What Contraceptive rod NXT is and what it is used for

Contraceptive rod NXT 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.

contraceptive rod NXT is used to prevent pregnancy.
How does contraceptive rod NXT work

The implant is inserted just below the skin. The active compound, etonogestrel, works in two ways:

  • It prevents the release of an egg cell from the ovaries.
  • It causes changes in the cervix that make it difficult for sperm to enter the womb.

As a result, contraceptive rod NXT protects you against pregnancy for a period of three years, but if you are overweight the doctor may advise you to replace the implant earlier. contraceptive rod NXT is one of several means of preventing pregnancy. Another frequently used birth control method is the combined Pill. In contrast to combined Pills, contraceptive rod NXT can be used by women who may not, or do not want to use estrogens. When you use contraceptive rod NXT you do not have to remember to take a pill every day. This is one of the reasons that contraceptive rod NXT is very reliable (over 99 % effective). If in rare cases the implant is not inserted correctly or is not inserted at all, you may not be protected against pregnancy. When you are using contraceptive rod NXT, your menstrual bleeding may change and become absent, irregular, infrequent, frequent, prolonged, or rarely heavy. The bleeding pattern that you experience during the first three months generally indicates your future bleeding pattern. Painful periods may improve.

You may stop using contraceptive rod NXT at any time (See also "When you want to stop using contraceptive rod NXT"). 2

What you need to know before you use contraceptive rod NXT

Hormonal contraceptives, also including contraceptive rod NXT, do not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Do not use contraceptive rod NXT

Do not use contraceptive rod NXT if you have any of the conditions listed below. If any of these conditions apply to you, tell your doctor before contraceptive rod NXT 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 contraceptive rod NXT, consult your doctor immediately.
Warnings and precautions

Talk to your doctor, pharmacist or nurse before using contraceptive rod NXT.

If contraceptive rod NXT 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 contraceptive rod NXT is inserted. Also if the condition develops or gets worse while you are using contraceptive rod NXT 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 3 breasts and you should contact your doctor if you feel any lump in your breasts. You should also tell your doctor if a close relative has or ever had breast cancer.

In rare cases, benign and even more rarely malignant liver tumours have been reported in women using the Pill. If you experience severe abdominal pain, you should contact your doctor immediately.

Thrombosis

A blood clot in a vein (known as a ‘venous thrombosis’) can block the vein. This can happen in veins in the leg, the lung (a lung embolus), or other organs. A blood clot in an artery (known as 'arterial thrombosis') can block the artery. For example, a blood clot in an artery may cause a heart attack, or in the brain may cause a stroke.

Using any combined hormonal contraceptive increases a woman’s risk of developing such clots compared with a woman not taking any combined hormonal contraceptive. The risk is not as high as the risk of developing a blood clot during pregnancy. The risk with progestagen-only methods like contraceptive rod NXT, 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 contraceptive rod NXT. 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 contraceptive rod NXT 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, if not correctly or too deeply inserted and/or due to external forces (e.g. manipulation of the implant or contact sports). In these cases localization of the implant may be more difficult and removal may require a larger incision. If the implant 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.

Ovarian cysts

During the use of all low-dose hormonal contraceptives, small fluid-filled sacs may develop in the ovaries. These are called ovarian cysts. They usually disappear on their own. Sometimes they cause mild abdominal pain. Only rarely, they may lead to more serious problems.

Broken or bent implant

If the implant breaks or bends while in your arm, how the implant works should not be affected. If you have questions contact your healthcare provider.

Other medicines and contraceptive rod NXT

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 contraceptive rod NXT 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)).
  • contraceptive rod NXT 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 contraceptive rod NXT, 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 contraceptive rod NXT. 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 contraceptive rod NXT 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 contraceptive rod NXT you should consult your doctor first.

    contraceptive rod NXT with food and drink

    There are no indications of any effect of food and drink on the use of contraceptive rod NXT.

    Pregnancy and breast-feeding

    You must not use contraceptive rod NXT 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 contraceptive rod NXT.

    contraceptive rod NXT may be used while you are breast-feeding. Although a small amount of the active substance of contraceptive rod NXT passes over into the breast milk, there is no effect on the production or the quality of breast milk, nor on the growth and development of the child.

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

    Driving and using machines

    There are no indications of any effect of the use of contraceptive rod NXT on alertness and concentration.

