Velaglucerase alfa Pregnancy and Breastfeeding Warnings

Velaglucerase alfa is also known as: VPRIV

Velaglucerase alfa Pregnancy Warnings

FDA pregnancy category: B Velaglucerase alfa should be used during pregnancy only if clearly needed. 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. 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. -Similar agents (alglucerase and imiglucerase) have been used without apparent harmful effects in the nursing infant.

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