IMPLANON NXT IMPLANT 68MG [SIN14086P]

Product Info

IMPLANON NXT IMPLANT 68MG

[SIN14086P]

Indication

4.1 Therapeutic indication

Contraception.

Dosing

4.2 Posology and method of administration

Pregnancy 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 the techniques for insertion and removal of the Implanon NXT implant and, where appropriate, request supervision prior to inserting or removing the implant.

Before inserting the implant, carefully read and follow the instructions for insertion and removal of the implant in section 4.2.3 “How to insert Implanon NXT” and section 4.2.4 “How to remove Implanon NXT”.

Videos demonstrating insertion and removal of the implant are available online at www.implanonnxtvideos.com. Please contact Organon, Designated Point of Contact (DPOC) at dpoc.singapore@organon.com if you have any questions.

If you are unsure of the necessary steps to safely insert and/or remove Implanon NXT, do not attempt the procedure.

4.2.1 How to use Implanon NXT

Implanon 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 4.4.1 “Warnings” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 4.2.3 "How to insert Implanon NXT”), and on the correct day (see section 4.2.2 "When to insert Implanon NXT"), this may result in an unintended pregnancy. An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localization and/or removal can be difficult (see sections 4.2.4 “How to remove Implanon NXT” and 4.4.1 “Warnings” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The Implanon NXT implant should be inserted subdermally just under the skin at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8–10 cm (3–4 inches) from the medial epicondyle of the humerus and 3–5 cm (1.25–2 inches) posterior to (below) the sulcus (groove) between the biceps and triceps muscles. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus. (See Figures 2a and 2b.)

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, see section 4.2.3 “How to insert Implanon NXT”.

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.

4.2.2 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 month

The 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 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 COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of the previous COC. In case a vaginal ring or transdermal patch has been used, the implant should be inserted preferably on the day of removal, but at the latest when the next application would have been due.

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 5 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

• Breast-feeding: The implant should be inserted after the fourth postpartum week (see section 4.6 “Pregnancy and lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

• 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.

4.2.3 How to insert Implanon NXT

The 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 at the inner side of the non-dominant upper arm.

• An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localization and/or removal can be difficult (see sections 4.2.4 “How to remove Implanon NXT” and 4.4.1 “Warnings” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• If the implant is inserted deeply, neural or vascular damage may occur. Deep or incorrect insertions have been associated with paresthesia (due to neural damage) and migration of the implant (due to intramuscular or fascial insertion), and in rare cases with intravascular insertion.

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.

Insertion Procedure

To help make sure the implant is inserted just under the skin, the HCP should be positioned to see the advancement of the needle by viewing the applicator from the side and not from above the arm. From the side view, the insertion site and the movement of the needle just under the skin can be clearly visualized.

For illustrative purposes, Figures depict the left inner arm.

• 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 hand is underneath her head (or as close as possible) (Figure 1).

Identify the insertion site, which is at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8–10 cm (3–4 inches) from the medial epicondyle of the humerus and 3–5 cm (1.25–2 inches) posterior to (below) the sulcus (groove) between the biceps and triceps muscles. (Figures 2a, 2b, and 2c). This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus. If it is not possible to insert the implant in this location (e.g. in women with thin arms), it should be inserted as far posterior from the sulcus as possible.

• Make two marks with a surgical marker: first, mark the spot where the implant will be inserted, and second, mark a spot at 5 centimeters (2 inches) proximal (toward the shoulder) to the first mark (Figure 2a and 2b). This second mark (guiding mark) will later serve as a direction guide during insertion.

• After marking the arm, confirm the site is in the correct location on the inner side of the arm.

• Clean the skin from the insertion site to the guiding mark with an antiseptic solution.

• Anesthetize the insertion area (for example, with anesthetic 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. Visually inspect for breaches of packaging integrity prior to use for damages (e.g. torn, punctured, etc). If the packaging has any visual damage that could compromise sterility, do not use the applicator.

