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Safety

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Three adult women smiling with arms behind each other

REZUROCK was well tolerated in patients with cGVHD1

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

  • Fatal adverse reaction was reported in 1 patient with severe nausea, vomiting, diarrhea and multiorgan failure1
  • 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%)1
  • 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 hypertension1
  • There were no reports of CMV infection in both the ROCKstar and the foundational, dose-finding KD025-208 studies, and only 1 report of CMV reactivation in total2,3
  • In the ROCKstar and KD025-208 clinical studies of REZUROCK, grade ≥3 cytopenias were reported in <4% and 4% of patients, respectively2,3

Most patients were able to maintain treatment with rezurock 200 mg once daily (n=83)1,a

9.2
months

Patients had a median duration of treatment of 9.2 months (range, 0.5-44.7 months).

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

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

well-tolerated safety profile of rezurock.1

LEARN ABOUT REZUROCK DOSING

cGVHD, chronic graft-versus-host disease; CMV, cytomegalovirus; MOA, mechanism of action.

References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2. Cutler C, Lee SJ, Arai S, et al; on behalf of the ROCKstar Study Investigators. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021;138(22):2278-2289. doi:10.1182/blood.2021012021. 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

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