Dosing

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

A once-daily oral tablet for patients with cGVHD1

Dose modifications for adverse reactions are related to the
grade of cGVHD severity1

Recommended dose modifications for REZUROCK for adverse reactions

table of dose modifications for REZUROCK, including hepatotoxicity and other adverse reactions
table of dose modifications for REZUROCK, including hepatotoxicity and other adverse reactions

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

Dose modifications for patients with renal or hepatic impairment1

Renal impairment

Patients with mild to moderate renal impairment

  • No clinically significant differences in REZUROCK pharmacokinetics observed

Patients with severe renal impairment

  • No data are available for patients with severe renal impairment

Hepatic impairment

Patients with hepatic impairment

  • No data are available for patients with hepatic impairment

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 at least 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

Drug interactions1

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

Storage1

Store REZUROCK at room temperature, ranging from 68 °F to 77 °F (20 °C-25 °C); excursions are permitted from 59 °F to 86 °F (15 °C-30 °C).

Dispense REZUROCK to patients in its original container only. Store REZUROCK in its original container to protect from moisture. Replace the cap securely each time after opening. Do not discard desiccant.

Help your patients get started on REZUROCK.

LEARN ABOUT KADMON ASSISTTM

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

Reference: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021.

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.

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.