IMPLANON NXT Clinical Information and Training
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IMPLANON NXT™
Clinical Information and Training
These educational materials are provided for purposes of assisting in training health care providers
in countries outside the United States on the insertion and removal procedures for IMPLANON NXT.
They do not replace a review of the Prescribing Information, which should be reviewed prior to
administering or removing the product. 1
Agenda
► Clinical Information
► Counseling
► Insertion Procedure and Practice
► Localization Before Removal
► Removal Procedure and Practice
► Reinsertion
► Conclusion
2
Attending this training does not replace the need to
consult the regulatory approved Prescribing Information
regarding insertion, removal, and replacement
instructions and other information for IMPLANON NXT™.
These educational materials are provided for
purposes of assisting in training health care providers
in countries outside the United States on the insertion
and removal procedures for IMPLANON NXT.
They do not replace a review of the Prescribing
Information, which should be reviewed prior to
administering or removing the product.
3
IMPLANON NXT™
► Subdermal, long-acting hormonal
contraceptive, effective for up to 3 years
► Progestogen-only implant preloaded in a
disposable applicator
► IMPLANON NXT™ is radiopaque and
comparable to IMPLANON™
► Clinical trials with IMPLANON in 17 countries,
including the United States
► Clinical trials with IMPLANON NXT in 6 countries
(comparability and insertion)
4
Implant
4 cm
2 mm
Core:
• ethylene vinyl acetate (EVA) copolymer
• etonogestrel (68 mg)
• barium sulfate (15 mg)
Rate-controlling membrane: (0.06 mm)
100% EVA
5
Applicator
► Preloaded, sterile applicator
► Single use and disposable
► To be used only in accordance with instructions
for insertion by health care providers authorized
to carry out these procedures
► Inserters familiar with the applicator for
IMPLANON™ need to familiarize themselves with
the one for IMPLANON NXT™
6
Applicator
7
Clinical Information
8
Efficacy
► IMPLANON™ is over 99% effective in the population of users
– IMPLANON NXT™ was not studied in women who were greater
than 130% of ideal body weight
The contraceptive effect of IMPLANON NXT is related to the plasma levels of
etonogestrel, which are inversely related to body weight and decrease with
time after insertion. The clinical experience in heavier women in the third year
of use is limited. It cannot be excluded that the contraceptive effect in these
women during the third year of use may be lower than for women of normal
weight. HCPs may therefore consider earlier replacement of the implant in
heavier women.
► No method of contraception is 100% effective
► Medicines that frequently reduce the efficacy of oral
contraceptives reduce the efficacy of IMPLANON NXT
as well
9
Mechanisms of Action
► Ovulation inhibition
► Changes in the viscosity of cervical mucus
10Pharmacokinetics
► Etonogestrel is rapidly absorbed into the circulation
after insertion
► Ovulation-inhibiting concentrations are reached
within 1 day
► Maximum serum concentrations Day 1-13: 472-
1270 pg/ml
► The release rate of the implant decreases with time.
− End of Year 1: ~200 pg/ml
− End of Year 3: ~156 pg/ml
11Estradiol Levels
During Treatment
1500
Mean estradiol (pmol/L)
IMPLANON™ n = 44
1250
Copper IUD n = 29
1000
750
500
250
0
Baseline Month 12 Month 24 Last
Measurement
Despite ovulation inhibition mean estradiol concentrations
remain above the level seen in the early to follicular phase
Beerthuizen R, et al. Bone mineral density during long-term use of the progestagen contraceptive implant
IMPLANON™ compared to a non-hormonal method of contraception. Hum Reprod. 2000;15(1):118-122. This is a
prospective comparative study of a progestogen-only contraceptive and a non-hormonal IUD for the duration of 2
years with a primary outcome the change in BMD z-score at last measure.
