Implanon nxt

Package leaflet: Information for the user

Implanon NXT, 68 mg, subdermal implant
Etonogestrel
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

The patient will receive from the treating physician a Patient Warning Card containing important information that she should be aware of. The card should be kept in a safe place and shown during every visit related to the use of the subdermal implant.

Contents of the leaflet

1. What Implanon NXT is and what it is used for
2. Important information before using the Implanon NXT subdermal implant
3. How to use the Implanon NXT subdermal implant
4. Possible side effects
5. How to store the Implanon NXT subdermal implant
6. Contents of the pack and other information
7. Information intended exclusively for healthcare professionals

1. What Implanon NXT is and what it is used for

Implanon NXT is a contraceptive subdermal implant contained in a single-use applicator. The safety and efficacy of this medicinal product have been established in women aged 18–40 years. The subdermal implant is a small, soft, flexible, plastic rod 4 cm in length and 2 mm in diameter, containing 68 milligrams of the active substance – etonogestrel. The applicator enables the physician to insert the subdermal implant just beneath the skin of the upper arm. Etonogestrel is a synthetic female hormone similar to progesterone. A small amount of etonogestrel is continuously released into the bloodstream. The implant itself is made of ethylene and vinyl acetate copolymer, a plastic that does not dissolve in the body. The implant also contains a small amount of barium sulfate, making it visible on X-ray imaging.

Implanon NXT is used for contraception.

How Implanon NXT works
The subdermal implant is inserted just under the skin. The active substance, etonogestrel, works in two ways:

• Prevents the release of an egg from the ovary (ovulation).
• Causes changes in cervical mucus, making it more difficult for sperm to enter the uterus.

As a result, Implanon NXT prevents pregnancy for up to three years. However, if the patient is overweight, the doctor may recommend earlier replacement of the implant. Implanon NXT is one of several methods of contraception. Another commonly used method is the combined oral contraceptive pill. Unlike the combined oral contraceptive pill, Implanon NXT can be used by women who cannot or do not wish to use estrogens. With Implanon NXT, there is no need to remember to take a daily pill. This is one of the reasons why Implanon NXT is considered a highly reliable method (over 99% effective). In rare cases, it has been observed that the implant was not inserted correctly or was not inserted at all, which may result in unintended pregnancy.

During use of the Implanon NXT subdermal implant, menstrual bleeding patterns may change or may cease altogether. Bleeding may become irregular, less frequent, more frequent, prolonged, or rarely, very heavy. Based on the bleeding pattern during the first three months, the patient may anticipate the pattern in subsequent months. Painful periods may become milder. Use of the Implanon NXT subdermal implant may be discontinued at any time (see also: “Discontinuation of the Implanon NXT subdermal implant”).

2. Important information before using the Implanon NXT subdermal implant

Implanon NXT, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or other sexually transmitted infections.
When not to use the Implanon NXT subdermal implant
Do not use the Implanon NXT subdermal implant if any of the conditions listed below apply. Inform your doctor before insertion of the Implanon NXT subdermal implant about such conditions. Your doctor may recommend a non-hormonal method of contraception.

• If you are allergic to etonogestrel or any of the other ingredients of this medicine (listed in section 6).
• If you currently have venous thromboembolic disease. In venous thromboembolic disease, blood clots form and block blood vessels [for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)].
• If you currently have or have had in the past jaundice (yellowing of the skin), severe liver disease (when the liver does not function properly), or a liver tumour.
• If you currently have or have had breast cancer or reproductive organ tumours.
• If you have vaginal bleeding of unknown cause.

If any of the above conditions occur for the first time during use of the
Implanon NXT subdermal implant, contact your doctor immediately.
Warnings and precautions
Before starting use of the Implanon NXT subdermal implant, discuss this with your doctor, pharmacist, or nurse.
If Implanon NXT is used in the presence of any of the diseases listed below, close medical monitoring is required. Your doctor will explain how to proceed. Inform your doctor about any of these conditions before implant insertion. Contact your doctor also if any of the following conditions occur or worsen during use of the Implanon NXT subdermal implant:

• History of breast cancer;
• Current or past liver disease;
• Venous thromboembolic disease;
• Diabetes;
• Overweight;
• Epilepsy;
• Tuberculosis;
• Arterial hypertension;
• Current or past chloasma (brownish pigmentation patches on the skin, especially on the face); in such cases avoid exposure to sunlight or ultraviolet radiation.

