Rezurock Application Scope

Treatment of chronic graft-versus-host disease (cGVHD) in adult and pediatric patients aged ≥12 years who have failed at least two prior lines of systemic therapy.

Rezurock Characteristics

Ingredients: Belumosudil
Properties: A small molecule, oral, selective inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2)
Packaging Specification: 200 mg tablets
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F)
Expiry Date: Refer to the expiration date printed on the packaging
Executive Standard: Standards set by the National Medical Products Administration (NMPA) in China and the FDA in the U.S.
Approval Number: FDA Approval Number: NDA 214783
Date of Revision: Labeling Revision Date: February 1, 2022
Manufacturer: Kadmon Pharmaceuticals, LLC

Guidelines for the Use of Rezurock

Dosage and Administration:
- Recommended Dose: The recommended dosage is 200 mg (one tablet) taken orally once daily with food.
- Administration: Swallow tablets whole with a glass of water; do not chew, crush, or split tablets.
- Missed Dose: If a dose is missed, take it as soon as possible on the same day. If missed for the entire day, take the next dose at the regular time the following day. Do not double the dose to make up for a missed one.
Adverse Reactions:
- Common Adverse Reactions: Fatigue, diarrhea, nausea, vomiting, liver enzyme elevations (ALT, AST), hypertension.
- Serious Adverse Reactions: Severe hepatotoxicity, infections, bleeding events.
Contraindications: Hypersensitivity: Contraindicated in patients with known hypersensitivity to belumosudil or any component of the formulation.
Precautions:
- Hepatic Impairment: Avoid use in patients with moderate or severe hepatic impairment (Child-Pugh B or C) without liver GVHD.
- Pregnancy: Category D; may cause fetal harm.
- Contraception: Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.

Rezurock Interactions

Strong CYP3A Inhibitors: Coadministration may increase belumosudil levels; monitor for adverse reactions.
Strong CYP3A Inducers: Coadministration may decrease belumosudil levels; increase dose to 200 mg twice daily if coadministered.
Proton Pump Inhibitors: Coadministration may decrease belumosudil levels; increase dose to 200 mg twice daily if coadministered.
OATP1B1/1B3 or BCRP Substrates (e.g., rosuvastatin): Coadministration may increase exposure to these substrates; avoid or use alternative drugs when possible.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.