Rezurock(belumosudil)
REZUROCK 200 MG Oral Tablet
NO BOXED WARNING
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Rezurock FAQs
Can REZUROCK cause fetal harm?Yes, 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.
What were the adverse developmental outcomes in animal reproduction studies?Adverse developmental outcomes in animal reproduction studies included alterations to growth, embryo-fetal mortality, and embryo-fetal malformations at maternal exposures (AUC) approximately ≥3- (rat) and ≥0.07 (rabbit) times the human exposure (AUC) at the recommended dose.
Is REZUROCK safe for lactating women?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.
What precautions should females and males of reproductive potential take when using REZUROCK?Females should verify their pregnancy status before initiating treatment with REZUROCK, and use effective contraception during treatment and for at least one week after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment and for at least one week after the last dose.
Can REZUROCK impair fertility in females and males?Yes, based on findings from rats, REZUROCK may impair female and male fertility. However, the effects on fertility are reversible.
What is the pediatric use of REZUROCK?The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. Use of REZUROCK in this age group is supported by evidence from adequate and well-controlled studies of REZUROCK in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the pharmacokinetics of drug substance. The exposure of drug substance is expected to be similar between adults and pediatric patients age 12 years and older, and the course of disease is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established.
What is the geriatric use of REZUROCK?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.
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