Possible serious diseases
Cancer
The information below comes from clinical studies in women using combined oral contraceptives containing two different female hormones ("the pill"). It is not known whether these observations also apply to women using other hormonal contraceptives, such as progestogen-only implants.
Breast cancer has been diagnosed slightly more frequently in women using combined oral contraceptives, although it is not known whether this was caused by their use. For example, tumours may be detected more frequently in women using combined oral contraceptives because they are examined by a doctor more often. The increased frequency of breast cancer decreases gradually after stopping combined oral contraceptives. It is very important
that the patient regularly examines her breasts. If she detects a lump,
she should contact her doctor. The patient should inform her doctor about any history of breast cancer in close relatives.
Benign liver tumours have been observed rarely, and malignant liver tumours very rarely, in women using combined oral contraceptives. If the patient experiences severe abdominal pain, she should
contact her doctor immediately.
Thrombosis
Venous thrombosis occurs when blood clots form and block veins. This may occur, for example, in the veins of the legs, in the lungs (pulmonary embolism), or in blood vessels of other organs and body parts. A clot may also block an artery (arterial thrombosis), which may lead to heart attack or stroke.
The use of combined hormonal contraceptives increases the risk of such clots compared to women who do not use any combined hormonal contraceptives. This risk is not as high as the risk of blood clots in pregnant women. It is believed that the risk in women using progestogen-only contraceptives, such as Implanon NXT, is lower than in women using combined oral contraceptives containing oestrogens. Cases of blood clots such as pulmonary embolism, deep vein thrombosis, myocardial infarction, and stroke have been reported in women using etonogestrel implants. However, available data do not indicate an increased risk of these events in women using the subdermal implant.
If a woman observes symptoms of venous thromboembolic disease,
she should contact her doctor immediately (see also “When to contact a doctor”).
Other conditions
Changes in menstrual bleeding pattern
During use of the Implanon NXT subdermal implant, as with other progestogen-only contraceptives, menstrual periods may become irregular. Changes may occur in frequency (absence of bleeding, infrequent, more frequent, or continuous bleeding), intensity (increased or decreased), or duration. Absence of menstruation occurs in 1 out of 5 women, while in another 1 out of 5 women, periods become more frequent and/or prolonged. Occasionally, very heavy bleeding may occur. In clinical trials, irregular bleeding was the most common reason for discontinuation of the subdermal implant (about 11%). Based on bleeding patterns during the first three months, women may predict subsequent patterns.
Changes in bleeding pattern do not mean that Implanon NXT is unsuitable for the patient or that it is not providing contraceptive effect. Generally, no special action is required. However, if bleeding is very heavy or prolonged, contact your doctor.
Events related to insertion and removal of the subdermal implant
Due to incorrect insertion or external forces (e.g. manipulation of the implant or participation in contact sports), the subdermal implant may migrate from its original insertion site in the arm. In rare cases, subdermal implants have been found in blood vessels of the arm or in the pulmonary artery (lung blood vessel). When migration occurs, locating the implant may be more difficult, and removal may require a larger incision or a surgical procedure performed in hospital. If the subdermal implant cannot be located in the arm, medical professionals may perform a chest X-ray or other imaging tests. If the implant is located in the chest cavity, surgical removal may be necessary.
If the subdermal implant cannot be located and there is no evidence that it has been expelled, contraceptive effect and risk of progestogen-related adverse effects may persist longer than desired.
If the subdermal implant cannot be felt at any time, contact your doctor as soon as possible.
Psychiatric disorders
Some women using hormonal contraceptives, including Implanon NXT, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.
Ovarian cysts
Small fluid-filled sacs may develop in the ovaries during use of hormonal contraceptives containing low hormone doses. These are ovarian cysts. They usually resolve spontaneously. Occasionally, they may cause mild abdominal pain. Only rarely do they become a serious problem.
Fracture or bending of the implant
Fracture or bending of the subdermal implant in the patient’s arm should not affect its function. Fracture or bending may be caused by external forces. A fractured implant may migrate from its original site. If you have any questions, contact your doctor.
Implanon NXT and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other specialist doctor or dentist (or pharmacist) prescribing other medicines about your use of the Implanon NXT subdermal implant. They may advise you about the need for additional contraceptive methods (e.g. condoms), how long this should be used, and whether adjustment of other medication is necessary.
Some medicines

• may affect blood levels of the Implanon NXT subdermal implant
• may reduce its contraceptive effectiveness
• may cause unexpected bleeding.

This applies to medicines used in the treatment of:

• Epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• Tuberculosis (e.g. rifampicin),
• HIV infection (e.g. nelfinavir, nevirapine, efavirenz),
• Hepatitis C virus infection (e.g. boceprevir, telaprevir),
• Other infections (e.g. griseofulvin),
• Pulmonary hypertension (bosentan),
• Depressive disorders [herbal medicine - St John's wort (Hypericum perforatum)].

Implanon NXT may affect the action of other medicines such as:

• Medicines containing cyclosporine
• The antiepileptic drug lamotrigine (this may lead to increased frequency of seizures).

