This website contains promotional content and is intended for Healthcare Professionals based in the United Kingdom only. Some content is only relevant to HCPs practising in Great Britain (England, Scotland, Wales). This website is optimised for desktop use, and some features may perform differently on mobile devices.

Adverse event reporting can be found at the bottom of the page.

Campus
  1. Article
  2. Source: Campus Sanofi
  3. 23 Oct 2023

Safety Profile

Author: Sanofi

Editorial Team

REZUROCK®▼(belumosudil)
safety banner
Insulin Trurapi (Insulin aspart 100 units/mL)

This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.

Prescribing Information (GB only)

In the ROCKstar and KD025-208 studies
REZUROCK was generally well tolerated in patients with cGVHD1

Safety was evaluated across 2 clinical studies (n=186)2,3

Consider the safety profile of REZUROCK in patients with cGVHD who often receive immunosuppressive therapy. 

Please refer to the full Summary of Product Characteristics before prescribing.

The most common adverse reactions leading to discontinuation were nausea (2.4%) and headache (2.4%). Adverse reactions leading to dose interruption occurred in 9.6% of patients and were mainly investigations (3.6%), including ALT increased, GGT increased and blood creatine phosphokinase increased (1.2% each), and infections (2.4%)1

The most common adverse reactions (≥5%) were asthenia (21.0%), nausea (12.4%), liver function test abnormalities of elevation of AST (7.5%), elevation of ALT (7.0%) and elevation of GGT (4.8%), headache (8.6%), diarrhoea (7.0%) and musculoskeletal pain (5.9%)1

Serious adverse reactions were pneumonia (1.1%), cellulitis, infectious colitis, staphylococcal bacteraemia, diarrhoea, nausea, vomiting, microangiopathic haemolytic anaemia, multiple organ dysfunction syndrome and cGVHD (0.5% each)1

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

cGVHD, chronic graft-versus-host disease; CMV, cytomegalovirus.

SEE MORE FROM SCIENCE

REZUROCK

Get the latest updates about REZUROCK​.
This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only​

ROCKstar Study

Download ROCKstar study summary.
This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only​

Get in touch with the Transplant Team
MAT-XU-2201545 (v5.0) Date of Preparation: October 2023
References
  1. REZUROCK. Summary of Product Characteristics
  2. Jagasia M, Lazaryan A, Bachier CR, 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
  3. 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

MAT-XU-2204907 (v7.0) Date of Preparation: October 2023