Instruction for use: Implanon NXT

Active substance: Etonogestrel

ÀÒÕ Code: G03AC08 Etonogestrel

Pharmacological groups

Contraceptive agent [Estrogens, gestagens; their homologs and antagonists]

Nosological classification (ICD-10)

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Z30.0 General advice and advice on contraception

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception)

Composition

Implant 1 pc.

active substance:

etonogestrel 68 mg

auxiliary substances: barium sulfate - 15 mg; ethylene and vinyl acetate copolymer (28% vinyl acetate) - 43 mg; ethylene and vinyl acetate copolymer (14% vinyl acetate) - 15 mg

Description of dosage form

A single-knot implant, from white to white with a yellowish or brownish hue of color, is placed in the needle of a sterile disposable applicator.

The implant should be easily removed from the applicator.

Dimensions of the implant:

- length - from 3.8 to 4.2 cm;

- diameter - from 1.95 to 2.05 mm;

- shell thickness - from 54 to 66 microns.

pharmachologic effect

Pharmacological action - contraceptive.

Pharmacodynamics

The drug Implanon NXT® is a radiopaque, sterile, single-use applicator containing an etonogestrel implant for use, which is not biodegradable. Ethonogestrel is a biologically active metabolite of desogestrel, a progestogen widely used as an oral contraceptive hormone (OC). Structurally, it is a derivative of 19-nortestosterone and binds to the receptors of progesterone in the target organs with high affinity. The contraceptive effect of etonogestrel is mainly achieved by suppressing ovulation. Ovulation was not observed during the first 2 years of use, and only rarely did they occur during the 3rd year. In addition to suppressing ovulation, etonogestrel also causes an increase in the viscosity of the secretion of the cervix, which prevents the passage of spermatozoa. Clinical studies were conducted in women aged 18-40 years. Despite the absence of direct comparison, the contraceptive effect of the implant is at least comparable to the contraceptive effect of combined OC (more than 99%). A high degree of protection against pregnancy is achieved, among other reasons, by the fact that the contraceptive effect of Implanon NXT® does not depend on a woman's strict adherence to a daily, weekly or monthly regimen. The contraceptive effect of etonogestrel is reversible, which is reflected in the rapid recovery of the normal ovulatory menstrual cycle after removal of the implant. Although etonogestrel suppresses ovulation, ovarian activity is not completely suppressed. The average concentrations of estradiol in the blood plasma remain above the value observed in the early phase of follicle formation. Etonogestrel does not affect the change in bone mineral density and lipid metabolism. The use of contraceptive hormonal agents containing progestogens may have an effect on insulin resistance and glucose tolerance. It has been shown that dysmenorrhoea is less common in patients using Implanon NXT®.

Pharmacokinetics

Suction. After the implantation, the etonogestrel is rapidly absorbed into the circulating blood. Concentrations suppressing ovulation are achieved after 1 day. Cmax in plasma (from 472 to 1270 pg / ml) is achieved after 1-13 days. The release rate of etonogestrel from the implant decreases over time, resulting in a rapid decrease in plasma concentration in the first few months after administration. By the end of the 1st year of application, the average concentration is approximately 200 pg / ml (150-261 pg / ml) and slowly decreases to 156 pg / ml (111-202 pg / ml) by the end of the 3rd year. The observed variations in plasma concentrations may in part be due to differences in body weight.

Distribution. Etonogestrel is 95.5-99% bound to plasma proteins, mostly with albumin and to a lesser degree with globulin binding sex hormones. Vd in the central chamber and the total Vd are 27 and 220 L, respectively, and it is unlikely that these values change during the finding of Implanon NXT® in a woman's body.

Metabolism. Ethonogestrel undergoes hydroxylation and reduction. Metabolites are sulfates and glucuronides.

