Consider the safety profile of REZUROCK in patients with cGVHD who often receive immunosuppressive therapy.
The safety and tolerability data for REZUROCK are based on results from a pooled analysis of 2 open-label clinical trials, the pivotal ROCKstar (KD025-213) study and the foundational dose-finding KD025-208 study.1
Most patients were able to maintain treatment with rezurock 200 mg once daily (n=83)1,a |
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|
All Grades, % | Grades 3-4, % | |
Infections and infestations | ||
Infection (pathogen not specified)b | 53 | 16 |
Viral infectionc | 19 | 4 |
Bacterial infectiond | 16 | 4 |
General disorders and administration site conditions | ||
Astheniae | 46 | 4 |
Edemaf | 27 | 1 |
Pyrexia | 18 | 1 |
Gastrointestinal | ||
Nauseag | 42 | 4 |
Diarrhea | 35 | 5 |
Abdominal painh | 22 | 1 |
Dysphagia | 16 | 0 |
Respiratory, thoracic and mediastinal | ||
Dyspneai | 33 | 5 |
Coughj | 30 | 0 |
Nasal congestion | 12 | 0 |
Vascular | ||
Hemorrhagek | 23 | 5 |
Hypertension | 21 | 7 |
Musculoskeletal and connective tissue | ||
Musculoskeletal painl | 22 | 4 |
Muscle spasm | 17 | 0 |
Arthralgia | 15 | 2 |
Nervous system | ||
Headachem | 21 | 0 |
Metabolism and nutrition | ||
Decreased appetite | 17 | 1 |
Skin and subcutaneous | ||
Rashn | 12 | 0 |
Prurituso | 11 | 0 |
aData include results from a dose-finding multicenter study of REZUROCK for the treatment of patients with cGVHD (n=54) who had received 1 to 3 prior lines of systemic therapy and required additional treatment. REZUROCK was administered by mouth at 200 mg once daily, 200 mg twice daily or 400 mg once daily.3
bInfection 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.1
cIncludes 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.1
dIncludes cellulitis, Helicobacter infection, Staphylococcal bacteremia, catheter site cellulitis, Clostridium difficile colitis, Escherichia urinary tract infection, gastroenteritis Escherichia coli, Pseudomonas infection, urinary tract infection bacterial.1
eIncludes fatigue, asthenia, malaise.1
fIncludes edema peripheral, generalized edema, face edema, localized edema, edema.1
gIncludes nausea, vomiting.1
hIncludes abdominal pain, abdominal pain upper, abdominal pain lower.1
iIncludes dyspnea, dyspnea exertional, apnea, orthopnea, sleep apnea syndrome.1
jIncludes cough, productive cough.1
kIncludes contusion, hematoma, epistaxis, increased tendency to bruise, conjunctival hemorrhage, hematochezia, mouth hemorrhage, catheter site hemorrhage, hematuria, hemothorax, purpura.1
lIncludes pain in extremity, back pain, flank pain, limb discomfort, musculoskeletal chest pain, neck pain, musculoskeletal pain.1
mIncludes headache, migraine.1
nIncludes rash, rash maculo-papular, rash erythematous, rash generalized, dermatitis exfoliative.1
oIncludes pruritus, pruritus generalized.1
Both the ROCKstar and KD025-208 studies demonstrated the