REZUROCK SIDE EFFECTS
- Generic Name: belumosudil tablets
- Brand Name: Rezurock
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. |
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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 |