belumosudil 200 MG Oral Tablet [Rezurock]
NO BOXED WARNING
Dosage & administration
Recommended Dosage: 200 mg taken orally once daily with food. ( 2.1)
Rezurock prescribing information
Rezurock financial assistance options
Co-pay savings program
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
- Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
- Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)
- 100% free (outside of insurance)
- HCP must enroll patient
- May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries
How to sign up
- Typically HCP assisted enrollment (via form)
PubMed™ | Rezurock
Rezurock PubMed™ News
people also ask
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.
FAQ Data Source
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