68 mg implants for subdermal use
etonogestrel
What Nexplanon is and what it is used for
Nexplanon is a contraceptive implant pre-loaded in a disposable applicator. Safety and efficacy have been established in women between 18 and 40 years of age. The implant is a small, soft, flexible plastic rod 4 cm long and 2 mm in diameter, which contains 68 milligrams of the active substance etonogestrel. The applicator allows healthcare professionals to insert implants just under the skin of your upper arm. Etonogestrel is a synthetic female hormone similar to progesterone. A small amount of etonogestrel is continuously released into the bloodstream. The implants themselves are made of ethylene-vinyl acetate copolymer, a plastic that can not be dissolved in the body. It also contains a small amount of barium sulfate which makes it visible on X-rays.
Nexplanon is used to prevent pregnancy.
How Nexplanon works.
The implant is inserted directly under the skin. The active substance, etonogestrel, works in two different ways:
- It prevents an egg cell from detaching from the ovaries.
- It changes the mucus in the cervix so it becomes difficult for sperm to enter the uterus.
As a result, Nexplanon protects against pregnancy for three years, but if you are overweight, your doctor/midwife may advise you to replace the implant earlier. Nexplanon is one of many ways to prevent pregnancy. Another common method is combined birth control pills. Women who cannot or do not want to use estrogen can use Nexplanon as opposed to combined oral contraceptives. When using Nexplanon, you do not need to remember to take one tablet every day. This is one of the reasons why Nexplanon is very reliable (over 99% efficiency). In rare cases, the implant has not been inserted correctly or is not inserted at all, the pregnancy protection may not be available. When you use Nexplanon, your period may change and not occur, becoming irregular, sparse, denser, longer, and sometimes heavier. The bleeding pattern you get in the first three months is usually predictable for the future bleeding pattern. Painful menstruation can get better.
You can stop using Nexplanon at any time (see also “When you want to stop using Nexplanon”).
What you need to know before you use Nexplanon
Hormonal contraceptives, including Nexplanon, do not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Do not use Nexplanon
You should not use Nexplanon if you have any of the conditions listed below. If any of these apply to you, tell your doctor/midwife before using Nexplanon. Your doctor/midwife may advise you to use a contraceptive that does not contain hormones.
- if you are allergic to etonogestrel or any of the other ingredients of this medicine (listed in section 6).
- if you have thrombosis . Thrombosis is when a blood clot forms in a blood vessel [for example in the legs (deep vein thrombosis ) or in the lungs ( pulmonary embolism )].
- if you have or have had jaundice (yellowing of the skin), a serious liver disease (when the liver is not working properly) or a liver tumor.
- if you have (had) or may have breast or abdominal cancer.
- if you have any genital bleeding where the cause is not known.
If any of these conditions occur for the first time when you use Nexplanon, contact your doctor/midwife immediately.
Warnings and cautions
Talk to your doctor/midwife, pharmacist, or nurse before using Nexplanon.
If you are using Nexplanon for any of the conditions listed below, you may need additional controls. Your doctor/midwife can explain what to do. If any of these apply to you, tell your doctor/midwife before using Nexplanon. Should any of these occur for the first time or worsen when you use Nexplanon, you must tell your doctor/midwife.
- if you have or have had a liver disease
- if you have or have had a blood clot
- if you have diabetes
- if you are overweight
- if you suffer from epilepsy
- if you suffer from tuberculosis
- if you have high blood pressure
- you have or have had chloasma (yellow-brown spots on the skin, especially on the face); in this case, avoid too much sunlight or ultraviolet radiation.
Conditions that can be serious
Cancer
This information has been obtained from studies with women who have taken combined birth control pills containing two different hormones (“birth control pills”) every day. It is not known whether these observations also apply to women who use another form of hormonal contraceptives, such as implants that only contain progestogens.
Breast cancer is detected slightly more often in women who use combined contraceptive pills, but it is not known if it is caused by the treatment. For example, tumors can be found more often in women who use combined contraceptive pills because they are examined more often by a doctor. The increased incidence of breast cancer gradually decreases after stopping the pill. It is important that you regularly check your breasts and that you contact your doctor if you feel any lump in any of the breasts. You should also contact a doctor if a close relative has or has had breast cancer.
In rare cases, benign, and in even more rare cases, malignant, liver tumors have been seen in women using birth control pills. If you experience severe abdominal pain, contact your doctor immediately.
