This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
REZUROCK is recommended by NICE, within its marketing authorisation, for treating chronic graft-versus-host disease (chronic GVHD) in people 12 years and older after 2 or more systemic treatments.6 |
Profile
REZUROCK is indicated for the treatment of patients aged 12 years old or older with chronic GVHD who have recieved at least two prior lines of systemic therapy.1
REZUROCK targets both the inflammatory and fibrotic processes of cGVHD through selective inhibition of the ROCK2 pathway.1-3
REZUROCK demonstrated efficacy in a broad range of patients with cGVHD.4
The safety profile of REZUROCK was evaluated across 2 multicenter clinical studies.4-5
REZUROCK targets both the inflammatory and fibrotic processes of cGVHD through selective inhibition of the ROCK2 pathway.1-3
REZUROCK demonstrated efficacy in a broad range of patients with cGVHD.4
The safety profile of REZUROCK was evaluated across 2 multicenter clinical studies.4-5
Eligibility for REZUROCK
When any 2 prior lines of systemic therapy fail, consider REZUROCK.1
Dosing and Administration
A once-daily oral tablet for patients with cGVHD.1
- Do not store REZUROCK above 25°C.
- Each pale-yellow, oblong, 200-mg tablet is debossed with "KDM" on one side and “200” on the other side, with dimensions of 7.40x14.77mm.1
- REZUROCK should be dispensed to the patient in the original container only. Store in original container to protect from moisture. Replace cap securely each time after opening. Do not discard desiccant.1
Please refer to the full Summary of Product Characteristics before prescribing.
The recommended dose of REZUROCK is 200 mg once daily administered orally.1
Inform patients that the REZUROCK tablets should be swallowed whole with a glass of water without cutting, crushing or chewing the tablets.
Advise patients to take REZUROCK at approximately the same time each day with a meal. If the patient vomits after taking REZUROCK, the next dose should be taken the following day as usual.
If the patient misses a dose of REZUROCK for <12 hours, REZUROCK should be taken as soon as possible on the same day with a return to the normal schedule the following day. If the patient misses a dose of REZUROCK >12 hours, REZUROCK should be taken the following day as usual. Patients should not take extra doses to make up for the missed dose.
Perform liver function tests at least monthly (see full Summary of Product Characteristics for more details on when to hold, or discontinue REZUROCK due to hepatotoxicity or other adverse reactions). A complete blood cell count and liver function test must be performed before initiating therapy with REZUROCK.
Strong CYP3A inducers: Increase the dosage of REZUROCK to 200 mg twice daily when co-administered with strong CYP3A inducers.
Proton pump inhibitors: Increase the dosage of REZUROCK to 200 mg twice daily when co-administered with PPIs.
OATP1B1/BCRP substrates: Consider switching to a drug less sensitive to OATP1B1 and BCRP inhibition when possible. If used together the dose of rosuvastatin should not exceed 5 mg once daily. Monitor patients closely for signs and symptoms of excessive exposure to the drugs that are substrates of OATP1B1 and BCRP.
Patient Support
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Mechanism of Action
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BCRP: Breast Cancer Resistance Protein
CYP3A: Cytochrome P450 family 3 subfamily A
OATP1B1: Organic anion transporting polypeptides (OATP) 1B1
PPI: proton pump inhibitor
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REZUROCK. Summary of Product Characteristics
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Zanin-Zhorov A, Weiss JM, Nyuydzefe MS, et al. Selective oral ROCK2 inhibitor down-regulates IL-21 and IL17 secretion in human T cells via STAT3-dependent mechanism. Proc Natl Acad Sci USA. 2014;111(47):16814-16819. doi:10.1073/pnas.1414189111
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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
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Cutler C, Lee SJ, Arai S. et al. 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
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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
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NICE. Technology appraisal guidance TA949. https://www.nice.org.uk/guidance/TA949. Last accessed: August 2024
MAT-XU-2305107 (v3.0) Date of Preparation: August 2024