Implanon NXT® [Etonogestrel]

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Implanon NXT® [Etonogestrel]

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Before the introduction of the drug Implanon NXT®^® it is necessary to exclude pregnancy. The gynecologist is strongly recommended to participate in the training session in order to familiarize himself with the use of the applicator of the drug Implanon NXT®^® and methods of introduction and removal of the implant Implanon NXT®^®. Before the introduction of the implant, it is necessary to carefully read the instructions for use and follow the instructions for the introduction and removal of the implant, presented in subsectionsHow to enter Implanon NXT®^® andHow to remove Implanon NXT®^®.

How to apply Implanon NXT®^®

Preparation Implanon NXT®^® It is a long-acting contraceptive hormonal agent. A single implant is inserted, which can remain at the injection site for 3 years. Remove the implant no later than 3 years from the date of introduction. The woman must be informed about the possibility of removing the implant at any time, if she wishes. A gynecologist may consider the possibility of earlier removal of the implant in overweight women. After removal of the implant, the immediate introduction of another implant will lead to the continuation of contraceptive protection. If a woman does not want to continue using the drug Implanon NXT®^®but she needs contraception, another method of contraception should be recommended.

The basis for the successful application and subsequent removal of the implant Implanon NXT®^®is the correct and carefully performed subcutaneous injection of the implant in accordance with this instruction. Impairment of time and implant insertion techniques (see subsectionsWhen to introduce Implanon NXT®^®, How to enter Implanon NXT®^®) may lead to pregnancy.

Implant Implanon NXT®^® it is necessary to introduce a sc /, directly under the skin on the inner side of the shoulder in order to avoid injury to the large blood vessels and nerves, which are located deeper in the connective tissue between the biceps and triceps muscles.

Immediately after insertion of the implant, palpation of its presence under the skin is necessary. If the implant cannot be felt or its presence is in doubt, other diagnostic methods must be used to confirm its presence (see subsectionHow to enter Implanon NXT®^®). Until the implant is confirmed, the woman should be advised to use a non-hormonal (barrier) method of contraception.

Packaging of the drug Implanon NXT®^® contains a User Card for recording the implant's batch number. The gynecologist must write down the date of insertion, indicate the hand in which the implant was inserted, and the planned day of its removal in the User Card. The product packaging contains stickers for the gynecologist's records, which indicate the serial number of the implant.

When to introduce Implanon NXT®^®

Important. Before the introduction of the implant, pregnancy should be excluded.

The timing of the introduction depends on the recent use of contraceptive hormonal drugs by a woman as follows.

In the absence of the use of contraceptive hormonal drugs in the previous month.The implant should be inserted between the 1st day (1st day of menstrual bleeding) and the 5th day of the menstrual cycle, even if the menstrual bleeding is still ongoing.

With proper implant insertion, an additional method of contraception is not required. If there is a deviation from the recommended implant insertion period, a woman should be warned about the need to use a barrier method of contraception for the next 7 days. If during this period there was sexual intercourse, pregnancy should be excluded.

Transition from the hormonal method of contraception to Implanon NXT®^®

When switching from the combined method of hormonal contraception (combined oral contraceptive agent (CEC), a combined hormonal vaginal ring or a combined hormonal transdermal patch). The implant should be inserted preferably on the day following the day of the last active tablet (the last tablet containing the active ingredients) of the COC, but no later than the day following the usual interval for taking the pills or the period during which the COC placebo pills were taken.If a vaginal ring or transdermal patch was previously used, the implant should be inserted preferably on the day of removal, but no later than the day of the next use of the previous preparation.

With proper implant insertion, an additional method of contraception is not required. If there is a deviation from the recommended implant insertion period, a woman should be warned about the need to use a barrier method of contraception for 7 days. If during this period there was sexual intercourse, pregnancy should be excluded.

When switching from a progestogenic method of contraception (for example, pills containing only progestogen, injections, an implant or hormonal intrauterine system (IUD). Since there are several types of progestogenic methods, the implant should be inserted as follows:

- Injectable contraceptive hormonal agents: implant the implant on the day when you need to do the next injection;

- pills containing only progestogen: a woman can switch from pills containing only progestogen to Implanon NXT®^® any day The implant must be inserted within 24 hours after taking the last tablet;

- Implant / IUD: An implant is inserted on the day the previous implant or IUD is removed.

With proper implant insertion, an additional method of contraception is not required. If there is a deviation from the recommended implant insertion period, a woman should be warned about the need to use a barrier method of contraception for 7 days. If during this period there was sexual intercourse, pregnancy should be excluded.

After abortion or miscarriage

- I trimester: the implant must be inserted within 5 days after an abortion or miscarriage in the first trimester;

- II trimester: The implant must be inserted between the 21st and 28th days after an abortion or miscarriage in the second trimester.

With proper implant insertion, an additional method of contraception is not required. If there is a deviation from the recommended implant insertion period, a woman should be warned about the need to use a barrier method of contraception for 7 days. If during this period there was sexual intercourse, pregnancy should be excluded.

