Update to Section 7.2 'How to insert Implanon NXT'.

Safety Label Update to update the information concerning broken or bent implant in SmPC and PL

Inclusion of a video link to demonstrate insertion and removal procedures, updates to  the insertion and removal text, Patient Alert card [formerly user card] instructing the patient to  palpate the implant and an update to reported side effects that can be associated with an implant found in the pulmonary artery.

A warning about hormonal contraception and suicidality

SPC Change Details:   Update on interactions with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors

SPC Change Details:   Risk of migration with Implanon NXT and updated recommendations on insertion, localisation and removal

Change to Sections: 4.2, 4.4, 7,8 & 10

Change to Sections: 4.4, 4.5, 4.8, 6.4, 6.5, 10

Reason for submission: Updates to section 4.4 special warnings and precautions for use, section 4.5, interaction with other medicinal products 4.8 Undesirable effects [HPRA AE statement] 6.4, Special precautions for storage, reworded, section 6.5, additional pack size, Section 10 Date of revision

Reason for submission: Renewal: Section 9 - Date of renewal of authorisation,

4.2    Posology and method of administration

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Additional information and more detailed instructions concerning the insertion and removal of the implant will be sent on request free of charge (Schering-Plough, telephone 00 44 1707 363418Merck Sharp & Dohme Ireland (Human Health) Limited, telephone: +353 1 299 8700).

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4.2.2 When to insert Implanon nxt

IMPORTANT: Rule our 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 combined oral contraceptive or on the day of removal of the vaginal ring or transdermal patch. has been used,At the latest,  the implant should be inserted preferably on the day of removal, but at the latestfollowing 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.

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·           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 monthfrom the progestagen-only pill. The implant should be inserted on the day after stopping the progestagen-only pillwithin 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 may should be inserted immediately following a complete first trimester abortion or miscarriage. If the implant is not inserted within five days following a first trimester abortion or miscarriage., follow the instructions under “No preceding hormonal contraceptive use in the past month”.

·         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”).

§         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 “Pregnancy and Lactation”). The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

 

Note:
It is important to follow the directions above regarding the proper timing of the insertion of the Implanon nxt implant. If deviating from the above directions, pregnancy should be first ruled out and the woman should be instructed to also use a non-hormonal contraceptive method, such as condoms, until 7 days after insertion of the implant.

4.2.3 How to insert Implanon nxt

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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.

 

·          Hold the applicator just above the needle at the textured surface area. R and remove the transparent protection cap by sliding it horizontally in the direction f the arrow away from the needle which contains the implant (Figure 3). If the cap does not come off easily the applicator should not be used. You may can 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 it will retract the needle and release the implant from the applicator.	Figure 3
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·          While keepingKeep the applicator in the same position and 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. , uUnlock the purple slider by pushing it slightly down. Move the slider fully back until it stops (Figure 7)., leaving t The implant is now in its final subdermal position, and locking the needle is locked inside the body of the applicator (Figure 7).  The applicator can now be Ifremoved. If  the 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 needle will not be fully retracted and the implant will not be inserted properly. The applicator can now be removed.	Figure 7

 

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·          If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision (Figure 15). Grasp the implant. 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.

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·          Confirm that the entire rod, which is 4 cm long, has been removed by measuring its length. If a partial implant (less than 4cm) is removed, the remaining piece should be removed by following the instructions in Section 4.2.4. “How to remove Implanon nxt.” [….]

 

4.3       Contraindications

·         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.

 

 

4.5       Interaction with other medicinal products and other forms of interaction

 

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Hepatic metabolism

Interactions can occur with medicinal products that induce hepatic enzymes, specifically cytochrome P450 enzymes, which can result in increased clearance of sex hormones (e.g., phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, and HIV-medicartion (e.g. ritonavir, nelfinavir, nevirapine, efavirenz) and possibly also oxcarbazepine, topiramate, felbamate, , griseofulvin and the herbal remedy St. John’s wort). 

 

Management

Women on treatment with any of the above mentioned drugs should use a non-hormonal contraceptive method in addition to Implanon nxt. With hepatic enzyme-inducing drugs, the non-hormonal contraceptive method should be used during the time of concomitant drug administration and for 28 days after their discontinuation.

In women on long-term treatment with hepatic enzyme-inducing drugs, it is recommended to remove the implant and to advise prescribe a contraceptive non-hormonal method that is unaffected by the interacting drug.

 

Increase in plasma hormone levels associated with co-administered drugs

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4.8       Undesirable effects

 

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Paresthesia or paresthesia-like events may occur. Expulsion or migration of the implant may be possible (see also section 4.4.1 ‘Warnings’). If instructions are not followed (see section 4.2 "Posology and method of administration"), incorrect insertions, difficult localizations and difficult removals of the implant may occur. Surgical intervention might be necessary when removing the implant.

 

10        DATE OF REVISION OF THE TEXT

April 2010December 2011