Important Safety Information
Updated on 15/03/2018
For full information, please refer to the NEXPLANON® (etonogestrel) SPC.1
If you think that NEXPLANON is suitable for your patient, you have counselled her on available options and relevant considerations, and she has chosen to try it, be aware that it should be inserted on the day the next progestogen-only injection is due. Refer to the prescribing information for further details on this.
Contraindications
The NEXPLANON implant should not be used in the following situations:
- Active venous thromboembolic disorder
- Known or suspected sex steroid sensitive malignancies
- Presence/history of liver tumours (benign or malignant)
- Presence/history of severe hepatic disease with abnormal liver function
- Undiagnosed vaginal bleeding
- Hypersensitivity to active substances or to any of the excipients of NEXPLANON
There have been rare reports of implant migration and rare postmarketing reports of implants located within the vessels of the arm and the pulmonary artery, which may refer to deep insertions or intravascular insertion. Please refer to the Summary of Product Characteristics for correct insertion technique.
Insertion of NEXPLANON should be performed under aseptic conditions and only by a qualified HCP who is familiar with the procedure.
During the use of NEXPLANON, women are likely to have changes in their menstrual bleeding pattern which are unpredictable beforehand. These may include the occurrence of an irregular bleeding pattern and changes in bleeding intensity or duration.
Information, counselling and the use of a bleeding diary can improve the woman’s acceptance of a bleeding pattern.1
Generally well tolerated
NEXPLANON may be associated with changes to menstrual bleeding.1 The bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women.
| Common side effects of NEXPLANON1 | ||
|---|---|---|
| Very common (>1/10 users) | Common ( <1/10, ≥1/100 users) | |
| Acne | Abdominal pain | Implant site reaction |
| Breast pain | Alopecia | Influenza-like illness |
| Breast tenderness | Appetite increased | Libido decreased |
| Headache | Depression | Mood swings |
| Irregular bleeding | Dizziness | Nausea |
| Weight increased | Dysmenorrhoea | Nervousness |
| Vaginal infection | Fatigue | Ovarian cyst |
| Flatulence | Weight decreased | |
| Hot flushes | Pain | |
References
- NEXPLANON 68 mg implant for subdermal use - Summary of Product Characteristics.
- NICE Clinical Guideline 30 . Long-acting reversible contraception. London: 2005.
- Faculty of Sexual & Reproductive Healthcare (FSRH). The UK Medical Eligibility Criteria for Contraceptive Use. Available from https://www.fsrh.org/news/ukmec-2016--guidance-for-nurses/. Updated August 2016.
- FSRH. Progestogen only Implants. February 2014.
- Trussel J. Contraception 2011; 83(5): 397–404.
- Graesslin O, et al. Eur J Contracept Reprod Health Care 2008; 13(Suppl. 1): 4–12.
- Funk S, et al. Contraception 2005; 71(5): 319–326.
- Kiriwat O, et al. Eur J Contracept Reprod Health Care 1998; 3(2): 85–91.
- Glasier A. Contraception 2002; 65(1): 29–37.
- Lipetz C, et al. Contraception 2009; 79(4): 304–309.
- Davie J, et al. Clin Ther 1996; 18(1): 150–159.
- Lakha F, et al. Contraception 2006; 74(4): 287–289.
- Reuter S, et al. Eur J Contracept Reprod Health Care 2003; 8(1): 27–36.
Many studies referenced here are about IMPLANON. NEXPLANON is bioequivalent to IMPLANON.
Supporting documentation
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet
WOMN-1247165-0000 | Date of Preparation: March 2018