Pregnancy: There is no evidence from animal studies that enoxaparin has teratogenic potential.
In the absence of any teratogenic effect in animals, no such effect is expected in man. To date, substances responsible for malformation in humans have proved to be teratogenic in animals during well-conducted studies into two species.
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.
Prophylactic treatment during the first trimester: There are 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, prophylactic 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.
Lactation: Since in principle, gastrointestinal absorption by neonates is unlikely in principle, treatment with enoxaparin is not contraindicated in breast-feeding.
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