Skip to Content

NEXPLANON

Active substance(s): ETONOGESTREL

View full screen / Print PDF » Download PDF ⇩
Transcript
For Position Only

For Position Only

XXXXX/XXXXXX-X

Package leaflet: Information for the patient

68 mg implant for subdermal use
Etonogestrel
For Position Only

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.
What is in this leaflet
1. What Nexplanon is and what it is 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
1. What Nexplanon is and what it is 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 sulphate which renders it visible under X-ray.
Nexplanon is used to prevent pregnancy.
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.

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.

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.

If you are breast-feeding, ask your doctor for advice before using
this medicine.

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

Driving and using machines
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;
• 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.
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 overleaf 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.

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.

• The implant will be inserted at the inner side of your upper
non-dominant 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.

• With your free hand, stretch the skin around the insertion
site with thumb and index finger (Figure 4).

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

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:
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 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
non-dominant 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).

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])
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.

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.

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 non-hormonal
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.

68 mg implant for subdermal use
Etonogestrel
Information for the healthcare professional

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.

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)).

and migration of the implant (due to intramuscular or fascial
insertion), and in rare cases with intravascular insertion.

Figure 2a

  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.

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.
• 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.

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.
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.
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)

  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 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.

  Figure 4

  Figure 8
• 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.
If the implant is not palpable:
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 two-dimensional 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.

For Position Only

For Position Only

XXXXX/XXXXXX-X

• Until you have verified the presence of the implant,
a non-hormonal 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).

• 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).

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.

• 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.
Localization and removal of a non-palpable implant

  Figure 13

  Figure 9
• 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).

  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).

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.

  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.

  Figure 15

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 16

Exploratory surgery without knowledge of the exact location of
the implant is strongly discouraged.
If the implant cannot be removed, please contact your local
representative of the Marketing Authorisation Holder for further
guidance.

  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

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.

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 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.

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.
© Merck Sharp & Dohme Limited 2016. All rights reserved.
PIL.NEX.15.UK.4650.WS-143

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.

• 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.

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

Nexplanon should be removed or replaced no more than three
years after insertion.

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

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!

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 side of this user package leaflet.

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.
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 can not be located the healthcare professional may
have to use X-ray, CT, ultrasound or magnetic resonance
imaging techniques.

• Your upper arm will be disinfected and anaesthetized.

• 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.

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
Malta: ADR Reporting at:
www.medicinesauthority.gov.mt/adrportal
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.
6. Contents of the pack and other information

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
(may affect
more than 1 in
10 people)

Common
(may affect up to
1 in 10 people)

Uncommon
(may affect up to
1 in 100 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.

• 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.

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, carton box with
5 blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Merck Sharp & Dohme Limited, Hertford Road,
Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB Oss,
The Netherlands
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Germany, Greece, Ireland,
Luxembourg, the Netherlands, Slovakia, Poland, Portugal,
Spain: Implanon NXT
Czech Republic, Denmark, Estonia, Finland, France, Iceland,
Italy, Latvia, Lithuania, Malta, Norway, Romania, Slovenia,
Sweden, UK: Nexplanon
This leaflet was last revised in April 2016.
PIL.NEX.15.UK.4650.WS-143

Expand view ⇕

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.

Hide