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NEXPLANON 68 MG IMPLANT FOR SUBDERMAL USE

Active substance(s): ETONOGESTREL

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Package Leaflet: Information for the user
4. POSSIBLE SIDE EFFECTS

If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

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:
Common (may
Uncommon (may
Very Common (may
affect up to 1 in 10
affect up to 1 in 100
Affect more than 1
people)
people)
in 10 people)
 acne
 headache
 increase in body
weight
 breasts
tenderness and
pain
 irregular bleeding
 infection of the
vagina.






















hair loss
dizziness
depressive moods
emotional lability
nervousness
decreased sexual
drive
increased appetite
abdominal pain
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

Nexplanon® 68 mg implant for subdermal use

Reporting of side effects

5. HOW TO STORE NEXPLANON®
Keep 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 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.

 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nexplanon® contains:
Each applicator contains one implant with 68 mg etonogestrel.
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 offwhite 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 size: Carton box with 1 blister pack.
Product Licence Holder and Manufacturer:
Manufactured by Organon N.V., P.O. Box 20, 5340 BH Oss, The
Netherlands and Procured from the EU and repackaged by Product
Licence Holder: Beachcourse Limited., 20 Alliance Court, Alliance Road,
London WSR 0RB, UK.
PL 16378/0588

POM

Revision date: 08.09.2016
Leaflet reference: NEXPLA

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.

Nexplanon® is a registered trademark of Merck Sharp & Dohme B.V.

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. In rare cases, implants have been reported to be found
in a blood vessel, including a blood vessel in the lung.
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.

(Etonogestrel)
 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
Read all of this leaflet carefully before you start using this medicine
the sun or ultraviolet radiation.
because it contains important information for you.
Possible serious conditions
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
Cancer
The information presented below has been obtained in studies with
 If you get any side effects talk to your doctor or pharmacist. This
women who daily take an oral combined contraceptive containing two
includes any possible side effects not listed in this leaflet. See section
different female hormones (“the Pill”). It is not known whether these
4.
observations are also applicable to women who use a different hormonal
What is in this leaflet:
contraceptive, such as implants containing only a progestagen.
Breast cancer has been found slightly more often in women using oral
®
1. What Nexplanon is and what it is used for
combined pills, but it is not known whether this is caused by the
2. What you need to know before you use Nexplanon®
treatment. For example, it may be that tumours are found more in women
®
3. How to use Nexplanon
on combined pills because they are examined by the doctor more often.
4. Possible side effects
The increased occurrence of breast cancer becomes gradually less after
stopping the combined pill. It is important to regularly check your
5. How to store Nexplanon®
breasts and you should contact your doctor if you feel any lump in
6. Contents of the pack and other information
your breasts. You should also tell your doctor if a close relative has or
ever had breast cancer.
®
1. WHAT NEXPLANON IS AND WHAT IT IS USED FOR
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.
Nexplanon® is a contraceptive implant preloaded in a disposable
Thrombosis
applicator. The implant is a small, soft, flexible, plastic rod,
A blood clot in a vein (known as a ‘venous thrombosis’) can block the
4 cm in length and 2 mm in diameter, which contains
vein. This can happen in veins in the leg, the lung (a lung embolus), or
68 milligrams of the active substance, etonogestrel. The
other organs. A blood clot in an artery (known as ‘arterial thrombosis’) can
applicator allows the healthcare professional to insert the implant
block the artery. For example, a blood clot in an artery may cause a heart
just under the skin of your upper arm. Etonogestrel is a synthetic
attack, or in the brain may cause a stroke.
female hormone resembling progesterone. A small amount
Using any combined hormonal contraceptive increases a woman’s risk of
of etonogestrel is continuously released into the bloodstream.
developing such clots compared with a woman not taking any combined
The implant itself is made of ethylene vinyl acetate copolymer,
hormonal contraceptive.
a plastic that will not dissolve in the body. It also contains a small
The risk is not as high as the risk of developing a blood clot during
amount of barium sulphate which renders it visible under X-ray.
pregnancy. The risk with progestagen-only methods like Nexplanon®, is
Nexplanon® is used to prevent pregnancy.
believed to be lower than in users of Pills that also contain estrogens.
You may stop using Nexplanon® at any time (See also “When you want to
There have been reports of blood clot formation like lung emboli, deep
stop using Nexplanon®”).
vein thrombosis, heart attacks and strokes in women using etonogestrel
implants; however, available data do not suggest an increase in risk of
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NEXPLANON ®
these events in women using the implant.
If you suddenly notice possible signs of a thrombosis, you should
®
Hormonal contraceptives, also including Nexplanon , do not protect
see your doctor immediately. (See also “When should you contact your
against HIV infection (AIDS) or any other sexually transmitted
doctor?”).
disease.
®
Other conditions
Do not use Nexplanon
Your medicine is known by the above name, but will be referred to as
Nexplanon® throughout this leaflet.

