"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 involving 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 the non-radiopaque etonogestrel implant (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 the Non-Radiopaque
Etonogestrel Implant (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 the non-radiopaque etonogestrel implant clinical trials are listed in Table 4.
Table 4: Common Adverse Reactions Reported by ≥ 5%
of Subjects in Clinical Trials With the Non-Radiopaque Etonogestrel Implant
|Adverse Reactions||All Studies
N = 942
|Insertion site pain||5.2%|
In a clinical trial of NEXPLANON, in which investigators were asked to examine the implant site after insertion, implant site reactions were reported in 8.6% of women. Erythema was the most frequent implant site complication, reported during and/or shortly after insertion, occurring in 3.3% of subjects. Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported.
The following additional adverse reactions have been identified during post-approval use of IMPLANON and NEXPLANON. 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.
Infections and infestations: rhinitis, urinary tract infection.
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 etonogestrel implants reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site, paresthesia or paresthesia-like events, scarring and abscess. Expulsion or migration of the implant have been reported, including to the chest wall. In some cases, implants have been found within the vasculature, including the pulmonary artery. Some cases of implants found within the pulmonary artery reported chest pain and/or dyspnea; others have been reported as asymptomatic [see WARNINGS AND PRECAUTIONS]. Surgical intervention might be necessary when removing the implant.
Read the Nexplanon (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 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.
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 co-administration 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: 3/25/2016
Additional Nexplanon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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