Olicoxib Use In Pregnancy & Lactation

Effects on fertility: Parecoxib sodium did not impair rat fertility at intravenous doses of 25 mg/kg/day (males) or 12.5 mg/kg/day (females). These doses resulted in systemic exposures (plasma AUC) that were 1.4-fold human exposure for valdecoxib, at the maximum recommended therapeutic dose (40 mg BD). Based on the mechanism of action, the use of NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including OLICOXIB, should be considered.
Use in pregnancy: Category C.
Teratogenic Effects: Embryo-fetal development studies conducted with intravenous parecoxib sodium in rats and rabbits have not shown any evidence of developmental malformations. Doses used (respectively up to 25 and 40 mg/kg/day) resulted in systemic exposures (plasma AUC) to valdecoxib that were 4.3-fold and 2.2-fold human exposure at the maximum recommended therapeutic dose, respectively. Animal reproduction studies are not always predictive of human responses, and there are no adequate and well-controlled studies in pregnant women. Use of OLICOXIB Injection during pregnancy is not recommended.
Non-Teratogenic Effects: Parecoxib sodium increased post-implantation losses in rats and rabbits at doses that resulted in systemic exposures (plasma AUC) to valdecoxib that were similar to the human exposure at the maximum recommended therapeutic dose. This effect is thought to be a consequence of the inhibition of prostaglandin synthesis, and has been reported to occur with other NSAIDs. No studies have been conducted to evaluate the effect of valdecoxib on the closure of the ductus arteriosus in humans or animals. The use of cyclooxygenase inhibitors may result in premature closure of the ductus arteriosus or uterine inertia. Therefore, the use of OLICOXIB Injection during the third trimester should be avoided.
Inhibition of prostaglandin synthesis might adversely affect pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss.
If used during second or third trimester of pregnancy, NSAIDs may cause fetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible. Pregnant women on parecoxib should be closely monitored for amniotic fluid volume.
Labour and Delivery: Parecoxib sodium has not been studied in late pregnancy and parturition in either animals or humans. In animal studies, both COX-1 and COX-2 have been shown to be present in the ductus arteriosus of fetal lambs and to contribute to the maintenance of patency and the fetal ductus arteriosus was constricted significantly in near-term rats.
Use in lactation: Parecoxib, valdecoxib and an active metabolite of valdecoxib, are excreted in the milk of lactating rats. Parecoxib and valdecoxib are also reported to be transferred into the breast milk of lactating women. Because of the potential for adverse effects in nursing infants from OLICOXIB Injection, breast-feeding should be discontinued during treatment.