Before taking any medicine, consult your doctor or pharmacist.
Implanon NXT with food and drink
No effect of food or drink on the action of the Implanon NXT subdermal implant has been demonstrated.
Pregnancy and breastfeeding
The Implanon NXT subdermal implant must not be used in pregnant women or when pregnancy is suspected. If there is any doubt whether a woman is pregnant, a pregnancy test should be performed before starting use of the Implanon NXT subdermal implant.
Implanon NXT may be used during breastfeeding. Although a small amount of the active substance of the Implanon NXT subdermal implant passes into breast milk, this does not affect the quantity or quality of breast milk or the growth and development of infants.
During breastfeeding, consult your doctor before using this medicine.
Children and adolescents
The safety and efficacy of the Implanon NXT subdermal implant have not been studied in adolescents under 18 years of age.
Driving and operating machinery
No effect of the Implanon NXT subdermal implant on alertness or concentration has been demonstrated.
When to contact a doctor
Regular check-ups
Before insertion of the Implanon NXT subdermal implant, your doctor will take a medical history including that of your immediate family, measure your blood pressure, and if necessary, order additional tests. After implant insertion, your doctor may recommend routine medical check-ups after a certain period. The frequency and purpose of these visits will depend on individual patient needs. Medical personnel should palpate the implant site at each follow-up visit to confirm correct positioning.
Contact your doctor immediately if:

• Any changes occur in your health status, especially those mentioned in this leaflet (see also “When not to use the Implanon NXT subdermal implant” and “Warnings and precautions”; do not forget information related to the health of your immediate family);
• Possible signs of thrombosis occur, such as severe pain or swelling in one leg, unexplained chest pain, breathing difficulties, unusual cough, especially with coughing up blood;
• Sudden, severe abdominal pain or jaundice occurs;
• A breast lump is felt (see also “Cancer”);
• Sudden or severe lower abdominal pain occurs;
• Irregular, heavy vaginal bleeding occurs;
• You are going to be immobilised (e.g. confined to bed for a long time) or undergo surgery (consult your doctor at least 4 weeks in advance);
• Pregnancy is suspected;
• The subdermal implant cannot be felt after insertion or at any time thereafter.

3. How to use the Implanon NXT subdermal implant

Before insertion of the Implanon NXT subdermal implant, inform the doctor if
the patient is pregnant or suspects she may be pregnant (e.g. had unprotected intercourse during
the current menstrual cycle).

How to use
Implanon NXT must be inserted and removed only by a physician experienced in this procedure,
as described later in this leaflet. The physician will decide the most appropriate time for insertion
of the subdermal implant, which will depend on the individual patient's circumstances (e.g. the current
contraceptive method being used). If a patient is switching from a hormonal contraceptive method
to the subdermal implant, it should be inserted between days 1–5 of the natural menstrual cycle
to ensure that the patient is not pregnant. If the subdermal implant is inserted after day 5 of the
menstrual cycle, the patient should use an additional non-hormonal contraceptive method (e.g.
condom) for the first 7 days after insertion.

Prior to insertion and removal of the Implanon NXT subdermal implant, the physician will administer
local anaesthesia. Implanon NXT is inserted just under the skin on the inner side of the non-dominant
arm (the arm not used for writing). The technique for insertion and removal of the Implanon NXT
subdermal implant is described in section 6.

The subdermal implant must be palpable after insertion
After the insertion procedure, it is recommended that the patient herself check by palpation for the
presence of the subdermal implant (feel the implant under the skin). A correctly inserted subdermal
implant should be palpable both by trained medical personnel and by the patient, who should be able
to feel each end of the implant between her thumb and index finger. It should be noted that palpation
does not provide 100% certainty that Implanon NXT has been inserted. If the subdermal implant
cannot be felt by palpation immediately after insertion or at any time thereafter, this may indicate
that the implant was not inserted, was inserted too deeply, or has migrated from its original site.

Therefore, it is important to gently feel the implant from time to time to ensure the patient knows
its location. If at any time the subdermal implant cannot be felt, the patient should contact her
doctor as soon as possible.
Until both the patient and trained medical personnel are certain that the implant has been correctly
inserted, mechanical contraception (e.g. condom) should be used if there is any doubt. It may be
necessary to perform an X-ray, ultrasound examination, magnetic resonance imaging (MRI), or blood
test to confirm that Implanon NXT is indeed present in the arm. If, after thorough investigation, the
subdermal implant cannot be located in the arm, trained medical personnel may perform a chest X-ray
or other imaging study. Once a non-palpable subdermal implant has been located, it should be removed.

The Implanon NXT subdermal implant must be removed or replaced with a new one no later than
three years after insertion.

Patient Warning Card
To help the patient remember when and where the Implanon NXT subdermal implant was inserted
and by when it must be removed at the latest, the physician will provide a Patient Warning Card
containing this information. The Patient Warning Card also includes instructions for the patient to
gently feel the implant from time to time to confirm she can detect its location. The patient should
contact her doctor promptly if she is ever unable to feel the subdermal implant. This card should be
kept in a safe place! The Patient Warning Card should be shown to medical personnel at every visit
related to the use of the subdermal implant.

If the patient wishes to replace Implanon NXT, a new implant may be inserted immediately after removal
of the previous one. The new implant may be inserted in the same arm and at the same site as the
previous one, provided that the site was correctly located. The physician will provide advice.

Discontinuation of the Implanon NXT subdermal implant
The patient may discontinue use of the Implanon NXT subdermal implant at any time.
If the subdermal implant cannot be located by palpation, trained medical personnel may determine
its location using X-ray imaging, ultrasound, or magnetic resonance imaging (MRI). Depending on the
exact location of the subdermal implant, removal may be difficult and may require a surgical procedure.

If the patient does not wish to become pregnant, she should consult her doctor for an alternative
contraceptive method after removal of the subdermal implant.