Excretion. With IV injection of etonogestrel, the average T1 / 2 is approximately 25 hours, and the clearance from the plasma is approximately 7.5 liters / hour. Clearance and T1 / 2 remain constant during application of the drug. Etonogestrel and its metabolites, both in the form of free steroids, and in the form of conjugates, are excreted by the kidneys and through the intestine (the ratio is 1.5: 1). After administration to women during breastfeeding, etonogestrel is excreted in breast milk at a milk / plasma ratio of 0.44-0.5 during the first 4 months. The average dose of etonogestrel entering the body of a baby with breast milk is approximately 0.2% of the maternal daily dose of etonogestrel (about 2.2% when recalculated per 1 kg of the child's body weight). It is shown that concentrations gradually and statistically significantly decrease with time.

Indications

Contraception.

Contraindications

Contraceptive hormones containing only progestagen should not be used in the presence of any of the conditions / diseases listed below. If any of these conditions occur, the drug should be discontinued immediately when Implanon NXT® is used.

hypersensitivity to the active substance or any auxiliary substance of Implanon NXT®;

thrombosis (arterial and venous) and thromboembolism now or in the anamnesis (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders);

the presence of antibodies to phospholipids;

migraine with focal neurological symptoms;

breast cancer, incl. in the anamnesis;

established or suspected malignant hormone-dependent tumors;

benign or malignant liver tumors at present or in the anamnesis;

severe forms of liver disease (before normalization of functional liver samples), incl. jaundice, congenital hyperbilirubinemia (including in the anamnesis);

uncontrolled arterial hypertension;

bleeding from the vagina of an unclear etiology;

pregnancy (including alleged);

childhood.

With caution (in the presence of any of the conditions or risk factors listed below, one should weigh the benefits of using the implant with respect to the possible risks for each individual woman and discuss them with her before she decides to start using Implanon NXT® .In case of impairment, or at the first appearance of any of these conditions, a woman should consult a doctor, after which the doctor must decide whether to continue or abolish Implanon NXT®): prolonged immobilization caused by surgeons or other reasons; conditions preceding thrombosis (including transient ischemic attacks, angina pectoris, complicated heart valve disease, atrial fibrillation, extensive trauma); persistent arterial hypertension; diabetes mellitus, incl. diabetes mellitus with diabetic angiopathy; hereditary or acquired predisposition to arterial thrombosis, incl. deficiency of protein C, protein S, antithrombin III; liver diseases of mild and moderate severity with normal indicators of functional liver samples; therapy with anticoagulants; severe depression.

pregnancy and lactation

The use of Implanon NXT® is not indicated during pregnancy. In case of pregnancy during the use of Implanon, the NXT® implant should be removed. Pre-clinical studies have found that very high doses of progestogen 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 is insufficient.

The drug Implanon NXT® does not affect the formation or quality of breast milk (protein, lactose or fat concentration). However, it is known that a small amount of etonogestrel is excreted in milk. Based on the average daily milk intake 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 recalculated per 1 kg of body weight of the child). During the period of breastfeeding, the concentration of etonogestrel in milk gradually decreases.

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

Side effects

During the application of the drug Implanon NXT® in women, changes in the nature of menstrual bleeding are likely. They may include changes in frequency (absence, less or more frequent), intensity (decrease or increase), or bleeding time. The absence of menstrual bloody discharge was observed in 20% of women, the same number of women experienced more frequent and / or prolonged bleeding. Sometimes heavy bleeding was reported. In clinical studies, a change in the character of bloody vaginal discharge was the most common reason for discontinuing the implant (approximately 11%). During the use of the drug Implanon NXT®, painful menstrual-like spotting tends to improve. The nature of bleeding that occurs during the first 3 months, allows you to predict the future nature of bleeding in most women. Possible adverse effects associated with the use of the drug, reported in clinical trials.

In the clinical study, violations at the site of administration were also studied, which were noted in 8.6% of women. The most common disorder observed during administration or for a short period after administration was erythema (3.3% of women). Also, hematomas (3%), bruising (2%), pain (1%) and local edema (0.7%) were observed.

During post-marketing follow-up, a clinically significant increase in blood pressure was observed in rare cases. There are also reports of seborrhea. Anaphylactic reactions, hives and angioedema (or its more severe course) and / or a more severe course of hereditary angioedema may develop. The introduction and removal of the implant can cause bruising, minor local irritation, pain or itching. At the site of dissection, fibrosis can develop, a scar may form or an abscess develop. Paresthesia or similar phenomena may occur, and implant loss or migration may occur. When removing the implant, surgical intervention may be required.

