Implanon Nxt 68 Mg

Implanon NXT is indicated for contraception.

A single implant is inserted subdermally and can be left in place for 3 years. Remove the implant no later than 3 years after the date of insertion. The user should be informed that she can request the removal of the implant at any time.

Implanon NXT should not be used in the presence of any of the conditions listed below. Should any of the conditions, appear for the first time during the use of Implanon NXT, the product should be removed immediately.

• Hypersensitivity to the active substance or to any of the inactive ingredients of Implanon NXT.
• Active venous or arterial thromboembolic disorders or history thereof (see WARNINGS AND SPECIAL PRECAUTIONS).
• Known or suspected sex-steroid sensitive malignancies such as breast and ovarian cancers.
• Presence or history of liver tumours (benign or malignant).
• Presence or history of any hepatic disease for as long as liver function values have not returned to normal.
• Known or suspected pregnancy.
• Undiagnosed vaginal bleeding.

If any of the conditions or risk factors mentioned below are present, the potential risk should be discussed with the woman before the decision to implement treatment with Implanon NXT is made. In the event of aggravation, exacerbation or first appearance of any of these conditions, the woman should contact her medical practitioner. The medical practitioner should then decide on whether Implanon NXT should be removed.

Pregnancy should be excluded before insertion of Implanon NXT.

Carcinoma of the Breast

The risk for breast cancer increases in general with increasing age. During the use of (combined) oral contraceptives the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of oral contraceptive use and is not related to the duration of use, but to the age of the woman when using the oral contraceptive. The risk in users of contraceptive methods which only contain progestagens, such as Implanon NXT, is possibly of similar magnitude as that associated with combined oral contraceptives. However, for these methods, the evidence is less conclusive.

Venous and arterial thromboembolism

Epidemiological investigations have associated the use of combined oral contraceptives with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for etonogestrel (the biologically active metabolites of desogestrel in Implanon NXT) used as a contraceptive in the absence of an estrogenic component is unknown, Implanon NXT should be removed in the event of a confirmed thrombosis. Removal of Implanon NXT should also be considered in case of long-term immobilisation due to surgery or illness. Although Implanon NXT is a progestagen only contraceptive, it is recommended to assess risk factors, which are known to increase the risk of venous and arterial thromboembolism. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence (see CONTRAINDICATIONS).

There have been post-marketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction and strokes, in women using etonogestrel implants such as Implanon NXT. Implanon NXT should be removed in the event of any venous or arterial thrombotic event.

Carbohydrate and Lipid Metabolic Effects and body weight

The use of progestagen-containing contraceptives such as Implanon NXT 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.

Women who are being treated for hyperlipidaemia should be monitored closely if they elect to use Implanon NXT. Progestogens such as Implanon NXT may elevate LDL cholesterol levels and may render the control of hyperlipidaemia more difficult.

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. More frequent replacement of Implanon NXT may be required in women with higher body weight.

Ectopic Pregnancies

Ectopic pregnancy should be taken into account in the differential diagnosis, if the woman gets amenorrhoea or abdominal pain.

Hypertension

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, Implanon NXT should be removed.

Liver Disease

When acute or chronic disturbances of liver function occur, the woman should be referred to a specialist for examination and advice.

Chloasma

Chloasma may 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 while using Implanon NXT.

Other Conditions

Insertion or removal of Implanon NXT may cause bruising. Scar formation has been reported. Itching, pain and infection at the implantation site may occur. The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of Implanon NXT 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.

Note: The prescribing information of concomitant medicines should be consulted to identify potential interactions.

Influence of other medicinal products on Implanon NXT

Interactions between Implanon NXT and other medicines may lead to menstrual bleeding and/or contraceptive failure. The following interactions have been reported in the literature, mainly with combined contraceptives, but also with progestagen-only contraceptives, such as Implanon NXT.

Hepatic metabolism: Interactions can occur with medicinal or herbal products that induce hepatic enzymes, specifically cytochrome P450 enzymes (CYP), which can result in increased clearance, reducing plasma concentrations of etonogestrel as in Implanon NXT, and may decrease the effectiveness of Implanon NXT. These products include (phenytoin, barbiturates, primidone, bosentan, carbamazepine, rifampicin; HIV medication (e.g. ritonavir, nelfinavir, nevirapine, efavirenz); and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and the herbal remedy St Johnu2019s wort).

Enzyme induction can occur within a few days of treatment. Maximum enzyme induction is generally observed within a few weeks. After medicine therapy is discontinued, enzyme induction can last for about 28 days.

