Wherever life takes her , plan on with
NEXPLANON ®
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Designed for her lifestyle
With up to 3 years of reliable contraception , and over 99 % effectiveness , NEXPLANON ® offers a low-maintenance approach . 1 , 2 Available for women aged 18 – 40 , NEXPLANON ® gives you the choice of a minimally-invasive , non-uterine insertion . 1 , 2 *
For a contraceptive designed for her , choose NEXPLANON ®
The most common ( ≥1 / 10 ) side effects reported are ; vaginal infection , headache , acne , breast tenderness , breast pain , irregular menstruation and increased weight . 1
Contraindications include ; active venous thromboembolic disorder , known or suspected gonadocorticoid sensitive malignancies , presence or history of severe hepatic disease or hepatic tumours , undiagnosed vaginal bleeding , hypersensitivity to the active substance or excipients . 1
Nexplanon ® Etonogestrel PRESCRIBING INFORMATION
Refer to Summary of Product Characteristics ( SmPC ) before Prescribing PRESENTATION Preloaded applicator with a radiopaque nonbiodegradable implant containing 68mg of etonogestrel . USES Contraception . Safety and efficacy have been established in women between 18 and 40 years of age . DOSAGE AND ADMINISTRATION One implant should be inserted subdermally overlying the triceps muscle of the non-dominant upper arm . Exclude pregnancy prior to insertion . Each implant can be left in place for 3 years . Broken implants should be removed . Nexplanon should only be inserted or removed by HCPs who have completed training for the use of the Nexplanon applicator and are familiar with the insertion and removal technique . Insertion , removal and replacement instructions must be strictly followed . Videos demonstrating insertion and removal procedures are available at www . nexplanonvideos . eu CONTRA-INDICATIONS 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 current abnormal liver function tests , undiagnosed vaginal bleeding , hypersensitivity to ingredients . PRECAUTIONS During the use of combined oral contraceptives ( OC ), the risk of having breast cancer is slightly increased possibly due to an earlier diagnosis , biological effects of OC or a combination of both . A similar increased risk of breast cancer diagnosis may be seen in users of progestagen only preparations . Epidemiological studies have associated combined OC ( oestrogen and progestogen ) use with an increased incidence of venous thromboembolism ( VTE , DVT and PE ) and arterial thromboembolism ( ATE , myocardial infarction and ischaemic strokes ). Limited epidemiological data do not suggest an increased risk of VTE or ATE in women using the implant ; however , there have been post-marketing reports of VTE and ATE . Assess risk factors , for VTE and ATE . Remove following thrombosis and consider removal with long-term immobilisation . Advise patients with a history of thromboembolic disorders of the possibility of recurrence . Depressed mood and depression can be associated with hormonal contraceptive use . Depression can be a risk factor for suicidal behaviour and suicide . Advise women to contact their physician if they develop mood changes and depressive symptoms . Refer to a specialist if acute or chronic disturbances in liver function occur . Discontinue Nexplanon use if sustained hypertension develops or if there is a significant increase in BP which cannot be adequately controlled . Monitor diabetic women during the first months as there may be an effect on peripheral insulin resistance and glucose tolerance . Women with a tendency to chloasma should avoid sun or U . V radiation whilst using Nexplanon . Consider earlier replacement of the implant in heavier women . Ovarian cysts may occur and disappear spontaneously . Exclude ectopic pregnancy in the event of abdominal pain and amenorrhoea . Conditions which have reported during pregnancy and during the use of sex steroids include jaundice and / or pruritis related to cholestasis ; gallstone formation ; porphyria ; SLE ; HUS ; Sydenham ’ s chorea ; herpes gestationis ; otosclerosis -related hearing loss and ( hereditary ) angioedema . Changes in the menstrual bleeding pattern are likely . Expulsion may occur if the implant is not inserted correctly or with local inflammation . Rarely the implant may migrate from the insertion site possibly due to deep insertions or intravascular insertion . Localisation of the implant may then be more difficult and removal may require a minor surgical procedure with a larger incision or a surgical procedure in an operating theatre . In cases where the implant has migrated to the