    When should you contact your doctor?
    Regular check-ups

    Before contraceptive rod NXT 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 contraceptive rod NXT, your healthcare professional may ask you to return for a (routine) medical check-up sometime after insertion of the implant. The frequency and nature of further check-ups will depend on your personal situation.

    Contact your doctor as soon as possible if: 5

    • you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also "Do not use contraceptive rod NXT" 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.
How to use Contraceptive rod NXT

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

contraceptive rod NXT 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 contraceptive rod NXT, your healthcare professional will give you a local anaesthetic. contraceptive rod NXT 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 contraceptive rod NXT is shown in section 6.

contraceptive rod NXT should be removed or replaced no more than three years after insertion.

To help you remember when and where contraceptive rod NXT was inserted, and when contraceptive rod NXT must be removed at the latest, your healthcare professional will give you a User Card that shows this information. Store the card in a safe place!

At the end of the insertion procedure, the healthcare professional will ask you to feel the implant by palpation. A correctly inserted implant should be clearly palpable by the healthcare professional as well as by you, certainly if both ends can be lifted between thumb and finger. It should be realized that palpation is not suitable for 100 % verification of the presence of the implant. In case of the slightest doubt you have to use a barrier method (e.g. a condom) until the healthcare professional and you are absolutely sure that the implant has been inserted. In rare cases the healthcare professional may have to use X-rays, ultrasound or magnetic resonance imaging, or may have to take a blood sample, to make sure that the implant is inside your arm.

In case you would like to have contraceptive rod NXT 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 contraceptive rod NXT 6

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 a little difficult and may require minor surgery.

If you do not want to become pregnant after removal of contraceptive rod NXT, ask your healthcare professional about other reliable methods of birth control.

If you stop using contraceptive rod NXT 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.

Possible side effects

Like all medicines, contraceptive rod NXT can cause side effects, although not everybody gets them.

Menstrual bleeding may occur at irregular intervals during the use of contraceptive rod NXT. 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 contraceptive rod NXT 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;Hair loss;Itching;
headache;dizziness;itching in the genital area;
increase in body weight;depressive moods;rash;
breasts tenderness and pain;emotional lability;excessive hair growth;
irregular bleeding;nervousness;migraine;
infection of the vagina. decreased sexual drive;anxiety;
increased appetite;sleeplessness;
abdominal pain;sleepiness;
nausea;diarrhoea;
gas in stomach and intestines;vomiting;
painful menstruation;constipation;
decrease in body weight;urinary tract infection;
influenza-like symptoms;vaginal discomfort (e.g. vaginal secretion);
pain;breast enlargement;
fatigue;breast secretion;
hot flushes;back pain;
implant site pain;fever;
implant site reaction;fluid retention;
ovarian cyst.difficult or painful urination;
allergic reactions;
inflammation and pain of the
Thinking about getting Contraceptive rod? Check with doctor.

Doctors at the Pakenham medical clinic expert on putting contraceptive rod and removing it. It is done under Local anaesthesia, takes few minute. which doesn’t hurt.

For removal also done under local anaesthesia, injected under the lower end of the rod. A small cut is made in the skin to remove it and bandage the arm.


Picture after inseration
contraceptive rod®

Contraceptive rod® is a small plastic rod, about the size of a matchstick, which is inserted just under the skin on the inside of a girl's upper arm. The rod slowly releases a female hormone called progesterone into the bloodstream over a period of three years. But contraceptive rod® won't protect you against sexually transmitted infections (STIs). It's a good idea that both partners have an STI test before having unprotected sex (sex without a condom), even if the girl has contraceptive rod®.

contraceptive rod® works in three ways:
  • Temporarily prevents ovulation (an egg from being released from the ovaries every month).
  • Temporarily thins the lining of the womb (uterus) to prevent a fertilised egg from attaching to it.
  • Thickens the discharge (juices) from the cervix to help prevent sperm from going into the womb (uterus).
When the rod is inserted correctly by a doctor, contraceptive rod® is 99%effective in preventing pregnancy.

Advantages:
  • Convenient - you don't have to remember to take anything.
  • Lasts for a long time - three years.
  • Effective.
  • Easily removed.
Disadvantages:
  • Does not protect against STIs - protection such as condoms must be used
  • The menstrual cycle is altered, causing irregular periods and spotting through the cycle.
Talk to us when wanted to have insertion done or removal done For more information on contraceptive rod, please visit: www.implanon-usa.com/