Two-month contraceptive injection Side Effects

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

Part of contraceptive injections side effects.

What is two-month contraceptive injection?

Two-Month-Contraceptive-Injection contains the active ingredient Norethisterone enantate.

• Active ingredient — Norethisterone enantate
• Registration number — J/21.8.2/136
• Registration holder — Bayer (Pty) Ltd

It is approved for:

• NUR-ISTERATE is a hormonal contraceptive for intramuscular injection

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines used for the treatment of: o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), o tuberculosis (e.g. rifampicin, rifabutin)
• HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors), o fungal infections (griseofulvin, azole antifungals, e.g. fluconazole, itraconazole, ketoconazole, voriconazole), o bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin) o certain heart diseases, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem)
• the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods)
• grapefruit juice. NUR-ISTERATE may influence the effect of other medicines, e.g
• ciclosporin, Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Laboratory tests If you need a blood test or other laboratory test, tell your Healthcare Provider or the laboratory staff that you are using NUR-ISTERATE, because it can affect the results of some tests. NUR-ISTERATE with food and drink Not applicable

Who should take extra care

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are pregnant or think you might be pregnant
• If you are suffering from or have a history of a thromboembolic disorder in your veins. Thrombosis is the formation of a blood clot. This may occur for example in the blood vessels of the legs (deep vein thrombosis) and the lungs (pulmonary embolism). See also the section “NUR-ISTERATE and thrombosis”
• If you have or have had a severe arterial, including cardiovascular, disease such as heart attack, stroke or ischaemic heart disease (angina pectoris). See also the section “NUR-ISTERATE and thrombosis”
• If you suffer from increased blood pressure requiring treatment
• If you suffer or have suffered from a severe liver disease (as long as your liver function values have not returned to normal). Symptoms of a liver disease may be, for instance, yellowing of the skin and/or itching of the whole body
• If you have or have had a benign or malignant liver tumour
• If you suffer or have suffered from a malignant sex hormone-dependent tumour such as cancer of the breast or the genital organs
• If you have diabetes mellitus with blood vessel damage
• If you suffer from disturbances of your blood fat metabolism
• If you are allergic to any of the ingredients of NUR-ISTERATE
• If you have any unexplained vaginal bleeding
• If you have an inherited disease called porphyria. If any of these conditions appear for the first time while using NUR-ISTERATE, consult your Healthcare Provider because it may be necessary to discontinue NUR-ISTERATE. See also “General notes” in the next section

Use with care, and tell your doctor, if

• you smoke
• you have diabetes
• you are overweight
• you have had venous thromboembolism or anyone in your immediate family has had a thrombosis (venous thromboembolism in a sibling or a parent at a relatively early age)
• anyone in your immediate family has had breast cancer
• you have high blood pressure
• you suffer from migraine
• you have haemolytic uremic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys)
• you have liver or gallbladder disease
• you have experienced jaundice and/or itching all over your body during a pregnancy or during use of the Pill
• you have experienced a depression
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face)
• you have systemic lupus erythematosus (SLE; a disease affecting the skin all over the body)
• you have a neurological disease called Sydenham’s chorea
• you have had an extrauterine pregnancy (if the embryo had developed outside the womb) or an impairment of tube function (e.g. caused by inflammation of the tube). If any of the above conditions appear for the first time, recur, or worsen while using NUR- ISTERATE, you should contact your Healthcare Provider. NUR-ISTERATE and thrombosis Thrombosis is the formation of a blood clot which may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary embolism”. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are using NUR-ISTERATE. It can also happen if you become pregnant. It is generally recognized that the risk for venous thromboembolism increases for example with increasing age, if you are overweight, if you have had venous thromboembolism or if anyone in your immediate family has had a thrombosis (venous thromboembolism in a sibling or a parent at a relatively early age). The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilization (for example, when you have your leg or legs in plaster or splints). In women who use hormonal contraceptives such as NUR-ISTERATE the risk may be yet higher. Tell your Healthcare Provider well in advance (as soon as you get to know) of any expected hospitalization or surgery. Your Healthcare Provider may tell you that NUR-ISTERATE needs to be discontinued before surgery or at the time of immobilization. Your Healthcare Provider will also tell you when NUR-ISTERATE can be started again after you are back on your feet. The risk of thromboembolism is also increased shortly after childbirth. See also “After having a baby” (in the section “Starting NUR-ISTERATE”). Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). If you develop high blood pressure while using NUR-ISTERATE, you may be told to stop using it. If you notice possible signs of a thrombosis, consult your Healthcare Provider immediately. NUR-ISTERATE and cancer In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of hormonal contraceptives. These tumours may lead to internal bleeding. Contact your Healthcare Provider immediately if you have severe pain in your abdomen. NUR-ISTERATE and depression Some women using hormonal contraceptives including NUR-ISTERATE have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible. Reduced efficacy The efficacy of NUR-ISTERATE may be reduced in the event of e.g. prolonged injection intervals or concomitant medication. Reduced cycle control Menstrual bleeding Individually different cycle disturbances may occur during the treatment. In case of questions please ask your Healthcare Provider for advice before the start of the treatment. These disturbances are rarely a reason for the discontinuation of NUR-ISTERATE. In general, the cycle under NUR-ISTERATE does not change significantly in about 50 to 70 % of the women (bleeding intervals between 26 and 35 days, duration of bleeding 1 to 7 days). Procedure in the event of intermenstrual bleeding Intermenstrual bleeding of varying intensity may occur, particularly during the first few months. These disturbances need not concern you and do not impair the contraceptive reliability. Treatment is usually unnecessary and normally, NUR-ISTERATE does not need to be discontinued. However, you should inform your Healthcare Provider in any case because it may be necessary for him to rule out other potential causes. Absence of withdrawal bleeding Absence of the withdrawal bleeding occurred in 8 to 25 % of the women during clinical investigations. It was generally of short duration and disappeared again in the further course of treatment. The rate of missed bleedings did not increase with prolonged use. In any case, if no withdrawal bleeding has occurred within the preceding 10 weeks, contact your Healthcare Provider because pregnancy must be ruled out by means of a suitable test

Pregnancy and breastfeeding

• The administration of NUR-ISTERATE during pregnancy is contraindicated
• If pregnancy occurs during treatment, further injections must not be given
• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, please consult your doctor, pharmacist, or other healthcare provider for advice before using this medicine

Common side effects of two-month contraceptive injection

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

• uterine/vaginal bleeding including spotting (light bleeding from the vagina similar to, but lighter than, a period)
• short lasting absence of monthly bleeding (amenorrhoea)
• increased weight
• dizziness
• headache
• nausea
• skin disorder such as rashes
• injection site reaction

Less frequent side effects

• depressed mood

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 two-month contraceptive injection 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 two-month contraceptive injection 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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