In rare cases, ectopic pregnancy has been reported (see "Special instructions").

In women using contraceptive hormonal drugs, the following (serious) adverse reactions were noted:

- venous thromboembolism (VTE, deep vein thrombosis and pulmonary embolism);

- arterial thromboembolism;

- hormone-dependent tumors (liver tumors, breast cancer);

- Chloasma;

- jaundice and / or itching associated with cholestasis;

- cholelithiasis;

- porphyria;

- systemic lupus erythematosus;

- hemolytic-uremic syndrome;

- Sydenham's chorea;

- herpes during pregnancy;

- loss of hearing associated with otosclerosis.

Interaction

Effect of other drugs on Implanon NXT®

The interaction between contraceptive hormonal drugs and other drugs can lead to menstrual bleeding and / or a decrease in contraceptive effect. Special studies devoted to the study of interaction with the Implanon NXT® preparation have not been carried out. In the literature, the following interactions are reported (mainly with COCs, but sometimes also reported for contraceptive hormonal agents containing only progestogen).

Hepatic metabolism: interaction is possible with drugs - inducers of microsomal liver enzymes, especially cytochrome P450 isoenzymes (eg phenytoin, phenobarbital, primidon, bozentan, carbamazepine, rifampicin and possibly also with oxcarbazepine, topiramate, felbamate, griseofulvin, herbal preparations containing Hypericum perforatum, HIV protease inhibitors (eg ritonavir, nelfinavir), non-nucleoside reverse transcriptase inhibitors (eg, nevirapine, efav urens) and combinations of the latter, which can lead to an increase in the clearance of sex hormones.

Women receiving treatment with one of the above medicines should also use the barrier method of contraception during their use and within 28 days after stopping their intake.

Women who receive long-term treatment of drugs that induce microsomal enzymes of the liver, it is recommended to remove the implant and prescribe a non-hormonal (barrier) method of contraception.

Increase in the concentration of hormones in the plasma, associated with the joint use of drugs. Drugs (eg ketoconazole) that inhibit microsomal liver enzymes (such as CYP3A4) can increase plasma hormone concentrations.

Effect of Implanon NXT® on other medication

Contraceptive hormonal agents can affect the metabolism of other drugs. Accordingly, concentrations of drugs in plasma and in tissues may increase (eg, cyclosporine) or decrease (eg lamotrigine).

Note: to identify possible interactions, you should read the instructions for the use of concurrently taken drugs.

Dosing and Administration

Before the introduction of the drug Implanon NXT® it is necessary to exclude pregnancy. The doctor-gynecologist is strongly encouraged to take part in the training session to become familiar with the use of the Implanon NXT® applicator and the Implanon NXT® implant insertion and removal techniques. Before insertion of the implant, it is necessary to carefully read the instructions for use and follow the instructions for insertion and removal of the implant, presented in the section How to administer Implanon NKTS® and How to remove Implanon NXT®.

How to apply Implanon NXT®

The drug Implanon NXT® is a long-acting contraceptive hormone. A single implant is injected into the implant, which can stay at the injection site for 3 years. Remove the implant no later than 3 years from the date of administration. A woman should be informed about the possibility of removing the implant at any time, at her request. A gynecologist may consider the possibility of an earlier implant removal in women with overweight. 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 Implanon NXT®, but she needs contraception, another method of contraception should be recommended.

The basis for the successful application and subsequent removal of implant Implanon NXT® is the correct and accurately executed SC implant in accordance with this instruction. Impaired time and technique of insertion of the implant (see subsections When to administer Implanone NXT®, How to administer Implanone NKTS®) can lead to pregnancy.

Implanon implant NXT® enter n / a directly under the skin on the inside of the shoulder to avoid injury to major blood vessels and nerves that are located deeper in the connective tissue between the biceps and triceps muscles.

Immediately after the insertion of the implant by palpation is necessary to check its availability under the skin .. If the implant can not find or its availability is in doubt, it is necessary to apply the other diagnostic methods to confirm its presence (see. How to enter sub NXT® Implanon). Until the implant is confirmed, a woman should recommend the use of non-hormonal (barrier) method of contraception.