If pregnancy is planned, it is generally recommended to wait until the first natural menstrual period
occurs, as this will facilitate calculation of the expected date of delivery.

4. Possible adverse reactions

Like all medicines, Implanon NXT can cause adverse reactions, although not everyone experiences them.

During use of the Implanon NXT subdermal implant, menstrual bleeding may become irregular. There may be slight spotting, not requiring the use of sanitary protection, or heavier bleeding resembling light menstrual bleeding, when sanitary protection is necessary. Bleeding may also cease completely. Irregular bleeding is not a sign of reduced contraceptive effectiveness of the Implanon NXT subdermal implant and does not require any special action. However, if bleeding is very heavy or prolonged, you should contact your doctor.

Serious adverse reactions are described in section 2, "Cancer" and "Thrombosis". Please read this section for additional information and, if necessary, contact your doctor immediately.

The following adverse reactions have been reported:

Very common (may occur in more than 1 in 10 women)	Common (may occur in up to 1 in 10 women)	Uncommon (may occur in up to 1 in 100 women)
Acne; headache; weight gain; breast tenderness and pain; irregular menstrual bleeding; vaginal infections.	Loss of hair; dizziness; depressed mood; emotional lability; nervousness; decreased libido; increased appetite; abdominal pain; nausea; bloating; painful menstrual bleeding; weight loss; influenza-like symptoms; pain; fatigue; hot flushes; pain at the subdermal implant insertion site; local reactions at the subdermal implant insertion site; ovarian cysts.	Itching; itching around the vaginal opening; rash; excessive hair growth; migraine; anxiety; insomnia; drowsiness; diarrhoea; vomiting; constipation; urinary tract infections; vaginal discomfort (e.g. vaginal discharge); breast enlargement; breast discharge; back pain; fever; fluid retention; painful or difficult urination; allergic reactions; sore throat and inflammation; nasal congestion; joint pain; muscle pain; musculoskeletal pain.

In addition to the adverse reactions listed above, increased blood pressure has sometimes been observed. Increased intracranial pressure (benign intracranial hypertension) has been reported, with symptoms such as persistent headache, nausea, vomiting, and visual disturbances, including blurred vision. Oily skin has also been observed. Immediate medical attention should be sought if severe allergic reactions occur, such as swelling of the face, tongue, or throat; difficulty swallowing; or hives and breathing difficulties.

During insertion and removal of the Implanon NXT subdermal implant, bruising (sometimes severe), pain, swelling, or itching may occur, and in rare cases infection may develop. Scarring or abscess formation may occur at the site. After insertion, the patient may experience weakness. Numbness or loss of sensation (or reduced sensation) may also occur. Expulsion or migration of the subdermal implant is possible, especially if it has not been correctly inserted. Rarely, cases of subdermal implants located within blood vessels, including in the pulmonary blood vessel, have been reported, which may be associated with shortness of breath and (or) coughing, with or without bleeding.

A surgical procedure may be required during removal of the subdermal implant.

In women using etonogestrel implants, cases of blood clots in veins (so-called venous thrombosis) or in arteries (so-called arterial thrombosis) have been observed. A blood clot may block veins in the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs. A blood clot may also block an artery, potentially leading to heart attack or stroke.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor, pharmacist, or nurse.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the Implanon NXT subdermal implant

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
No special precautions regarding storage conditions of the medicine are necessary.

6. Contents of the Package and Other Information

What Implanon NXT Subdermal Implant Contains
Each applicator contains one subdermal implant with:

• The active substance is etonogestrel (68 mg).
• Other ingredients:
  Core: Ethylene-vinyl acetate copolymer (28% vinyl acetate)
  Barium sulfate
  Magnesium stearate
  Outer layer: Ethylene-vinyl acetate copolymer (15% vinyl acetate)

What Implanon NXT Subdermal Implant Looks Like and Contents of the Pack
Implanon NXT is a long-acting subdermal contraceptive medicine.
A single-use, innovative, easy-to-use applicator contains a radiopaque subdermal implant containing only a progestogen. The implant is 4 cm in length and 2 mm in diameter, nearly white in colour, and contains etonogestrel and barium sulfate. The applicator has been specially designed to allow the subdermal implant to be easily inserted just under the skin on the inner side of the upper arm (non-dominant arm). The subdermal implant should only be inserted and removed by a healthcare professional experienced in this procedure. To ensure the implant can be removed without difficulty, it must be inserted just under the skin (see further in the leaflet). Local anaesthesia should be used during insertion or removal of the subdermal implant. The risk of complications is low if the instructions below are followed.
Pack sizes: Carton box containing 1 blister, carton box containing 5 blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]

Manufacturer:
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

This medicinal product is authorised for marketing in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Germany, Ireland, Luxembourg, Malta, The Netherlands, Slovakia, Poland, Portugal, Spain: Implanon NXT
Denmark, Estonia, Finland, France, Iceland, Italy, Norway, Romania, Sweden, United Kingdom (Northern Ireland): Nexplanon

Note:
The following pictograms are intended for the patient in whom the subdermal implant will be inserted and are meant to illustrate the procedure for insertion and removal of the subdermal implant.
Note: The detailed procedure for insertion and removal of the Implanon NXT subdermal implant by healthcare professionals is described in the Product Characteristics and in section 7 of this patient leaflet.