After childbirth

- When breastfeeding: The implant should be inserted at the end of the 4th week after delivery (see “Use during pregnancy and lactation”). A woman should use a barrier method of contraception for 7 days after the implant. If during this period there was sexual intercourse, pregnancy should be excluded.

- In the absence of breastfeeding: The implant should be inserted between the 21st and 28th days after delivery. With proper implant insertion, an additional method of contraception is not required. If there is a deviation from the recommended implant insertion period, a woman should be warned about the need to use a barrier method of contraception for 7 days. If during this period there was sexual intercourse, pregnancy should be excluded.

How to enter Implanon NXT®^®

The basis for the successful application and subsequent removal of the drug Implanon NXT®^®is the correct and carefully performed subcutaneous injection of the implant in a non-dominant hand, in accordance with the instructions. The gynecologist and the woman should palpatorically determine the presence of the implant after its introduction. The implant should be inserted directly under the skin. Too deep or incorrect introduction of the implant may be complicated by paresthesia (due to nerve damage), implant migration (due to i / m or fascial injection) and, in rare cases, intravascular injection. In addition, when the implant is inserted too deeply, it may not be palpated, and its localization and / or removal may be difficult.

The introduction of the drug Implanon NXT®^® must be performed under aseptic conditions and only by a qualified gynecologist who is well acquainted with the method of administration. The implant should be inserted only with a special applicator.

It is recommended that the gynecologist be in a sitting position throughout the entire procedure, so that he can clearly see the insertion point and the movement of the needle under the skin.

Use of the drug Implanon NXT®^® not shown during pregnancy. In case of pregnancy during the use of the drug Implanon NXT®^® implant should be removed. When conducting preclinical studies found that very high doses of progestogenic compounds can cause masculinization of the female fetus. Information on the effect of the drug Implanon NXT®^® on the body of a pregnant woman and the fetus are insufficient.

Preparation Implanon NXT®^® does not affect the formation or quality of breast milk (protein, lactose or fat concentrations). However, it is known that a small amount of etonogestrel is excreted in milk. Based on an average daily intake of milk of 150 ml / kg, the average daily dose of etonogestrel for a child, calculated after one month of etonogestrel release, is approximately 27 ng / kg / day. This corresponds to approximately 0.2% of the estimated absolute maternal daily dose (about 2.2% when converted to 1 kg of body weight of the child). During the breastfeeding period, the concentration of etonogestrel in milk gradually decreases.

Based on the available data, the use of the drug Implanon NXT®^® during breastfeeding is possible, but only under the supervision of a doctor for the development and growth of the infant. Preparation Implanon NXT®^® should be administered 4 weeks after delivery.

As a rule, the risk of developing breast cancer increases with increasing age. During the application of OK (including combined), the risk of developing breast cancer increases slightly. This increased risk gradually decreases within 10 years after the termination of the application of OC, and it is not related to the duration of the application of OA, but is related to the age of the woman during the application of OA. The ratio of the expected number of diagnosed cases of breast cancer in 10,000 women who used combined OC (including for 10 years after stopping their use) and women who have never used them, for the same period, calculated for the respective age groups amounted to 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 women using contraceptive methods that contain only gestagens may be similar to the risk when using combined OC. However, data regarding these methods are not so specific. Compared to the risk of breast cancer throughout life, the increase in risk associated with OC is small. Cases of breast cancer diagnosed in women who use OK tend to be less clinically pronounced than cases of cancer diagnosed in women who have never used OK. The increased risk observed in women using QA may be due to an earlier diagnosis, the biological effects of QA, or a combination of these 2 factors.

In case of acute or exacerbation of chronic liver disease, a woman should consult a specialist for examination and consultation.

In the course of epidemiological studies, it was found that there is a link between the use of combined OA and an increase in the incidence of VTE (deep vein thrombosis and pulmonary embolism). Although the clinical significance of these results for etonogestrel (the biologically active metabolite of desogestrel) used as a contraceptive hormonal agent is unknown in the absence of the estrogen component, in the case of thrombosis, the implant should be removed.

Consideration should also be given to removing the implant in case of prolonged immobilization due to surgery or illness. Although the drug Implanon NXT®^® is a contraceptive hormonal agent containing only progestogen, it is recommended to assess risk factors that are known to increase the risk of venous or arterial thromboembolism. Women with a history of thromboembolic disease should be warned about the possibility of their recurrence.

In the post-registration period of using a non-X-ray contrast implant containing etonogestrel, there were reports of severe arterial and venous thromboembolic complications, including about pulmonary embolism (including fatal outcome), deep vein thrombosis, myocardial infarction, stroke. Implanon NXT®^® should be removed in case of thrombosis.

If during the period of use of the drug Implanon NXT®^® persistent hypertension develops or significantly increased blood pressure does not decrease adequately in response to ongoing antihypertensive therapy, the implant NKST should be removed^®.

Although progestogens may affect peripheral insulin resistance and glucose tolerance, there is no evidence that there is a need to change the treatment regimen in diabetic patients using hormone contraceptives containing only progestogen. However, women with diabetes should be closely monitored during the entire period of use of contraceptive hormonal agents containing progestogen only.