Beerthuizen et al. Hum Reprod. 2000 12Bone Mineral Density
► In a comparative study of IMPLANON™ (n=44) vs non-
hormonal IUD users (n=29), bone density remained
unaltered over 2 years, with no detectable difference
between the 2 groups1
1. Beerthuizen R, et al. Human Reproduction, 2000
13Bleeding Patterns – Study Design
Mansour et al, European Journal of Contraception and Reproductive
Health Care, 2008
► Study Design: Data from 11 clinical trials conducted in multiple countries (n=923, 18-40
years of age). The trials all had an open-label design and were noncomparative or
comparative with either Norplant (levonorgestrol implants) or a nonmedicated intrauterine
device. Most trials were at least 2 years in duration, had contraceptive efficacy and
bleeding among their outcome measures, and had a 3-month visit schedule up to and
including 3 months after implant removal. All subjects recorded bleeding data in 90-day
reference periods.
► Key definitions used in the study:
− A bleeding day was defined as any day with vaginal discharge containing blood that
required more than one sanitary napkin or tampon per day
− A spotting day was defined as any day with vaginal discharge containing blood that
required at most one sanitary napkin or tampon per day
− A bleeding-free day was defined as a day during which neither bleeding nor spotting
was entered in the diary
Mansour et al, European Journal of Contraception and Reproductive Health Care, 2008 14Bleeding Patterns
► During the use of IMPLANON NXT™, women are likely to have
changes in their bleeding pattern
► Changes may relate to bleeding frequency (absent, less, more
frequent, or continuous), intensity (reduced or increased), or
duration
► Bleeding pattern experienced during the first 3 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 woman’s acceptance of a bleeding pattern
► Evaluation of vaginal bleeding or absence may be indicated
to exclude gynecological pathology or pregnancy on an
ad-hoc basis
Mansour et al, European Journal of Contraception and Reproductive Health Care, 2008 15Bleeding/Spotting (B/S) During
IMPLANON™ Use
Per 90-day reference period for all participants
Mean B/S days 17.7
Mean B/S episodes 2.4
Study Design: Data from 11 clinical trials conducted in multiple countries (n=923, 18-
40 years of age). The trials all had an open-label design and were noncomparative
or comparative with either Norplant or a nonmedicated intrauterine device. Most
Reference periods 2-12 trials were at least 2 years in duration, had contraceptive efficacy and bleeding
among their outcome measures, and had a 3 month visit schedule up to and
including 3 months after implant removal. All subjects recorded bleeding data in 90-
Number of women = 783-202 day reference periods (RPs).
90-day reference period – As dictated by WHO guidelines, the study reference
period analysis divided a subject’s bleeding information into 90-day segments. Each
segment represented one reference period, starting with the day of implant insertion
as the first day of the first reference period.
Mansour et al, European Journal of Contraception and Reproductive Health Care 2008 16Dysmenorrhea
► At baseline, 315 of 647 women reported mild, severe,
or very severe dysmenorrhea (48.7%)
► 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 and was reported as a common
(>0.1% andDiscontinuation Rates
► The overall discontinuation rate in 11 clinical trials was
18% (n=942)1
• The discontinuation rate due to bleeding
irregularities was 11%
► Study design: Integrated safety analysis based on 11
international studies (n=942), women using
IMPLANON™ for 24,679 cycles over 1‐5 years.
1 Blumenthal et al, European Journal of Contraception and Reproduction Health Care 1/2008 Pg 32
18Adverse Reactions
Based on Clinical Trials
Very Common Common
System Organ Class (>1/10) (1/100)
Infections and infestations Vaginal infection
Metabolism/nutritional Increased appetite
Affect lability, depressed
Psychiatric mood, nervousness, libido
decreased
Nervous system disorder Headache Dizziness
Vascular disorders Hot flush
Blumenthal et al, European Journal of Contraception and Reproductive Health Care, 2008 19Adverse Events
Based on Clinical Trials
Very Common Common
System Organ Class (>1/10) (1/100)
Abdominal pain, nausea,
Gastrointestinal disorders
flatulence
Skin and subcutaneous
Acne Alopecia
tissue disorders
Reproductive system and Breast tenderness, breast pain,
Dysmenorrhea, ovarian cyst
breast disorders menstruation irregular
General disorders and Implant site pain, implant site
administration site reaction, fatigue, influenza like
condition illness, pain
Investigations Weight increased Weight decreased
Blumenthal et al, European Journal of Contraception and Reproductive Health Care, 2008 20Adverse Reactions
Based on Clinical Trials
Site Reactions:
In clinical trials of IMPLANON NXT™, in which investigators were
asked to examine the implant site after insertion, implant site
reactions were reported in 8.6% of women. Erythema was the
most frequent implant site complication, reported during and/or
shortly after insertion, occurring in 3.3% of subjects. Additionally,
hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling
(0.7%) were reported.
21Use While Breastfeeding
► Small amounts of etonogestrel are excreted in breast
milk (~0.2% of estimated absolute maternal daily dose)
► Comparative study: Cu-IUD (n=33) vs IMPLANON™
(n=38), infants followed up to 36 months
• No effect on milk quality (protein, lactose, or fat
concentration) or quantity was detected2
• No difference for infant growth and development
between IMPLANON and an IUD3
► For further information about breastfeeding, refer to
the approved Product Information
22Contraindications
► Known or suspected pregnancy
► Active venous thromboembolic disorder
► Known or suspected sex steroid sensitive malignancies
► Presence of history of liver tumors (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™
Approved Product Information 23Interactions
► Interactions can occur with medicinal products
that induce hepatic enzymes, specifically
cytochrome P450 enzymes, which can result in
increased clearance of sex hormones
• eg, phenytoin, phenobarbital, primidone,
bosentan, carbamazepine, rifampicin
• HIV medication (eg, ritonavir, nelfinavir, nevirapine,
efavirenz)
• Possibly also oxcarbazepine, topiramate,
felbamate, griseofulvin, and the herbal remedy
St. John’s wort
Approved Product Information 24Exposure to IMPLANON™
During Pregnancy
► If pregnancy occurs during use of IMPLANON NXT™, the
implant should be removed
► Postmarketing surveillance since worldwide launch of
IMPLANON (1998) does not indicate adverse effects on
fetus1
► Extensive epidemiological studies have revealed neither
an increased risk of birth defects in children born to women
who used oral contraceptives (OCs) prior to pregnancy,
nor of a teratogenic effect when OCs were inadvertently
used during pregnancy
► Although this probably applies to all OCs, it is not clear
whether this is also the case for IMPLANON NXT
1. Data on file
25
2. Approved Product InformationSummary
► Subdermal long-acting hormonal contraceptive
► Radiopaque
► More than 99% effective in the population of users
► Should be removed after 3 years
► Rapid onset of action
► Reversible with a quick return to menstruation
► Does not require daily, weekly, or monthly
administration
26Summary (continued)
► Rapid return to normal menstruation
► The most common side effect associated with
discontinuation is irregular bleeding
► Counseling of women is very important
27Questions
28Counseling
29Counseling Points
Discuss benefits, risks, and possible side effects
► Highly effective
► No method of contraception is 100% effective
► Return to normal menstrual cycle
► If inserted correctly, can be removed any time
► Should not be used for longer than 3 years and will need to be
removed at the end of that time period
► Contraindications
► Side effects, emphasizing the alteration of the bleeding pattern
► No protection against STD or HIV
30Counseling Points
Alterations in bleeding pattern and dysmenorrhea
► During the use of IMPLANON NXT™, women are likely to
have changes in their menstrual bleeding pattern
► About 20% of women had amenorrhea
► About 20% of women experienced frequent and/or
prolonged bleeding
► Dysmenorrhea tended to improve
31Counseling Points
► Tell women that in clinical trials bleeding changes were
the most common reason for stopping treatment with
IMPLANON™ (11%)
► Explain insertion and removal procedures
• The implant should be palpable
• Difficult removal and scars/complications may occur
► Provide sufficient time for woman to review, consider,
and ask questions
32When to Insert IMPLANON NXT™
► The possibility of ovulation and conception should
always be considered and pregnancy must be
excluded prior to insertion of IMPLANON NXT –
according to usual routine
► IMPLANON NXT will protect against pregnancy
immediately after insertion if inserted at the
recommended time
► If inserted any other time: exclude pregnancy and use
barrier method for at least 7 days
► Always verify the presence of the implant in the
woman’s arm immediately after insertion by palpation
33Recommended
Timing of Insertion
Previous method/Clinical setting Timing of insertion
None Day 1-5 of cycle
Combined method (COC - combined oral contraceptive, During drug-free week
patch, ring)
POP – Progestogen only pill Within 24 hours of last dose
IMPLANON™/IUS Same day as removal
Injectable progestogen only When next injection is due
First trimester termination of pregnancy Within 5 days of termination
Second trimester termination of pregnancy/miscarriage Between 21-28 days after
termination or miscarriage
Postpartum – breastfeed/not breastfeeding After 4th week postpartum/
between 21-28 days postpartum,
respectively
Approved Product Information 34Questions
35Insertion Procedure
and Practice
36Attending this training does not
replace the need to consult the
regulatory approved Prescribing
Information regarding insertion,
removal, and replacement
instructions and other information
for IMPLANON NXT™.
37IMPLANON™ NXT Applicator
Applicator design elements
► Preloaded for single use only
► Cap-blocking mechanism with cap/lever
► Implant retained in needle before insertion
► Single-handed movement with slider
► Needle partly visible
38Preparation for Insertion
► Insertion of IMPLANON NXT™ should be performed under aseptic
conditions, strictly in accordance with the instructions as
provided in the regulatory approved Prescribing Information
and by a health care provider authorized to prescribe and
perform the procedure
► Insertion of the implant should only be performed with the
preloaded applicator
► It is recommended that the health care provider performs the
procedure in a sitting position
► Confirm no allergies to antiseptic and anesthetic
► Allow the woman to lie on her back with her non-dominant arm
turned outwards and bent at the elbow
39Preparation for Insertion
► To minimize the risk of neural or vascular damage, the implant should be
inserted subdermally at the inner side of the non-dominant upper arm about
8-10 cm above the medial epicondyle of the humerus in order to avoid the
large blood vessels and nerves that lie deeper in the subcutaneous tissue in
the sulcus between the triceps and biceps muscles
► Make 2 marks: one at insertion site and a second one a few centimeters
above the insertion site to be used as direction guide during insertion
► Clean the insertion site with an antiseptic
► 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 disposable applicator carrying the implant from its blister
► Keep the needle and the implant sterile (if contamination occurs, a new
package with a new sterile applicator must be used)
40Location of IMPLANON NXT™
in the Arm
41Importance of Subdermal Placement
► IMPLANON NXT™ should be inserted subdermally
► If the implant is inserted too
deeply, neural or vascular
damage may occur. Too
deep or incorrect insertions
have been associated with
paresthesia (due to neural
damage) and migration of
the implant (due to IMPLANON NXT
intramuscular or fascial
insertion), and in rare cases
with intravascular insertion.
Moreover, when the implant
is inserted too deeply, it may
not be palpable and the
localization and/or removal
can be difficult.
42How to Insert
► Remove the sterile preloaded disposable IMPLANON NXT™ applicator
carrying the implant from the blister
► Hold the applicator just above the needle at the textured surface area
and remove the transparent protection cap from the needle which
contains the implant
► If the cap does not come off easily the applicator should not be used
and replaced by a new one
► You may 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
subcutaneously, as it will retract
the needle and release the
implant from the applicator
43How to Insert IMPLANON NXT™
► Stretch the skin around the insertion site with
thumb and index finger
► Puncture the skin with the tip of the needle
angled about 30°
► During the entire insertion procedure you
should be able to see the insertion site and
the movement of the needle
► 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
► If the needle is not inserted to its full length,
the implant will not be inserted properly
44How to Insert IMPLANON NXT™
► While keeping the applicator in the
same position and the needle inserted
to its full length, unlock the purple slider
by pushing it slightly down
► Move the slider fully back until it stops,
leaving the implant now in its final
subdermal position and locking the
needle inside the body of the
applicator
► Now the implant is in its final subdermal position
• Inserting the needle to its full length is crucial; failure to do so will result
in a partly visible implant protruding from the skin
• If partial protrusion occurs, discard the implant and reinsert a new
sterile implant using a new applicator
► Remove the applicator
45How to Insert IMPLANON NXT™
► 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
► A correctly inserted implant should be palpable
46Live Insertion Video
47Post-Insertion Steps
► Apply a small adhesive bandage over the insertion site
► Apply a 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
► Complete the User Card and give it to the woman to keep
and complete the adhesive labels and affix to the
woman’s medical record
► The applicator is for single use only and must be disposed
of the inserting physician in accordance with local
regulations for biohazardous waste
48Confirmation Immediately
After Insertion
► Always verify the presence of the implant by
palpation
► If the implant is not palpable, confirm its presence in
the arm with imaging techniques as soon as possible
► The woman must use a
backup method of
contraception until the
presence of the implant
has been confirmed
49If 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. In any other
case, the insertion must be considered to not have been
complete
► Use other methods to confirm the presence of the implant
presence in the arm. Suitable methods are: two-dimensional
X-ray, ultrasound scanning (USS) with a high-frequency linear
array transducer (10 MHz or greater), X-ray computerized
tomography (CT scan), or magnetic resonance imaging (MRI).
Prior to the application of X-ray, USS, CT, or MRI for the
localization of the implant, it is recommended, to consult the
local supplier of IMPLANON NXT™ for instructions
50If You Cannot Feel the Implant
or in Doubt of Its Presence
► In case these imaging methods fail, it is advised to
verify the presence of the implant in the arm 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
51Questions
52Localization
53Localization
► Localization is an essential component of the
removal process
► Always localize
• Immediately after insertion
• Immediately prior to removal
► Localization begins with palpation
► Confirm presence of implant in the arm with imaging
techniques (ultrasound, X-ray) as soon as possible
► The woman must use a backup method of
contraception until the presence of IMPLANON NXT™
has been confirmed
54Localization Before Removal
► 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
health care providers familiar with the anatomy of the arm
► There have been occasional reports of migration of the
implant; usually this involves minor movement relative to the
original position unless inserted too deeply. This may
complicate localization of the implant by palpation, USS,
and/or MRI, and removal may require a larger incision and
more time.
55Imaging of IMPLANON™ and
IMPLANON NXT™
IMPLANON IMPLANON NXT
non-radiopaque radiopaque
Visible on X ray no yes
Visible on US yes yes
Visible on CT no yes
Visible on MRI yes yes
Positive ENG Assay yes yes
• If the imaging results are inconclusive, the presence of IMPLANON and IMPLANON NXT can
be verified by ENG determination. Please contact manufacturer for further guidance
• Regardless of chosen technique for confirmation of presence, it is recommended deep
implants are removed under ultrasound guidance
56Radiopaque Implant
Localization X-ray
57Ultrasound Localization
► Ultrasound
• Should be performed by a health care provider who is familiar with
implant localization procedures and with US equipment
• With a linear array transducer
• With a frequency of 10 MHz or greater
• Set US focus superficial (increases visibility of shadow) and switch off
image enhancing software
• With correct technique and transducer, implants can be located
• Ideally perform removal shortly after/during localization to increase
accuracy of removal
► 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
58Properly Inserted IMPLANON™
Transverse Image
implant
acoustic shadow
59Implant Located Below the
Fascia Muscularis
implant
acoustic shadow
60Implant Deep in Biceps:
Transverse
implant
acoustic shadow
61MRI Localization
► MRI
• Radiopaque implant appears as a
hypodense area
• Important to differentiate from blood vessels
• Can be followed through images for 40 mm
62MRI
The implant
appears as a
hypodense area
► Important to
differentiate from
blood vessels
► Can be followed
through images
for 40 mm
63Deep Placement Into Biceps Muscle
64ENG Assay
► Serum etonogestrel levels
● Can only indicate presence, never confirm location
● Obtain when unable to localize by palpation and
imaging techniques
● The woman should not be using other contraceptive
hormones to avoid cross reactivity
● Assay can only be performed by approved laboratories
● Contact manufacturer for assistance in submitting the
sample
65Removal Procedure
and Practice
66Removal
► Indications ► Removal of IMPLANON NXT™ should be
performed under aseptic conditions, and
for removal strictly in accordance with the instructions
• Woman request as provided in the regulatory approved
• Medical indication Product Information and by a health care
• At the end of provider authorized to perform the
removal procedure
3 years of use
► Prior to removal, carefully read the full
instructions for removal in the regulatory
approved Product Information
► If the woman does not wish to become
pregnant, another contraceptive method
should be started immediately (return to
normal menstruation may be very rapid)
67Removal
► Counsel women about removal
► Determine whether the woman has IMPLANON™
or IMPLANON NXT™
► Do Not attempt removal until the location of the
implant has been unambiguously verified
► Confirm no allergies to antiseptic and anesthetic
► Place the woman in same position as for insertion
► Maintain aseptic conditions
68Removal
► Possible situations complicating localization and/or removal
• Formation of fibrosis • Deep insertion
• Implant not palpable • Broken or damaged implant
• Implant not present • Migration
► Only start removal procedure if location of implant is unambiguously
confirmed
► In case of broken or damaged implant, remove all pieces and contact
manufacturer
► Removal of deeply inserted implants should be conducted with caution
in order to prevent damage to deeper neural or vascular structures in
the arm
► Consider referral to experienced colleague in case of difficult removal
► Exploratory surgery without knowledge of the exact location of the
implant is strongly discouraged
69Removal
► Locate the implant by palpation
and mark the distal end (end
closest to the elbow)
► Wash the area and apply an
antiseptic
► Anesthetize the arm with 0.5-1ml
lidocaine (1%) just below the distal
end of the implant at the marked
site where the incision will be made
► Be sure to inject the local
anesthetic under the implant to
keep it close to the skin surface
70Removal
► Push down the proximal
end of the implant 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
71Removal
► Gently push the implant toward
the incision until the tip is visible
► Grasp the implant with forceps
and remove the implant
► If the implant is encapsulated,
make an incision into the tissue
sheath and then remove the
implant with the forceps
72Removal
► If the tip of the implant does not become visible in
the incision, gently insert a forceps into the incision.
Grasp the implant. Flip the forceps over with your
other hand and gently pull out the distal part of
the implant
► If needed, carefully dissect fibrotic tissue around
the implant and grasp the implant with a second
pair of forceps
► The implant can then be removed
► Confirm that the entire rod, which is 4 cm long,
has been removed by measuring its length.
If the implant is shorter, a piece is still located in
the arm and needs to be removed as well
73Removal Video
74Post-Removal Steps
► 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
► If the woman does not wish to become pregnant, a
method of contraception should be started immediately
► The implant must be disposed of by the removing
physician in accordance with local legislation for
biohazardous waste
75Questions
76Removal Practice
77Reinsertion
78How to Replace IMPLANON NXT™
► Replacement of IMPLANON NXT should be performed under aseptic
conditions, and strictly in accordance with the instructions as
provided in the regulatory approved Product Information and by a
health care provider authorized to perform the removal procedure
► Immediate replacement can be done after removal of the previous
implant as described in ‘How to remove IMPLANON™, in the
regulatory approved Product Information’
► 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
79How to Replace IMPLANON NXT™
► 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
► Anesthetize the insertion site along the ‘insertion canal’ 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 protrusion of the implant occurs, discard the implant
and reinsert a new sterile implant using a new applicator
80How to Replace IMPLANON NXT™
► Always verify the presence
of the implant in the woman’s
arm immediately after
reinsertion by palpation
► By palpating both ends of the
implant, you should be able to
confirm the presence of the 4 cm rod
► A correctly inserted implant should be palpable
81How to Replace IMPLANON NXT™
► After replacing the implant, close the incision with a
steri-strip and apply a small 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
► 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 used implant and the applicator must be disposed of
by the removing physician in accordance with local
legislation for biohazardous waste
82Confirmation Immediately
After Insertion
► Always verify the presence of the implant by palpation
► If the implant is not palpable, confirm its presence in the
arm with imaging techniques as soon as possible
► The woman must use
a backup method of
contraception until
the presence of the
implant has been
confirmed
83Questions
84Thank You
85Attending this training does not replace the need to
consult the regulatory approved Prescribing Information
regarding insertion, removal, and replacement
instructions and other information for IMPLANON NXT™.
These educational materials are provided for
purposes of assisting in training health care providers
in countries outside the United States on the insertion
and removal procedures for IMPLANON NXT.
They do not replace a review of the Prescribing
Information, which should be reviewed prior to
administering or removing the product.
Copyright © 2013 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA.
All rights reserved. WOMN-1086674-0000 08/13
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