Selected Safety Information
- CYP3A4 inhibitors, such as itraconzaole or ketoconazole, may increase plasma concentrations of etonogestrel.
- Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporin) or decrease (for example, lamotrigine).
Information for patients
Counsel women about the insertion and removal procedure of the NEXPLANON implant. Provide the woman with a copy of the Patient Labeling and ensure that she understands the information in the Patient Labeling before insertion and removal. A USER CARD and consent form are included in the packaging. Have the woman complete a consent form and retain it in your records. The USER CARD should be filled out and given to the woman after insertion of the NEXPLANON implant so that she will have a record of the location of the implant in the upper arm and when it should be removed.
Counsel women that NEXPLANON does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Counsel women that the use of NEXPLANON may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect.
Please see the Patient Information for NEXPLANON.
Selected Safety Information
About NEXPLANON (etonogestrel implant) 68 mg (continued)
- Rule out pregnancy before inserting NEXPLANON.
- Based on limited clinical data, NEXPLANON may be used during breastfeeding 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. 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.
