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Implanon Workshop'13
Implanon Workshop'13
Agenda
Clinical Information Counselling Insertion Procedure and practise Localisation Removal Procedure and practise Reinsertion Conclusion
IMPLANON NXT
Subdermal, long-acting hormonal contraceptive, effective for up to 3 years1 Progestogen-only implant preloaded in a disposable applicator1 IMPLANON NXT is radiopaque1 and bioequivalent to IMPLANON2 IMPLANON NXT studied in an open label study in 6 countries (clinician satisfaction and insertion) 3
1. IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref.9.0) 2. Data on file, MSD
IMPLANON
Implant
4 cm
2 mm
Core:
ethylene vinyl acetate (EVA) copolymer (28% vinyl acetate) etonogestrel (68 mg) barium sulfate
Release Rate: Initial- 60 g/day Week 5 to 6 60 to 70 g/day End of 1st year 35 to 45 g/day End of 2nd year 30 to 40 g/day End of 3rd year 25 to 30 g/day
Applicator
Preloaded, sterile and disposable applicator1 Designed to facilitate subdermal insertion of the implant2 To be used only in accordance with instructions for insertion, removal and replacement, and by HCPs familiar with the insertion procedure HCPs familiar with the previous applicator need to familiarise themselves with IMPLANON NXT
1.IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref. 9.0) 2. Mansour et al. Contraception 82(2010) 243-249
Clinical Data
Efficacy
When inserted correctly, IMPLANON is over 99% effective1 Majority of reported pregnancies in clinical practice related to insertion issues (incorrect timing, non-insertion, etc.) 1 No method of contraception is 100% effective Some medicines which reduce the efficacy of oral contraceptives may reduce the efficacy of IMPLANON NXT as well The clinical experience in heavier women in the 3rd year of use is limited. the contraceptive effect during the 3rd year of use may be lower than for women of normal weight. HCPs can consider earlier replacement of the implant in heavier women.
1. Graesslin et al, European Journal of Contraception and Reproductive Health Care,13:1,4-12 2008
Ovulation inhibition
In clinical trials, ovulations were not observed in the first two years of use and only rarely in the third year
Quickly Reversile
In 2 separate clinical studies, etonogestrel levels of women with IMPLANON were measured at fixed intervals
ENG release rate: 60-70 g/day, decreasing to 25-30 g/day after 3 years
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11
250
0 Baseline Month 12* Month 24** Last measurement
Despite ovulation inhibition mean estradiol concentrations were not significantly different between the two treatment groups.
Beerthuizen R et al. Human Reproduction 15(1) (2000) 118-122.
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Bleeding Patterns
During the use of IMPLANON NXT, women are likely to have changes in their menstrual bleeding pattern These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration Bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women. Amenorrhea was reported in about 1 of 5 women while another 1 of 5 women reported frequent and/or prolonged bleeding Information, counselling and the use of a bleeding diary can improve the womans acceptance of a bleeding pattern. Evaluation of vaginal bleeding should be done on an ad hoc basis to exclude gynaecological pathology or pregnancy
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IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref. 9.0)
Bleeding day: any day with vaginal discharge containing blood that required more than one sanitary towel or tampon per day.
Spotting day: any day with vaginal discharge containing blood that required at most one sanitary towel or tampon per day.
Bleeding-free day: a day during which neither bleeding nor spotting was entered in the diary. B-S episodes: one or more consecutive days during which bleeding or spotting was entered in the diary, bounded by bleeding-free days.
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Mansour et al, European Journal of Contraception and Reproductive Health Care (2008) 13-28
Amenorrhoea: no bleeding or spotting days throughout the 90 day reference period (RP) Infrequent bleeding: less than 3 B/S episodes in a 90 day RP, excluding amenorrhoea Normal frequency: 3 5 B/S episodes in a 90 day RP Frequent bleeding: more than 5 B/S episodes in a 90 day RP Prolonged bleeding: any B/S episode (uninterrupted) lasting more than 14 days in a 90 day RP
* Normal refers to normal frequency (ie 3-5 bleeding episodes in a 90 day reference period), including prolonged episodes (>14 days) 16
Mansour et al, European Journal of Contraception and Reproductive Health Care (2008) 13-28
Dysmenorrhoea
In an analysis of 11 clinical trials (n=923),
At baseline, 48.7% of subject reported dymenorrhoea. During the use of IMPLANON, 77% reported that their symptoms resolved, and 6% reported decreased severity. Dysmenorrhoea developed or became worse in 5.5% of women.
Mansour et al, European Journal of Contraception and Reproductive Health Care (2008) 13-28
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Adverse Events
thought to be related to IMPLANON in >5% of women
WHO preferred term
Headache Weight increase Acne Breast pain Emotional lability Abdominal pain
Adapted from Blumenthal et al
*Related AE %
15.3 11.8 11.4 10.2 5.7 5.2
*Related AE is defined as possibly, probably, or definitely related to study drug according to the investigator.
Blumenthal et al, European Journal of Contraception and Reproductive Health Care (2008) 29-36
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n=942
31
25 24 % of women
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Weight increase in kg
Adapted from Blumenthal et al.
Blumenthal et al, European Journal of Contraception and Reproductive Health Care (2008) 29-36
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Small amounts of etonogestrel are excreted in breast milk (~ 0.2% of estimated absolute maternal daily dose) In a comparative study of breastfeeding women (Cu-IUD (n=38) vs. IMPLANON (n=42)) and infants followed up to 36 months:
- No significant difference in composition of breast milk when measured at regular intervals. - No significant difference for body length, body weight and biparietal head circumference
IMPLANON NXT may be used during lactation and should be inserted after 4th post-partum week.