• 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 should see the white colored implant by looking into the tip of the needle. Do not touch the purple slider until you have fully inserted the needle subdermally, as doing so will retract the needle and prematurely release the implant from the applicator.

• If the purple slider is released prematurely, restart the procedure with a new applicator.

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

• The implant should be inserted subdermally just under the skin (see section 4.4.1 "Warnings" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

To help make sure the implant is inserted just under the skin, you should position yourself to see the advancement of the needle by viewing the applicator from the side and not from above the arm. From the side view you can clearly see the insertion site and the movement of the needle just under the skin (see Figure 6).

• Puncture the skin with the tip of the needle slightly angled less than 30° (Figure 5a).

• Insert the needle until the bevel (slanted opening of the tip) is just under the skin (and no further) (Figure 5b). If you inserted the needle deeper than the bevel, withdraw the needle until only the bevel is beneath the skin.

• Lower the applicator to a nearly horizontal position. To facilitate subdermal placement, lift the skin with the needle while sliding the needle to its full length (Figure 6). You may feel slight resistance but do not exert excessive force. If the needle is not inserted to its full length, the implant will not be inserted properly.

If the needle tip emerges from the skin before needle insertion is complete, the needle should be pulled back and be readjusted to subdermal position before completing the insertion procedure.

• Keep the applicator in the same position with the needle inserted to its full length (Figure 7). If needed, you may use your free hand to stabilize the applicator.

• Unlock the purple slider by pushing it slightly down (Figure 8a). Move the slider fully back until it stops. Do not move the applicator while moving the purple slider (Figure 8b). 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 (Figure 8c).

If the applicator is not kept in the same position during this procedure or if the purple slider is not moved fully back until it stops, the implant will not be inserted properly and may protrude from the insertion site.

If the implant is protruding from the insertion site, remove the implant and perform a new procedure at the same insertion site using a new applicator. Do not push the protruding implant back into the incision.

• Apply a small adhesive bandage over the insertion site.

• 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 9). See section below “If the rod is not palpable after insertion”.

• 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 adhesive 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.

If the rod is not palpable after insertion:

If you cannot palpate the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply:

• 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 the presence of the implant. Given the radiopaque nature of the implant, suitable methods for localization are two-dimensional X-ray and 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) may be used. 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 from the woman. In this case the local supplier will provide the appropriate protocol. Until you have verified the presence of the implant, the woman must use a non-hormonal contraceptive method.

• Deeply-placed implants should be localized and removed as soon as possible to avoid the potential for distant migration (see section 4.4.1 “Warnings” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.4 How to remove Implanon NXT

Removal of the implant should only be performed under aseptic conditions by a HCP who is familiar with the removal technique. If you are unfamiliar with the removal technique, contact the local supplier for further information.

Before initiating the removal procedure, the HCP should assess the location of the implant. Verify the exact location of the implant in the arm by palpation.

If the implant is not palpable, consult the User Card or medical record to verify the arm which contains the implant. If the implant cannot be palpated, it may be deeply located or have migrated. Consider that it may lie close to vessels and nerves. Removal of non-palpable implants should only be performed by a HCP experienced in removing deeply placed implants and familiar with localizing the implant and the anatomy of the arm. Contact the local supplier for further information.

See Section below on “Localization and removal of a non-palpable implant” if the implant cannot be palpated.

Procedure for removal of an implant that is palpable

For illustrative purposes, Figures depict the left inner arm

• Have the woman lie on her back on the table. The arm should be positioned with the elbow flexed and the hand underneath the head (or as close as possible). (See Figure 1)

• Locate the implant by palpation. Push down the end of the implant closest to the shoulder (Figure 10) to stabilize it; a bulge should appear indicating the tip of the implant that is closest to the elbow. If the tip does not pop up, removal of the implant may be more challenging and should be performed by providers experienced with removing deeper implants. Contact the local supplier for further information.

• Mark the distal end (end closest to the elbow), for example, with a surgical marker.

• Clean the site with an antiseptic solution.

