Rezurock Pregnancy Warnings
Use should be avoided.
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 during pregnancy. In animal reproduction studies, administration to pregnant rats and rabbits during organogenesis resulted in alterations to growth, embryofetal mortality, and embryofetal malformations at maternal exposures approximately greater than or equal to 3 (rat) and greater than or equal to 0.07 (rabbit) times the human exposure at the recommended dose.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 1 week after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 1 week after.
-This drug may cause reversible male and female infertility.
Animal studies have revealed evidence of maternal toxicity (reduced weight gain) and embryotoxicity. Fetal malformations included absence of anus and tail, omphalocele, and dome shaped head. 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
Rezurock Breastfeeding Warnings
Use should be avoided.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Because of the potential for serious adverse reactions from this drug in the breastfed child, advise lactating women not to breastfeed during therapy and for at least 1 week after.
See references