6.1. How to Insert Implanon NXT

• Insertion of the Implanon NXT subdermal implant should only be performed by healthcare professionals experienced in this procedure.
• To facilitate insertion, the patient should lie on her back with her arm bent at the elbow and her hand placed behind her head (or in the closest possible position to this).

• The implant will be inserted on the inner side of the non-dominant upper arm (the arm not used for writing).
• The insertion site will be marked on the skin, then disinfected and anaesthetised.
• The skin will be stretched, and the needle inserted directly under the skin. When the tip of the needle is under the skin, the entire needle will be advanced parallel to the skin surface.

P, proximally (towards the shoulder);
D, distally (towards the elbow)

• The healthcare professional will unlock the purple slider to retract the needle from the arm. The subdermal implant will remain in the upper arm after needle retraction.

P D

• It is recommended to check immediately after insertion whether the subdermal implant is palpable. A correctly inserted implant should be easily felt between the thumb and index finger by both healthcare professionals and the patient. Note that palpation does not provide 100% certainty that Implanon NXT has been inserted.

• If the subdermal implant cannot be palpated or if there is any doubt about its presence, other methods should be used to confirm its presence.
• Once located, an implant that was not palpable should be removed.
• Until the presence of the subdermal implant is definitively confirmed, a barrier method of contraception (e.g., condom) must be used.
• The insertion site will be covered with a small adhesive plaster, and a pressure dressing will be applied to minimise the risk of bruising. The pressure dressing may be removed after 24 hours, and the small plaster after 3–5 days.
• After insertion, the patient will receive a Patient Alert Card from the healthcare professional, containing information on the implant insertion site, the date of insertion, and the date when it should be removed or replaced. This card should be kept in a safe place, as the information will facilitate future removal of the subdermal implant.

6.2. How to Remove Implanon NXT

• The subdermal implant should be removed by a healthcare professional experienced in this procedure.
• The subdermal implant should be removed at the patient's request or no later than three years after insertion.
• Precise information regarding the location of the subdermal implant is recorded on the Patient Alert Card.
• The healthcare professional will locate the subdermal implant. If it cannot be found, imaging techniques such as X-ray, computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI) may be used.

• To facilitate removal, the patient should lie on her back with her arm bent at the elbow and her hand placed behind her head (or in the closest possible position to this).
• The upper arm will be disinfected and anaesthetised.

• A small incision will be made along the arm, directly below the end of the subdermal implant.

• The subdermal implant will be gently pushed towards the incision and removed using forceps.

• Occasionally, the subdermal implant may be surrounded by dense tissue. In such cases, the tissue must be incised before the implant can be removed.
• If the patient wishes, a new implant may be inserted through the same incision immediately after removal, provided the previous implant site was correctly located.
• The incision will be closed with sterile wound closure strips.
• A pressure dressing will be applied to minimise the risk of bruising. The patient may remove the pressure dressing after 24 hours, and the sterile wound closure strips at the implant site after 3–5 days.

Information intended exclusively for healthcare professionals:

7. Information intended exclusively for healthcare professionals

7.1 When to insert Implanon NXT

IMPORTANT: Before inserting the subdermal implant, ensure that the patient is not pregnant.
The timing of subdermal implant insertion depends on the previously used contraceptive method:

If no hormonal contraception was used in the previous month
The subdermal implant should be inserted between days 1 and 5 of the natural menstrual cycle, even if bleeding is still occurring (day 1 of the cycle is the first day of menstrual bleeding).
If the subdermal implant is inserted as recommended, no additional contraceptive methods are necessary. If the insertion date deviates from the recommended timing, advise the woman to use a barrier method for 7 days after insertion of the subdermal implant. If sexual intercourse has occurred, ensure that the patient is not pregnant.

Replacing another hormonal contraceptive method with Implanon NXT
Switching from combined hormonal contraception (combined oral contraceptives, vaginal ring, or transdermal system)
It is preferable to insert the subdermal implant on the day following the last active tablet of the current combined oral contraceptive, or on the day of removal of the vaginal ring or transdermal system. The subdermal implant should be inserted no later than the next day after the scheduled break in taking oral contraceptives, vaginal ring, transdermal system, or placebo tablets in the previous cycle of combined hormonal contraceptives, when the next cycle would normally begin. Not all contraceptive methods (transdermal system, vaginal ring) are available in every country.
If the subdermal implant is inserted as recommended, no additional contraceptive methods are necessary. If the insertion date deviates from the recommended timing, advise the woman to use a barrier method for 7 days after insertion of the subdermal implant. If sexual intercourse has occurred, ensure that the patient is not pregnant.

Switching from progestogen-only hormonal contraception (progestogen-only pills, injections, implant, intrauterine system releasing progestogen [IUS])
There are several progestogen-only contraceptive methods; therefore, the insertion of the subdermal implant should be performed as follows:

• Injection: insert the subdermal implant on the day the next injection is due.
• Progestogen-only pill: the patient may switch from a progestogen-only pill to Implanon NXT on any day of the month. The subdermal implant should be inserted within 24 hours after taking the last pill.
• Subdermal implant and (or) intrauterine system releasing progestogen (IUS): insert the new subdermal implant on the same day the previous subdermal implant or IUS is removed.