Thrombosis
A blood clot in a vein (called a “deep vein thrombosis”) can block a vein. It can occur in the veins of the legs, lungs ( pulmonary embolism ), or in other organs. A blood clot in an artery (so-called “arterial thrombosis”) can block an artery. For example, a blood clot in an artery can cause a heart attack or a stroke in the brain.
Using a combined hormonal contraceptive method increases the risk for the woman to get this type of blood clot compared to women who do not use contraceptives with hormones. The risk is not as great as the risk of getting a blood clot during pregnancy. If you use a method that only contains progestogens, such as Nexplanon, the risk is considered lower than if you use birth control pills that also contain estrogen. There have been reports of blood clots such as pulmonary embolism, deep vein thrombosis, myocardial infarction, and stroke in women using etonogestrel implants. However, available data do not indicate an increased risk of these events in women who use implants et.
If you notice any signs of thrombosis, contact your doctor immediately. (see also “When to contact your doctor” ).
Other conditions
Changes in the menstrual bleeding pattern
As with all progestogen-only contraceptive methods, the menstrual bleeding pattern may change when using Nexplanon. You may experience a change in frequency (no, fewer, more frequent, or continuous bleeding), amount (decreased or increased), or duration. The fact that bleeding completely disappears has been reported in approximately 1 in 5 women, while another 1 in 5 women reported more frequent or prolonged bleeding. Occasionally there have been heavy bleeding. In clinical trials altered bleeding was the most common reason for stopping (approximately 11%). The bleeding pattern you get in the first three months is usually predictable for the future bleeding pattern. The fact that the bleeding changes does not mean that Nexplanon does not suit you or does not give you sufficient protection. In general, you do not need to do anything. You should contact your doctor/midwife if your menstrual bleeding becomes heavy or prolonged.
Events that have to do with deposits and withdrawals
The implant can move from the original insertion point in the arm, if it has not been inserted correctly, or if it has been exposed to external influences (eg if you have tampered with the implant or at contact ports). In rare cases, implants have been located in the blood vessel of the armor in the pulmonary artery (a blood vessel in the lung). In cases where the implant has moved from the original insertion site, it may be more difficult to locate and remove the implant and it may be necessary to make a larger incision or surgical removal in the hospital. If the implant cannot be located in the arm, the doctor/midwife can use X-rays or other methods on the chest. If implants are found in the chest, surgery may be necessary. If you cannot find the implant, and there is no indication that it has been rejected, the protection against pregnancy and the risk of progestogenic side effects may persist for longer than you wish.
If it is not possible to feel the implant at any time, contact your doctor/midwife immediately.
Mental disorders
Some women who use hormonal contraceptives, including Nexplanon, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
Ovarian cysts
When using low-dose hormonal contraceptives, you can get small fluid-filled blisters on the ovaries. They are called ovarian cysts. They usually disappear on their own. Sometimes they can cause mild abdominal pain. Only in exceptional cases can they lead to more serious problems.
Broken or bent implants
If the implant breaks or bends in the arm, it should not affect how the implant works. The implant can break or bend if exposed to external forces. The broken implant can move from the insertion site. If you have any questions, contact your doctor/midwife.
Other medicines and Nexplanon
| Always tell your doctor/midwife which medicines or herbal remedies you are already using. Also, tell other doctors and dentists who prescribe medicines (or pharmacists) that you are using Nexplanon. They can tell you if you need to use supplemental protection (such as a condom) and if so, for how long or if the use of any other medicine you need needs to be changed. |
Some medicines
– may affect the blood levels of Nexplanon
– may make it less effective in preventing pregnancy
– may cause unexpected bleeding.
This applies to drugs for the treatment of
- epilepsy (eg primidone, phenytoin , barbiturate , carbamazepine, oxcarbazepine, topiramate, felbamate)
- tuberculosis (eg rifampicin)
- HIV infection is (eg ritonavir, nelfinavir , nevirapine, efavirenz)
- Hepatitis C virus infections (eg boceprevir, telaprevir)
- other infectious diseases (eg griseofulvin)
- high blood pressure in the blood vessels of the lungs ( bosentan )
- depression (herbal medicine containing St. John’s wort ( Hypericum perforatum )).
Nexplanon may affect the effectiveness of other medicines; e.g.
- medicines containing ciclosporin
- the epilepsy drug lamotrigine (this may lead to an increased seizure frequency)
Ask your doctor or pharmacist for advice before taking any medicine.
Nexplanon with food and drink
There is no evidence that food or drink would affect Nexplanon.
Pregnancy and breastfeeding
You should not use Nexplanon if you are pregnant or think you may be pregnant. If you are not sure if you are pregnant or not, take a pregnancy test before using Nexplanon.
