Safety

Three adult women smiling with arms behind each other
Three adult women smiling with arms behind each other

REZUROCK was well tolerated1

The safety and tolerability data for REZUROCK are based on results from the 2 open-label clinical trials, the pivotal ROCKstar (KD025-213) study and the foundational dose-finding KD025-208 study.1

  • The most common adverse reactions in patients who received REZUROCK 200 mg once daily in the cGVHD studies (≥20%), 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 hypertension1
  • There was a low rate of serious (grade ≥3) cytopenias2,3
  • In the ROCKstar and KD025-208 clinical studies of REZUROCK, grade ≥3 cytopenias were reported in <4% and 4% of patients, respectively
  • There were no reports of CMV infection in both the ROCKstar and the foundational, dose-finding KD025-208 studies, and there was only 1 report of CMV reactivation in total3,4

NONLABORATORY ADVERSE REACTIONS IN ≥10% OF PATIENTS WITH cGVHD TREATED WTH REZUROCK 200 mg ONCE DAILY (N=83)1,a

table showing nonlaboratory adverse reactions of all grades and grades 3-4 in ≥10% of patients with cGVHD treated with REZUROCK 200 mg once daily table showing nonlaboratory adverse reactions of all grades and grades 3-4 in ≥10% of patients with cGVHD treated with REZUROCK 200 mg once daily
the median duration of treatment with REZUROCK was 9.2 months in the ROCKstar study
the median duration of treatment with REZUROCK was 9.2 months in the ROCKstar study

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 BID 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

well-tolerated safety profile of rezurock.1

LEARN ABOUT REZUROCK DOSING

ALT, alanine aminotransferase; AST, aspartate aminotransferase; cGVHD, chronic graft-versus-host disease; CMV, cytomegalovirus; MOA, mechanism of action.

References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2. Data on file 1. Kadmon Pharmaceuticals, LLC; 2021. 3. Jagasia M, Lazaryan A, Bachier DR, et al. ROCK2 inhibition with belumosudil (KD025) for the treatment of chronic graft-versus-host disease. J Clin Oncol. 2021;39(17):1888-1898. doi:10.1200/JCO.20.02754 4. Cutler CS, Lee SJ, Arai S, et al. Belumosudil for chronic graft-versus-host disease (cGVHD) after 2 or more prior lines of therapy: the ROCKstar study. Blood. 2021;blood.2021012021. doi:10.1182/blood.2021012021