecified pathogen includes acute sinusitis, device related infection, ear infection, folliculitis, gastroenteritis, gastrointestinal 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.
b includes 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.
c includes cellulitis, Helicobacter infection, Staphylococcal bacteremia, catheter site cellulitis, Clostridium difficile colitis, Escherichia urinary tract infection, gastroenteritis Escherichia coli, Pseudomonas infection, urinary tract infection bacterial.
d includes fatigue, asthenia, malaise.
e includes edema peripheral, generalized edema, face edema, localized edema, edema.
f includes nausea, vomiting.
g includes abdominal pain, abdominal pain upper, abdominal pain lower.
h includes dyspnea, dyspnea exertional, apnea, orthopnea, sleep apnea syndrome.
i includes cough, productive cough.
j includes contusion, hematoma, epistaxis, increased tendency to bruise, conjunctival hemorrhage, hematochezia, mouth hemorrhage, catheter site hemorrhage, hematuria, hemothorax, purpura.
k includes pain in extremity, back pain, flank pain, limb discomfort, musculoskeletal chest pain, neck pain, musculoskeletal pain.
l includes headache, migraine.
m includes rash, rash maculo-papular, rash erythematous, rash generalized, dermatitis exfoliative.
n includes pruritus, pruritus generalized.

 

Table 2 summarizes the laboratory abnormalities in REZUROCK.

Table 2: Selected Laboratory Abnormalities in Patients with Chronic GVHD Treated with REZUROCK

Parameter REZUROCK 200 mg once daily
Grade 0-1 Baseline (N) Grade 2-4 Max Post (%) Grade 3-4 Max Post (%)
Chemistry
Phosphate Decreased 76 28 7
Gamma Glutamyl Transferase Increased 47 21 11
Calcium Decreased 82 12 1
Alkaline Phosphatase Increased 80 9 0
Potassium Increased 82 7 1
Alanine Aminotransferase Increased 83 7 2
Creatinine Increased 83 4 0
Hematology
Lymphocytes Decreased 62 29 13
Hemoglobin Decreased 79 11 1
Platelets Decreased 82 10 5
Neutrophil Count Decreased 83 8 4

 

SRC: NLM .