Packaging Implanon NXT® contains a user card designed to record the number of the implant series. The doctor-gynecologist should write down the date of administration, indicate the hand in which the implant was inserted, and the planned day of its removal in the User's Card. Packaging of the product contains stickers for records of a gynecologist, in which the number of the implant series is indicated.

When to introduce Implanon NXT®

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

The timing of administration depends on the woman's recent use of contraceptive hormones as follows.

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

With the correct introduction of the implant, an additional method of contraception is not required. In the event of a deviation from the recommended implantation period, a woman should be warned about the need for a barrier method of contraception within the next 7 days. If there were sexual intercourse during this period, pregnancy should be excluded.

Transition from the hormonal contraceptive method to Implanon NXT®

When changing from the combined method of hormonal contraception (combined oral contraceptive (COC), combined hormonal vaginal ring or a combined hormonal transdermal patch). The implant should preferably enter in the day following the day of reception of the last active tablets (the latter tablets containing the active substance) COC, but not later than the day following the usual tablet-interval or period during which a placebo tablet COCs. In the event that a vaginal ring or transdermal patch has previously been used, the implant should preferably be administered on the day of removal, but not later than the day of the next application of the previous preparation.

With the correct introduction of the implant, an additional method of contraception is not required. In case of deviation from the recommended period of implant administration, a woman should be warned about the need to use the barrier method of contraception within 7 days. If there were sexual intercourse during this period, pregnancy should be excluded.

. When changing from progestogen contraceptive method (e.g., tablets containing only the progestogen, injection, implant or hormonal intrauterine system (IUS) Since there are several types of progestational methods, the introduction of the implant should be carried out as follows:

- injectable contraceptive hormonal agents: inject the implant daily, when the next injection should be done;

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

- Implant / IUD: Implant is administered on the day of removal of the previous implant or IUD.

With the correct introduction of the implant, an additional method of contraception is not required. In case of deviation from the recommended period of implant administration, a woman should be warned about the need to use the barrier method of contraception within 7 days. If there were sexual intercourse during this period, pregnancy should be excluded.

After childbirth

- When breastfeeding: the implant should be inserted at the end of the 4th week after childbirth (see "Application during pregnancy and lactation"). A woman should use the barrier method of contraception within 7 days after the implantation. If there were sexual intercourse during this period, pregnancy should be excluded.

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

How to administer Implanon NXT®

The basis for the successful application and subsequent removal of the Implanon NXT® preparation is the correct and accurately executed w / o implant insertion into the non-dominant hand, in accordance with the instructions. A gynecologist and a woman should palpatorically determine the presence of an implant after its introduction. Implant should be administered directly under the skin. Too deep or incorrect insertion of the implant may be complicated by paresthesia (due to nerve damage), implant migration (due to w / m or fascial injection) and, in rare cases, intravascular injection. In addition, when the implant is inserted too deeply, it may not be palpable, and its localization and / or removal can be difficult.

Implanone NXT® should be administered under aseptic conditions and only by a qualified gynecologist who is familiar with the administration technique. The implant should be implanted only with a special applicator.

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

A woman needs to lie on the diagnostic table on her back, bending the non-dominant hand at the elbow and turning it outward so that her wrist is parallel to her ear or her hand was located next to her head .

Determine the place of injection, which is on the inside of the shoulder of the non-dominant hand about 8-10 cm above the medial epicondyle of the humerus. Implant should be administered directly under the skin in order to avoid damage to large vessels and nerves that are located deeper in the subcutaneous tissues in the intermuscular groove between the biceps and triceps muscles.

Make 2 marks with a sterile marker: first, mark the point at which the implant will be inserted; second, mark a point a few centimeters proximal to the first mark. The second mark will subsequently serve as a guide during the introduction.

Treat the injection site with an antiseptic solution. Anesthesia of the injection site (eg using an anesthetic aerosol or injection of 2 ml of 1% lidocaine directly under the skin along the planned delivery channel) is performed.

A sterile disposable Implanon NXT® applicator is removed from the blister, in which the implant is located. The applicator is not used if there is any doubt about the sterility.

