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

Indication

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose

Adverse Reactions

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

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)

Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly

Drug Interactions

Strong CYP3A Inducers: Coadministration of REZUROCK with strong CYP3A inducers decreases belumosudil exposure, which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with strong CYP3A inducers

Proton Pump Inhibitors: Coadministration of REZUROCK with proton pump inhibitors decreases belumosudil exposure, which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with proton pump inhibitors

Use in Specific Populations

Pregnancy: Based on findings from animal studies and the mechanism of action, REZUROCK can cause fetal harm when administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. Advise pregnant women and females of reproductive potential of the potential risk to the fetus

Lactation: There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions from belumosudil in the breastfed child, advise lactating women not to breastfeed during treatment with REZUROCK and for at least one week after the last dose

Pediatric Use: The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established

Geriatric Use: Of the 186 patients with chronic GVHD in clinical studies of REZUROCK, 26% were 65 years and older. No clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients

Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with REZUROCK

Please see full Prescribing Information for additional Important Safety Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC, at 1-877-377-7862 to report side effects.

Indication

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

Important safety information Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose

Indication & Important safety information

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.