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Perflutren Pregnancy and Breastfeeding Warnings

Perflutren is also known as: Definity, Optison

Perflutren Pregnancy Warnings

Unlike the perflutren lipid microsphere injectable suspension (Definity(R)), the perflutren protein-type A microsphere injectable suspension has shown evidence of fetotoxicity, embryofetal toxicity, and teratogenicity in rats and rabbits. AU TGA pregnancy category B3 (Definity(R)): 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 B (Definity(R)): Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C (Optison(TM)): 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.

Definity(R): This drug should be used in pregnancy only if clearly needed. Optison(TM): This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: Definity(R): B3 US FDA pregnancy category: Definity(R): B; Optison(TM): C

Perflutren Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Women that are nursing should be advised to pump and discard breast milk once after treatment.

There is no information on the use of perflutren in breastfeeding mothers, but due to the short elimination half-life from the body use is acceptable. Caution is recommended and mothers should be advised to pump and discard breast milk once after treatment.

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