The applicator is taken directly above the needle in the area of the textured surface and the transparent protective cap is removed from the needle containing the implant. If the cap is not easily removed, this applicator should not be used. You can see the white-colored implant, looking at the tip of the needle. Do not touch the purple slider until the needle is completely inserted in the s / c, as this will lead to retraction of the needle and premature release of the implant from the applicator.

Using a free hand, the thumb and forefinger stretch the skin around the injection site.

The tip of the needle, located approximately at an angle of 30 °, is pierced by the skin.

The applicator is lowered to the horizontal position. Raising the skin with the tip of the needle, the needle is continuously inserted over its entire length. You can feel a little resistance, but do not exert pressure with excessive force. If the needle is not inserted over its entire length, the implant will not be inserted properly. The movement of the needle is more convenient to observe when the doctor sits and watches from the side, and does not look from above. In this position, the place of introduction and movement of the needle is clearly visible.

The applicator is held in the same position after insertion of the needle over its entire length. If necessary, you can hold the applicator in the same position with your free hand during the next steps. Unlock the purple slider by gently pressing down on it. Slide the slider all the way back until it stops. Now the implant is under the skin, and the needle is blocked in the applicator. Then the applicator can be removed. If the applicator is not held in the same position during the procedure, or the magenta slider is not completely moved back, the implant will not be inserted.

After the introduction, it is necessary to check the presence of the implant under the skin of the shoulder with the help of palpation. If palpation of both ends of the implant is necessary, make sure the rod is 4 cm long.

If it is impossible to feel the implant or there are doubts about its presence:

- check the applicator. The needle should be drawn completely, and only the purple tip of the obturator should be visible;

- Two-dimensional X-ray, X-ray computed tomography (CT scan), ultrasound scanning with a high-frequency ultrasonic sensor for linear scanning (10 MHz or more) or MRI can be used to confirm the presence of an implant. If these imaging methods can not confirm the presence of an implant, it is recommended to determine the concentration of etonogestrel in a woman's blood plasma. Until the presence of an implant is confirmed, a non-hormonal (barrier) contraceptive method should be used;

- apply a small sticker from the adhesive plaster to the injection site. Ask a woman to palp an implant;

- Apply a sterile gauze bandage to reduce bruising. A woman can remove the pressure bandage after 24 hours, and a small sticker from the injection site - after 3-5 days;

- fill in the user's card and transfer it to the woman for storage. In addition, fill the stickers and attach them to the woman's medical record;

- the applicator is intended for single use only and must be properly disposed of in accordance with the existing requirements for the handling of biohazardous wastes.

How to remove Implanon NXT®

Before starting the procedure, the gynecologist must locate the implant location indicated in the User's Card and check it with palpation. If the implant is not palpable, then additional testing methods should be used to confirm its presence (see subsection. If it is impossible to feel the implant or there are doubts about its presence).

After localization of the non-palpable implant, the possibility of surgical removal of the implant under the control of the USS is considered.

There are rare reports on the movement of the implant; This usually refers to a slight movement relative to the starting position, except for too deep introduction (see also "Special instructions"). This can complicate implant localization with the help of palpation, USS and / or MRI, and removal may require a larger incision and more time.

Removal of the implant should only be performed under aseptic conditions by a gynecologist who is familiar with the removal technique.

Surgery to find an implant without knowing its exact location is not recommended.

Removal of deeply implanted implants should be carried out with care, to avoid damage to the deep nerve or vascular structures of the shoulder, and performed by a specialist well versed in the anatomy of the shoulder.

The site of the future section is treated with an antiseptic. Determine the location of the implant by palpation and note its distal end (the end closest to the elbow), for example a sterile marker.

Anesthetize the place where a cut will be made, for example 0.5-1 ml with a 1% solution of lidocaine. Make sure that the local anesthetic is inserted under the implant so that it remains close to the surface of the skin.

Press down on the proximal end of the implant to fix it; On the skin, a bulge may appear, which will indicate the distal end of the implant. Starting from the distal end of the implant make a longitudinal incision of 2 mm towards the elbow.

