Selected Safety Information
- Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
- The most common adverse reaction causing discontinuation of use of the implant in clinical trials was change in menstrual bleeding patterns, specifically irregular menses (11.1%). The most common adverse reactions (≥10%) reported in clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%).
Indication and efficacy
NEXPLANON is indicated for use by women to prevent pregnancy.
NEXPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired. The efficacy of NEXPLANON does not depend on daily, weekly, or monthly administration.
In clinical trials of up to 3 years' duration that involved 923 subjects, 18-40 years of age at entry, and 1,756 women-years of use with the non-radiopaque etonogestrel implant (IMPLANON), the total exposures expressed as 28-day cycle equivalents by study year were:
Year 1: 10,866 cycles
Year 2: 8,581 cycles
Year 3: 3,442 cycles
The clinical trials excluded women who:
Weighed more than 130% of their ideal body weight
Were chronically taking medications that induce liver enzymes
In the subgroup of women 18-35 years of age at entry, 6 pregnancies during 20,648 cycles were reported. Two pregnancies occurred in each of years 1, 2, and 3. Each conception was likely to have occurred shortly before or within 2 weeks after removal of the non-radiopaque etonogestrel implant. With these 6 pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.
Selected Safety Information
About NEXPLANON (etonogestrel implant) 68 mg (continued)
- Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins and may decrease the effectiveness of NEXPLANON. In women on long-term treatment with hepatic enzyme inducing drugs, it is recommended to remove the implant and to advise a contraceptive method that is unaffected by the interacting drug. Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of coadministration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
- CYP3A4 inhibitors, such as itraconzaole or ketoconazole, may increase plasma concentrations of etonogestrel.
