Velaglucerase alfa Pregnancy and Breastfeeding Warnings
Velaglucerase alfa is also known as: VPRIV
Velaglucerase alfa Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed; caution is recommended. AU TGA pregnancy category: B2 US FDA pregnancy category: B Comments: Maternal and embryo/fetal risk due to the mother's underlying condition should be considered.
Animal studies have failed to reveal evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy. Increased risk of spontaneous abortion in women with type 1 Gaucher disease, especially if disease symptoms are not treated and controlled before conception and during pregnancy. Type 1 Gaucher disease symptoms may worsen or new symptoms may develop due to pregnancy. Such symptoms may lead to adverse pregnancy outcomes. AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.
Velaglucerase alfa Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The developmental and health benefits of human milk feeding should be considered. -Potential side effects in the human milk fed child due to the drug or the mother's underlying condition should be considered. -To avoid excessive bone loss in the nursing mother, limiting the duration of breastfeeding to about 6 months should be considered. -The amount in milk is likely to be very low; absorption unlikely as it is probably destroyed in the infant gastrointestinal tract. -Similar agents (alglucerase and imiglucerase) have been used without apparent harmful effects in the nursing infant.
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