IMPLANON NXT Implant for subdermal use Ref.[49861] Active ingredients: Etonogestrel

Posology

1 implant, which can be left in place for three years.

Paediatric population

The safety and efficacy of Implanon NXT in adolescents under the age of 18 have not been established.

Method of administration

Pregnancy should be excluded before insertion of Implanon NXT.

It is strongly recommended that Implanon NXT be inserted and removed only by healthcare professionals (HCPs) who have completed training for the use of the Implanon NXT applicator and the techniques for insertion and removal of the Implanon NXT implant, and, where appropriate, that supervision be requested 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 How to insert Implanon NXT and How to remove Implanon NXT.

Videos demonstrating insertion and removal of the implant are available online at www.implanonnxtvideos.eu. Please contact: Organon Pharma (Ireland) Limited at Tel: +353 (01) 5828260 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.

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). 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 Implanon NXT package contains a Patient Alert 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 date of removal on the Patient Alert Card. Patients should be instructed to keep the Patient Alert Card in a safe place and show the Card at any visits related to the use of her implant. The Patient Alert Card also contains instructions for the patient to occasionally gently palpate the implant to be sure that she knows its location. Patients should be instructed to contact their doctor as soon as possible if at any time they cannot feel the implant. The package also includes adhesive labels intended for HCP records showing the batch number. This information should be included in the electronic medical records of the patient if such are used.

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 and not on the correct day, this may result in an unintended pregnancy (see section 4.2 How to insert Implanon NXT and When to insert Implanon NXT).
• An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localisation and/or removal can be difficult (see section 4.2 How to remove Implanon NXT and section 4.4).

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, 2b and 2c).

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 How to insert Implanon NXT subsection ‘If the implant is not palpable after insertion’.

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 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 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 localisation and/or removal can be difficult (section 4.2 How to remove Implanon NXT and section 4.4).
• If the implant is inserted deeply, neural or vascular damage may occur. 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.

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 visualised.

For illustrative purposes, Figures depict the left inner arm.

• 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 Patient Alert Card and give it to the woman to keep. Also, complete the adhesive labels and affix it to the woman’s medical record. If electronic patient records are used, the information on the adhesive label should be recorded.
• 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 implant 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 its presence. 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 the implant cannot be found with these imaging methods, 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, contact the local representative of the Marketing Authorisation Holder who 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).

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 representative of the Marketing Authorisation Holder [Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay – North Dock, Dublin, D01 V4A3, Ireland Tel: +353 (01) 5828260] 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 Patient Alert 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 localising the implant and the anatomy of the arm. Contact the local representative of the Marketing Authorisation Holder [Organon Pharma (Ireland) Limited, Ireland. Tel: +353 (01) 5828260] for further information. See Section below on"Localisation 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

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), 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 localised 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 extremely rare cases 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 the local representative of the Marketing Authorisation Holder 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 the local representative of the Marketing Authorisation Holder for further guidance.

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 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 How to insert Implanon NXT). 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.

An implant should always be removed before inserting a new one. There is no data available on overdose with etonogestrel. There have been no reports of serious deleterious effects from an overdose of contraceptives in general.

5 years.

Implanon NXT should not be inserted after the expiry date as indicated on the primary package.

This medicinal product does not require any special storage conditions.

Store in the original blister package.

The blister pack contains one implant (4 cm in length and 2 mm in diameter) which is preloaded in the stainless steel needle of a ready-for-use, disposable sterile applicator. The applicator containing the implant is packed in a blister pack made of transparent polyethyleneterephthalate glycol (PETG) sealed with a lidding made of high density poly ethylene (HDPE). The content of the blister pack is sterile unless the package is damaged or opened.

Pack sizes: Carton box with 1 blister pack, carton box with 5 blister packs.

Not all pack sizes may be marketed.

See section 4.2.

The applicator is for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.