"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling:
- Changes in Menstrual Bleeding Patterns [see WARNINGS AND PRECAUTIONS]
- Ectopic Pregnancies [see WARNINGS AND PRECAUTIONS]
- Thrombotic and Other Vascular Events [see WARNINGS AND PRECAUTIONS]
- Liver Disease [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials including 942 women who were evaluated for safety, change in menstrual bleeding patterns (irregular menses) was the most common adverse reaction causing discontinuation of use of IMPLANON (11.1% of women).
Adverse reactions that resulted in a rate of discontinuation of ≥ 1% are shown in Table 3.
Table 3: Adverse Reactions Leading to Discontinuation
of Treatment in 1% or More of Subjects in Clinical Trials of IMPLANON
|Adverse Reactions||All Studies
N = 942
|* Includes “frequent”, “heavy”, “prolonged”, “spotting”,
and other patterns of bleeding irregularity.
† Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation.
‡ Among US subjects (N=330), 2.4% experienced depression that led to discontinuation.
Other adverse reactions that were reported by at least 5% of subjects in clinical trials of IMPLANON are listed in Table 4.
Table 4: Common Adverse Reactions Reported by
≥ 5% of Subjects in Clinical Trials with IMPLANON
|Adverse Reaction||All Studies
|Insertion site pain||5.2%|
Implant site complications were reported by 3.6% of subjects during any of the assessments in clinical trials. Pain was the most frequent implant site complication, reported during and/or after insertion, occurring in 2.9% of subjects. Additionally, hematoma, redness, and swelling were reported by 0.1%, 0.3%, and 0.3% of patients, respectively [see WARNINGS AND PRECAUTIONS].
The following additional adverse reactions have been identified during post-approval use of IMPLANON. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: constipation, diarrhea, flatulence, vomiting.
General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia.
Immune system disorders: anaphylactic reactions
Investigations: clinically relevant rise in blood pressure, weight decreased.
Metabolism and nutrition disorders: increased appetite.
Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.
Psychiatric disorders: anxiety, insomnia, libido decreased.
Renal and urinary disorders: dysuria.
Vascular disorders: hot flush.
Complications related to insertion or removal of the implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess.
Read the Implanon (etonogestrel implant) Side Effects Center for a complete guide to possible side effects
Changes In Contraceptive Effectiveness Associated With Coadministration Of Other Products
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 IMPLANON. 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.
Some of these drugs or herbal products that induce enzymes, including CYP3A4, include:
- St. John's wort
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. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Increase In Plasma Concentrations Of Etonogestrel Associated With Coadministered Drugs
CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma concentrations of etonogestrel.
Changes In Plasma Concentrations Of Coadministered Drugs
Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporin) or decrease (for example, lamotrigine). Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/21/2014
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