- Article
- Source: Campus Sanofi
- 23 Oct 2023
Safety Profile
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This is intended for HCPs practising in Great Britain (England, Scotland, Wales) 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.
![](https://pro.campus.sanofi/dam/jcr:945bc784-f116-42f6-bc88-59e706814641/check.2022-11-03-12-25-13.jpg)
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
![](https://pro.campus.sanofi/dam/jcr:945bc784-f116-42f6-bc88-59e706814641/check.2022-11-03-12-25-13.jpg)
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
![](https://pro.campus.sanofi/dam/jcr:945bc784-f116-42f6-bc88-59e706814641/check.2022-11-03-12-25-13.jpg)
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
![](https://pro.campus.sanofi/dam/jcr:945bc784-f116-42f6-bc88-59e706814641/check.2022-11-03-12-25-13.jpg)
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
![](https://pro.campus.sanofi/dam/jcr:945bc784-f116-42f6-bc88-59e706814641/check.2022-11-03-12-25-13.jpg)
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.
REZUROCK
Get the latest updates about REZUROCK.
This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only
![](https://pro.campus.sanofi/.imaging/mte/portal/3840/dam/Portal/UK/Articles/updated-Rezurock-Black-Traingle.jpg1/jcr:content/updated%20Rezurock%20Black%20Traingle.jpg)
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References
- REZUROCK. Summary of Product Characteristics
- 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
- 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