pulmonary artery endovascular or surgical procedures may be needed for removal . Advise patients to seek medical advice if implant cannot be palpated at any time . External forces may cause broken or bent implants , broken implant fragments may migrate . The release rate of etonogestrel may be slightly increased when an implant is broken or bent “ in situ ”. No clinically meaningful effects expected . Broken or bent implants must be removed in their entirety . Drug interactions : The prescribing information of concomitant medications should be consulted to identify potential interactions . Substances that induce microsomal enzymes ( e . g : barbiturates , bosentan , carbamazepine , phenytoin , primidone , rifampicin , and HIV / HCV medication like ritonavir , efavirenz , boceprevir , nevirapine and possibly also felbamate , griseofulvin , oxcarbazepine , topiramate and products containing the herbal remedy St . John ’ s Wort ( hypericum perforatum ) can reduce the efficacy of hormonal contraceptives . Concomitant administration of strong ( e . g . ketoconazole , itraconazole , clarithromycin ) or moderate ( e . g . fluconazole , diltiazem , erythromycin ) CYP3A4 inhibitors may increase the serum concentrations of progestins , including etonogestrel . Nexplanon may affect the metabolism of other active substances e . g ciclosporin and lamotrigine . Pregnancy and Lactation : Not indicated during pregnancy . Exclude pregnancy prior to insertion . If pregnancy occurs the implant should be removed . Nexplanon may be used during lactation ; growth and development of the child should be carefully followed . SIDE EFFECTS Refer to Summary of Product Characteristic for complete information on side effects Frequencies can be defined as : Very Common ( ≥1 / 10 ); Common = ≥ 1 / 100 < 1 / 10 ; Uncommon = > 1 / 1,000 < 1 / 100 ; Rare = > 1 / 10,000 < 1 / 1,000 ; Very rare = < 1 / 10,000 ; not known = cannot be estimated from the available data . Very Common : Vaginal infection , headache , acne , irregular menstruation , weight increase , breast tenderness and pain . Common : Alopecia , dizziness , depressed mood , affect lability , nervousness , nausea , flatulence , libido decreased , increased appetite , abdominal pain , ovarian cyst , dysmenorrhoea , flu-like illness , pain , fatigue , weight decrease , insertion site pain or reaction and hot flushes . Not known : During post marketing surveillance anaphylactic reactions and angioedema have also been reported . Insertion of the implant may cause vasovagal reactions ( such as hypotension , dizziness , or syncope ). Expulsion or migration of the implant has been reported , including rarely to the chest wall . Rarely implants have been found within the vasculature including the pulmonary artery which may cause chest pain and / or dyspnea or maybe asymptomatic . Overdose Remove previous implant before inserting a new one . There are no data on overdose with etonogestrel . PACKAGE QUANTITIES AND BASIC NHS COST 1 x implant £ 83.43 Marketing Authorisation number PL 00025 / 0563 . Marketing Authorisation holder Organon Pharma ( UK ) Limited The Hewett Building , 14 Hewett Street , London EC2A 3NP United Kingdom . Legal Category : POM . Date of review of prescribing information : August 2022 .
© 2022 Organon group of companies . All rights reserved . PI . NEX . 22 . UK . 0118 . IA-ORG-LDN . NORCN .
Adverse events should be reported . Reporting forms and information can be found at www . mhra . gov . uk / yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . Adverse events should also be reported to Organon , UK ( Tel : 0208 1593593 ).
NEXPLANON ® is indicated for contraception . Safety and efficacy have been established in women between 18 and 40 years of age . 1 * NEXPLANON ® should only be inserted or removed by healthcare professionals who have completed required training . 1
References : 1 . NEXPLANON ® Summary of Product Characteristics . 2 . The Faculty of Sexual & Reproductive Healthcare . Clinical guidance : progestogen-only implant , clinical effectiveness unit , February 2021 . Available at : fsrh . org .
Organon Pharma ( UK ) Limited . Registered Office : The Hewitt Building , 14 Hewett Street , London , EC2A 3NP .
For UK healthcare professionals only .
A company registered in England and Wales . Company Registration Number : 820771 © 2022 Organon group of companies . All rights reserved .
Please refer to PI and RMM ( Risk Minimisation Materials ) before prescribing and for full
GB-XPL-115313 | Date of preparation : September 2022 Prescribing Information and a full list of side effects and contraindications , please refer to the SmPC .