Posology1 implant, which can be left in place for three years.
Paediatric populationThe safety and efficacy of Implanon NXT in adolescents under the age of 18 have not been established.
Method of administrationPregnancy should be excluded before insertion of Implanon NXT.Healthcare professionals (HCPs) are strongly recommended to participate in a training session to become familiar with the use of the Implanon NXT applicator and techniques for insertion and removal of the Implanon NXT implant and where appropriate, request supervision prior to inserting or removing the implant. Additional information and more detailed instructions concerning the insertion and removal of the implant will be sent on request free of charge (Merck Sharp & Dohme Ireland (Human Health) Limited, telephone: +353 1 299 8700).Prior to inserting the implant, carefully read and follow the instructions for insertion and removal of the implant in section 4.2 How to insert Implanon NXT and How to remove Implanon NXT.
How to use Implanon NXTImplanon NXT is a long-acting hormonal contraceptive. A single implant is inserted subdermally and can be left in place for three years. Remove the implant no later than three years after the date of insertion. The user should be informed that she can request the removal of the implant at any time. HCPs may consider earlier replacement of the implant in heavier women (see section 4.4). After the removal of the implant, immediate insertion of another implant will result in continued contraceptive protection. If the woman does not wish to continue using Implanon NXT, but wants to continue preventing pregnancy, another contraceptive method should be recommended.The basis for successful use and subsequent removal of the Implanon NXT implant is a correct and carefully performed subdermal insertion of the implant in accordance with the instructions. If the implant is not inserted in accordance with the instructions (see section 4.2 When to insert Implanon NXT and How to insert Implanon NXT) , and on the correct day, this may result in an unintended pregnancy.The Implanon NXT implant should be inserted subdermally just under the skin at the inner side of the upper arm to avoid the large blood vessels and nerves that lie deeper in the connective tissue between the biceps and triceps muscles. Immediately after insertion, the presence of the implant should be verified by palpation. In case the implant cannot be palpated or when the presence of the implant is doubtful, other methods must be applied to confirm its presence (see section 4.2 How to insert Implanon NXT). Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method.The Implanon NXT package contains a User Card intended for the woman which records the batch number of the implant. HCPs are requested to record the date of insertion, the arm of insertion and the intended day of removal on the User Card. The package also includes adhesive labels intended for HCP records showing the batch number.
When to insert Implanon NXT
IMPORTANT: Rule out pregnancy before inserting the implant.Timing of insertion depends on the woman's recent contraceptive history, as follows:
No preceding hormonal contraceptive use in the past monthThe implant should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
Switching hormonal contraceptive method to Implanon NXT
Changing from a combined hormonal contraceptive method (combined oral contraceptive (COC), vaginal ring or transdermal patch).The implant should be inserted preferably on the day after the last active tablet (the last tablet containing the active substances) of the previous combined oral contraceptive or on the day of removal of the vaginal ring or transdermal patch. At the latest, the implant should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive when the next application would have been due. Not all contraceptive methods (transdermal patch, vaginal ring) may be available in all countries. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.Changing from a progestagen-only contraceptive method (e.g. progestagen-only pill, injectable, implant, or intrauterine system [IUS]) As there are several types of progestagen-only methods, the insertion of the implant must be performed as follows:• Injectable contraceptives: Insert the implant on the day the next injection is due. • Progestagen-only pill: A woman may switch from the progestagen-only pill to Implanon NXT on any day of the month. The implant should be inserted within 24 hours after taking the last tablet.• Implant/Intrauterine system (IUS): Insert the implant on the same day the previous implant or IUS is removed.If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
Following abortion or miscarriage• First trimester: The implant should be inserted within five days following a first trimester abortion or miscarriage.• Second trimester: Insert the implant between 21 to 28 days following second trimester abortion or miscarriage.If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
Postpartum• Not breast-feeding: The implant should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If the implant is inserted later than 28 days postpartum, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. • Breast-feeding: The implant should be inserted after the fourth postpartum week (see section 4.6). The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
How to insert Implanon NXTThe basis for successful use and subsequent removal of Implanon NXT is a correct and carefully performed subdermal insertion of the implant in the non-dominant arm in accordance with the instructions. Both the HCP and the woman should be able to feel the implant under the woman's skin after placement. The implant should be inserted subdermally just under the skin. If the implant is inserted too deep, neural or vascular damage may occur. Too deep or incorrect insertions have been associated with paraesthesia (due to neural damage) and migration of the implant (due to intramuscular or fascial insertion), and in rare cases with intravascular insertion. Moreover, when the implant is inserted too deep, it may not be palpable and the localization and/or removal can be difficult.Insertion of Implanon NXT should be performed under aseptic conditions and only by a qualified HCP who is familiar with the procedure. Insertion of the implant should only be performed with the preloaded applicator.It is recommended that the HCP is in a seated position during the entire insertion procedure so that the insertion site and the movement of the needle just under the skin can be clearly seen from the side.
|• Have the woman lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head (Figure 1).
|• Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus.
|• Make two marks with a sterile marker: first, mark the spot where the implant will be inserted, and second, mark a spot a few centimetres proximal to the first mark (Figure 2). This second mark will later serve as a direction guide during insertion.
|• Clean the insertion site with an antiseptic solution.
• Anaesthetize the insertion area (for example, with anaesthetic spray or by injecting 2 ml of 1 % lidocaine just under the skin along the planned insertion tunnel).