It is necessary to conduct periodic examinations of women who are undergoing therapy for hyperlipidemia. Some progestogens can increase LDL levels and worsen hyperlipidemia control.

Chloasma can sometimes occur, especially in women with a history of chloasma in pregnant women. Women with a predisposition to chloasma should avoid exposure to sunlight or UV radiation while using the drug Implanon NXT®^® .

Contraceptive effect of the drug Implanon NXT®^® associated with the concentration of etonogestrel in plasma, which is inversely proportional to the body weight and decreases over time after drug administration. Clinical experience in women with overweight in the third year of the drug is limited. It cannot be ruled out that the contraceptive effect of such women during the third year of the drug may be lower than that of women with normal body weight, therefore, the physician may need to provide for an earlier implant replacement in overweight women.

As a result of local inflammation or if the implant is not inserted in accordance with the instructions set out in the section "How to use and dose", subsectionHow to enter Implanon NXT®^®, implant exudation may occur.

In rare cases, mainly associated with or with too deep administration (see also the section "Dosage and administration", subsectionHow to enter Implanon NXT®^®), and / or as a result of the influence of external forces (for example, manipulation with the implant or contact sports), the implant can migrate from the injection site.In such cases, determining the location of the implant may be difficult and removing may require a larger incision and time (see also the section “Dosage and administration”, subsection How to remove Implanon NXT®^®). If the implant is not removed, then contraception and the risk of undesirable effects associated with progestogen may persist beyond the time desired by the woman.

With the use of all low-dose contraceptive hormonal agents, follicle growth can occur, and sometimes the follicle can reach a larger size than in the normal cycle. Usually, these follicles disappear spontaneously and often asymptomatically; in some cases, mild pain in the lower abdomen. In rare cases, surgery is necessary.

Prevention of ectopic pregnancy with traditional progestogen-containing contraceptive hormonal drugs is not as effective as when using combined OK, which is associated with the frequent occurrence of ovulation during the application of these methods. This statement does not apply to the use of progestin oral contraceptives with desogestrel and implant with desogestrel. Despite the fact that the drug Implanon NXT®^® inhibits ovulation, if a woman has amenorrhea or abdominal pain, a differential diagnosis should take into account ectopic pregnancy.

The following conditions have been reported in both pregnancy and the use of sex steroid hormones, but the association with the use of progestogens has not been established: jaundice and / or pruritus associated with cholestasis; gallstones formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis and (hereditary) angioedema.

Safety and efficacy of the drug Implanon NXT®^® were evaluated for women of reproductive age. It is expected that the efficacy and safety of adolescents in the postpubertal period will be similar. However, clinical studies in women aged less than 18 years have not been conducted. The use of this drug is not indicated until menarche (first menstruation).

Medical examinations / consultations

Before use or before replacement of the drug Implanon NXT®^® should carefully review the history of women (including family history) and exclude pregnancy. It is necessary to measure blood pressure, conduct a physical examination and be guided by contraindications (see "Contraindications") and warnings (see section "Contraindications",Carefully).

It is recommended that a woman 3 months after the administration of the drug Implanon NXT®^® visited a doctor for a medical examination. During a medical examination, blood pressure should be measured and the patient should find out if she has any undesirable effects, questions or complaints. The frequency and nature of further periodic medical examinations should be set individually for each woman (at least 1 time in 6 months).

The woman should be informed that the drug Implanon NXT®^® does not protect HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug Implanon NXT®^® may be reduced when using the drug in combination with other drugs (see "Interaction").

Changes in the nature of bleeding

During the use of the drug Implanon NXT®^® in women, the nature of menstrual bleeding is likely to change. These may include changes in frequency (absence, less or more frequent), intensity (decrease or increase) or duration of bleeding. Amenorrhea was observed in 20% of women, while in the other 20% more frequent and / or prolonged bleeding was observed.Dysmenorrhea tends to improve during the use of the drug Implanon NXT®^®. The nature of bleeding that occurs during the first 3 months, allows us to predict the future nature of bleeding in most women. Informing, additional explanations and keeping an individual diary will help a woman to adequately perceive the bleeding that occurs. Evaluation of vaginal bleeding should be done individually. It may include examination to exclude gynecological pathology or pregnancy.

Laboratory values

Data obtained in relation to combined OA have shown that the use of contraceptive hormonal drugs may affect some laboratory parameters, including biochemical indicators of liver, thyroid, adrenal gland and kidney function, plasma (transport) protein concentration, for example, corticosteroid binding globulin and lipid fraction / lipoproteins, carbohydrate metabolism, blood clotting and fibrinolysis. Usually these changes remain within the normal range. It is not known to what extent this applies to contraceptive hormonal drugs that contain only progestogen.

Influence on ability to steer vehicles and work with mechanisms. Reactions in the management of vehicles and the use of complex technology has not been studied. Implanon NXT®^® may cause dizziness. Patients should be warned that if dizziness occurs, do not drive or use sophisticated equipment.

The implant should always be removed before introducing a new one. There is no data on etonogestrel overdose. There are no reports of serious adverse effects resulting from an overdose of contraceptive hormonal drugs.