Vyleesi Pregnancy Warnings
Not Recommended
US FDA pregnancy category: Not assigned
Risk Summary: There is insufficient data to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; animal data suggests a potential for fetal harm.
Comments:
-Females of reproductive potential should use effective contraception; discontinue use if pregnancy is suspected
-A pregnancy registry has been established to monitor pregnancy outcomes; healthcare providers are encouraged to register pregnant patients or pregnant women may enroll themselves at 1-877-411-2510.
Daily subcutaneous administration to pregnant dogs at exposures estimated to be 16 times the maximum recommended human dose (MRHD) produced fetal harm. Dogs are not routinely used for reproductive toxicity assessments but were used because it was possible to dose by subcutaneous administration during gestation. Embryofetal toxicity (measured by post-implantation loss) was elevated compared to controls and was not dose-dependent. Female mice dosed from gestational day 6 through lactation day 28 had 2 generations of offspring assessed. There were no effects on reproductive parameters, but developmental delays were observed in the first-generation offspring at approximately 125 times MRHD. There were 7 pregnancies in clinical trials. No major congenital anomalies were reported but data is insufficient for evaluating a drug associated risk; there was 1 miscarriage, 5 full-term live births, and 1 lost to follow-up. 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.
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Vyleesi Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
See references
