"Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the Uni"...
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Details with Side Effects
Mechanism of Action
Exposure-response relationships of IMPLANON are unknown.
The mean peak serum concentrations in 3 pharmacokinetic studies ranged between 781 and 894 pg/mL and were reached within the first few weeks after insertion. The mean serum etonogestrel concentration decreases gradually over time declining to 192 to 261 pg/mL at 12 months (n=41), 154 to 194 pg/mL at 24 months (n=35), and 156 to 177 pg/mL at 36 months (n=17).
The pharmacokinetic profile of IMPLANON from 1 of 3 pharmacokinetic studies is shown in Figure 24.
Figure 24 : Mean Serum Concentration-time Profile of
Etonogestrel During 2 Years of IMPLANON Use and After Removal in 20 Healthy
The elimination half-life of etonogestrel is approximately 25 hours. Excretion of etonogestrel and its metabolites, either as free steroid or as conjugates, is mainly in urine and to a lesser extent in feces. After removal of the implant, etonogestrel concentrations decreased below sensitivity of the assay by 1 week.
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 IMPLANON use, 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 to 35 years of age at entry, 6 pregnancies during 20,648 cycles of use 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 IMPLANON removal. With these 6 pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.
Return to Ovulation
In clinical trials with IMPLANON, the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.
Last reviewed on RxList: 2/28/2012
This monograph has been modified to include the generic and brand name in many instances.
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