Azelastine / fluticasone nasal Pregnancy and Breastfeeding Warnings

Brand names: Dymista

Medically reviewed by Drugs.com. Last updated on Oct 27, 2023.

Azelastine / fluticasone nasal Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Animal studies have not been conducted with the combination product, but have been conducted with both active ingredients individually.

Animal azelastine studies have revealed evidence of fetal harm at oral doses 10 times the clinical study dose; oral administration during organogenesis at doses 530 times the maximum recommended human daily intranasal dose (MRHDID) given during organogenesis produced developmental toxicities (including structural abnormalities and decreased embryo-fetal survival and fetal body weights), but the relevance of this high dose study is questionable.

Animal fluticasone studies showed decreased fetal weight with nose only inhalation, but teratogenicity was not seen at maternally toxic doses less than the MRHDID; subcutaneous maternally toxic doses of less than MRHDID showed characteristic corticosteroid teratogenicity (decreased fetal weight and/or skeletal variations); experience suggests rodents are more prone to corticosteroid teratogenicity than humans are.

There are no adequate and well-controlled studies in pregnant women.

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

Azelastine / fluticasone nasal Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (fluticasone)

Comments:
-There is no information regarding azelastine on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Other corticosteroids have been found in human milk.
-Fluticasone serum levels are low after intranasal administration of therapeutic doses, and breastmilk concentrations are expected to be correspondingly low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Monitor breastfed infants for signs of milk rejection from azelastine's bitter taste.

Fluticasone is present in rat milk; 10 mcg/kg given subcutaneously during lactation resulted in measurable radioactivity in the milk.

See references

Further information

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