Pregnancy & Lactation : הריון/הנקה

4.6         Fertility, pregnancy and lactation

Pregnancy
In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester.
Animal studies have not shown any evidence of foetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal.
Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).


If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4).


Breastfeeding
It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. This medicinal product can be used during breastfeeding.


Fertility
There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).