REZUROCK (belumosudil) tablets logo

For US Health Care
Professionals Only

REZUROCK (belumosudil) tablets logo

For US Health Care
Professionals Only

Full Prescribing
Information CONNECT WITH A REPRESENTATIVE

Dosing

happy young men and women gathered around a table while eating food
happy young men and women gathered around a table while eating food

A once-daily oral tablet for patients with cGVHD1

REZUROCK product image and packaging REZUROCK product image and packaging

Each pale-yellow oblong 200-mg tablet is debossed with “KDM” on one side and “200” on the other side.1

Not actual size.

The recommended dose of REZUROCK is 200 mg once daily administered orally1

  • Inform patients that the REZUROCK tablet should be swallowed whole with a glass of water without cutting, crushing or chewing the tablet
  • Advise patients to take REZUROCK at approximately the same time each day with a meal
  • If the patient misses a dose of REZUROCK, instruct the patient not to take extra doses to make up for the missed dose
  • Monitor total bilirubin, AST and ALT at least monthly (see below for details on when to hold or discontinue REZUROCK due to hepatotoxicity or other adverse reactions)

Recommended dose modifications for REZUROCK for adverse reactions1


 
Adverse reaction Severitya REZUROCK dose modifications
Hepatotoxicity Grade 3 AST or ALT (5x to 20x ULN) or Grade 2 bilirubin (1.5x to 3x ULN) Hold REZUROCK until recovery of bilirubin, ALT and AST to Grade 0-1, then resume REZUROCK at the recommended dose.
Grade 4 AST or ALT (>20x ULN) or Grade ≥3 bilirubin (>3x ULN) blue and purple circle with slash through it Discontinue REZUROCK permanently.
Other adverse reactions Grade 3 Hold REZUROCK until recovery to Grade 0-1, then resume REZUROCK at the recommended dose level.
Grade 4 blue and purple circle with slash through it Discontinue REZUROCK permanently.
Severitya REZUROCK dose modifications
Adverse reaction: Hepatotoxicity
Grade 3 AST or ALT (5x to 20x ULN) or Grade 2 bilirubin (1.5x to 3x ULN) Hold REZUROCK until recovery of bilirubin, ALT and AST to Grade 0-1, then resume REZUROCK at the recommended dose.
Grade 4 AST or ALT (>20x ULN) or Grade ≥3 bilirubin (>3x ULN) circle-backslash symbol Discontinue REZUROCK permanently.
Adverse reaction: Other adverse reactions
Grade 3 Hold REZUROCK until recovery to Grade 0-1, then resume REZUROCK at the recommended dose level.
Grade 4 circle-backslash symbol Discontinue REZUROCK permanently.

aBased on CTCAE v4.03.

Please see the full Prescribing Information for additional guidance for other populations.

Dose recommendations for patients with renal or hepatic impairment1

Renal impairment

Patients with mild to moderate renal impairment

  • No clinically significant differences in REZUROCK pharmacokinetics observed (mild to moderate renal impairment was defined as eGFR ≥60 and <90 mL/min/1.72m2 to eGFR ≥30 and <60 mL/min/1.72m2)

Patients with severe renal impairment

  • No data are available for patients with severe renal impairment

Hepatic impairment

Patients with moderate or severe hepatic impairment

  • Avoid use in patients with moderate hepatic impairment (Child-Pugh B) or severe hepatic impairment (Child-Pugh C) without liver GVHD

Patients with mild hepatic impairment

  • No dosage adjustment is recommended when administering REZUROCK to patients with mild hepatic impairment

Drug interactions1

Please see the full Prescribing Information for additional information on drug interactions.

Use in specific populations1

Pregnancy

  • REZUROCK can cause fetal harm when administered to pregnant women
  • Advise pregnant women of the potential risk to the fetus. Advise women of reproductive potential, and their male partners, to use effective contraception during treatment with REZUROCK and for 1 week after the last dose
    of REZUROCK

Pediatric use

  • The safety and effectiveness of REZUROCK in pediatric patients aged <12 years have not been established

Geriatric use

  • Of the 186 patients with cGVHD in clinical studies of REZUROCK, 26% were aged ≥65 years. No clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients

Renal impairment

  • Treatment with REZUROCK has not been studied in patients with pre-existing severe renal impairment. For patients with pre-existing severe renal impairment, consider the risks and potential benefits before initiating treatment with REZUROCK

Hepatic impairment

  • Avoid use in patients with moderate hepatic impairment (Child-Pugh B) or severe hepatic impairment (Child-Pugh C) without liver GVHD

Storage1

Store REZUROCK tablets at room temperature (68 °F to 77 °F [20 °C to 25 °C]) in the original container.

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.

Help your patients get started on REZUROCK.

LEARN ABOUT KADMON ASSISTTMLEARN ABOUT KADMON ASSISTTM

ALT, alanine aminotransferase; AST, aspartate aminotransferase; cGVHD, chronic graft-versus-host disease; CTCAE, Common Terminology Criteria for Adverse Events; CYP3A, cytochrome P450 3A; MOA, mechanism of action; ULN, upper limit of normal.

Reference: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2023.

© 2023 Kadmon Pharmaceuticals, LLC.
All Rights Reserved.
This site is intended for use by US Health Care Professionals only.
MAT-US-2201629-v2.0-12/2023    
Last updated: December 2023

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