When co-administered with Implanon NXT, many combinations of HIV protease inhibitors (e.g. nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine), and/or combinations with medicines used to treat HCV (e.g. boceprevir, telaprevir), can increase or decrease plasma concentrations of etonogestrel as in Implanon NXT, as the net effect of these changes cannot be predicted and may result in decreased efficacy of IMPLANON NXT.

Management

Women receiving any of these above mentioned hepatic enzyme-inducing medicines or herbal products should be advised that the efficacy of Implanon NXT may be reduced. If it is decided to continue using Implanon NXT, women should be advised to also use a non-hormonal contraceptive method during the time of concomitant medication administration and for 28 days after their discontinuation.

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.

Influence of Implanon NXT on other medicines

Implanon NXT may interfere with the metabolism of other medicines. Accordingly, plasma and tissue concentrations of these medicines may either increase (e.g. ciclosporin) or decrease (e.g. lamotrigine).

Laboratory investigations

Data obtained with combined oral contraceptives have shown that contraceptive steroids may affect some laboratory investigations, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to Implanon NXT is not known.

Implanon NXT is contraindicated during pregnancy. If pregnancy occurs during use of Implanon NXT, the implant should be removed. Animal studies have shown that progestagenic substances may cause masculinisation of female foetuses.

Implanon NXT does not influence the production or the quality (protein, lactose or fat concentrations) of breast milk. Etonogestrel is excreted in breast milk. Based on limited available data, Implanon NXT may be used during lactation and should be inserted after the 4th post-partum week.

No effects have been observed.

Serious undesirable effects see WARNINGS AND SPECIAL PRECAUTIONS. After insertion of Implanon NXT, women are likely to have changes in their menstrual bleeding pattern which are unpredictable beforehand. These may include occurrence of an irregular bleeding pattern (absent, less, more frequent or continuous), and changes in bleeding intensity (reduced or increased) or duration. Amenorrhoea was reported in about 20 % of women while another 20 % of women reported frequent and/or prolonged bleeding.

Occasionally, heavy bleeding has been reported. In clinical trials, Bleeding changes were the most common reason for stopping treatment (about 11 %).

Undesirable effects reported in clinical trials have been listed in the Table below.

System Organ Class Adverse reaction in MedDRA Termu00b9 Very Common > 1/10 Common < 1/10 to u2265 1/ 100 Uncommon < 1/100 to u2265 1/1 000 Infections and Infestations Vaginal infections - Pharyngitis, rhinitis, urinary tract infection Immune system disorders - - Hypersensitivity Metabolism and nutritional disorders - Increased appetite - Psychiatric disorders - Affect lability, depressed mood, nervousness, libido decreased Anxiety, insomnia Nervous system disorders Headache Dizziness Migraine, somnolence Vascular disorders - Hot flushes - Gastrointestinal disorders - Abdominal pain, nausea, flatulence Vomiting, constipation, diarrhoea Skin and subcutaneous tissue disorders Acne Alopecia Hypertrichosis, rash, pruritus Musculoskeletal and - - Back pain, arthralgia, myalgia, musculoskeletal pain Renal and urinary disorders - - Dysuria Reproductive system and breast disorders Breast tenderness, breast pain, irregular menstruation Dysmenorrhoea, ovarian cyst Genital discharge, vulvovaginal discomfort, galactorrhoea, breast enlargement, genital pruritus General disorders and administration site condition - Implant site pain, implant site reaction, fatigue, influenza like illness, pain Pyrexia, oedema Investigations Increased weight Decreased weight - u00b9 The most appropriate MedDRA term (version 10.1) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed but should be taken into account as well.

In a clinical trial of Implanon NXT, 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 patients. Additionally, haematoma (3,0 %), bruising (2,0 %), pain (1,0 %) and swelling (0,7 %) were reported.

During post-marketing surveillance:

A clinically relevant rise in blood pressure has been observed in rare cases. Seborrhoea has also been reported.

Anaphylactic reactions, urticaria, angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema may occur. Insertion or removal of Implanon NXT may cause bruising, local irritation, pain or itching. Fibrosis at the implant site may occur, a scar may be formed or an abscess may develop. Paraesthesia or paraesthesia-like events may occur. Expulsion or migration of Implanon NXT have been reported, including to the chest wall. Implants have also been found within the vasculature including the pulmonary artery. Some cases of implants found within the pulmonary artery reported chest pain and/or dyspnoea. Implanon NXT that has migrated to the pulmonary artery may be asymptomatic or may lead to clinical symptoms such as chest pain and/or dyspnoea (see WARNINGS AND SPECIAL PRECAUTIONS). Surgical intervention may be necessary when removing Implanon NXT. Ectopic pregnancies have been reported (see WARNINGS AND SPECIAL PRECAUTIONS).

An implant should always be removed before inserting a new one. There is no data available on overdose with etonogestrel.