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Important Safety
Information Full Prescribing
Information

 * Important Safety Information
 * Full Prescribing Information
 * Patient Website
 * Register for Updates
 * Connect with a Representative
   

 * IMPACT OF cGVHD ON
   PATIENTS
   * Manifestations of cGVHD
   * Patient Burden
 * EFFICACY
   * ROCKstar
     Study Design
   * ROCKstar
     Efficacy Data
     
 * SAFETY
 * MOA
 * DOSING
 * SUPPORT & RESOURCES
   * Kadmon ASSISTTM
   * Obtaining REZUROCK
   * HCP Resources
   * Patient Resources
 * Connect with a Representative
 * Register for Updates
 * Patient Website


NOW APPROVED



WITH A DIFFERENT WAY TO TREAT CGVHD,1-3

REZUROCK CAN HELP PATIENTS


ROCK ON

FOR PATIENTS WITH CGVHD AGED ≥12 YEARS AFTER FAILURE OF AT LEAST 2 PRIOR LINES
OF SYSTEMIC THERAPY.1

REZUROCK is the first and only selective ROCK2 inhibitor for the treatment of
cGVHD that gives patients the chance to be themselves again.1

FOR PATIENTS WITH CGVHD AGED ≥12 YEARS AFTER FAILURE OF AT LEAST 2 PRIOR LINES
OF SYSTEMIC THERAPY.1

REZUROCK is the first and only selective ROCK2 inhibitor for the treatment of
cGVHD that gives patients the chance to be themselves again.1

Belumosudil (REZUROCK™) has been added to the NCCN Clinical Practice Guidelines
in Oncology (NCCN Guidelines®) as a category 2A systemic option for
steroid-refractory cGVHD.4,a


REZUROCK DEMONSTRATED EFFICACY IN A BROAD RANGE OF PATIENTS WITH CGVHD1

The ORRb was 75% at the recommended dose of 200 mg once daily (n=65) in the
pivotal ROCKstar study.

EXPLORE EFFICACY

aNCCN makes no warranties of any kind whatsoever regarding their content, use or
application and disclaims any responsibility for their application or use in any
way.

bBased on a final analysis by the FDA (n=65).


REZUROCK DEMONSTRATED A WELL-TOLERATED SAFETY PROFILE IN 2 MULTICENTER CLINICAL
STUDIES1,5,6

The safety profile of REZUROCK supports its use in a diverse population of
patients with cGVHD.

EXPLORE Safety
and tolerability

aNCCN makes no warranties of any kind whatsoever regarding their content, use or
application and disclaims any responsibility for their application or use in any
way.

bBased on a final analysis by the FDA (n=65).

A treatment that specifically addresses both the


INFLAMMATION AND THE FIBROSIS

associated with cGVHD1-3

Discover AN INNOVATIVE
dual inhibitor See How REZUROCK works


ENSURE YOUR PATIENTS


GET STARTED AND SAVE ON REZUROCK

ACCESS kadmon assistTM


The QOL of patients with


CGVHD OFTEN
REMAINS COMPROMISED,

even in those currently on treatment7

See the impact cGVHD
has on patients



cGVHD, chronic graft-versus-host disease; FDA, US Food and Drug Administration;
MOA, mechanism of action; NCCN, National Comprehensive Cancer Network®; ORR,
overall response rate; QOL, quality of life; ROCK2, rho-associated
coiled-coil—containing protein kinase-2.

References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2.
Zanin-Zhorov A, Weiss JM, Nyuydzefe MS, et al. Selective oral ROCK2 inhibitor
down-regulates IL-21 and IL-17 secretion in human T cells via STAT3-dependent
mechanism. Proc Natl Acad Sci USA. 2014;111(47):16814-16819.
doi:10.1073/pnas.1414189111 3. Flynn R, Paz K, Du J, et al. Targeted
rho-associated kinase 2 inhibition suppresses murine and human chronic GVHD
through a Stat3-dependent mechanism. Blood. 2016;127(17):2144-2154.
doi:10.1182/blood-2015-10-678706 4. Referenced with permission from the NCCN
Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic
Cell Transplantation (HCT): Pre-Transplant Recipient Evaluation and Management
of Graft-Versus-Host Disease. V.4.2021. © National Comprehensive Cancer Network,
Inc. 2021. All rights reserved. Accessed September 30, 2021. To view the most
recent and complete version of the guideline, go online to NCCN.org 5. 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 6. 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 7. Kurosawa S, Oshima K, Yamaguchi T, et al. Quality of
life after allogeneic hematopoietic cell transplantation according to affected
organ and severity of chronic graft-versus-host disease. Biol Blood Marrow
Transplant. 2017;23(10):1749-1758. doi:10.1016/j.bbmt.2017.06.011


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.

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All Rights Reserved.
KAD25000025 12/21


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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.