Contraceptive implant Side Effects

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Answer side-effect and tolerability questions around contraceptive implant, including expected changes, warning signs and safe escalation guidance.

Part of contraceptive implants side effects.

What is contraceptive implant?

Contraceptive-Implant contains the active ingredient Etonogestrel.

• Active ingredient — Etonogestrel
• Registration number — 34/18.8/0448
• Registration holder — Organon South Africa (Pty) Ltd

It is approved for:

• Implanon NXT is used to prevent pregnancy

Interactions and medicines to check

The approved leaflet names these interactions.

• Epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• Tuberculosis (e.g. rifampicin)
• HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz)
• Hepatitis C Virus infection (e.g. boceprevir, telaprevir)
• 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). Implanon 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 Implanon 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 Implanon NXT. If you are taking medicines or herbal products that might make Implanon NXT less effective, you and your doctor may decide to leave Implanon NXT in place; in that case, an additional non-hormonal contraceptive method should be used. Since the effect of another medicine on Implanon NXT may last up to 28 days after stopping the medicine, it is necessary to use the additional non-hormonal contraceptive for that long

Who should take extra care

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic to etonogestrel or any of the other ingredients of Implanon NXT. S4
• If you have or have had a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, for example in the legs (deep vein thrombosis) or the lungs (pulmonary embolism)
• If you have or have had jaundice (yellowing of the skin) or severe liver disease (when the liver is not functioning properly) or liver growth (liver cancer)
• If you have or have had, or if you may have cancer of the breast or of the genital organs
• If you have any unexplained vaginal bleeding
• If you are pregnant or think you might be pregnant. Implanon NXT does not protect against HIV infection (AIDS) or any other sexually transmitted disease. If any of these conditions appear for the first time while using Implanon NXT, tell your doctor or healthcare professional immediately

Use with care, and tell your doctor, if

• If you have or have had cancer of the breast
• If you have or have had a liver disease
• If you have ever had a thrombosis
• If you have diabetes
• If you are overweight
• If you have high cholesterol or triglycerides
• If you suffer from epilepsy
• If you suffer from tuberculosis (TB)
• If you have high blood pressure
• If 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 pill (“the Pill”). It is not known whether these observations are also applicable to women who use Implanon NXT. Breast cancer has been found more often in women using oral combined contraceptive pills. The increased occurrence of breast cancer becomes gradually less after stopping the oral combined contraceptive 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. Liver growths 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 (deep vein thrombosis), the lung (a lung embolus) or other organs. A blood clot in the 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. There have been reports of blood clot formation like lung emboli, deep vein thrombosis, heart attacks and strokes in women using etonogestrel implants such as Implanon NXT. If you notice suddenly possible signs of thrombosis, you should see your doctor immediately. Menstrual bleeding pattern changes Your menstrual bleeding pattern may change when using Implanon NXT. You may experience a change in frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or in duration. Absence of bleeding was reported in about 20 % of women while another 20 % of women reported frequent and/or prolonged bleeding. Occasionally heavy bleeding has been observed. Bleeding changes were the most common reason for stopping treatment (about 11 %). A changing bleeding pattern does not mean that Implanon 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 Implanon NXT may move from the original insertion site in the arm, if incorrectly inserted, or due to external forces (e.g. manipulation of (fiddling) with the implant or contact sport activities). Finding 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, and there is no evidence it has been expelled, contraception and the risk of progestogen-related undesirable effects may last longer than you want. In rare cases implants have also been found in the pulmonary artery (a blood vessel in the lung). 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. Ovarian cysts During the use of Implanon NXT, small fluid-filled sacs may develop in the ovaries
• These are called ovarian cysts. They usually disappear on their own but may cause mild abdominal pain or they may lead to more serious problems. Other conditions Broken or bent implant If the implant breaks or bends while in your arm, how the implant works may be affected. If you have questions, contact your healthcare professional. Using Implanon NXT with food and drink Food and drink have no influence on the action of Implanon NXT

Pregnancy and breastfeeding

• Implanon NXT must not be inserted when you are pregnant or think you may be pregnant
• If you are unsure whether you are pregnant or not, a pregnancy test should be done before starting using Implanon NXT
• Implanon NXT has been used in women breastfeeding their infants
• Please consult with your doctor, pharmacist or other healthcare professional for advice
• If you are pregnant or breastfeeding your baby please consult your doctor, pharmacist or other healthcare professional for advice before using Implanon NXT
• Driving and using machinery Do not drive or use any tools or machines if you feel tired or sleepy from the use of Implanon NXT

Common side effects of contraceptive implant

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Hair loss
• Dizziness
• Depressive moods
• Emotional lability
• Nervousness
• Decrease sexual drive
• Increase 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

Less frequent side effects

• 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
• Difficulty 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 been observed. Also, oily skin has been observed. During the insertion or removal of Implanon NXT, bruising, pain, swelling, itching or infection may occur. A scar may be formed or an abscess (boil) 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. Surgery might be necessary when removing the implant. In rare cases, implants have been reported to be found in a blood vessel, including a blood vessel in the lung. If any of the side effects gets serious, please tell your doctor or pharmacist. 6. STORAGE AND DISPOSING OF Implanon NXT Store at or below 30 °C. Store all medicines out of reach of children. Do not use Implanon NXT after the expiry date which is stated on the blister and carton. Implanon NXT should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 7. PRESENTATION OF Implanon NXT One pack contains one implant which is pre-loaded in the stainless steel of a ready-to-use, disposable sterile applicator. The applicator containing the implant is packed in a blister pack made of transparent polyethyleneterephtalate glycol (PETG) sealed with a lidding made of high density polyethylene (HDPE). 8. IDENTIFICATION OF Implanon NXT The pack contains a smooth and flexible rod of a white to slightly yellow or slightly brown colour, 4 cm in length and 2 mm in diameter, in the stainless steel needle of a ready-to-use disposable sterile applicator

Bleeding, cycle and hormonal changes

Changes to bleeding and to the menstrual cycle are among the most commonly reported experiences with hormonal contraception, and they are one of the main reasons people stop a method. Knowing what pattern to expect with contraceptive implant makes it easier to tell an expected change from one worth checking.

Bleeding patterns can include lighter or shorter periods, irregular spotting between periods, or periods stopping altogether. Which of these is expected depends on the method, and on how long it has been used.

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

What happens after stopping or changing the method?

What happens after stopping or changing contraceptive implant depends on the method. Some methods stop working as soon as they are removed or discontinued; others take longer to clear. This matters both for side effects and for whether you are still protected against pregnancy.

Contraceptive cover

If you are changing method, there is often a window where you need additional protection. Getting that timing right is the single most important part of switching — ask a pharmacist, nurse or doctor to confirm it for your specific change rather than working it out from a general description.

Side effects and cycle after stopping

Side effects linked to a hormonal method usually ease once the hormone clears, though the time this takes varies by method. Cycles may take several months to settle into their own pattern, and that pattern may not be the same as before the method was started.

When to contact a healthcare professional urgently

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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