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.

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.
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.
Insertion and removal related events
The implant may migrate from the original insertion site in the arm, if
incorrectly inserted or due to external forces (e.g. manipulation of the
implant or contact sports). In rare cases implants have been found in the
blood vessels of the arm or in the pulmonary artery (a blood vessel in the
lung).
In cases where the implant has migrated from the original insertion site,
localization of the implant may be more difficult and removal may require
a larger incision or surgical removal in the hospital. If the implant cannot
be found in the arm your healthcare professional may use x-rays or other
imaging methods on the chest. If the implant is located in the chest,
surgery may be needed. If the implant cannot be found, and there is no
evidence it has been expelled, contraception and the risk of progestagenrelated undesirable effects may last longer than you want. If at any time
the implant cannot be felt, it should be found and removal may be
recommended.

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;

4

1

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.

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 cannot 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 difficult and may require 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
 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 cannot
be located the healthcare professional may have to use X-ray, CT,
ultrasound or magnetic resonance imaging techniques

 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.

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.
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.

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).
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 Health
professional’s user leaflet section 7.1).
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.
®

How is Nexplanon inserted
 Insertion of Nexplanon® should only be performed by a qualified
healthcare professional who is familiar with the procedure.
 To facilitate the insertion of the implant, you should lie on your
back, with your arm slightly bent at the elbow and turned
outwards.

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

 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.

There are no indications of any effect of the use of Nexplanon® on
alertness and concentration.
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 some
time 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;

 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.

2

 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
(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.
 Once the healthcare professional has located the implant that was
not palpable, your healthcare professional may recommend
removal based on your health needs.
 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 palpate the implant (feel the implant under your skin). A correctly
inserted implant should be clearly palpable by the healthcare professional
as well as by you, and you should be able to feel both ends between your
thumb and finger. It should be realized that palpation is not suitable for
100% verification of the presence of the implant. If the implant cannot be
palpated immediately after insertion, or at any time, the implant may not
have been inserted, or it may have been inserted deeply. 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.
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. If the implant cannot be
found in the arm after a thorough search, your healthcare professional
may use x-rays or other imaging methods on your chest. Once the
healthcare professional has located the implant that was not palpable,
your healthcare professional may recommend removal based on your
health needs.
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.

 Your upper arm will be disinfected and anaesthetized.

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

 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.
 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.
These pictograms are only meant to illustrate the insertion and
removal procedures for the woman who will be receiving the
implant.
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
Health professional’s user leaflet.

3

7.4 How to replace Nexplanon®

HEALTH PROFESSIONALS’ USER LEAFLET

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

Nexplanon 68 mg implant for subdermal use

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.

®

(Etonogestrel)
Information for the healthcare professional
The following information is intended for the healthcare
professionals only:

7.2 How to insert Nexplanon ®

®

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.

PL 16378/0588 Nexplanon® 68 mg implant for subdermal use

Procured from the EU and repackaged by Product Licence Holder:
Beachcourse Limited., 20 Alliance Court, Alliance Road, London WSR
0RB, UK.

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.
An implant inserted more deeply than subdermally (deep insertion) may
not be palpable and the localization and/or removal can be difficult (see
section 4.2 How to remove Nexplanon® and section 4.4 in the SPC). If the
implant is inserted deeply, neural or vascular damage may occur. Deep or
incorrect insertions have been associated with paraesthesia (due to
neural damage) and migration of the implant (due to intramuscular or
fascial insertion), and in rare cases with intravascular insertion.
Insertion of 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.

7. Information for the healthcare professional
7.1 When to insert Nexplanon®
IMPORTANT: Rule out pregnancy before inserting the implant.
Timing of insertion depends on the woman’s recent contraceptive history,
as follows:

POM
Revision date: 08.09.2016
Leaflet reference: NEXPLA

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.

Nexplanon® is a registered trademark of Merck Sharp & Dohme B.V.

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.
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])

Figure 1
 Have the woman lie on her back on the examination table with her
non-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 nondominant upper arm about 8-10 cm (3-4 inches) above the medial
epicondyle of the humerus, AVOIDING the sulcus (groove)
between the biceps and triceps muscle where the large blood
vessels and nerves that lie there in the neurovascular bundle
deeper in the subcutaneous tissue (Figures 2a and 2b). The
implant should be inserted subdermally just under the skin (see
section 4.4 in the SmPC).