If the subdermal implant is inserted as recommended, no additional contraceptive methods are necessary. If the insertion date deviates from the recommended timing, advise the woman to use a barrier method for 7 days after insertion of the subdermal implant. If sexual intercourse has occurred, ensure that the patient is not pregnant.

After abortion or miscarriage
The subdermal implant may be inserted immediately after abortion or miscarriage:

• First trimester of pregnancy: if inserted within 5 days, additional contraceptive methods are not required.
• Second trimester of pregnancy: if inserted within 21 days, additional contraceptive methods are not required.

If insertion of the subdermal implant occurs after the recommended time, advise the woman to use a barrier method for 7 days after insertion. If sexual intercourse has occurred, ensure before insertion that the patient is not pregnant.

After childbirth
The subdermal implant may be inserted immediately after delivery, both in breastfeeding and non-breastfeeding women, based on individual benefit-risk assessment.

• If the subdermal implant is inserted within 21 days, no additional contraceptive methods are necessary.
• If the subdermal implant is inserted more than 21 days after delivery, advise the woman to use a barrier method for 7 days after insertion. If sexual intercourse has occurred, ensure before insertion that the patient is not pregnant.

7.2 How to insert Implanon NXT

To ensure effective action and uncomplicated removal of the Implanon NXT subdermal implant, correct and careful subcutaneous insertion into the non-dominant arm, as per instructions, is essential. Both the healthcare professional and the patient should be able to palpate the presence of the implant after insertion.

The subdermal implant must be placed subcutaneously directly under the skin on the inner side of the upper part of the non-dominant arm.

• A subdermal implant inserted deeper than subcutaneously (deep insertion) may not be palpable, which could make localization and (or) removal difficult (see section 4.2 How to remove Implanon NXT and section 4.4 Product Characteristics).
• If the subdermal implant is placed deeply, nerves or blood vessels may be damaged. Deep or incorrect placement of the subdermal implant may lead to paresthesia (due to nerve damage) and displacement of the implant (due to intramuscular or fascial placement), and in rare cases may result in intravascular injection.

Insertion of the Implanon NXT subdermal implant must be performed under aseptic conditions by trained healthcare professionals familiar with the procedure. Insertion of the Implanon NXT subdermal implant is performed exclusively using the specially designed applicator.

Insertion of the subdermal implant
To ensure that the subdermal implant is inserted directly under the skin, the healthcare professional should position themselves so they can observe the movement of the needle from the side, not from above the arm. The insertion site and needle movement just under the skin will be clearly visible when viewed from the side.

For illustrative purposes, the images show the inner side of the left arm.

• Position the patient supine with the non-dominant arm externally rotated, elbow flexed so that the hand is placed behind the head (or in the closest possible position) (Figure 1).

Figure 1
Identify the insertion site on the inner side of the upper part of the non-dominant arm. The insertion site is located above the triceps muscle, approximately 8–10 cm from the medial epicondyle of the humerus and 3–5 cm posterior (below) the groove (sulcus) between the biceps and triceps muscles (Figures 2a, 2b, and 2c). This location avoids major blood vessels and nerves located in the groove. If insertion at this site is not possible (e.g., in women with slender arms), place the implant as far posterior to the groove as possible.

• Mark two points with a surgical marker: the first mark indicates where the subdermal implant will be inserted; the second mark is located 5 cm further from the first mark (toward the shoulder) (Figures 2a and 2b). The second mark (direction indicator) will guide the direction of subdermal implant insertion.

P D

P D
Figure 2a Figure 2b
P, proximally (toward shoulder);
D, distally (toward elbow)

Figure 2c
Cross-section of the upper part of the left arm, view from the elbow side
Medial (inner) side of the arm
Lateral (outer) side of the arm

• After marking the arm, confirm correct positioning of the insertion site on the inner side of the arm.
• Cleanse the skin with an antiseptic solution from the insertion site to the direction indicator.
• Administer local anesthesia (e.g., using a spray anesthetic or injecting 2 ml of 1% lidocaine solution subcutaneously along the "implant insertion channel").
• Remove the sterile single-use applicator containing Implanon NXT from its blister pack. Before use, visually inspect whether the packaging has been compromised (e.g., torn or punctured). Do not use the applicator if the packaging shows visible damage that may have affected sterility.
• Hold the applicator at the textured area near the needle. Remove the needle protector by sliding it horizontally off the needle in the direction indicated by the arrow (Figure 3). If the needle protector cannot be easily removed, do not use the applicator. Visually confirm the presence of the subdermal implant, which should appear as a white rod visible at the tip of the needle. Do not touch the purple slider until the needle is fully inserted under the skin, as this would cause the needle to retract and result in premature expulsion of the subdermal implant from the applicator.
• If the purple slider is released prematurely, restart the procedure using a new applicator.