Carefully push the implant toward the incision until its tip appears. Capture the implant with a surgical clamp (preferably a mosquito-type clamp) and remove the implant .

If the implant is enclosed in a connective tissue sheath, a tissue incision is made and then the implant is removed with a surgical clamp.

If the tip of the implant is not visible after the incision, carefully insert the surgical clamp into the incision.

Grab the implant. The clamp is turned over and taken into the other arm (Figure 16).

The second clamp should carefully cut off the tissue around the implant and grab the implant. After this, the implant can be removed

If a woman wants to continue using Implanon NXT®, a new implant can be inserted immediately, immediately after removal of the old implant, in the same incision (see How to replace Implanon NXT®).

After the removal of the implant, the incision is closed with sterile strips of tissue (sterile strip) and a sticker of adhesive plaster is applied.

To reduce bruising impose a sterile pressure bandage. A woman can remove a pressure bandage after 24 hours, and a sticker after 3-5 days.

How to replace Implanon NXT®

Immediate replacement can be done after removal of the previous implant, and it is similar to the introduction procedure described under How to Administer the Implanon NXT®. A new implant can be inserted into the same place and through the same incision from which the previous implant was removed. If the same incision is used to insert a new implant, an anesthetic of the injection site (eg 2 ml of a 1% lidocaine solution) is administered, directly under the skin, starting with the incision for removal, along the delivery channel, and follow the subsequent steps of the introduction instructions. Additional information and more detailed instructions for insertion and removal of the implant can be obtained from the manufacturer.

Overdose

The implant should always be removed before the introduction of a new one. Data on the overdose of etonogestrel is not available. There are no reports of serious side effects due to an overdose of contraceptive hormonal drugs in general.

special instructions

As a rule, the risk of developing breast cancer increases with 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 discontinuation of the use of OC, and it is not associated with the duration of the OC application, but is related to the age of the woman, during the application of the OC. The ratio of the expected number of diagnosed cases of breast cancer in 10,000 women who used combined OCs (including within 10 years after discontinuation of their use), and women who never used them, over the same period calculated for the respective age groups , was: 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 for women using contraceptive methods containing only gestagens may be similar to the risk of using combined OCs. However, the data on these methods are not so specific. Compared to the risk of breast cancer throughout life, the increased risk associated with OC is small. The incidence of breast cancer diagnosed in women using OC tends to be less clinically pronounced than the incidence of cancer diagnosed in women who have never used OC. The increased risk observed in women using OC may be due to earlier diagnosis, biological effects of OC, or a combination of these two factors.

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

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

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

In the post-marketing period of the application of a non-radiocontrast implant containing ethonogestrel, reports were received of severe arterial and venous thromboembolic complications, incl. about pulmonary embolism (including fatal outcome), deep vein thrombosis, myocardial infarction, stroke. Implanone NXT® should be removed in case of thrombosis.

If during the period of using Implanon NXT®, persistent hypertension develops, or if the significantly elevated blood pressure does not decrease adequately in response to ongoing antihypertensive therapy, Implanon NXT® implant should be removed.

Although progestogens can influence the resistance of peripheral tissues to insulin and glucose tolerance, there is no evidence that there is a need to change the treatment regimen in diabetic patients using contraceptive hormones containing only progestogen. Nevertheless, women with diabetes should be carefully monitored during the entire period of use of contraceptive hormones containing only progestogen.

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

Sometimes, chloasma may occur, especially in women with a history of pregnant women with chloasma. Women with a predisposition to chloasma should avoid exposure to sunlight or UV radiation during the application of Implanon NXT®.

The contraceptive effect of the drug Implanon NXT® is related to the concentration of etonogestrel in the blood plasma, which in inversely proportional relationship is related to body weight and decreases during the time after drug administration. Clinical experience in women with overweight in the third year of use of the drug is limited. It can not be ruled out that the contraceptive effect of such women during the third year of use of the drug may be lower than in women with normal body weight, so the doctor may need to provide for an earlier replacement of the implant in women with excessive body weight.

As a result of local inflammation or if the implant is not administered according to the instructions in the section "Method of administration and dose", the sub-section How to administer Implanon NKTS®, implant expulsion may occur.

