Delavirdine Pregnancy and Breastfeeding Warnings

Brand names: Rescriptor

Delavirdine Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of teratogenicity in rats at exposures equal to or less than expected human exposure at the recommended dose. There are no controlled data in human pregnancy.

Of 9 pregnancies reported during premarketing clinical trials and postmarketing experience with this drug, 10 infants were born (includes 1 set of twins); 8 infants were born healthy, 1 was born infected with HIV (but otherwise healthy; no congenital abnormalities detected), and 1 was born prematurely (34 to 35 weeks) with a small muscular ventricular septal defect that spontaneously resolved. The mother of the latter infant received about 6 weeks of therapy with this drug and zidovudine early during pregnancy.

To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Delavirdine Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred, especially if nursing a preterm or newborn infant.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.
-Local guidelines should be consulted if replacement feeding is not an option.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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