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.

Figure 2a

Following abortion or miscarriage
 First trimester: The implant should be inserted within five days
following a first trimester abortion or miscarriage.
 Second trimester: Insert the implant between 21 to 28 days
following second trimester abortion or miscarriage.
If inserted as recommended, back up contraception is not
necessary. If deviating from the recommended timing of insertion,
the woman should be advised to use a barrier method until 7 days
after insertion. If intercourse has already occurred, pregnancy
should be excluded.

Figure 2b
 Make two marks with a sterile marker: first, mark the spot where
the implant will be inserted, and second, mark a spot a few
centimetres proximal to the first mark (Figure 2a). This second
mark will later serve as a direction guide during insertion.
 Clean the insertion site with an antiseptic solution.

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

4

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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.

 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. The applicator should not be
used if sterility is in question.

Figure 10

Figure 8
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 prematurely release the implant from the
applicator.

 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 (Figure 8). See section below “If the implant is not
palpable”.
 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. If electronic patient records are used, the information on
the adhesive label should be recorded.
 The applicator is for single use only and must be adequately
disposed of, in accordance with local regulations for the handling
of biohazardous waste.

Figure 4

Figure 16

 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.

Figure 17
 If the tip of the implant does not become visible in the incision,
gently 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.

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.

If the implant is not palpable:
 With your free hand, stretch the skin around the insertion site with
thumb and index finger (Figure 4).

If you cannot palpate the implant or are in doubt of its presence, the
implant may not have been inserted or it may have been inserted
deeply:
 Check the applicator. The needle should be fully retracted and
only the purple tip of the obturator should be visible.
 Use other methods to confirm its presence. Given the radiopaque
nature of the implant, suitable methods for localization are twodimensional X-ray and X-ray computerized tomography (CT scan).
Ultrasound scanning (USS) with a high-frequency linear array
transducer (10 MHz or greater) or magnetic resonance imaging
(MRI) may be used. 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.
 Once the non-palpable implant has been located, removal is
recommended as soon as medically appropriate (see
“Localization and removal of a non-palpable implant” below and
also section 4.4 in the SmPC).

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

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.
 You can best see movement of the needle and that it is inserted
just under the skin, if you are seated and are looking at the
applicator from the side and NOT from above. In this position, you
can clearly see the insertion site and the movement of the needle
just under the skin.

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).

Localization and removal of a non-palpable implant
There have been occasional reports of migration of the implant; usually
this involves minor movement relative to the original position (see also
section 4.4 in the SmPC), but may lead to the implant not being palpable
at the location in which it was placed. An implant that has been deeply
inserted or has migrated may not be palpable and therefore imaging
procedures, as described below, may be required for localization.
A non-palpable implant should always be located prior to attempting
removal. Given the radiopaque nature of the implant, suitable methods for
localization include two-dimensional X-ray and X-ray computer
tomography (CT). Ultrasound scanning (USS) with a high-frequency linear
array transducer (10 MHZ or greater) or magnetic resonance imaging
(MRI) may be used. Once the implant has been localized in the arm, the
implant should be removed according to the instructions in “Procedure for
removal of an implant that is palpable”, and the use of ultrasound
guidance during the removal should be considered.
If the implant cannot be found in the arm after comprehensive localization
attempts, consider applying imaging techniques to the chest as extremely
rare cases of migration to the pulmonary vasculature have been reported.
If the implant is located in the chest, surgical or endovascular procedures
may be needed for removal; HCPs familiar with the anatomy of the chest
should be consulted.
If at any time these imaging methods fail to locate the implant,
etonogestrel blood level determination can be used for verification of the
presence of the implant. Please contact your local representative of the
Marketing Authorisation Holder for further guidance.
Removal of the implant should only be performed under aseptic
conditions by an HCP who is familiar with the removal technique.
If the implant migrates within the arm, removal may require a minor
surgical procedure with a larger incision or a surgical procedure in an
operating room. Removal of deeply inserted implants should be
conducted with caution in order to prevent damage to deeper neural or
vascular structures in the arm and should be performed by HCPs familiar
with the anatomy of the arm.

Figure 13

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. See Section below on “Localization
and removal of a non-palpable implant” if the implant cannot be palpated.
Procedure for removal of an implant that is palpable
Removal of the implant should only be performed under aseptic
conditions by a HCP who is familiar with the removal technique.

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 9
Figure 7

 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).

 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

2

Exploratory surgery without knowledge of the exact location of the
implant is strongly discouraged.

Figure 15

If the implant cannot be removed, please contact your local representative
of the Marketing Authorisation Holder for further guidance.

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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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