Denavir cream Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Comments: Patients should consult healthcare provider prior to use (AU, UK).
Animal studies have failed to reveal evidence of fetotoxicity associated with IV penciclovir. There are no controlled data in human pregnancy.
There is unlikely to be any reason for concern about side effects when this drug is used during pregnancy; systemic absorption of the active component after topical administration of this drug shown to be minimal.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Denavir cream Breastfeeding Warnings
Safety has not been established.
-AU: Caution is recommended.
-UK: Benefit should outweigh risk.
-US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes (after administration of oral prodrug of penciclovir [famciclovir])
Comments:
-The effects in the nursing infant are unknown; infant side effects unlikely with maternal use when applied topically to small areas away from the mother's breast.
-Patients should consult healthcare provider prior to use (AU, UK).
After oral administration of famciclovir to lactating rats, penciclovir was recovered from breast milk in levels exceeding those in plasma.
There is unlikely to be any reason for concern about side effects when this drug is used in lactating women; systemic absorption of the active component after topical administration of this drug shown to be minimal.
See references