• Remove the sterile preloaded disposable Implanon NXT applicator carrying the implant from its blister.|
|• Hold the applicator just above the needle at the textured surface area. Remove the transparent protection cap by sliding it horizontally in the direction of the arrow away from the needle (Figure 3). If the cap does not come off easily the applicator should not be used. You can see the white coloured implant by looking into the tip of the needle. Do not touch the purple slider until you have fully inserted the needle subdermally, as it will retract the needle and release the implant from the applicator.||Figure 3
|• With your free hand, stretch the skin around the insertion site with thumb and index finger (Figure 4).
|• Puncture the skin with the tip of the needle angled about 30° (Figure 5).
|• Lower the applicator to a horizontal position. While lifting the skin with the tip of the needle, slide the needle to its full length. You may feel slight resistance but do not exert excessive force (Figure 6). If the needle is not inserted to its full length, the implant will not be inserted properly.||Figure 6
|• Keep the applicator in the same position with the needle inserted to its full length. If needed, you may use your free hand to keep the applicator in the same position during the following procedure. Unlock the purple slider by pushing it slightly down. Move the slider fully back until it stops (Figure 7). The implant is now in its final subdermal position, and the needle is locked inside the body of the applicator. The applicator can now be removed. If the applicator is not kept in the same position during this procedure or if the purple slider is not completely moved to the back, the implant will not be inserted properly.||Figure 7
|• Always verify the presence of the implant in the woman's arm immediately after insertion by palpation.
By palpating both ends of the implant, you should be able to confirm the presence of the 4 cm rod (Figure 8).
|If you cannot feel the implant or in doubt of its presence: • Check the applicator. The needle should be fully retracted and only the purple tip of the obturator should be visible.
• Use other methods to confirm its presence. Suitable methods are: two-dimensional X-ray, X-ray computerized tomography (CT scan), ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). Prior to the application of X-ray CT, USS or MRI for the localization of the implant, it is recommended to consult the local supplier of Implanon NXT for instructions. In case these imaging methods fail, it is advised to verify the presence of the implant by measuring the etonogestrel level in a blood sample of the subject. In this case the local supplier will provide the appropriate procedure. Until you have verified the presence of the implant, a non-hormonal contraceptive method must be used.
|• Apply a small adhesive bandage over the insertion site. Request that the woman palpate the implant.
• Apply sterile gauze with a pressure bandage to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage over the insertion site after 3-5 days.
|• Complete the User Card and give it to the woman to keep. Also, complete the adhesive labels and affix it to the woman's medical record.
|• The applicator is for single use only and must be adequately disposed of, in accordance with local regulations for the handling of biohazardous waste.
How to remove Implanon NXTBefore initiating the removal procedure, the HCP should consult the User Card for the location of the Implanon NXT implant. Verify the exact location of the implant in the arm by palpation. If the implant is not palpable, two-dimensional X-ray can be performed to verify its presence. A non-palpable implant should always be first located prior to removal. Suitable methods for localization include X-ray computer tomography (CT), ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). If these imaging methods fail to locate the implant, etonogestrel determination can be used for verification of the presence of the implant. Please contact your local supplier for further guidance. After localization of a non-palpable implant, consider conducting removal with ultrasound guidance.There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position unless inserted too deeply (see also section 4.4). This may complicate localization of the implant by 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 HCP who is familiar with the removal technique.
Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.Removal of deeply inserted implants should be conducted with caution in order to prevent damage to deeper neural or vascular structures in the arm and should be performed by HCPs familiar with the anatomy of the arm.If the implant cannot be removed, please contact your local supplier for further guidance.
|• Clean the site where the incision will be made and apply an antiseptic. Locate the implant by palpation and mark the distal end (end closest to the elbow), for example, with a sterile marker (Figure 9).
|| ||Figure 9
|• Anaesthetize the arm, for example, with 0.5 to 1 ml 1 % lidocaine at the marked site where the incision will be made (Figure 10). Be sure to inject the local anaesthetic under the implant to keep it close to the skin surface.
|| ||Figure 10
|• Push down the proximal end of the implant (Figure 11) to stabilize it; a bulge may appear indicating the distal end of implant. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow.
|| ||Figure 11
|• Gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and remove the implant (Figure 12).
|| ||Figure 12
|• If the implant is encapsulated, make an incision into the tissue sheath and then remove the implant with the forceps (Figures 13 and 14).
| ||Figure 13
|| ||Figure 14
|• If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision (Figure 15). Flip the forceps over into your other hand (Figure 16). With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant (Figure 17). The implant can then be removed.
| || || |
|• Confirm that the entire rod, which is 4 cm long, has been removed by measuring its length. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in this section.
|• If the woman would like to continue using Implanon NXT, a new implant may be inserted immediately after the old implant is removed using the same incision (see section 4.2 How to replace Implanon NXT).
|• After removing the implant, close the incision with a steri-strip and apply an adhesive bandage.
|• Apply sterile gauze with a pressure bandage to minimize bruising. The woman may remove the pressure bandage after 24 hours and the small bandage after 3-5 days.
How to replace Implanon NXT Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 4.2 How to insert Implanon NXT.The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. If the same incision is being used to insert a new implant, anaesthetize the insertion site by injecting an anaesthetic (e.g. 2 ml lidocaine (1 %)) just under the skin commencing at the removal incision along the 'insertion canal' and follow the subsequent steps in the insertion instructions.