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If any of the conditions / risk factors mentioned as follows is present, the benefits of progestagen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Implanon NXT. In the event of aggravation, exacerbation or first appearance of any of these conditions, the woman should contact her HCP. The HCP should then decide on whether the use of Implanon NXT should be discontinued.
Carcinoma of the Breast: The risk for breast cancer increases in general with increasing age. During the use of (combined) oral contraceptives (OCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of OC use and is not related to the duration of use, but to the age of the woman when using the OC. The expected number of cases diagnosed per 10,000 women who use combined OCs (up to 10 years after stopping) relative to never users over the same period have been calculated for the respective age groups to be: 4.5/4 (16-19 years), 17.5/16 (20-24 years), 48.7/44 (25-29 years), 110/100 (30-34 years), 180/160 (35-39 years) and 260/230 (40-44 years). The risk in users of contraceptive methods, which only contain progestagens is possibly of a similar magnitude to that associated with combined OCs. However, for these methods, the evidence is less conclusive. Compared to the risk of getting breast cancer ever in life, the increased risk associated with OCs is low. The cases of breast cancer diagnosed in OC users tend to be less advanced than in those who have not used OCs. The increased risk observed in OC users may be due to an earlier diagnosis, biological effects of the OC or a combination of both.
Liver Disease: When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.
Thrombotic and Other Vascular Events: Epidemiological investigations have associated the use of combined OCs (estrogen + progestagen) with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism) and arterial thromboembolism (ATE, myocardial infarction and ischaemic stroke). The clinical relevance of these findings for etonogestrel (the biologically active metabolite of desogestrel) used as a progestagen-only contraceptive in the absence of an estrogenic component is unknown.
Limited epidemiological data do not suggest an increased risk of VTE or ATE in women using the implant; however, there have been postmarketing reports of VTE and ATE, in women using etonogestrel implants. It is recommended to assess risk factors, which are known to increase the risk of VTE and ATE.
Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. The implant should be removed in the event of a thrombosis. Removal of the implant should also be considered in the case of long-term immobilisation due to surgery or illness.
Elevated Blood Pressure: If a sustained hypertension develops during the use of Implanon NXT, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the use of Implanon NXT should be discontinued.
Carbohydrate Metabolic Effect: The use of progestagen-containing contraceptives may have an effect on peripheral insulin resistance and glucose tolerance. Therefore, diabetic women should be carefully monitored during the first months of Implanon NXT use.
Chloasma: Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst using Implanon NXT.
Body Weight: The contraceptive effect of Implanon NXT is related to the plasma levels of etonogestrel, which are inversely related to body weight, and decrease with time after insertion. The clinical experience in heavier women in the third year of use is limited. Therefore it cannot be excluded that the contraceptive effect in these women during the third year of use may be lower than for women of normal weight. HCPs may therefore consider earlier replacement of the implant in heavier women.
Complications of Insertion: There have been reports of migration of the implant within the arm from the insertion site, which may be related to a deep insertion (see How to insert Implanon NXT under Dosage & Administration), or external forces (e.g. manipulation of the implant or contact sports). There also have been rare postmarketing reports of implants located within the vessels of the arm and the pulmonary artery, which may be related to deep insertions or intravascular insertion. In cases where the implant has migrated within the arm from the insertion site, localisation of the implant may be more difficult and removal may require a minor surgical procedure with a larger incision or a surgical procedure in an operating room. In cases where the implant has migrated to the pulmonary artery endovascular or surgical procedures may be needed for removal (see How to remove Implanon NXT under Dosage & Administration). If at any time the implant cannot be palpated, it should be localised and removal is recommended as soon as medically appropriate. If the implant is not removed, contraception and the risk of progestagen-related undesirable effects may continue beyond the time desired by the woman.
Expulsion may occur especially if the implant is not inserted according to the instructions given in How to insert Implanon NXT under Dosage & Administration, or as a consequence of local inflammation.
Ovarian Cysts: With all low-dose hormonal contraceptives, follicular development occurs and occasionally the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Often, they are asymptomatic; in some cases they are associated with mild abdominal pain. They rarely require surgical intervention.
Ectopic Pregnancies: The protection with traditional progestagen-only contraceptives against ectopic pregnancies is not as good as with combined OCs, which has been associated with the frequent occurrence of ovulations during the use of these methods. Despite the fact that Implanon NXT will inhibit ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.
Psychiatric Disorders: Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see Adverse Reactions). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Other Conditions: The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestagens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss and (hereditary) angioedema.
Medical examination/consultation: Prior to the initiation or reinstitution of Implanon NXT a complete medical history (including family medical history) should be taken and pregnancy should be excluded. Blood pressure should be measured and a physical examination should be performed, guided by the contraindications and warnings. It is recommended that the woman returns for a medical check-up three months after insertion of Implanon NXT. During this check-up, the blood pressure should be measured and the woman should be asked whether she has any questions or complaints or has experienced any undesirable effects. The frequency and nature of further periodic checks should be adapted to the individual woman, guided by clinical judgement. The implant should be palpated at each check-up visit. The woman should be instructed to contact her doctor as soon as possible if she cannot palpate her implant at any time between check-ups.
Women should be advised that Implanon NXT does not protect against HIV (AIDS) and other sexually transmitted diseases.
Reduced efficacy with concomitant medications: The efficacy of Implanon NXT may be reduced when concomitant medications that decrease the plasma concentration of etonogestrel are used (see Interactions).
Changes in the menstrual bleeding pattern: During the use of Implanon NXT, 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 (absent, less frequent, more frequent or continuous), and changes in bleeding intensity (reduced or increased) or duration. Amenorrhoea was reported in about 1 of 5 women while another 1 of 5 women reported frequent and/or prolonged bleeding. The bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women. Information, counselling and the use of a bleeding diary can improve the woman's acceptance of a bleeding pattern. Evaluation of vaginal bleeding should be done on an ad hoc basis and may include an examination to exclude gynaecological pathology or pregnancy.
In situ broken or bent implant: There have been reports of broken or bent implants, which may be due to external forces applied while in the patient's arm. There have also been reports of migration of a broken implant fragment within the arm. Based on in vitro data, when the implant is broken or bent, the release rate of etonogestrel may be slightly increased. This change is not expected to have clinically meaningful effects. However, when an implant is broken, it should be removed, and it is important to remove it in its entirety. Refer to Dosage & Administration for the procedures of implant removal (either palpable or non-palpable).
Effects on ability to drive and use machines: On the basis of the pharmacodynamic profile, Implanon NXT is expected to have no or negligible influence on the ability to drive or use machines.