For further information about breast feeding, refer to the approved product information.
IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref.9.0) Reinprayoon D. Contraception (2000) 239-246
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Contraindications
Known or suspected pregnancy Active venous thromboembolic disorder Known or suspected sex steroid sensitive malignancies 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
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Drug Interactions
Interactions can occur with medicinal products that induce microsomal enzymes, specifically cytochrome P450 enzymes, which can result in increased clearance of sex hormones, such as:
Oxcarbazepine
Topiramate Felbamate Griseofulvin
Also HIV protease (e.g., ritonavir, nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine), and combinations of them, have been reported to potentially affect hepatic metabolism
IMPLANON NXTTM Local Approved Product Information RA 0450 OS S9 (ref.9.0)
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Drug Interactions
Women
on concomitant treatment with any of the drugs mentioned, - To use non-hormonal contraceptive methods in
addition to IMPLANON NXT - With microsomal enzyme-inducing drugs, the non-hormonal contraceptive method should be used during the time of concomitant drug administration and for 28 days after discontinuation.
Women
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Counselling
Contraindications
Side effects, emphasising the alteration of the menstrual bleeding pattern No protection against STD or HIV
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Timing of insertion
Day 1-5 of cycle
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Check the applicator. The needle should be fully retracted and only the purple tip of the obturator should be visible The following imaging methods can be used to confirm the presence of IMPLANON NXT: Two-dimensional x-ray (x-ray) X-ray computerised tomography (CT) Ultrasound scanning (USS) with high frequency linear array transducer (10MHz or greater) Magnetic resonance imaging (MRI) Prior to the application of any of these methods for the localisation of an implant it is recommended to consult the local supplier for instructions Please be aware that implants inserted prior to the launch of IMPLANON NXT are not radiopaque and will only be visible under USS or MRI.
IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref.9.0)
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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
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Localisation
Localisation is an essential component of the insertion and removal process Always localise:
immediately after insertion immediately prior to removal
Localisation begins with palpation If the implant is not palpable after insertion, confirm its presence in the arm with imaging techniques (ultrasound, X-ray, CT scan, MRI) as soon as possible A non-hormonal contraceptive method must be used until the presence of the implant can be verified.
IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref.9.0)
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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 healthcare providers familiar with the anatomy of the arm
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Visible on MRI
Positive ENG Assay
yes
yes
yes
yes
If the imaging results are inconclusive, the presence of IMPLANON NXT can be verified by ENG determination.
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Radiopaque Implant
Localisation X-ray
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Ultrasound Localisation
Ultrasound
Should be performed by a HealthCare Provider with proper equipment and who is familiar with implant localisation procedures
Ultrasound scanning (USS) with high frequency linear array transducer ( 10MHz)
Set US focus superficial (increases visibility of shadow) and switch off image enhancing software With correct technique and transducer, most implants can be located Perform removal shortly after/during localisation to increase accuracy of location
Ultrasound characteristics
Sharp acoustic shadow below the implant in the transverse position Implant is a small echogenic spot (2 mm) when viewed in transverse position
2.
1. Lantz A, Nosher JL, Pasquale S, Siegel RL, Contraception 1997:56:323-327 JamesP, Trenary J, Australian and New Zealand Journal of Obstetrics and Gynaecology 2006;46:225-228
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acoustic shadow
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MRI Localisation
MRI
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MRI
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ENG Assay
Serum etonogestrel levels
Can indicate presence, but not confirm location Obtain when unable to localise by palpation and imaging techniques The woman should not be using other contraceptive hormones (cross reactivity)
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Removal
Should be performed only by HealthCare Providers familiar with the procedure Prior to removal carefully read the full Product Information If the woman does not wish to become pregnant, another contraceptive method should be started immediately (return to pre-existing fertility may be very rapid)
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Removal
Only start removal procedure if location of implant is confirmed In case of broken or damaged implant, remove and contact local supplier In case of a difficult removal, consider referral to an experienced colleague If implant cannot be removed, please contact local supplier for further guidance
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Questions
Replacement of IMPLANON NXT should only be performed under aseptic conditions and only by a healthcare provider who is familiar with the removal and insertion procedure Immediate replacement can be done after removal of the previous implant as described in How to remove IMPLANON NXT The procedure to replace IMPLANON NXT is similar to the insertion procedure 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 implant is replaced immediately, no backup method of contraception is necessary
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If the same incision is being used, the instructions below must also be taken into account The small incision made during the removal procedure can be used as the entrance for the needle of the new applicator Anaesthetise the insertion site with 2 ml lidocaine (1%) applied just under the skin commencing at the removal incision along the insertion canal Inserting the needle to its full length is crucial; failure to do so will result in a partly visible implant in the removal incision in the skin If partial extrusion occurs, discard the implant and reinsert new sterile implant Always verify the presence of the rod by palpation. Request that the woman palpate the rod as well.
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After replacing the implant, close the incision with a steristrip and apply an adhesive bandage Apply sterile gauze with a pressure bandage to minimise bruising. The woman may remove the pressure bandage after 24 hours and the small bandage 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 old implant and the applicator must be disposed of by the removing physician in accordance with local legislation.
IMPLANON NXT Local Approved Product Information RA 0450 OS S9 (ref.9.0)
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Questions
Thank you