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
Strong CYP3A Inducers: Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with strong CYP3A inducers
Proton Pump Inhibitors: Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with proton pump inhibitors
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.