Brand Name

Rezurock

Generic Name
Belumosudil
View Brand Information
FDA approval date: July 16, 2021
Form: Tablet

What is Rezurock (Belumosudil)?

REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. REZUROCK is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.
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Brand Information

Rezurock (belumosudil)
1INDICATIONS AND USAGE
REZUROCK 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.
2DOSAGE FORMS AND STRENGTHS
Each 200 mg belumosudil tablet is a pale yellow film-coated oblong tablet debossed with "KDM" on one side and "200" on the other side.
3CONTRAINDICATIONS
None.
4DESCRIPTION
Belumosudil is a kinase inhibitor. The active pharmaceutical ingredient is belumosudil mesylate with the molecular formula C
Chemical Structure
Belumosudil mesylate is a yellow powder that is practically insoluble in water, slightly soluble in methanol and DMF and soluble in DMSO.
REZUROCK tablets are for oral administration. Each tablet contains 200 mg of the free base equivalent to 242.5 mg of belumosudil mesylate. The tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, and microcrystalline cellulose.
The tablet film consists of polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.
5HOW SUPPLIED/STORAGE AND HANDLING
REZUROCK 200 mg tablets are supplied as pale yellow film-coated oblong tablets containing 200 mg of belumosudil (equivalent to 242.5 mg belumosudil mesylate). Each tablet is debossed with "KDM" on one side and "200" on the other side and is packaged as follows:
  • 200 mg tablets in 30 count bottle: NDC 79802-200-30
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
7PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton
NDC 79802-200-30
REZUROCK
200 mg
Swallow tablets whole. Do not cut,
30 Tablets
sanofi
PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton