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NEXPLANON 68 MG IMPLANT FOR SUBDERMAL USE

Active substance(s): ETONOGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

2679
17.06.15[3]

Nexplanon® 68 mg implant for subdermal use
(etonogestrel)
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section
4.
Your medicine is available using the above name but will be referred to as
Nexplanon throughout the leaflet.
What is in this leaflet
1. What Nexplanon is and what is it used for
2. What you need to know before you use Nexplanon
3. How to use Nexplanon
4. Possible side effects
5. How to store Nexplanon
6. Contents of the pack and other information
7. Information for the health care professional
Section 7- Information for the health care professional is on other leaflet in
the package - INFORMATION FOR THE HEALTHCARE PROFESSIONAL
1. What Nexplanon is and what is it used for
Nexplanon is a contraceptive implant preloaded in a disposable
applicator. The implant is a small, soft, flexible, plastic rod, 4 cm in length
and 2 mm in diameter, which contains 68 milligrams of the active
substance, etonogestrel. The applicator allows the healthcare
professional to insert the implant just under the skin of your upper arm.
Etonogestrel is a synthetic female hormone resembling progesterone.
A small amount of etonogestrel is continuously released into the
bloodstream.
The implant itself is made of ethylene vinyl acetate copolymer, a plastic
that will not dissolve in the body. It also contains a small amount of
barium sulfate which renders it visible under X-ray.
Nexplanon is used to prevent pregnancy
How does Nexplanon work
The implant is inserted just below the skin. The active compound,
etonogestrel, works in two ways:
 It prevents the release of an egg cell from the ovaries.
 It causes changes in the cervix that make it difficult for sperm to enter
the womb.
As a result, Nexplanon protects you against pregnancy for a period of
three years, but if you are overweight the doctor may advise you to
replace the implant earlier. Nexplanon is one of several means of
preventing pregnancy. Another frequently used birth control method is the
combined Pill. In contrast to combined Pills, Nexplanon can be used by
women who may not, or do not want to use estrogens. When you use
Nexplanon you do not have to remember to take a pill every day. This is
one of the reasons that Nexplanon is very reliable (over 99% effective). If
in rare cases the implant is not inserted correctly or is not inserted at all,
you may not be protected against pregnancy. When you are using
Nexplanon, your menstrual bleeding may change and become absent,
irregular, infrequent, frequent, prolonged, or rarely heavy. The bleeding
pattern that you experience during the first three months generally
indicates your future bleeding pattern. Painful periods may improve.
You may stop using Nexplanon at any time (See also “When you want to
stop using Nexplanon”).
2. What you need to know before you use Nexplanon
Hormonal contraceptives, also including Nexplanon, do not protect
against HIV infection (AIDS) or any other sexually transmitted
disease.
Do not use Nexplanon
Do not use Nexplanon if you have any of the conditions listed below. If
any of these conditions apply to you, tell your doctor before Nexplanon is
inserted. Your doctor may advise you to use a non-hormonal method of
birth control.
 if you are allergic to etonogestrel or any of the other ingredients of this
medicine (listed in section 6).
 if you have a thrombosis. Thrombosis is the formation of a blood clot in
a blood vessel [for example in the legs (deep venous thrombosis) or the
lungs (pulmonary embolism)].
 if you have or have had jaundice (yellowing of the skin), severe liver
disease (when the liver is not functioning properly), or a liver tumour.
 if you have (had) or if you may have cancer of the breast or of the
genital organs.
 if you have any unexplained vaginal bleeding.
If any of these conditions appear for the first time while using
Nexplanon, consult your doctor immediately.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Nexplanon.
If Nexplanon is used in the presence of any of the conditions listed below,
you may need to be kept under close observation.
Your doctor can explain to you what to do. If any of these apply to you,
tell your doctor before Nexplanon is inserted. Also if the condition
develops or gets worse while you are using Nexplanon you must tell your
doctor.
 you have had cancer of the breast;
 you have or have had a liver disease;
 you have ever had a thrombosis;
 you have diabetes;
 you are overweight;
 you suffer from epilepsy;
 you suffer from tuberculosis;
 you have high blood pressure;
 you have or have had chloasma (yellowish-brown pigmentation patches
on the skin, particularly of the face); if so avoid too much exposure to
the sun or ultraviolet radiation.
Possible serious conditions
Cancer
The information presented below has been obtained in studies with
women who daily take an oral combined contraceptive containing two
different female hormones (“the Pill”). It is not known whether these
observations are also applicable to women who use a different hormonal
contraceptive, such as implants containing only a progestagen.

Breast cancer has been found slightly more often in women using oral
combined pills, but it is not known whether this is caused by the
treatment. For example, it may be that tumours are found more in women
on combined pills because they are examined by the doctor more often.
The increased occurrence of breast cancer becomes gradually less after
stopping the combined pill. It is important to regularly check your
breasts and you should contact your doctor if you feel any lump in
your breasts. You should also tell your doctor if a close relative has or
ever had breast cancer.
In rare cases, benign and even more rarely malignant liver tumours have
been reported in women using the Pill. If you experience severe
abdominal pain, you should contact your doctor immediately.
Thrombosis
A blood clot in a vein (known as a ‘venous thrombosis’) can block the
vein. This can happen in veins in the leg, the lung (a lung embolus), or
other organs. A blood clot in an artery (known as ‘arterial thrombosis’) can
block the artery. For example, a blood clot in an artery may cause a heart
attack, or in the brain may cause a stroke.
Using any combined hormonal contraceptive increases a woman’s risk of
developing such clots compared with a woman not taking any combined
hormonal contraceptive. The risk is not as high as the risk of developing a
blood clot during pregnancy. The risk with progestagen-only methods like
Nexplanon, is believed to be lower than in users of Pills that also contain
estrogens. There have been reports of blood clot formation like lung
emboli, deep vein thrombosis, heart attacks and strokes in women using
etonogestrel implants; however, available data do not suggest an
increase in risk of these events in women using the implant.

When should you contact your doctor?
Regular check-ups
Before Nexplanon is inserted, your healthcare professional will ask you
some questions about your personal health history and that of your close
relatives. The healthcare professional will also measure your blood
pressure, and depending on your personal situation, may also carry out
some other tests. When you are using Nexplanon, your healthcare
professional may ask you to return for a (routine) medical check-up
sometime after insertion of the implant. The frequency and nature of
further check-ups will depend on your personal situation.
Contact your doctor as soon as possible if:
 you notice any changes in your own health, especially involving any of
the items mentioned in this leaflet (see also “Do not use Nexplanon”
and “Warnings and precautions”; do not forget about the items related
to your immediate family);
 you notice possible signs of thrombosis such as severe pain or swelling
in either of your legs, unexplained pains in the chest, breathlessness,
an unusual cough, especially if you cough up blood;
 you have a sudden, severe stomach ache or look jaundiced;
 you feel a lump in your breast (see also “Cancer”);
 you have a sudden or severe pain in the lower part of your belly or
stomach;
 you have unusual, heavy vaginal bleeding;
 you are to be immobilized (for example being confined to bed) or are to
have surgery (consult your doctor at least four weeks in advance);
 you suspect that you are pregnant.

If you suddenly notice possible signs of a thrombosis, you should
see your doctor immediately. (See also “When should you contact your
doctor?").

3. How to use Nexplanon
Please tell your healthcare professional if you are pregnant or think
you might be pregnant before Nexplanon is inserted (e.g. if you had
unprotected intercourse during the current menstrual cycle).

Other conditions
Menstrual bleeding pattern changes
Like with other progestagen-only contraceptives, your menstrual bleeding
pattern may change when using Nexplanon. You may experience a
change in frequency (absent, less frequent, more frequent or continuous),
intensity (reduced or increased) or in duration. Absence of bleeding was
reported in about 1 of 5 women while another 1 of 5 women reported
frequent and/or prolonged bleeding. Occasionally heavy bleeding has
been observed. In clinical trials, bleeding changes were the most
common reason for stopping treatment (about 11 %). The bleeding
pattern that you experience during the first three months generally
indicates your future bleeding pattern.

How to use
Nexplanon should be inserted and removed only by a healthcare
professional who is familiar with procedures as described on the other
side of this leaflet. The healthcare professional will decide in consultation
with you the most suitable time for insertion. This depends on your
personal situation (for example on the birth control method that you are
currently using). Unless you are switching from another hormonal
contraceptive method, the insertion should be performed on day
1-5 of your spontaneous menstrual bleeding to rule out pregnancy. Your
healthcare professional will advise you (for more information see other
leaflet in the package – INFORMATION FOR THE HEALTHCARE
PROFESSIONAL- section 7.1).

A changing bleeding pattern does not mean that Nexplanon does not suit
you or is not giving you contraceptive protection. In general, you do not
need to take any action. You should consult your doctor if menstrual
bleeding is heavy or prolonged.

Before inserting or removing Nexplanon, your healthcare professional will
give you a local anaesthetic. Nexplanon is inserted directly under the
skin, on the inside of your upper non-dominant arm (the arm that you do
not write with). A description of the insertion and the removal procedure of
Nexplanon is shown below.

Insertion and removal related events
The implant may migrate from the original insertion site, if not correctly or
too deeply inserted and/or due to external forces (e.g. manipulation of the
implant or contact sports). In these cases localization of the implant may
be more difficult and removal may require a larger incision. If the implant
can not be found, and there is no evidence it has been expelled,
contraception and the risk of progestagen-related undesirable effects may
last longer than you want.

How is Nexplanon inserted
 Insertion of Nexplanon should only be performed by a qualified
healthcare professional who is familiar with the procedure.

Ovarian cysts
During the use of all low-dose hormonal contraceptives, small fluid-filled
sacs may develop in the ovaries. These are called ovarian cysts. They
usually disappear on their own. Sometimes they cause mild abdominal
pain. Only rarely, they may lead to more serious problems.
Broken or bent implant
If the implant breaks or bends while in your arm, how the implant works
should not be affected.
If you have questions contact your healthcare provider.
Other medicines and Nexplanon
Please tell your doctor if you are taking or have recently taken any other
medicines or herbal products, including medicines obtained without a
prescription. Some medicines may stop
Nexplanon from working properly. These include medicines used for the
treatment of
 epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine,
oxcarbazepine, topiramate, felbamate),
 tuberculosis (e.g. rifampicin),
 HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
 other infectious diseases (e.g. griseofulvin),
 high blood pressure in the blood vessels of the lungs (bosentan),
 depressive moods (the herbal remedy St. John’s wort (Hypericum
perforatum)).
Nexplanon may also interfere with the working of other medicines; e.g.
increase the activity of ciclosporin and decrease the effect of lamotrigine.

 To facilitate the insertion of the implant, you should lie on your back,
with your arm slightly bent at the elbow and turned outwards.

 The implant will be inserted at the inner side of your upper nondominant arm (the arm that you do not write with).

 The insertion site will be indicated on the skin, the site is disinfected
and anesthetized.

 The skin is stretched and the needle is inserted, directly under the

skin. Once the tip is inside the skin the needle is completely inserted in
a movement parallel to the skin.

Always tell the doctor, who prescribes Nexplanon, which medicines or
herbal products you are already using. Also tell any other doctor or dentist
who prescribes another medicine (or the dispensing pharmacist) that you
use Nexplanon. They can tell you if you need to take additional nonhormonal contraceptive precautions and if so, for how long since the
interaction may last up to four weeks after stopping with the medicine. If
there are medicines that you have been taking for a long time, that make
Nexplanon less effective, your doctor may also advise that the implant is
removed and recommend a birth control method that can be used
effectively with these medicines. If you want to use herbal products
containing St. John’s wort while you are already using Nexplanon you
should consult your doctor first.
Nexplanon with food and drink
There are no indications of any effect of food and drink on the use of
Nexplanon.
Pregnancy and breast-feeding
You must not use Nexplanon if you are pregnant, or think you may be
pregnant. In case you doubt whether you are pregnant or not, you should
perform a pregnancy test before starting using Nexplanon.
Nexplanon may be used while you are breast-feeding. Although a small
amount of the active substance of Nexplanon passes over into the breast
milk, there is no effect on the production or the quality of breast milk, nor
on the growth and development of the child.
If you are breast-feeding, ask your doctor for advice before using this
medicine.
Driving and using machines
There are no indications of any effect of the use of Nexplanon on
alertness and concentration.

 The purple slider is unlocked by pushing it slightly down and fully

pushing it backwards until it is arrested in the back in order to retract
the needle. The implant will remain in the upper arm when the needle is
withdrawn.

 The presence of the implant should be verified by feeling it

 You will be given sterile gauze with a pressure bandage to minimize



These pictograms are only meant to illustrate the insertion and
removal procedures for the woman who will be receiving the
implant.





(palpation) immediately following insertion. A correctly inserted
implant can be felt between thumb and finger by both the
healthcare professional and by you. It should be realized that
palpation is not suitable for 100% verification of the presence of
the implant.
In case the implant can not be palpated or when its presence is
doubtful other methods must be used to confirm the presence of
the implant.
Until the presence of the implant has been verified you may not be
protected against pregnancy and a contraceptive barrier method
(e.g. condoms) must be used.
You will be given sterile gauze with a pressure bandage to minimize
bruising. You may remove the pressure bandage in 24 hours and the
small bandage over the insertion site in 3-5 days.
After insertion of the implant, the healthcare professional will give you a
User Card with on it the insertion site, insertion date and the latest date
on which the implant has to be removed or replaced. Put it in a safe
place, since the information on the card may facilitate removal later on.

Nexplanon should be removed or replaced no more than three years
after insertion.
To help you remember when and where Nexplanon was inserted, and
when Nexplanon must be removed at the latest, your healthcare
professional will give you a User Card that shows this information. Store
the card in a safe place!
At the end of the insertion procedure, the healthcare professional will ask
you to feel the implant by palpation. A correctly inserted implant should be
clearly palpable by the healthcare professional as well as by you,
certainly if both ends can be lifted between thumb and finger. It should be
realized that palpation is not suitable for 100% verification of the presence
of the implant. In case of the slightest doubt you have to use a barrier
method (e.g. a condom) until the healthcare professional and you are
absolutely sure that the implant has been inserted. In rare cases the
healthcare professional may have to use X-rays, ultrasound or magnetic
resonance imaging, or may have to take a blood sample, to make sure
that the implant is inside your arm.
In case you would like to have Nexplanon replaced, a new implant may
be inserted immediately after the old implant is removed. The new implant
may be inserted in the same arm and at the same site as the previous
implant. Your healthcare professional will advise you.
When you want to stop using Nexplanon
You can ask your healthcare professional to remove the implant at any
time you want. If the implant can not be localized by palpation, the
healthcare professional may use X-rays, ultrasound or magnetic
resonance imaging to locate the implant. Depending on the exact position
of the implant removal may be a little difficult and may require minor
surgery.
If you do not want to become pregnant after removal of Nexplanon, ask
your healthcare professional about other reliable methods of birth control.
If you stop using Nexplanon because you want to get pregnant, it is
generally recommended that you wait until you have had a natural period
before trying to conceive. This helps you to work out when the baby will
be due.
How should Nexplanon be removed

bruising. You may remove the pressure bandage in 24 hours and the
small bandage over the insertion site in 3-5 days.

Note: The exact procedures for the insertion and removal of
Nexplanon by the qualified healthcare professional are described in
the Summary of product characteristics and in section 7 on the
other leaflet in the package – INFORMATION FOR THE
HEALTHCARE PROFESSIONAL.
4. Possible side effects
Like all medicines, Nexplanon can cause side effects, although not
everybody gets them.
Menstrual bleeding may occur at irregular intervals during the use of
Nexplanon. This may be just slight staining which may not even require a
pad, or heavier bleeding, which looks rather like a scanty period and
requires sanitary protection. You may also not have any bleeding at all.
The irregular bleedings are not a sign that the contraceptive protection of
Nexplanon is decreased. In general, you need not take any action. If,
however, bleeding is heavy or prolonged consult your doctor.
Serious undesirable effects are described in the paragraphs of section 2
“Cancer” and “Thrombosis”. Please read this section for additional
information and consult your doctor at once where appropriate.
The following side effects have been reported:
Very Common
Common
(may affect
(may affect up to
more than 1 in
1 in 10 people)
10 people)
• Acne
• hair loss
• headache
• dizziness
• increase in
• depressive moods
• body weight
• emotional
• breasts
lability
• tenderness and
• nervousness
pain
• decreased sexual
• irregular
drive
• bleeding
• increased appetite
• infection of the
• abdominal pain
vagina.
• nausea
• gas in stomach
and intestines
• painful
menstruation
• decrease in body
weight
• influenza-like
symptoms
• pain
• fatigue
• hot flushes
• implant site pain
• implant site
reaction
• ovarian cyst.

 The implant should only be removed by a qualified healthcare
professional who is familiar with the procedure.

 The implant is removed at your request or -at the latest- three years
after insertion.

 The location of the insertion site of the implant is indicated on the User
card.

 The healthcare professional will locate the implant. If the implant can
not be located the healthcare professional may have to use X-ray,
ultrasound or magnetic resonance imaging techniques.

 Your upper arm will be disinfected and anesthetized

Uncommon
(may affect up to
1 in 100 people)
• itching
• itching in the
genital area
• rash
• excessive hair
growth
• migraine
• anxiety
• sleeplessness
• sleepiness
• diarrhoea
• vomiting
• constipation
• urinary tract
infection
• vaginal discomfort
(e.g. vaginal
secretion)
• breast
enlargement
• breast secretion
• back pain
• fever
• fluid retention
• difficult or painful
urination
• allergic reactions
• inflammation and
pain of the throat
• rhinitis
• joint pain
• muscle pain
• skeletal pain.

Apart from these side effects, a rise in blood pressure has occasionally
been observed. Also oily skin has been observed. You should seek
immediate medical attention if you experience symptoms of a severe
allergic reaction, such as (i) swollen face, tongue or pharynx; (ii) trouble
swallowing; or (iii) hives and trouble breathing. During the insertion or
removal of Nexplanon, some bruising, pain, swelling, or itching may occur
and, in rare cases, infection. A scar may be formed or an abscess may
develop at the implantation site. A numb feeling or sensation of
numbness (or lack of feeling) may occur. Expulsion or migration of the
implant is possible, especially if it has not been inserted properly. Surgery
might be necessary when removing the implant.
There have been reports of blood clot in a vein (known as a ‘venous
thrombosis’) or in an artery (known as 'arterial thrombosis') in women
using etonogestrel implant. A blood clot in a vein can block the vein, and
can happen in veins in the leg (a deep vein thrombosis), the lung (a lung
embolus), or other organs. A blood clot in an artery can block the artery
and may cause a heart attack, or in the brain may cause a stroke.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting
side effects you can help provide more information on the safety of this
medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

 A small incision will be made along the arm just below the tip of the
implant.

5. How to store Nexplanon
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
blister and carton.
Store in the original blister package.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
This medicinal product does not require any special storage conditions.

 The implant is gently pushed towards the incision and removed with a
forceps.

 Occasionally, the implant may be surrounded by hard tissue. If this is



the case, a small cut needs to be made into the tissue before the
implant can be removed.
If you want your healthcare professional to replace Nexplanon with
another implant, the new implant may be inserted using the same
incision.
The incision will be closed by a steri-strip.

6. Contents of the pack and other information
What Nexplanon contains
Each applicator contains one implant with
 The active substance is: etonogestrel (68 mg)
 The other ingredients are: ethylene vinyl acetate copolymer, barium
sulfate and magnesium stearate.
What Nexplanon looks like and contents of the pack
Nexplanon is a subdermal long acting hormonal contraceptive. It consists
of a radiopaque progestagen-only implant preloaded in an innovative,
ready-for-use, user-friendly, disposable applicator.
The off-white implant is 4 cm in length and 2 mm in diameter and contains
etonogestrel and barium sulfate. The applicator has been designed to
facilitate the insertion of the implant just below the skin of your inner
upper (non dominant) arm. The implant is to be inserted and removed by
a healthcare professional who is familiar with the procedures. For
uncomplicated removal it is necessary that the implant is inserted just
below the skin (see other side of the leaflet). Local anaesthetic should be
used before inserting or removing the implant. The risk of complications is
small if the provided instructions are followed.
Pack sizes: Carton box with 1 blister pack.
Manufacturer and Product Licence Holder
Manufactured by Organon N.V., P.O. Box 20, 5340 BH OSS, The
Netherlands.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2679

Leaflet revision and issue date (Ref) 17.06.15[3]
Nexplanon is a trademark of Merck Sharp & Dohme B.V.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

2679
17.06.15[H-3]

Nexplanon® 68 mg implant for subdermal use
(etonogestrel)
The following information is intended for the healthcare
professionals only:
Insertion of Nexplanon should be performed under aseptic
conditions, and only by a physician or healthcare professional who
is familiar with the procedure, those who have completed (or are
participating under supervision in) a training programme such as
that leading to a letter of Competence in subdermal contraceptive
implants offered by the Faculty of Sexual and Reproductive
Healthcare of the Royal College of Obstetricians and
Gynaecologists.
7. Information for the healthcare professional

Figure 1

 Have the woman lie on her back on the examination table with her non-



7.1 When to insert Nexplanon
IMPORTANT: Rule out pregnancy before inserting the implant.

dominant arm flexed at the elbow and externally rotated so that her
wrist is parallel to her ear or her hand is positioned next to her head
(Figure 1).
Identify the insertion site, which is at the inner side of the non-dominant
upper arm about 8- 10 cm (3-4 inches) above the medial epicondyle of
the humerus.

Figure 7

 Keep the applicator in the same position with 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. Unlock the purple
slider by pushing it slightly down. Move the slider fully back until it stops
(Figure 7). 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. If 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 implant will not be inserted properly.

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.
Figure 2

Switching hormonal contraceptive method to Nexplanon
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.

 Make two marks with a sterile marker: first, mark the spot where the

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 Nexplanon 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.

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 8).




implant will be inserted, and second, mark a spot a few centimetres
proximal to the first mark (Figure 2). This second mark will later serve
as a direction guide during insertion.
Clean the insertion site with an antiseptic solution.
Anaesthetize the insertion area (for example, with anaesthetic spray or
by injecting 2 ml of 1% lidocaine just under the skin along the planned
insertion tunnel).
Remove the sterile preloaded disposable Nexplanon applicator carrying
the implant from its blister.

purple tip of the obturator should be visible.

 Use other methods to confirm its presence. Suitable methods are: two-



Figure 3

 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 can see the
white coloured 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.



dimensional X-ray, 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).
Prior to the application of X-ray CT, USS or MRI for the localization of
the implant, it is recommended to consult the local supplier of
Nexplanon for instructions. 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 nonhormonal contraceptive method
must be used.
Apply a small adhesive bandage over the insertion site. 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
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.

