Special populations
NEXPLANON is not indicated for use during pregnancy.
Teratology studies have been performed in rats and rabbits using oral administration up to 390 and 790 times the human etonogestrel dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure.
Studies have revealed no increased risk of birth defects in women who have used combination oral contraceptives before pregnancy or during early pregnancy. There is no evidence that the risk associated with etonogestrel is different from that of combination oral contraceptives.
NEXPLANON should be removed if maintaining a pregnancy.
Based on limited data, NEXPLANON may be used during lactation after the fourth postpartum week. Use of NEXPLANON before the fourth postpartum week has not been studied.
Small amounts of etonogestrel are excreted in breast milk. During the first months after NEXPLANON insertion, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Based on daily milk ingestion of 150 mL/kg, the mean daily infant etonogestrel dose one month after insertion of the non-radiopaque etonogestrel implant (IMPLANON) is about 2.2% of the weight-adjusted maternal daily dose, or about 0.2% of the estimated absolute maternal daily dose. The health of breast-fed infants whose mothers began using the non-radiopaque etonogestrel implant during the fourth to eighth week postpartum (n=38) was evaluated in a comparative study with infants of mothers using a non-hormonal IUD (n=33). They were breast-fed for a mean duration of 14 months and followed up to 36 months of age. No significant effects and no differences between the groups were observed on the physical and psychomotor development of these infants. No differences between groups in the production or quality of breast milk were detected.
Health care providers should discuss both hormonal and non-hormonal contraceptive options, as steroids may not be the initial choice for these patients.
Safety and efficacy of NEXPLANON have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents. However, no clinical studies have been conducted in women less than 18 years of age. Use of this product before menarche is not indicated.
This product has not been studied in women over 65 years of age and is not indicated in this population.
No studies were conducted to evaluate the effect of hepatic disease on the disposition of NEXPLANON.The use of NEXPLANON in women with active liver disease is contraindicated.
No studies were conducted to evaluate the effect of renal disease on the disposition of NEXPLANON.
The effectiveness of the etonogestrel implant in women who weighed more than 130% their ideal body weight has not been defined because such women were not studied in clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. It is therefore possible that NEXPLANON may be less effective in overweight women, especially in the presence of other factors that decrease serum etonogestrel concentration such as concomitant use of hepatic enzyme inducers.