You can use Nexplanon while breastfeeding. Although a small amount of the active substance in Nexplanon passes into breast milk, it does not affect the production or quality of breast milk, nor the growth and development of the baby.
If you are breastfeeding, talk to your doctor or pharmacist before taking this medicine.
Children and young people
The safety and efficacy of Nexplanon in adolescents below the age of 18 years have not been studied.
Driving and using machines
There is no evidence that Nexplanon would affect your reactivity or concentration.
When should you contact your doctor?
Regular checks
Before using Nexplanon, your doctor/midwife will ask you some questions about your and your immediate relatives’ health. Your doctor/midwife will also measure your blood pressure and, depending on your situation, may take other samples. When you use Nexplanon, your doctor/midwife may ask you to come back for a routine medical check-up sometime after you have been given Nexplanon. How often and what type of control will depend on your situation. Your doctor/midwife should palpate the implant at each check-up.
Contact your doctor/midwife as soon as possible
- if you notice any changes in your health, especially with regard to some of the things contained in this information (see also “Do not use Nexplanon” and “Warnings and precautions” also do not forget to mention if such conditions exist in your immediate family)
- if you notice possible signs of thrombosis such as severe pain or swelling in any of the legs, unexplained pain in the chest, shortness of breath, unusual cough, especially if you cough up blood
- if you suddenly have severe pain in the abdomen or if the skin becomes yellow
- if you feel a lump in your chest (see also “Cancer”)
- if you experience sudden and severe pain in the lower abdomen or abdomen
- if you experience unexpected or heavy abdominal bleeding
- if you will be immobile (eg bedridden) or have to undergo surgery (contact your doctor at least four weeks before)
- if you think you are pregnant
- if you cannot feel the implant when palpated after insertion or at any other time.
How to use Nexplanon
Tell your doctor/midwife if you are pregnant or think you may be pregnant before using Nexplanon (for example, if you have had unprotected sex during the current menstrual cycle).
How to use Nexplanon
Nexplanon should only be inserted and taken out by healthcare professionals who are well acquainted with the procedure described on the other side of the package leaflet. The healthcare staff will, in consultation with you, determine the best time for deposit. It depends on your situation (eg which contraceptive method you are using now). If you are not switching from another method of contraception to hormones, the deposit should be made on days 1-5 of your period to make sure you are not pregnant. If the implant is inserted after the fifth day after the start of the period, you should use a complementary method of contraception (eg a condom) for the first 7 days after insertion.
Before inserting or removing Nexplanon, your doctor/midwife will give you local anesthesia. Nexplanon is inserted directly under the skin on the inside of the non-dominant upper arm (the arm that you do not write with). A description of the procedure for inserting and removing Nexplanon can be found in section 6.
It must be possible to palpate the implant after insertion
At the end of the insertion procedure, your doctor/midwife will ask you to feel the implant by palpation (feel the implant under your skin). A properly inserted implant should be able to be felt clearly both by the healthcare professional and by yourself, and you should be able to feel both ends between the thumb and forefinger. One should be aware that palpation can not say with 100% certainty that Nexplanon is in place. If the implant cannot be felt immediately after insertion or at another time, it may be that the implant has not been inserted, that it has been inserted deeply, or that it has been moved from the insertion site.
It is therefore important to sometimes alpine the implant carefully to ensure placement. Contact a doctor/midwife immediately if you cannot feel the implant.
If in doubt, use a condom until the doctor/midwife and you are sure that the implant has been inserted. The doctor/midwife may need to use an X-ray, ultrasound, magnetic camera, or take a blood sample to make sure that the implant is on the inside of your arm. If the implant cannot be found in the arm after a thorough examination, the doctor/midwife can use X-rays or other methods on your chest. When a doctor/midwife has located an implant that cannot be felt through the skin, it must be removed.
Nexplanon should be taken out or replaced within 3 years of deposit.
Patient card
To help you remember when and where Nexplanon was inserted and when Nexplanon last had to be taken, your doctor/midwife will give you a patient card with this information. The patient card also contains instructions to sometimes palpate the implant carefully to ensure placement. Contact your doctor/midwife immediately if you cannot feel the implant. Keep the patient card in a safe place! Show the patient card to your doctor/midwife at visits related to the use of the implant.
If you want to continue with Nexplanon, a new implant can be inserted immediately after the removal of the old implant. The new implant can be inserted into the same arm and in the same place as the old implant as long as it is in the right place. Your doctor/midwife will give you advice.
When you want to stop using Nexplanon
You can ask your doctor/midwife to take Nexplanon at any time you want.
