Belumosudil Pregnancy and Breastfeeding Warnings

Brand names: Rezurock

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

Belumosudil Pregnancy Warnings

Use should be avoided.
According to some authorities: Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to pregnant women.

Comments:
-Based on findings from animal studies, this drug can impair male and female fertility.
-Women of childbearing potential and males with female partners of childbearing potential should be advised to use effective contraception during treatment and for 1 week after the last dose.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Pregnant patients and females of reproductive potential should be apprised of the potential risk to the fetus.

Animal studies have revealed evidence of embryofetal toxicity, teratogenicity, and maternal toxicity. In pregnant animals administered this drug during organogenesis, developmental toxicity occurred at an oral dose associated with maternal plasma exposure and similar to the maximum recommended human dose of 200 mg. Maternal toxicity was reported at 125 mg/kg/day and up to 300 mg/kg/day. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Belumosudil Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the presence of this drug in human milk, its effects on the breastfed infant, or milk production.
-This drug should not be used during breastfeeding due to the potential for serious adverse effects on the infant.

See references

Further information

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