• Anesthetize the site, for example, with 0.5 to 1 ml 1% lidocaine where the incision will be made (Figure 11). Be sure to inject the local anesthetic under the implant to keep the implant close to the skin surface. Injection of local anesthetic over the implant can make removal more difficult.

• Push down the end of the implant closest to the shoulder (Figure 12) to stabilize it throughout the procedure. Starting over the tip of the implant closest to the elbow, make a longitudinal (parallel to the implant) incision of 2 mm towards the elbow. Take care not to cut the tip of the implant.

• The tip of the implant should pop out of the incision. If it does not, gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps and if possible, remove the implant (Figure 13). If needed, gently remove adherent tissue from the tip of the implant using blunt dissection. If the implant tip is not exposed following blunt dissection, make an incision into the tissue sheath and then remove the implant with the forceps (Figures 14 and 15).

If the tip of the implant does not become visible in the incision, insert forceps (preferably curved mosquito forceps, with the tips pointed up) superficially into the incision (Figure 16). Gently grasp the implant and then flip the forceps over into your other hand (Figure 17). With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant (Figure 18). The implant can then be removed. If the implant cannot be grasped, stop the procedure and refer the woman to a HCP experienced with complex removals or contact the local supplier.

• Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. There have been reports of broken implants while in the patient’s arm. In some cases, difficult removal of the broken implant has been reported. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 4.2.4 "How to remove Implanon NXT".

• 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 as long as the site is in the correct location (Section 4.2.5 “How to replace Implanon NXT”).

• After removing the implant, close the incision with a sterile adhesive wound closure.

• Apply sterile gauze with a pressure bandage to minimize bruising. The woman may remove the pressure bandage after 24 hours and the sterile adhesive wound closure after 3–5 days.

Localization and removal of a non-palpable implant

There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position (see also section 4.4.1 “Warnings” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) but may lead to the implant not being palpable at the location in which it was placed. An implant that has been deeply inserted or has migrated may not be palpable and therefore imaging procedures, as described below, may be required for localization.

A non-palpable implant should always be located prior to attempting removal. Given the radiopaque nature of the implant, suitable methods for localization include two-dimensional X-ray and X-ray computer tomography (CT). Ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI) may be used. Once the implant has been localized in the arm, the implant should be removed by a HCP experienced in removing deeply placed implants and familiar with the anatomy of the arm. The use of ultrasound guidance during the removal should be considered.

If the implant cannot be found in the arm after comprehensive localization attempts, consider applying imaging techniques to the chest as rare events of migration to the pulmonary vasculature have been reported. If the implant is located in the chest, surgical or endovascular procedures may be needed for removal; HCPs familiar with the anatomy of the chest should be consulted.

If at any time these imaging methods fail to locate the implant, etonogestrel blood level determination can be used for verification of the presence of the implant. Please contact your local supplier for further guidance.

If the implant migrates within the arm, removal may require a minor surgical procedure with a larger incision or a surgical procedure in an operating room. Removal of deeply inserted implants should be conducted with caution in order to help prevent damage to deeper neural or vascular structures in the arm. Non-palpable and deeply inserted implants should be removed by HCPs familiar with the anatomy of the arm and removal of deeply-inserted implants.

Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.

Please contact your local supplier for further guidance.

4.2.5 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 4.2.3 “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, as long as the site is in the correct location, i.e., 8–10 cm from the medial epicondyle of the humerus and 3–5 cm posterior to (below) the sulcus (see section 4.2.3 “How to insert Implanon NXT”). If the same incision is being used to insert a new implant, anesthetize the insertion site (e.g. 2 ml lidocaine (1%)) applied just under the skin commencing at the removal incision along the ‘insertion canal’ and follow the subsequent steps in the insertion instructions.

Contraindications

4.3 Contraindications

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

• Known or suspected pregnancy.

• Active venous thromboembolic disorder.

• Known or suspected sex steroid sensitive malignancies.

• Presence or history of liver tumours (benign or malignant).

• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

• Undiagnosed vaginal bleeding.

• Hypersensitivity to the active substance or to any of the excipients of Implanon NXT.