7.3 How to remove Nexplanon
Before initiating the removal procedure, the HCP should consult the User
Card for the location of the Nexplanon implant. Verify the exact location of
the implant in the arm by palpation.
If the implant is not palpable, two-dimensional X-ray can be performed to
verify its presence. A non-palpable implant should always be first located
prior to removal. Suitable methods for localization include, X-ray
computer tomography (CT), ultrasound scanning (USS) with a high
frequency linear array transducer (10 MHz or greater) or magnetic
resonance imaging (MRI). If these imaging methods fail to locate the
implant, etonogestrel determination can be used for verification of the
presence of the implant. Please contact your local supplier for further
guidance.

 With your free hand, stretch the skinFigure
around4the insertion site with
thumb and index finger (Figure 4).

After localization of a non-palpable implant, consider conducting removal
with ultrasound guidance. There have been occasional reports of
migration of the implant; usually this involves minor movement relative to
the original position unless inserted too deeply (see also section 4.4 in the
SmPC). This may complicate localization of the implant by palpation, USS
and/or MRI, and removal may require a larger incision and more time.
Removal of the implant should only be performed under aseptic
conditions by a HCP who is familiar with the removal technique.
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 HCPs familiar with the anatomy of the
arm.

7.2 How to insert Nexplanon
The basis for successful use and subsequent removal of Nexplanon 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. If
the implant is inserted too deep, neural or vascular damage may occur.
Too 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.
Moreover, when the implant is inserted too deep, it may not be palpable
and the localization and/or removal can be difficult.

If you cannot feel the implant or in doubt of its presence:

 Check the applicator. The needle should be fully retracted and only the



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 in the SmPC). The woman should be
advised to use a barrier method until 7 days after insertion. If
intercourse has already occurred, pregnancy should be excluded.

Figure 8

 Always verify the presence of the implant in the woman’s arm

Figure 5

If the implant cannot be removed, please contact your local supplier for
further guidance.

 Puncture the skin with the tip of the needle angled about 30° (Figure 5).

Insertion of Nexplanon 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.
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.

Figure 9
Figure 6

 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 (Figure 6). If the
needle is not inserted to its full length, the implant will not be
inserted properly.

 Clean the site where the incision will be made and apply an antiseptic.

Locate the implant by palpation and mark the distal end (end closest to
the elbow), for example, with a sterile marker (Figure 9).

 If the tip of the implant does not become visible in the incision, gently



Figure 10

 Anaesthetize the arm, for example, with 0.5 to 1 ml 1% lidocaine at the

marked site where the incision will be made (Figure 10). Be sure to
inject the local anaesthetic under the implant to keep it close to the skin
surface.





insert a forceps into the incision (Figure 15). 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.
Confirm that the entire rod, 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 this section.
If the woman would like to continue using Nexplanon, a new implant
may be inserted immediately after the old implant is removed using the
same incision (see section 7.4).
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.

7.4 How to replace Nexplanon
Immediate replacement can be done after removal of the previous implant
and is similar to the insertion procedure described in section 7.2.

Figure 11

 Push down the proximal end of the implant (Figure 11) 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.

Figure 12

 Gently push the implant towards the incision until the tip is visible.

Grasp the implant with forceps (preferably curved mosquito forceps)
and remove the implant (Figure 12).

Figure 13

Figure 14

 If the implant is encapsulated, make an incision into the tissue sheath
and then remove the implant with the forceps (Figures 13 and 14).

Figure 15

Figure 16

Figure 17

The new implant may be inserted in the same arm, and through the same
incision from which the previous implant was removed. If the same
incision is being used to insert a new implant, anesthetize 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.
Leaflet revision and issue date (Ref) 17.06.15[H-3]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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