In rare cases, mainly associated with either too deep an introduction (see also the section on "Dosing and Administration", sub-section on How to Administer the Implanon NXT®) and / or by external forces (eg manipulation of the implant or contact sports) The implant can migrate from the injection site. In such cases, the location of the implant can be difficult and extraction may require a larger incision and time (see also the "Method of administration and dose" section, How to remove Implanon NXT®). If the implant is not removed, 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 drugs, follicles can grow, and sometimes the follicle can reach a larger size than in the normal cycle. Usually, these follicles disappear spontaneously and are often asymptomatic; in some cases there is a slight pain in the lower abdomen. In rare cases, surgical intervention is necessary.

Prevention of ectopic pregnancy with traditional progestogen-containing contraceptive hormonal agents is not as effective as when combined OC is used, 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-only oral contraceptives with desogestrel and an implant with desogestrel. Despite the fact that the drug Implanon NXT® suppresses ovulation, in the case of a woman having amenorrhea or abdominal pain in differential diagnosis, an ectopic pregnancy should be considered.

There are reports of the following conditions that occurred both with pregnancy and with the use of sex steroid hormones, but the connection with the use of progestogens has not been established: jaundice and / or pruritus associated with cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; loss of hearing associated with otosclerosis and (hereditary) angioedema.

The safety and efficacy of Implanone NXT® were evaluated for women of reproductive age. It is expected that the effectiveness and safety in adolescents in the post-pubertal period will be similar. Nevertheless, clinical studies in women under the age of 18 years have not been conducted. The use of this drug is not indicated until the onset of menarche (the first menstruation).

Medical examinations / consultations

Before starting or before replacing the Implanon NXT® drug, you should carefully review the woman's history (including family history) and exclude pregnancy. It is necessary to measure blood pressure (BP), conduct a physical examination and be guided by contraindications (see "Contraindications") and warnings (see "Contraindications", Caution).

It is recommended that the woman, 3 months after the administration of Implanon NKTT®, visit the doctor for medical examination. During the medical examination, blood pressure should be measured and the patient should be examined, if she had any undesirable effects, whether there are any questions or complaints. The frequency and nature of further periodic medical examinations should be set individually for each woman (at least once every 6 months).

A woman should be informed that Implanon NXT® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Decreased efficiency

The effectiveness of the drug Implanon NXT® can be reduced when the drug is used in combination with other medicinal products (see "Interaction").

Changes in the character of bloody discharge

During the application of Implanon NXT® in women, a change in the character of menstrual bleeding is likely. They may include changes in frequency (absence, less or more frequent), intensity (decrease or increase), or bleeding time. Amenorrhea was observed in 20% of women, while the other 20% had more frequent and / or prolonged bleeding. Dysmenorrhea tends to improve during the application of Implanon NXT®. The nature of bleeding that occurs during the first 3 months, allows you 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 bleeding. Evaluation of vaginal bleeding should be done individually. It may include examination to exclude gynecological pathology or pregnancy.

Laboratory indicators

Data on combined OCs showed that the use of contraceptive hormonal drugs may affect some laboratory indicators, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein concentrations, for example, corticosteroid-binding globulin and lipid fraction / lipoproteins, parameters of carbohydrate metabolism, blood coagulation and fibrinolysis. Usually these changes remain within the normal range. It is not known to what extent this applies to contraceptive hormonal agents containing only progestogen.

Influence on the ability to drive vehicles and work with machinery. Reactions in the management of vehicles and the use of complex equipment have not been studied. Implanone NXT® can cause dizziness. Patients should be warned that when dizziness occurs, do not drive or use complicated equipment.

Form of issue

Implant. Placed in a stainless steel needle ready for use sterile disposable applicator. The applicator is hermetically sealed in a contoured cellular package of transparent PE-terephthalate-glycol sealed with a film of HDPE and an ethylene-vinyl acetate copolymer. The outline package together with the patient's card and 2 stickers for the outpatient card are packed in a cardboard box.

Conditions of leave from pharmacies

On prescription.

Storage conditions

In dry, the dark place at a temperature of 2-30 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.