Enoxaparin STADA Use In Pregnancy & Lactation

Pregnancy: There is no evidence from animal studies that enoxaparin has teratogenic effects.
To date, substances responsible for malformation in humans have proved to be teratogenic in animals during well-conducted studies in two species.
As there are no adequate and well-controlled studies in pregnant women and because animal studies are not always predictive of human response, this drug should be used during pregnancy only if the physician has established a clear need.
Prophylactic treatment during the first trimester: There are currently not enough relevant clinical data concerning possible teratogenic or fetotoxic effects of enoxaparin when the drug is administered preventively during the first trimester. As a precautionary measure, enoxaparin prophylaxis should not be administered during the first trimester.
If epidural anesthesia is planned, preventive heparin treatment should be interrupted whenever possible within 12 hours before anesthesia at the latest.
Prophylactic treatment during the second and third trimesters: Administration of prophylactic doses of enoxaparin to women during the second and third trimesters in a limited number of pregnancies has apparently not resulted in any particular teratogenic or fetotoxic effects. However, additional studies are needed to evaluate the effects of exposure under these conditions. Therefore, enoxaparin prophylaxis during the second and third trimesters should only be administered if necessary.
If epidural anesthesia is planned, preventive heparin treatment should be interrupted whenever possible within 12 hours before anesthesia at the latest.
Curative treatment: Current clinical data are insufficiently relevant to determine a possible malformative or fetotoxic effect of enoxaparin administered at curative doses throughout pregnancy.
The use of curative doses of enoxaparin is therefore not recommended throughout pregnancy as a precaution. Spinal or epidural anesthesia must never be performed during curative treatment with LMWH.
Lactation: Since gastro-intestinal absorption by neonates is unlikely in principle, treatment with enoxaparin is not contraindicated in breast-feeding women. As a precaution, lactating mothers receiving enoxaparin sodium should be advised to avoid breast-feeding.