Figure 3

• With the free hand, stretch the skin around the insertion site toward the elbow (Figure 4).

P D

Figure 4

• The subdermal implant must be inserted subcutaneously directly under the skin (see section 4.4 Product Characteristics). To ensure that the subdermal implant is inserted directly under the skin, position yourself so that you can observe the movement of the needle from the side, not from above the arm. The insertion site and needle movement just under the skin are clearly visible when viewed from the side (see Figure 6).
• Insert only the very tip of the needle at a shallow angle (less than 30°) (Figure 5a).
• Insert only the beveled tip of the needle just under the skin, but no further (Figure 5b). If the needle is inserted too deeply, withdraw it so that only the tip remains under the skin.

Figure 5a Figure 5b

• Lower the applicator to an almost horizontal position. To facilitate placement of the implant under the skin, gently advance the needle to its full length, lifting the skin with the needle (Figure 6). There may be slight resistance, but do not apply force. If the needle is not inserted to its full length, the subdermal implant will not be correctly placed.

If the needle tip emerges through the skin before full insertion, withdraw it and reposition it under the skin to complete the insertion procedure.

Figure 6 Figure 7

• Hold the applicator parallel to the skin surface and insert the needle to its full length (Figure 7). If necessary, stabilize the applicator with the free hand.
• To unlock the purple slider, gently push it downward (Figure 8a).

Slide the slider backward until it stops. Do not move ( ) the applicator while sliding the purple slider (Figure 8b). The subdermal implant is now under the skin, and the needle is locked inside the applicator. The applicator can now be removed (Figure 8c).

Figure 8a Figure 8b

Figure 8c
If the applicator is not held in the same position throughout the procedure or if the purple slider is not slid fully backward, the subdermal implant will not be correctly placed and may protrude from the insertion site.
If the subdermal implant protrudes from the insertion site, remove it and repeat the procedure at the same site using a new applicator. Do not push a protruding subdermal implant back into the incision.

• Apply a small adhesive bandage at the insertion site.
• Always palpate the presence of the subdermal implant immediately after insertion. Both ends of the 4 cm subdermal implant should be palpable (Figure 9). See the section below "If the subdermal implant cannot be palpated after insertion."

Figure 9

• Inform the patient to regularly palpate for the presence of the subdermal implant.
• Apply a sterile gauze pad and pressure dressing to prevent bruising at the insertion site. The patient may remove the pressure dressing after 24 hours and the adhesive gauze after 3–5 days.
• Complete the Patient Warning Card and provide it to the patient. Also complete the label and attach it to the patient's medical record. If electronic patient records are used, the information from the label should also be included.
• The applicator is for single use only and must be disposed of properly according to local regulations for handling hazardous waste.

If the subdermal implant cannot be palpated after insertion:
If the subdermal implant cannot be palpated or there is uncertainty about its placement, this may indicate that the implant was not inserted or was placed deeply:

• Check the applicator. The needle should be fully retracted, and only the purple end of the obturator should be visible.
• Use other methods to confirm the presence of the subdermal implant. Since the subdermal implant is radiopaque, appropriate localization methods include two-dimensional X-ray imaging and computed tomography (CT scan, Computerized Tomography). Ultrasound scanning (USS, Ultrasound Scanning) using a high-frequency linear probe (10 MHz or higher) or magnetic resonance imaging (MRI, Magnetic Resonance Imaging) may also be used. If the implant cannot be located using these imaging methods, measure the patient's serum etonogestrel concentration. In such cases, contact the responsible party for further guidance (protocol).
• Until the presence of Implanon NXT is confirmed, the patient must use a non-hormonal contraceptive method.
• Deeply placed subdermal implants should be located and removed as soon as possible to avoid the possibility of migration to distant sites (see section 4.4 Product Characteristics).

7.3 How to remove Implanon NXT

The subdermal implant may be removed only by trained healthcare professionals under aseptic conditions, who are familiar with this removal technique. Individuals unfamiliar with the subdermal implant removal technique should contact the responsible party to obtain additional information.
Before beginning the removal procedure, the healthcare professional should assess the location of the subdermal implant. The subdermal implant should be palpated in the arm.

If the subdermal implant is not palpable, check the Patient Warning Card or medical records to determine in which arm the implant is located. If the implant cannot be felt, it may have been placed deeply or may have migrated. Consider that the subdermal implant may lie close to blood vessels and nerves. Non-palpable subdermal implants should only be removed by healthcare professionals experienced in removing deeply placed implants and familiar with implant localization techniques and the anatomy of the arm. Contact the responsible party for additional information.
If the subdermal implant is not palpable, see the section below "Localization and removal of non-palpable subdermal implant."

Procedure for removal of a palpable subdermal implant
For illustrative purposes, the images show the inner side of the left arm.

• Position the patient supine on the examination table. The arm should be flexed at the elbow with the hand placed behind the head (or in the closest possible position) (see Figure 10).

Figure 10

• Palpate and locate the subdermal implant. Push downward on the end of the implant closest to the shoulder (Figure 11) to stabilize it; a bulge indicating the end of the implant closest to the elbow should appear. If the end does not elevate, removal may be difficult, and the procedure should be performed by a healthcare professional experienced in removing deeper implants. Contact the responsible party for additional information.
• Mark the distal end (the end closer to the elbow) with a surgical marker.
• Cleanse the area with an antiseptic solution.

