Idhifa Pregnancy Warnings
Animal studies have revealed evidence of embryofetal mortality and growth alterations (e.g., spontaneous abortions, post-implantation loss, resorptions, decreased viable fetuses, lower fetal birth weights, skeletal variations) at maternally toxic doses starting at approximately 0.1 times the steady state clinical exposure based on the AUC at the recommended human dose. Changes in the reproductive organs of male and female animals (e.g., seminiferous tubular degeneration, hypospermia, atrophy of the seminal vesicle and prostate, decreased corpora lutea, increased atretic follicles in the ovaries, atrophy in the uterus) suggest this drug may impair fertility in females and males of reproductive potential; it is unknown whether these effects are reversible. 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.
Safety has not been established during pregnancy; based on animal studies, this drug can cause fetal harm.
US FDA pregnancy category: Not Assigned
Comments:
-Obtain a pregnancy test on females of reproductive potential prior to treatment initiation.
-Direct females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose.
-This drug may increase or decrease the concentrations of combined hormonal contraceptives; the clinical significance of this potential drug interaction is unknown.
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