If you cannot feel the implant, your doctor/midwife may need to use an X-ray, ultrasound, or magnetic camera to locate it. Depending on the exact position of the implant, removal may be difficult and surgery may be necessary.
If you do not want to get pregnant after taking Nexplanon, ask your doctor/midwife for another reliable contraceptive.
If you stop taking Nexplanon because you want to get pregnant, it is generally advisable to wait until you have your first natural period before trying to conceive. It helps you calculate when the baby will be born.
Possible side effects
Like all medicines, Nexplanon can cause side effects, although not everybody gets them.
Menstrual bleeding may become more irregular when using Nexplanon. It can be just a little blood that does not even require a bandage or bleeding that is similar to sparse menstrual bleeding and you need menstrual protection. You may also not experience any bleeding at all. The irregular bleeding does not mean that the pregnancy protection with Nexplanon has decreased. In general, you do not need to do anything at all, but if the bleeding becomes heavy or prolonged, you should contact your doctor/midwife.
Serious side effects are described in the sections “Cancer” and “Thrombosis” in section 2. Read that section for further information and, if necessary, contact your doctor/midwife.
The following side effects have been reported:
| Very common (may affect more than 1 user in 10) | Common (may affect up to 1 in 10 people) | Uncommon (may affect up to 1 in 100 people) |
|---|---|---|
| acne, headache,weight gain, sore or painful breasts, irregular bleeding, vaginal infection | hair loss,dizziness,Depression,emotional lability,nervousness,decreased sexual desire,increased appetite,abdominal pain,nausea,gases,painful menstruation,weight loss,flu-like symptoms ,pain,extreme fatigue,hot flashes,pain at the site of the implant ,reaction at the site of the implant ,ovarian cysts | itching ,itching in the abdomen,rash,excessive hair growth,migraine ,anxiety,insomnia,somnolence,diarrhea,vomiting,constipation,urinary tract infection,vaginal discomfort (eg discharge),breast augmentation,exuding breasts,back hurts,fever,fluid retention,difficulty or pain when urinating,allergic reaction ,inflammation and pain in the throat,snuva,joint pain,muscle aches,skeletal pain |
In addition to these side effects, an increase in blood pressure has sometimes been observed. Oily skin has also been observed. You should contact a doctor immediately if you experience any symptoms of a severe allergic reaction, such as (i) swelling of the face, tongue, or throat; (ii) difficulty swallowing; or (iii) hives and difficulty breathing.
When you insert Nexplanon you can get a bruise (really in some cases), pain and itching, and in rare cases an infection. You can get a scar or an abscess at the deposit point. You can also get a feeling of numbness (or loss of emotion). Ejection or movement of the implant may occur, especially if it has not been inserted correctly. In rare cases, implants have been found in blood vessels, including vessels in the lungs, which may be associated with shortness of breath and/or coughing with or without bleeding. Implants may need to be surgically removed.
There have been reports of blood clots in a vein (so-called “venous thrombosis”) or an artery (so-called “arterial thrombosis”) in women using etonogestrel implants. A blood clot in a vein can block the vein and this can happen in the veins of the legs (deep vein thrombosis ), the lungs ( pulmonary embolism ), or other organs. A blood clot in an artery can block an artery and cause a heart attack or stroke.
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 label and carton after EXP.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
No special storage instructions.
Contents of the pack and other information
What Nexplanon contains
Each applicator contains an implant with
- the active substance etonogestrel (68 mg)
- The other ingredients are: ethylene vinyl acetate copolymer , barium sulphate and magnesium stearate.
What the medicine looks like and contents of the pack
Nexplanon is a subdermal, long-acting, hormonal contraceptive. It contains an X-ray-proof implant with only progestin in an innovative user-friendly disposable applicator that is ready to use. The yellowish-white implant, which is 4 cm long and 2 mm in diameter, contains etonogestrel and barium sulfate. The applicator is designed to facilitate insertion just under the skin on the inside of your (non-dominant) upper arm. The implants must be inserted and removed by healthcare professionals who know the technology. For the withdrawal to be uncomplicated, the implant must be inserted just under the skin (see the back of the package leaflet). Before inserting or removing implants, use local anesthesia. The risk of complications is small if you follow the instructions.
Pack sizes: carton with 1 blister pack, carton with 5 blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
This medicinal product is authorized under the European Economic Area under the names:
Belgium, Ireland, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, Germany, Austria: Implanon NXT
Denmark, Estonia, Finland, France, Iceland, Italy, Norway, Romania, Sweden, UK: Nexplanon