Figure 11
P, proximally (toward shoulder);
D, distally (toward elbow)

• Administer local anesthesia at the planned incision site, e.g., by injecting 0.5 to 1 ml of 1% lidocaine solution (Figure 12). Inject the anesthetic under the subdermal implant so that the implant lies close to the skin surface. Injecting the local anesthetic above the implant may make removal more difficult.

Figure 12

• Push down on the end of the subdermal implant closest to the shoulder (Figure 13) to stabilize it throughout the procedure. Starting at the point over the end of the implant closest to the elbow, make a 2 mm longitudinal incision (parallel to the implant) toward the elbow. Take care not to cut the end of the subdermal implant.

Figure 13
The end of the subdermal implant should emerge from the incision. If it does not, gently push the implant toward the incision site until its end becomes visible. Grasp the implant with forceps and remove it if possible (Figure 14). If necessary, gently separate tissues adherent to the implant tip by blunt dissection. If the implant tip is not exposed after tissue separation, incise the surrounding tissue capsule and then remove the implant with forceps (Figures 15 and 16).

Figure 14

Figure 15 Figure 16

• If the subdermal implant is not visible, gently insert forceps (preferably curved Halstead vascular forceps with tips pointing upward) superficially at the incision site (Figure 17).
• Gently grasp the subdermal implant, then transfer the forceps to the other hand (Figure 18).
• Using other forceps, carefully dissect the tissue surrounding the subdermal implant (Figure 19). The subdermal implant can then be removed.
• If the subdermal implant cannot be grasped, discontinue the procedure and refer the patient to a physician experienced in performing complex implant removal procedures or contact the responsible party.

Figure 17 Figure 18

Figure 19

• Confirm that the entire 4 cm subdermal implant has been removed by measuring its length. Cases of subdermal implant fracture within the patient's arm have been reported. In some cases, difficulty in removing the fractured implant has been reported. If only part of the subdermal implant is removed (less than 4 cm), the remaining fragment should be removed following the instructions provided in this section.
• If the patient wishes to continue using the Implanon NXT subdermal implant, a new implant may be inserted immediately after removal of the previous one using the same incision, provided the previous site was correctly located (see section 7.4).
• After removal of the subdermal implant, close the incision site with sterile wound closure strips.
• Apply a sterile gauze pad and pressure dressing to prevent bruising. The patient may remove the pressure dressing after 24 hours and the sterile wound closure strips after 3–5 days.

Localization and removal of non-palpable subdermal implant
In rare cases, migration of the subdermal implant has been reported; usually this is minor displacement from the original site (see also section 4.4 Product Characteristics), but it may make palpation of the original location impossible. A subdermal implant that has been placed deeply or has migrated may not be palpable, and therefore, as described below, imaging techniques may be necessary to locate it.
Before attempting removal of a non-palpable subdermal implant, it must first be localized. Since the subdermal implant is radiopaque, appropriate localization methods include two-dimensional X-ray imaging and computed tomography (CT). Ultrasound scanning (USS) using a high-frequency linear probe (10 MHz or higher) or magnetic resonance imaging (MRI) may also be used.
After localization of the implant in the arm, it should be removed by a healthcare professional experienced in removing deeply placed subdermal implants and familiar with the anatomy of the arm. Consider using ultrasound guidance during the removal procedure.
If the subdermal implant cannot be located in the arm after multiple attempts, consider imaging of the chest, as in extremely rare cases migration of the subdermal implant to the pulmonary vessels has been reported. If the subdermal implant is located in the chest, surgical or intravascular procedures may be necessary for removal; consult with healthcare professionals familiar with chest anatomy.
If these imaging methods fail to locate the implant, serum etonogestrel concentration may be measured to confirm presence of the implant. Contact the responsible party for further guidance.
If the implant has migrated within the arm, removal may require a minor surgical procedure with a larger incision or a surgical procedure in the operating room. Removal of a deeply placed subdermal implant should be performed carefully to avoid damage to nerves or blood vessels in the arm.
Non-palpable and deeply placed subdermal implants should be removed only by healthcare professionals familiar with the anatomy of the arm and procedures for removing deeply placed subdermal implants.
Exploratory surgical procedures without prior localization of the subdermal implant are strongly discouraged.
Contact the responsible party for further guidance.

7.4 How to replace Implanon NXT

After removal of the previous subdermal implant, a new one may be inserted immediately, as described in section 7.2.
A new subdermal implant may be inserted into the same arm and often through the same incision used to remove the previous implant, provided the incision is correctly positioned—i.e., located 8–10 cm from the medial epicondyle of the humerus and 3–5 cm posterior (below) the groove (see section 4.2 "How to insert Implanon NXT" in Product Characteristics). If the same incision is used, administer local anesthesia by injecting anesthetic (e.g., 2 ml of 1% lidocaine solution) subcutaneously near the incision along the "implant insertion channel," and follow the instructions.